166 results on '"Nair, Gonasagrie"'
Search Results
2. Copper intrauterine device increases vaginal concentrations of inflammatory anaerobes and depletes lactobacilli compared to hormonal options in a randomized trial
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Brown, Bryan P., Feng, Colin, Tanko, Ramla F., Jaumdally, Shameem Z., Bunjun, Rubina, Dabee, Smritee, Happel, Anna-Ursula, Gasper, Melanie, Nyangahu, Donald D., Onono, Maricianah, Nair, Gonasagrie, Palanee-Phillips, Thesla, Scoville, Caitlin W., Heller, Kate, Baeten, Jared M., Bosinger, Steven E., Burgener, Adam, Passmore, Jo-Ann S., Heffron, Renee, and Jaspan, Heather B.
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- 2023
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3. Update on the Impact of Depot Medroxyprogesterone Acetate on Vaginal Mucosal Endpoints and Relevance to Sexually Transmitted Infections
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Dabee, Smritee, Balle, Christina, Onono, Maricianah, Innes, Steve, Nair, Gonasagrie, Palanee-Phillips, Thesla, Burgener, Adam D., Bosinger, Steven E., Passmore, Jo-Ann S., Heffron, Renee, Jaspan, Heather, and Happel, Anna-Ursula
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- 2023
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4. Prevalent human papillomavirus infection increases the risk of HIV acquisition in African women: advancing the argument for human papillomavirus immunization
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Liu, Gui, Mugo, Nelly R, Brown, Elizabeth R, Mgodi, Nyaradzo M, Chirenje, Zvavahera M, Marrazzo, Jeanne M, Winer, Rachel L, Mansoor, Leila, Palanee-Phillips, Thesla, Siva, Samantha S, Naidoo, Logashvari, Jeenarain, Nitesha, Gaffoor, Zakir, Nair, Gonasagrie L, Selepe, Pearl, Nakabiito, Clemensia, Mkhize, Baningi, Mirembe, Brenda Gati, Taljaard, Marthinette, Panchia, Ravindre, Baeten, Jared M, Balkus, Jennifer E, Hladik, Florian, Celum, Connie L, and Barnabas, Ruanne V
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Sexually Transmitted Infections ,Infectious Diseases ,Cancer ,Cervical Cancer ,Prevention ,Immunization ,HIV/AIDS ,Adolescent Sexual Activity ,Clinical Research ,HPV and/or Cervical Cancer Vaccines ,Vaccine Related ,Pediatric ,Prevention of disease and conditions ,and promotion of well-being ,3.4 Vaccines ,Infection ,Good Health and Well Being ,Adult ,Alphapapillomavirus ,Case-Control Studies ,Female ,HIV Infections ,Humans ,Papillomaviridae ,Papillomavirus Infections ,Papillomavirus Vaccines ,Prevalence ,Risk Factors ,Vaccination ,Young Adult ,adolescent girls and young women ,cervical cancer ,HIV acquisition ,human papillomavirus ,Biological Sciences ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Virology ,Biomedical and clinical sciences ,Health sciences - Abstract
ObjectiveVaccine-preventable human papillomavirus (HPV) infection is common, especially in sub-Saharan Africa where HIV risk is also high. However, unlike other sexually transmitted infections (STIs), HPV's role in HIV acquisition is unclear. We evaluated this relationship using data from MTN-003, a clinical trial of HIV chemoprophylaxis among cisgender women in sub-Saharan Africa.DesignA case-control study.MethodsWe matched 138 women who acquired HIV (cases) to 412 HIV-negative controls. Cervicovaginal swabs collected within 6 months before HIV seroconversion were tested for HPV DNA. We estimated the associations between carcinogenic (high-risk) and low-risk HPV types and types targeted by HPV vaccines and HIV acquisition, using conditional logistic regression models adjusted for time-varying sexual behaviors and other STIs.ResultsMean age was 23 (±4) years. Any, high-risk and low-risk HPV was detected in 84, 74 and 66% of cases, and 65, 55 and 48% of controls. Infection with at least two HPV types was common in cases (67%) and controls (49%), as was infection with nonavalent vaccine-targeted types (60 and 42%). HIV acquisition increased with any [adjusted odds ratio (aOR) 2.5, 95% confidence interval (95% CI) 1.3-4.7], high-risk (aOR 2.6, 95% CI 1.5-4.6) and low-risk (aOR 1.8, 95% CI 1.1-2.9) HPV. Each additional type detected increased HIV risk by 20% (aOR 1.2, 95% CI 1.1-1.4). HIV acquisition was associated with HPV types targeted by the nonavalent (aOR 2.1, 95% CI 1.3-3.6) and quadrivalent vaccines (aOR 1.9, 95% CI 1.1-3.2).ConclusionHPV infection is associated with HIV acquisition in sub-Saharan African women. In addition to preventing HPV-associated cancers, increasing HPV vaccination coverage could potentially reduce HIV incidence.
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- 2022
5. Post-randomization Differences in Condomless Vaginal Sex Among Women Randomized to Intramuscular Depot Medroxyprogesterone Acetate Injections, a Copper Intrauterine Device or a Levonorgestrel Implant in the ECHO Trial
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Deese, Jennifer, Chen, Pai Lien, Gao, Xiaoming, Heffron, Renee, Hobbs, Marcia, Lapple, Dana, Jaspan, Heather, Miller, Ashley, Nair, Gonasagrie, Onono, Maricianah, Palanee-Phillips, Thesla, Reddy, Krishnaveni, and Steiner, Markus J.
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- 2023
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6. Correlates of Dapivirine Vaginal Ring Acceptance among Women Participating in an Open Label Extension Trial
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Mirembe, Brenda Gati, Cabrera, Maria Valdez, van der Straten, Ariane, Nakalega, Rita, Cobbing, Mandy, Mgodi, Nyaradzo M., Palanee-Phillips, Thesla, Mayo, Ashley J., Dadabhai, Sufia, Mansoor, Leila E., Siva, Samantha, Nair, Gonasagrie, Chinula, Lameck, Akello, Carolyne A., Nakabiito, Clemensia, Soto-Torres, Lydia E., Baeten, Jared M., and Brown, Elizabeth R.
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- 2023
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7. Adherence, safety, and choice of the monthly dapivirine vaginal ring or oral emtricitabine plus tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis among African adolescent girls and young women: a randomised, open-label, crossover trial
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Nair, Gonasagrie, Celum, Connie, Szydlo, Daniel, Brown, Elizabeth R, Akello, Carolyne A, Nakalega, Rita, Macdonald, Pippa, Milan, Gakiema, Palanee-Phillips, Thesla, Reddy, Krishnaveni, Tahuringana, Eunice, Muhlanga, Felix, Nakabiito, Clemensia, Bekker, Linda-Gail, Siziba, Bekezela, Hillier, Sharon L, Baeten, Jared M, Garcia, Morgan, Johnson, Sherri, McClure, Tara, Levy, Lisa, Livant, Edward, Jacobson, Cindy, Soto-Torres, Lydia, van der Straten, Ariane, Hosek, Sybil, Rooney, James F, Steytler, John, Bunge, Katherine, Parikh, Urvi, Hendrix, Craig, Anderson, Peter, and Ngure, Kenneth
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- 2023
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8. Prevalence and Incidence of Sexually Transmitted Infection in Injectable Progestin Contraception Users in South Africa
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Noguchi, Lisa M, Marrazzo, Jeanne M, Richardson, Barbara, Hillier, Sharon L, Balkus, Jennifer E, Palanee-Phillips, Thesla, Nair, Gonasagrie, Panchia, Ravindre, Piper, Jeanna, Gomez, Kailazarid, Ramjee, Gita, and Chirenje, Z Mike
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Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Clinical Trials and Supportive Activities ,Sexually Transmitted Infections ,Prevention ,HIV/AIDS ,Infectious Diseases ,Infection ,Good Health and Well Being ,depot medroxyprogesterone acetate ,norethisterone enanthate ,chlamydia ,gonorrhea ,contraception ,trichomoniasis ,syphilis ,HSV-2 - Abstract
IntroductionWhether intramuscular depot medroxyprogesterone acetate (DMPA-IM) and norethisterone enanthate (NET-EN) have a differential impact on the incidence of sexually transmitted infection (STI) remains unclear. In the Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial, HIV-1 acquisition was higher for DMPA-IM users vs. NET-EN users. We compared DMPA-IM and NET-EN users with regard to chlamydia, gonorrhea, trichomoniasis, syphilis, and herpes simplex virus type 2 (HSV-2) infection.Materials and methodsProspective data were analyzed from VOICE, a randomized trial of HIV-1 chemoprophylaxis. Participants were evaluated annually and as indicated for chlamydia, gonorrhea, trichomoniasis, and syphilis. Stored specimens were tested for HSV-2. Proportional hazards models compared the risk of STI between DMPA-IM and NET-EN users.ResultsAmong 2,911 injectable contraception users in South Africa, 1,800 (61.8%) used DMPA-IM and 1,111 used NET-EN (38.2%). DMPA-IM and NET-EN users did not differ in baseline chlamydia: 15.1 vs. 14.3%, p= 0.54; gonorrhea: 3.4 vs. 3.7%, p= 0.70; trichomoniasis: 5.7 vs.5.0%, p= 0.40; or syphilis: 1.5 vs. 0.7%, p= 0.08; but differed for baseline HSV-2: (51.3 vs. 38.6%, p < 0.001). Four hundred forty-eight incident chlamydia, 103 gonorrhea, 150 trichomonas, 17 syphilis, and 48 HSV-2 infections were detected over 2,742, 2,742, 2,783, 2,945, and 756 person-years (py), respectively (chlamydia 16.3/100 py; gonorrhea 3.8/100 py; trichomoniasis 5.4/100 py; syphilis 0.6/100 py; HSV-2 6.4/100 py). Comparing DMPA-IM with NET-EN users, no difference was noted in the incidence of chlamydia, gonorrhea, trichomoniasis, syphilis, or HSV2 infections, including when adjusted for confounders [chlamydia (aHR 1.03, 95% CI 0.85-1.25), gonorrhea (aHR 0.88, 95% CI 0.60-1.31), trichomoniasis (aHR 1.07, 95% CI 0.74-1.54), syphilis (aHR 0.41, 95% CI 0.15-1.10), and HSV-2 (aHR 0.83, 95% CI 0.45-1.54, p= 0.56)].DiscussionAmong South African participants enrolled in VOICE, DMPA-IM and NETEN users differed in prevalence of HSV-2 at baseline but did not differ in the incidence of chlamydia, gonorrhea, trichomoniasis, syphilis, or HSV-2 infection. Differential HIV-1 acquisition, previously demonstrated in this cohort, does not appear to be explained by differential STI acquisition. However, the high incidence of multiple STIs reinforces the need to accelerate access to comprehensive sexual and reproductive health services.
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- 2021
9. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study
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Baeten, Jared M, Palanee-Phillips, Thesla, Mgodi, Nyaradzo M, Mayo, Ashley J, Szydlo, Daniel W, Ramjee, Gita, Mirembe, Brenda Gati, Mhlanga, Felix, Hunidzarira, Portia, Mansoor, Leila E, Siva, Samantha, Govender, Vaneshree, Makanani, Bonus, Naidoo, Logashvari, Singh, Nishanta, Nair, Gonasagrie, Chinula, Lameck, Parikh, Urvi M, Mellors, John W, Balán, Iván C, Ngure, Kenneth, van der Straten, Ariane, Scheckter, Rachel, Garcia, Morgan, Peda, Melissa, Patterson, Karen, Livant, Edward, Bunge, Katherine, Singh, Devika, Jacobson, Cindy, Jiao, Yuqing, Hendrix, Craig W, Chirenje, Zvavahera M, Nakabiito, Clemensia, Taha, Taha E, Jones, Judith, Torjesen, Kristine, Nel, Annalene, Rosenberg, Zeda, Soto-Torres, Lydia E, Hillier, Sharon L, Brown, Elizabeth R, Aanyu, Dorothy, Abima, John, Abullarade, Janne, Agarwal, Priyanka, Ahluwalia, Surabhi, Akasiima, Simon Africa, Akello, Carolyne Agwau, Albert, Samuel, Alphale, Motsamai, Alphonse, Calins, Apeduno, Lucy, Aranda, Sara, Aridor, Orly, Arnolds, Shakeera, Asiimwe, Prossy, Atujuna, Millicent, Atwebembere, Didas, Baboolall, Lakshmi, Badana, Kiran, Balamusani, David, Banda, Gabriel, Banda, Towera Whitney, Baugh, Jennifer, Baziira, James Amos, Beamer, May, Bebeza, Sivuyisiwe Asanda, Bekker, Linda-Gail, Bell, Ian, Bemer, Meagan, Berman, Richard, Berthiaume, Jennifer, Bezak, Linda, Bhagwandin, Yashveer, Bhayat, Hassen Anwar, Bhengu, Nokulunga, Bhengu, Sonto, Bhoola, Aruna, Biira, Florence Asiimwe, Bittoni, Daniel, Black, Roberta, Blose, Nombuso Jacqueline, Boks, Pearl, Bolton, Stephen Gordon, Botya, Phathiswa, Brown, Amanda, Brown, Elizabeth, Brown, Helen, Bruce, Robyn Helen, Bukenya, Luke Erismus, Bukirwa, Aidah, Bunts, Lisa, Buthelezi, Fezile, Buthelezi, Mbongeleni William, Buthelezi, Samkelisiwe Dumisile, and Byogero, Rose
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Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Prevention ,HIV/AIDS ,Mental Health ,Infectious Diseases ,Clinical Trials and Supportive Activities ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Infection ,Good Health and Well Being ,Administration ,Intravaginal ,Adult ,Anti-HIV Agents ,Contraceptive Devices ,Female ,Female ,HIV Infections ,HIV-1 ,Humans ,Malawi ,Patient Compliance ,Patient Safety ,Pyrimidines ,Seroconversion ,South Africa ,Tenofovir ,Treatment Outcome ,Uganda ,Zimbabwe ,MTN-025/HOPE Study Team ,Medical and Health Sciences ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundTwo phase 3 clinical trials showed that use of a monthly vaginal ring containing 25 mg dapivirine was well tolerated and reduced HIV-1 incidence in women by approximately 30% compared with placebo. We aimed to evaluate use and safety of the dapivirine vaginal ring (DVR) in open-label settings with high background rates of HIV-1 infection, an important step for future implementation.MethodsWe did a phase 3B open-label extension trial of the DVR (MTN-025/HIV Open-label Prevention Extension [HOPE]). Women who were HIV-1-negative and had participated in the MTN-020/ASPIRE phase 3 trial were offered 12 months of access to the DVR at 14 clinical research centres in Malawi, South Africa, Uganda, and Zimbabwe. At each visit (monthly for 3 months, then once every 3 months), women chose whether or not to accept the offer of the ring. Used, returned rings were tested for residual amounts of dapivirine as a surrogate marker for adherence. HIV-1 serological testing was done at each visit. Dapivirine amounts in returned rings and HIV-1 incidence were compared with data from the ASPIRE trial, and safety was assessed. This study is registered with ClinicalTrials.gov, NCT02858037.FindingsBetween July 16, 2016, and Oct 10, 2018, of 1756 women assessed for eligibility, 1456 were enrolled and participated in the study. Median age was 31 years (IQR 27-37). At baseline, 1342 (92·2%) women chose to take the DVR; ring acceptance was more than 79% at each visit up until 12 months and 936 (73·2%) of 1279 chose to take the ring at all visits. 12 530 (89·3%) of 14 034 returned rings had residual dapivirine amounts consistent with some use during the previous month (>0·9 mg released) and the mean dapivirine amount released was greater than in the ASPIRE trial (by 0·21 mg; p
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- 2021
10. Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities.
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Reddy, Krishnaveni, Kelly, Cliff, Brown, Elizabeth R, Jeenarain, Nitesha, Naidoo, Logashvari, Siva, Samantha, Bekker, Linda-Gail, Nair, Gonasagrie, Makanani, Bonus, Chinula, Lameck, Mgodi, Nyaradzo, Chirenje, Zvavahera, Kiweewa, Flavia Matovu, Marrazzo, Jeanne, Bunge, Katherine, Soto-Torres, Lydia, Piper, Jeanna, Baeten, Jared M, and Palanee-Phillips, Thesla
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Trials and Supportive Activities ,Topical Microbicides ,Prevention ,Clinical Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adult ,Anti-HIV Agents ,Contraceptive Devices ,Female ,Double-Blind Method ,Female ,HIV Infections ,HIV Seropositivity ,HIV-1 ,Humans ,Pyrimidines ,Vagina ,Young Adult ,cytology ,dapivirine ,preexposure prophylaxis ,vaginal ring ,MTN-020/ASPIRE and MTN-003/VOICE Study Teams ,Biological Sciences ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Virology ,Biomedical and clinical sciences ,Health sciences - Abstract
ObjectiveWe aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer) was associated with the development of cervical cytology abnormalities.DesignSecondary analysis comparing cervical cytology results between two randomized controlled microbicide trials (MTN-020/ASPIRE and MTN-003/VOICE).MethodsData from ASPIRE, a phase III, placebo-controlled trial of the dapivirine vaginal ring, were used in this analysis. Cervical cytology smears were evaluated at baseline and at the final visit with product use. We compared cytology results between women randomized to dapivirine versus placebo vaginal ring. We further assessed for the effect of the vaginal ring device on cervical cytology by comparing results with data from the oral placebo arm of VOICE, a prior HIV-1 prevention trial conducted in a similar population.ResultsCervical cytology results for 2394 women from ASPIRE (1197 per study arm) were used in this analysis; median time between baseline and final visit with product use was 22.1 months. Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6 versus 91.5%, ASC-US//LSIL: 7.8 versus 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7 versus 1.1%, P = 0.44. Cytology data from VOICE had findings (normal: 87.8%, ASC-US/LSIL: 9.8%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 2.4%) comparable with that of both dapivirine (P = 0.93) and placebo vaginal ring arms (P = 0.24).ConclusionThese findings indicate that neither use of the dapivirine vaginal ring nor the vaginal ring device alone, over a period of 2 years, is associated with development of cervical cytology abnormalities that could lead to precancerous or cancerous lesions.
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- 2020
11. Social harms in female-initiated HIV prevention method research: state of the evidence.
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Montgomery, Elizabeth T, Roberts, Sarah T, Nel, Annalene, Malherbe, Mariette, Torjesen, Kristine, Bunge, Katherine, Singh, Devika, Baeten, Jared M, Marrazzo, Jeanne, Chirenje, Z Mike, Kabwigu, Samuel, Beigi, Richard, Riddler, Sharon A, Gaffour, Zakir, Reddy, Krishnaveni, Mansoor, Leila E, Nair, Gonasagrie, Woeber, Kusbashni, Moodley, Jayajothi, Jeenarain, Nitesha, Siva, Samantha, Naidoo, Logashvari, Govender, Vaneshree, and Palanee-Phillips, Thesla
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Biomedical and Clinical Sciences ,Health Services and Systems ,Public Health ,Health Sciences ,Clinical Sciences ,Topical Microbicides ,Behavioral and Social Science ,HIV/AIDS ,Prevention ,Clinical Research ,Infectious Diseases ,Mental Health ,Patient Safety ,Clinical Trials and Supportive Activities ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Infection ,Good Health and Well Being ,Africa South of the Sahara ,Anti-HIV Agents ,Double-Blind Method ,Ethics ,Research ,Female ,HIV Infections ,Humans ,Intimate Partner Violence ,Male ,Patient Participation ,Prospective Studies ,Safety ,Vaginal Creams ,Foams ,and Jellies ,Africa ,HIV ,microbicide ,social harms ,women ,Biological Sciences ,Medical and Health Sciences ,Psychology and Cognitive Sciences ,Virology ,Biomedical and clinical sciences ,Health sciences - Abstract
ObjectivesAssessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for 'social harms', generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts.MethodsSecondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.ResultsSocial harms reporting was low across the largest and most recent microbicide studies. Social harm incidence per 100 person-years ranged from 1.10 (95% CI 0.78-1.52) to 3.25 (95% CI 2.83-3.74) in the phased trials. Reporting differed by dosing mechanism (e.g. vaginal gel, oral tablet, ring) and study, most likely as a function of measurement differences. Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.ConclusionMeasurement and screening for social harms is an important component of conducting ethical research of novel HIV prevention methods. To date, social harm incidence reported in microbicide trials has been relatively low (
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- 2019
12. Ethics and governance challenges related to genomic data sharing in southern Africa: the case of SARS-CoV-2
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Moodley, Keymanthri, Cengiz, Nezerith, Domingo, Aneeka, Nair, Gonasagrie, Obasa, Adetayo Emmanuel, Lessells, Richard John, and de Oliveira, Tulio
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- 2022
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13. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study
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Aanyu, Dorothy, Abima, John, Abullarade, Janne, Agarwal, Priyanka, Ahluwalia, Surabhi, Akasiima, Simon Africa, Akello, Carolyne Agwau, Albert, Samuel, Alphale, Motsamai, Alphonse, Calins, Apeduno, Lucy, Aranda, Sara, Aridor, Orly, Arnolds, Shakeera, Asiimwe, Prossy, Atujuna, Millicent, Atwebembere, Didas, Baboolall, Lakshmi, Badana, Kiran, Baeten, Jared M., Balamusani, David, Balán, Iván C., Banda, Gabriel, Banda, Towera Whitney, Baugh, Jennifer, Baziira, James Amos, Beamer, May, Bebeza, Sivuyisiwe Asanda, Bekker, Linda-Gail, Bell, Ian, Bemer, Meagan, Berman, Richard, Berthiaume, Jennifer, Bezak, Linda, Bhagwandin, Yashveer, Bhayat, Hassen Anwar, Bhengu, Nokulunga, Bhengu, Sonto, Bhoola, Aruna, Biira, Florence Asiimwe, Bittoni, Daniel, Black, Roberta, Blose, Nombuso Jacqueline, Boks, Pearl, Bolton, Stephen Gordon, Botya, Phathiswa, Brown, Amanda, Brown, Elizabeth, Brown, Helen, Bruce, Robyn Helen, Bukenya, Luke Erismus, Bukirwa, Aidah, Bunge, Katherine, Bunts, Lisa, Buthelezi, Fezile, Buthelezi, Mbongeleni William, Buthelezi, Samkelisiwe Dumisile, Byogero, Rose, Byroo, Samiksha, Byuma, Robert, Carstens, Johanna Albertha, Carter, Allison, Cassim, Nazneen, Cebekhulu, Busisiwe, Cele, Bongekile, Cele, Dolly Judith, Cele, Phindile, Cele, Simangele, Cele, Sithabile, Chadza, Mary, Chakhtoura, Nahida, Chapdu, Claire, Chareka, Gift Tafadzwa, Chasakara, Charles, Chatani-Gada, Manju, Chetty, Diana, Chidanyika, Mary, Chifambi, Tafadzwa Tariro Lisa, Chihota, Emelder, Chikono, Sungano, Chikonyora, Anesu, Chikukwa, Brett Dzidzai, Chin, Craig, Chindevu, Mary, Chinula, Lameck, Chinyanda, Tendai Blessing, Chirenda, Thandiwe Hilda, Chirenje, Zvavahera Mike, Chirisa, Chiedza, Chisale, Patience, Chishanga, Angela, Chitambo, Tobias, Chitema, Fred, Chithila, Flora, Chitowa, Tinei Helen, Chitsinde, Catherine, Chitsulo, Gladys, Chitukuta, Miria, Chiveso, Spiwe, Chome, Nelecy, Chonco, Phumelele Fortune, Christopher, Emily, Chunderduri, Kerusha, Cibi, Vutomi, Cleland, Naana, Coba, Thobeka, Cobbing, Mandy Rae, Collins, Clare, Comer, Kim, Cozzi, Shameen, Crida, Danielle, Dadabhai, Sufia, Daki, Thembakazi, Danster, Nwabisa, Dassaye, Reshmi, David, Renita, Davis, Jontraye M., Dawood, Sumaya, Deb, Pallabi, Degnam, Leslie, Derrick, Tiffany Sharron, Devlin, Bríd Teresa, Dezzutti, Charlene, Dhlakama, Patricia Mae, Dias, Lorna, Dimairo, Jean Chivoniso, Dinnie, Elaine, Dlabanta, Avile, Dladla, Msizi, Dladla, Thandeka Immaculate, Dlungele, Andile Princess, Dolezal, Curtis, Donaty, Kristine, Dott, Clare, Dubbs, Jenna, Dubula-Majola, Vuyiseka, Dukwe, Pamella, Duma, Cebo Ivan, Duma, Portia Ignatia Makhosazana, Duma, Promise, Duncan, Vimbai Kudzanai, Duran, Luis, Dyabeni, Lindelwa, Edwards, Andrew, Etikala, Radhika, Etima, Juliane, Fairlie, Lee, Fischer, Henry, Fitzpatrick, Jacqueline, Fleurs, Llewellyn, Fowler, Mary Glenn, Freeman, Lester, Gaffoor, Zakir, Gama, Lizzy, Garcia, Morgan, Garg, Anita, Gatsi, Vanesa Margret, Gcwensa, Clifford, Gebashe, Emmanuel Lwandile, Geduld, Samantha, Gelant, Jennipher, Germuga, Donna, Ggita, Joseph, Giguere, Rebecca, Godo, Lucy, Goetz, B. Jay, Gogo, Litha, Goliati, Esther, Gondwe, Daniel Kondwani, Gordon, Kelley C., Goreraza, Rodney, Gounden, Jayandree, Govender, Dhevium, Govender, Justin Sivalingum, Govender, Nerusha, Govender, Subramonien, Govender, Vaneshree, Gqwara, Nonkululeko Nosipho, Gravelle, Anisa (Tracy), Guga, Phindile, Guma, Victor, Gumede, Delisile Zilungile, Gumede, Sibusiso, Gumede, Thembelihle, Gumede, Thobeka Winifred, Gundani, Orgrah, Gunnam, Ravi, Gupta, Rahul, Gwande, Mirriam, Gxako, Xolani, Hall, Kim, Hall, Wayne, Hargrave, Perry, Harkoo, Ishana, Harrell, Tanya, Heaps, Amy L., Hendricks, Simone Lara, Hendrix, Craig W., Hlabisa, Bongeka, Hlabisa, Lungile Bongeka, Hlahla, Kudzai, Hlela, Thulebona Martin, Hobongwana, Thandiwe, Horn, Eva, Howard, Ridley, Huang, Haixiao, Hunidzairia, Portia, Hurbans, Nivriti, Husnik, Marla, Hwehwe, Tendai Doreen, Imamdin, Rabia, Ismail, Amina, Jacobs, Ebrahiema, Jacobson, Cindy, Jacques, Ashleigh Catherine, Jamabya, Jane, James, Grace, Janse van Rensburg, Karla, Jaya, Ziningi Nobuhle, Jeenarain, Nitesha, Jennings, Lauren, Jiang, Haoping, Jiang, Ning, Jiao, Yuqing, Jijana, Nwabisa Laurianne, Jokoniya, Godfrey, Jones, Judith, Kabasonga, Mildred, Kabenge, Daniel Kizza, Kabwigu, Samuel, Kachale, Evans, Kachenjera, Lonely, Kachingamire, Fiona, Kachipapa, Emma, Kadiwa, Mary, Kadyamusuma, McLoddy, Kafufu, Bosco, Kagwa, Mary Mukasa, Kajura-Manyindo, Clare, Kakayi, Brenda Catherine, Kaliwo, Victoria, Kalonji, Dishiki Jenny, Kamanga, Nyasha Elizabeth, Kamira, Betty, Kampangire, Zerif, Kamwana, Getrude, Kamya, Justine, Kapa, La-Donna, Karugaba, Patrick, Kasambara, Khumbo, Kassim, Priya, Kassim, Sheetal, Katana, Milly, Katongole, Francis, Katongole, Sulaiman, Katsis, Alexis, Katumbi, Chaplain, Katz, Ariana W.K., Kawanje, Edmore, Kawuma, Caroline Nassozi, Kayongo, Sowedi, Kekana, Emily, Kemigisha, Doreen, Khanyile, Siphosihle, Khanyisile, Nombuso Happiness, Khaya, Babalwa, Khiya, Noluthando, Khoza, Norah Ntombikayise, Khumalo, Thembisile, Khwela, Christina, Khwela, Zamo, Kibiribiri, Edith, Kibirige, Ismael, Kiiza, Beatrice, Kikonyogo, Florence Sempa, Kin, Melissa, Kirkwood, Catherine, Kistnasami, Girisha, Kiweewa, Flavia Matovu, Kiweewa, Max, Konatham, Deepika, Kubheka, Lungile, Kufakunesu, Terrence, Kumwenda, Phaleda, Kumwenda, Wiza Wisdom Isaac, Kush, Maura, Kutner, Bryan A., Kwatsha, Ntomboxolo, Kwedza, Rosper, Kyomukama, Erinah, Lands, Debra, Langa, Phumelele Nokuthula, Lebeta, Kalkidan, Lentz, Cody, Leremi, Brendley Tebogo, Leszczewski, Michelle, Levy, Lisa, Livant, Edward, Livant, Ted, Lukas, Irene, Mabanga, Lungile Pearl, Mabaso, Nomusa, Machisa, Vimbainashe, Maddox, Toni M., Madlala, Bernadette, Magobiane, Nocwaka, Magolela, Melda, Maguramhinga, Fungai, Magwaza, Phumzile Desiree, Maharaj, Keshnee, Mahed, Ferial, Mahlase, Tankiso Vuyiswa, Maila, Moshukutjoane Lebogang, Makala, Yvonne, Makamure, Patrick, Makanani, Bonus, Makgoka, Kgabo Phineas, Makhamba, Pamela, Makhanya, Nompumelelo, Makondo, Rulani, Makoni, Rujeko, Makooka, Henry, Makunganya, Jennie, Makwenda, Sibongile, Malan, Gakiema, Malemia, Agnes, Malherbe, Mariette, Malunga, Faith, Mamba Nhassengo, Temantfulini, Mampa, Mogau, Mamvura, Tendai Karen, Manengamambo, Elmah, Mangove, Loreen Zandile, Mangxilana, Nomvuyo Thelma, Manjera, Tsungai Patience, Mans, Winifred Elizabeth, Mansoor, Leila, Maoko, Memory, Mapfunde, Annie, Maphumulo, Nonhlanhla Yvonne, Martinson, Francis E.A., Maruwo, Abel, Marx, Emmerentia Yvonne, Marzinke, Mark A., Masango, Moira, Mashego, Mmathabo Nnana, Mashinini, Gwendoline Thotele Refilwe, Masuko, Shingirayi Irene, Matambanadzo, Kudzai Viviana, Mathebula, Florence Tintswalo, Mathipa, Matheus, Matsa, Jacob Munyaradzi, Matta, Eleanor Agnes, Matubu, Allen Taguma, Mavundla, Ayanda Comfort, Mavundla, Sandile, Mawindo, Billy, Mayani, Josiah, Mayanja, Emmanuel, Mayekiso, Nombongo, Mayisela, Nonkululeko Precious, Mayo, Ashley J., Mbabali, Mary Speciosa, Mbanjwa, Nonhlakanipho Masibonge Gciniwe, Mbatha, Constance Seanokeng, Mbatha, Nomcedo Janice, Mbewe, Dorica, Mbichila, Tinkhani, Mbilizi, Yamikani Rose, Mbokazi, Sithokoza, Mbwerera, Mwandifitsa, Mchunu, Zethu, McKinstry, Laura, Mdlongwa, Bongiwe, Mellors, John W., Meyiwa, Sihle Perfect, Mgodi, Nyaradzo Mavis, Mhizha, Erasmus Samuel, Mhlanga, Felix, Mhlanga, Nomsa Sibongile, Mirembe, Brenda Gail, Mirembe, Dorothy, Mkandawire, Fumbani, Mkhabela, Ntombizethu Hazel, Mkhize, Baningi, Mkhize, Princess Hlengiwe, Mkhize, Zaba, Mlangeni, Elizabeth Gugu, Mlingo, Margaret, Mngqebisa, Bukiwe, Mngxekeza, Noluxolo, Mninzi, Anele, Mnqonywa, Nonzwakazi, Mogkoro, Mammekwa, Mogodiri, Thembisile Wilmah, Mohuba, Rebone Frengelina, Mokoena, Maseponki Cecilia, Mona, Noxolo, Montoya, Deidra, Monyethabeng, Willie, Moodley, Jayajothi, Moodley, Jeeva, Moodley, Kerushini, Moonsamy, Suri, Morar, Neetha Shagan, Morudu, Sophie Nomsa, Mpekula, Angela, Mphisa, Gerald Thsepo, Mpofu, Jayne, Mposula, Hlengiwe Theodora, Mqadi, Avril, Msiska, Emmie, Msumba, Lusungu, Mtambo, Nana, Mthalane, Emmanuel Sinothi, Mthembu, Thabisile Susan, Mthethi, Zanoxolo, Mthethwa, Magdeline Judith, Mthethwa, Ntokozo Zabathethwa, Mthimkhulu, Sicelo Samuel, Mtlokoa, Itsepheng, Mubiru, Michael Charles, Mudavanhu, Mary, Mufumisi, Anna Zvirevo, Mugagga, Agnes Mary, Muganga, Joanita, Mugava, Michelle, Mugenyi, Margaret, Mugocha, Caroline, Mugodhi, Faith, Mugwagwa, Norma, Muhlanga, Felix Godwin Sivhukile, Mukaka, Shorai, Mukasa, Dick, Mukasa, Restituta, Mukatipa, Mathews, Mukova, Shedina, Mulebeke, Sarah, Mulima, Joyce, Muller, Julio, Mulumba, Faith, Mupamombe, Tsitsi, Murandu, Constance, Murefu, Tarisai, Murewa, Fungai, Muringayi, Kudakwashe, Murombedzi, Caroline, Musara, Petina, Musisi, Jane Nsubuga, Musisi, Mary Maria, Musoke, Philippa, Mutebo, Joseph, Mutero, Prisca, Mutiti, Kudzai Santana, Mutizira, Shadreck, Mutsvunguma, Sharon, Muungani, Netsai, Muvunzi, Tariro, Muwawu, Rosemary, Mvelase, Samkelisiwe, Mvinjelwa, Priscilla Pamela, Mvuyane, Goodness Zoh, Mwafulirwa, Liness, Mwagomba, Pokiwe, Mwakhwawa, Thoko Gift, Mwebaza, Deborah, Mwenda, Wezi Longwe, Myeni, Nqobile, Mzolo, Angeline Doreen Nonhlanhla, Nabatanzi, Regina Bukenya, Nabisere, Joselyne, Nabukeera, Josephine, Nagawa, Christine Valerie, Naicker, Cherise, Naicker, Kumari, Naicker, Vimla, Naidoo, Ishana, Naidoo, Jason, Naidoo, Jayganthie, Naidoo, Kalendri, Naidoo, Logashvari, Naidoo, Renissa, Naidoo, Sandy, Naidu, Nalini, Nair, Gonasagrie Lulu, Nakabiito, Clemensia, Nakacwa, Susan, Nakakande, Joyce Gladys, Nakalega, Rita, Nakalema, Maria Gorreti, Nakibuka, Jesca, Nakyanzi, Teopista, Nakyeyune, Justine, Nalusiba, Stella, Namakula, Rhoda, Namalueso, Felix, Namayanja, Paula Mubiru, Nampala, Christine Tapuwa, Nampiira, Suzan Nkalubo, Namuddu, Agnes, Nandundu, Norah, Nansamba, Winnie, Nanyonga, Stella, Nanziri, Sophie Clare, Nassoma, Zainab Nakivumbi, Ncube, Duduzile Ethel, Ncube, Eva, Ncube, Sithabile, Ndadziyira, Pepukayi, Ndamase, Pamella Pumla, Nderecha, Walter Seth Taurayi, Ndhlovu-Forde, Zanele, Ndimande, Thembelihle Cynthia, Ndlovu, Bukekile, Ndlovu, Grecenia, Ndlovu, James, Ndlovu, Nontokozo Happiness, Ndlovu, Thakisile Nontokozo, Ndlovu, Zodwa, Ndovie, Margret, Nel, Annalene, Nemasango, Beauty, Neradilek, Blazej, Ngani, Susan, Ngcebethsha, Nokwanda Queeneth, Ngcobela, Lizbon, Ngcobo, Nolwazi, Ngcobo, Nompumelelo, Ngcobo, Sindisiwe Promise, Ngcukana, Nidleka, Ngo, Julie, Ngqabe, Nontshukumo, Ngqame, Siyabonga, Ngubane, Mduduzi Dawood, Ngure, Kenneth, Ngwenya, Nancy Nokuthula, Nhkoma, Mugowe, Nhlapho, Bongiwe Ntombizodwa, Nhleko, Sibusiso, Nkwanyana, Hlengiwe, Noble, Heather, Nobula, Lumka Lucia, Nolan, Monica, Nompondwana, Mluleki, Notshokovu, Busiwe, Ntanzi, Vukani Sandile, Nursaye, Nishi, Nutall, Jeremy Peter, Nyabadza, Omega, Nyaka, Evelesi, Nyakudya, Sandra, Nyakura, Envioletta Chiedza, Nyamadzawo, Shingayi, Nyamuzihwa, Tsitsi, Nyanzi, Zubayiri, Nyathi, Angel Tinny, Nyirenda, Fadire, Nyirenda, Makandwe, Nyirenda, Mary, Nzama, Sinqobile Charity, Nzuza, Lamec Sbongisomi, O'Byrne, Bhavesha, Okello, Fabian, Okumu, Eunice, Oluka, Emmanuel, Onen, Francis, Onyango, Carolyne Peris, Ostbye, Katherine, Padayachee, Kerusha, Palanee-Phillips, Thesla, Palichina, Victor, Pan, Zhenyu, Pappajohn, Colin, Paramanund, Levanya, Parikh, Urvi M., Patterson, Karen, Pearce, Nazmie, Peda, Melissa, Penrose, Kerri J., Phahlamohlaka, Bathandekile Molly, Phidane, Nokulunga Ruth, Pillay, Omisha, Premrajh, Anamika, Prosad, Nikita, Rabe, Lorna, Rajman, Alishka, Ramjee, Gita, Rampai, Keneoe Maphuti, Rampyapedi, Hlalifi Sylvia, Randhawa, April, Rasmeni, Sabelo, Rausch, Dianne, Reddy, Avanita, Reddy, Isayum, Reddy, Jerusha, Reddy, Krishnaveni, Rees, Vera Helen, Repetto, Andrea, Richards, Cheryl, Riddler, Sharon, Rini, Nobubele, Roeber, Brendon, Rohan, Lisa, Romer, Zachary, Rose, Matthew, Rosenberg, Zeda Fran, Rossi, Lisa, Ruch, Aviva, Rullo, Christine, Runeyi, Sinazo, Rupemba, Olivia, Rushwaya, Chenai, Russell, Marisa, Ruzive, Patience Sharai, Rwanzogyera, Godfrey, Saava, Margaret Nakato, Sagela, Tshepo Jimmy, Sakwa, Rebecca, Sayed, Fathima, Scheckter, Rachel, Schille, Jennifer, Scotch, Nokwayintombi, Scott, William, Scoville, Caitlin, Sebagala, Richard, Sebastian, Elaine, Sedze, Natasha Tina, Seedat, Nasreen Hoosen, Semakula, Joseph, Senn, Teri, Serugo, Francis, Seyama, Linly, Shabalala, Bhekanani Khumulani, Shangase, Charlotte Phumzile, Shanhinga, Pamela Caroline, Shaver, Jeremy, Shen, Hanjie, Shogole, Mogobalale Corlett, Shonhiwa, Rachel, Shozi, Claudia, Sibanda, Marvelous, Sibeko, Sylvia Sibongile, Sibisi, Ncamisile Teressa, Sibisi, Samuel Siphelele, Sibiya, Brighty Zweni, Sibiya, Happiness, Sichali, Dorothy, Sikosana, Phumzile Yvonne, Silva, Craig, Simelane, Ayanda Purity, Simon, Melissa, Sing, Triesha, Singh, Devika, Singh, Nishanta, Sithole, Hailey Virginia, Sitima, Edith, Siva, Samantha, Siyasiya, Alex, Sizane, Vuyane, Siziba, Bekezela, Slezinger, Edward, Smolinski, Daria, Snapinn, Katie, Sogoni, Olwethu, Soko, Dean, Solai, Leonard Nichiren, Somga, Mandiphumle, Song, Mei, Song, Xiaoling, Soobryan, Devarani, Soto-Torres, Lydia, Spence, Patrick Lawrence, Spooner, Elizabeth, Sseguya, Vincent, Ssentongo, Augustine, Ssenyonga, Mark, Sseremba, Lawrence Lollian, Stais, Michael, Steytler, John, Stockton, Sharon, Stofel, Julie, Stuurman, Tinyiko Reginah, Sukazi, Sizakele, Sukdao, Jasmin Lynn, Swarna, Kranthi, Szydlo, Daniel, Tagliaferri Rael, Christine, Taguta, Dorothy Rumbidzai, Taha, Taha, Tahuringana, Eunice, Tamale, Joshua, Tambama, Penelope, Taulo, Edna, Taulo, Frank, Tauya, Thelma Tonderai, Tegha, Gerald, Tembe, Sindisiwe Lucia, Tembo, Tchangani, Thatelo, Constance Lebo, Thobela, Pinky Mery, Thom, Annie, Thompson, Christine, Thompson, Monica, Thusi, Linda, Tock, Lauri, Tofile, Thandokazi, Torjesen, Kristine, Tranfaglia, Carol, Tseng, Jenny, Tshabalala, Themba, Tshongoyi, Nomvuselelo, Tsidya, Mercy, Tsikiwa, Wendy Rufaro, Tuswa-Haynes, NoCamagu, Tutshana, Bomkazi Onini, Twala, Andile Premrose, Udith, Ashvir Viren, Unten, Christine, van der Straten, Ariane, van Niekerk, Neliette, Varela, Amanda, Vatsha, Nangamso, Vijayendran, Gayathri, Vuma, Amukelani California, Wabwire, Deo Ogema, Walani, Madalo, Wanda, Bhekisisa, Wasberg, Lisa, White, Rhonda R., Windle, Kathleen Marie, Woeber, Kubashni, Wright, Danica, Wright, Tiffanee, Xaba, Thembalethu Nontokozo, Yambira, Makanaka Jean Savie, Yola, Ntando, Zaca, Sindisiwe Lydia, Zalwango, Aisha, Zemanek, Jullian, Zimba, Chifundo, Zinyengere, Tsitsi, Zinyongo, Margaret, Zondi, Thabile Goodness, Zou, Chun, Zuma, Jabulisile, Zungu, Nokuthula Princess, Zungu, Nompumelelo, Baeten, Jared M, Mgodi, Nyaradzo M, Mayo, Ashley J, Szydlo, Daniel W, Gati Mirembe, Brenda, Hunidzarira, Portia, Mansoor, Leila E, Nair, Gonasagrie, Parikh, Urvi M, Mellors, John W, Balán, Iván C, Hendrix, Craig W, Chirenje, Zvavahera M, Taha, Taha E, Rosenberg, Zeda, Soto-Torres, Lydia E, Hillier, Sharon L, and Brown, Elizabeth R
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- 2021
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14. Complex decisions: correlates of injectable contraceptive discontinuation following HIV-1 seroconversion in an HIV prevention trial
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Caplan, Margaret R, Landovitz, Raphael J, Palanee-Phillips, Thesla, Nair, Gonasagrie, Mhlanga, Felix, Balkus, Jennifer E, Riddler, Sharon A, and Gorbach, Pamina M
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Public Health ,Health Sciences ,HIV/AIDS ,Behavioral and Social Science ,Clinical Research ,Contraception/Reproduction ,Infectious Diseases ,Prevention ,Reproductive health and childbirth ,Infection ,Good Health and Well Being ,Adult ,Contraception ,Contraception Behavior ,Contraceptive Agents ,Female ,Family Planning Services ,Female ,HIV Infections ,HIV Seropositivity ,HIV-1 ,Humans ,Incidence ,Infectious Disease Transmission ,Vertical ,Injections ,Pregnancy ,Seroconversion ,South Africa ,Uganda ,Zimbabwe ,Injectable ,female contraception ,HIV infection ,Africa ,seroconversion ,Public Health and Health Services ,Psychology ,Public health ,Sociology ,Clinical and health psychology - Abstract
Contraceptive adherence during acute and recent HIV-1 infection is important to maternal and child health given the elevated risk of vertical HIV-1 transmission and additional complications of pregnancy. Injectable contraception (IC) is the most common non-barrier modern contraception method used in sub-Saharan Africa (SSA). Adherence to IC after HIV-1 seroconversion is not well understood. We examined factors associated with IC discontinuation among women in SSA diagnosed with HIV-1 infection while participating in a clinical trial of biomedical HIV-1 prevention. After diagnosis with HIV-1 infection in the VOICE trial, 255 women from South Africa, Uganda, and Zimbabwe enrolled in a longitudinal observational study (MTN-015). Contraceptive method was assessed at MTN-015 baseline and at 3, 12, and 24 months post-seroconversion. Correlates of IC discontinuation were examined by Cox proportional hazard modeling. IC use was reported at baseline by 78% of women enrolled (198/255), of which 92% (182/198) completed at least one follow-up visit. Two-thirds of women (66%, 121/182) continued on IC during the follow-up period (median 24 months). Lower rates of IC discontinuation were observed in women who reported having had at least one child (HR 0.39, 95% CI 0.20-0.82) or earning a personal income (HR 0.51, 95% CI 0.30-0.87) at baseline. These findings suggest that many women with HIV-1 infection face complex decision-making regarding family planning in the years that follow seroconversion and highlight that some women may discontinue IC use despite on-site provision of family planning services. Understanding the broader context of family planning choices in recently seroconverted women may be key to more effective linkages between family planning services and HIV-1 testing and care.
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- 2019
15. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial
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Asmelash, Aida, Sehurutshi, Alice, Baguma, Allan, Marais, Anita, Kawoozo, Barbarah, Malinga, Bongiwe Prudence, Mirembe, Brenda Gati, Okech, Brenda, Esterhuizen, Bryan, Murombedzi, Caroline, Gadama, Daphne, Hwengwere, Eldinah, Roos, Elizabeth, Magada, Elizabeth S, Shava, Emily, Piwowar-Manning, Estelle, Tahuringana, Eunice, Muhlanga, Felix GS, Conradie, Francesca, Angira, Frank, Nanyonjo, Gertrude, Kistnasami, Girisha, Mvula, Hazzie, Naidoo, Ishana, Horak, Jaco, Jere, Jane, Moodley, Jeeva, Shin, Katie, Nel, Kerry, Bokoch, Kevin, Birungi, Lilian, Emel, Lynda, Monametsi, Maletsatsi, Sibanda, Marvelous, Mutambanengwe, Mercy, Chitukuta, Miria, Matimbira, Moleen, Bhondai-Mhuri, Muchaneta, Sibisi, Ncamsile, Morar, Neetha, Mudzonga, Netsai, Natureeba, Paul, Richardson, Paul, Musara, Petina, Macdonald, Pippa, Nkambule, Rejoice, Mosime, Repelang, White, Rhonda, Berhanu, Ribka, Ncube-Sihlongonyane, Ritha, Sekabira, Rogers, Siva, Samantha, Pillay, Saresha, Govender, Shamelle, Bamweyana, Sheiala, Nzimande, Siyabonga, Innes, Steve, Dadabhai, Sufia, Samandari, Taraz, Tembo, Tchangani, Lungu Mabedi, Thandie, Chirenda, Thandiwe, Chidemo, Tinashe, Mudhune, Victor, Naidoo, Vikesh, Samaneka, Wadzanai, Agyei, Yaw, Musodza, Yeukai, Fourie, Yolandie, Gaffoor, Zakir, Delany-Moretlwe, Sinead, Hughes, James P, Bock, Peter, Ouma, Samuel Gurrion, Hunidzarira, Portia, Kalonji, Dishiki, Kayange, Noel, Makhema, Joseph, Mandima, Patricia, Mathew, Carrie, Spooner, Elizabeth, Mpendo, Juliet, Mukwekwerere, Pamela, Mgodi, Nyaradzo, Ntege, Patricia Nahirya, Nair, Gonasagrie, Nakabiito, Clemensia, Nuwagaba-Biribonwoha, Harriet, Panchia, Ravindre, Singh, Nishanta, Siziba, Bekezela, Farrior, Jennifer, Rose, Scott, Anderson, Peter L, Eshleman, Susan H, Marzinke, Mark A, Hendrix, Craig W, Beigel-Orme, Stephanie, Hosek, Sybil, Tolley, Elizabeth, Sista, Nirupama, Adeyeye, Adeola, Rooney, James F, Rinehart, Alex, Spreen, William R, Smith, Kimberly, Hanscom, Brett, Cohen, Myron S, and Hosseinipour, Mina C
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- 2022
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16. Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study
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Gichangi, Peter B, Heller, Kate B, Mbandazayo, Nomthandazo, Morrison, Charles S, Nanda, Kavita, Scoville, Caitlin W, Shears, Kathleen, Steyn, Petrus S, Taylor, Douglas, Thomas, Katherine K, Kiarie, James, Justman, Jessica, Nhlabatsi, Zelda, Bekker, Linda-Gail, Nair, Gonasagrie, Hofmeyr, G Justus, Singata-Madliki, Mandisa, Selepe, Raesibe Agnes Pearl, Sibiya, Sydney, Phiri Kasaro, Margaret, Stringer, Jeffrey, Mugo, Nelly R, Donnell, Deborah, Beesham, Ivana, Welch, Julia D, Heffron, Renee, Pleaner, Melanie, Kidoguchi, Lara, Palanee-Phillips, Thesla, Ahmed, Khatija, Baron, Deborah, Bukusi, Elizabeth A, Louw, Cheryl, Mastro, Timothy D, Smit, Jennifer, Batting, Joanne R, Malahleha, Mookho, Bailey, Veronique C, Beksinska, Mags, Rees, Helen, and Baeten, Jared M
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- 2021
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17. Weight change among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: Findings from a randomised, multicentre, open-label trial
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Beksinska, Mags, Issema, Rodal, Beesham, Ivana, Lalbahadur, Tharnija, Thomas, Katherine, Morrison, Charles, Hofmeyr, G.Justus, Steyn, Petrus S., Mugo, Nelly, Palanee-Phillips, Thesla, Ahmed, Khatija, Nair, Gonasagrie, Baeten, Jared M., and Smit, Jenni
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- 2021
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18. Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial
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Chirenje, Zvavahera Mike, Gundacker, Holly M, Richardson, Barbra, Rabe, Lorna, Gaffoor, Zakir, Nair, Gonasagrie, Mirembe, Brenda Gati, Piper, Jeanna M, Hillier, Sharon, and Marrazzo, Jeanne
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Public Health ,Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Infectious Diseases ,Rare Diseases ,Clinical Trials and Supportive Activities ,Sexually Transmitted Infections ,Prevention ,Clinical Research ,2.4 Surveillance and distribution ,Aetiology ,Infection ,Good Health and Well Being ,Adolescent ,Adult ,Africa South of the Sahara ,Chemoprevention ,Condoms ,Female ,Follow-Up Studies ,HIV Infections ,Humans ,Incidence ,Prospective Studies ,Risk Factors ,Risk Reduction Behavior ,Sexually Transmitted Diseases ,Uganda ,Young Adult ,Zimbabwe ,Biological Sciences ,Medical and Health Sciences ,Clinical sciences ,Epidemiology ,Public health - Abstract
BackgroundIn sub-Saharan Africa, there are limited data on the incidence of sexually transmitted infections (STIs) among women, largely because routine screening for asymptomatic infection is not performed. We conducted a secondary analysis to measure STI incidence rates and determine risk factors for new STI acquisition among women enrolled in the VOICE trial.MethodsWe analyzed data from 4843 women screened for chlamydia, gonorrhoea, syphilis, and trichomonas infection at baseline, annually, at interim visits when clinically indicated and at their study termination visit. Risk reduction counseling and condoms were provided throughout the trial.ResultsTwenty percent of evaluable participants had one or more curable STIs at baseline. Over 5660 person-years at risk (PYAR) of observation, incidence rates were 13.8% (95% confidence interval [CI], 12.7-14.8) PYAR for chlamydia, 3.5% (95% CI, 3.0-4.1) PYAR gonorrhea, 0.1% (95% CI, 0.6-1.1) PYAR syphilis, and 6.6% (95% CI, 5.8-7.2) PYAR trichomoniasis. South African sites had the highest incidence of chlamydia. The Uganda site had the highest incidence of gonorrhoea and syphilis, and Zimbabwe the lowest incidence overall. The majority of these cases were diagnosed at a routine scheduled testing visit. In multivariate analysis, positive baseline STI, younger than 25 years, being unmarried, and some alcohol consumption were associated with acquiring a new STI.ConclusionsWe observed high rates of STIs during follow up among women in the VOICE study. Women living in human immunodeficiency virus endemic countries should be screened for common STIs.
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- 2017
19. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women
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Baeten, Jared M, Palanee-Phillips, Thesla, Brown, Elizabeth R, Schwartz, Katie, Soto-Torres, Lydia E, Govender, Vaneshree, Mgodi, Nyaradzo M, Matovu Kiweewa, Flavia, Nair, Gonasagrie, Mhlanga, Felix, Siva, Samantha, Bekker, Linda-Gail, Jeenarain, Nitesha, Gaffoor, Zakir, Martinson, Francis, Makanani, Bonus, Pather, Arendevi, Naidoo, Logashvari, Husnik, Marla, Richardson, Barbra A, Parikh, Urvi M, Mellors, John W, Marzinke, Mark A, Hendrix, Craig W, van der Straten, Ariane, Ramjee, Gita, Chirenje, Zvavahera M, Nakabiito, Clemensia, Taha, Taha E, Jones, Judith, Mayo, Ashley, Scheckter, Rachel, Berthiaume, Jennifer, Livant, Edward, Jacobson, Cindy, Ndase, Patrick, White, Rhonda, Patterson, Karen, Germuga, Donna, Galaska, Beth, Bunge, Katherine, Singh, Devika, Szydlo, Daniel W, Montgomery, Elizabeth T, Mensch, Barbara S, Torjesen, Kristine, Grossman, Cynthia I, Chakhtoura, Nahida, Nel, Annalene, Rosenberg, Zeda, McGowan, Ian, and Hillier, Sharon
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Reproductive Medicine ,Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Pediatric ,HIV/AIDS ,Clinical Trials and Supportive Activities ,Infectious Diseases ,Prevention ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Reproductive health and childbirth ,Infection ,Adolescent ,Adult ,Africa ,Southern ,Age Factors ,Double-Blind Method ,Drug Resistance ,Viral ,Female ,HIV Infections ,HIV-1 ,Humans ,Incidence ,Middle Aged ,Patient Compliance ,Pyrimidines ,Reverse Transcriptase Inhibitors ,Vagina ,Young Adult ,MTN-020–ASPIRE Study Team ,Medical and Health Sciences ,General & Internal Medicine ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundAntiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection.MethodsWe conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe.ResultsAmong the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0.046) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P=0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P
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- 2016
20. Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial
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Browne, Erica N., Brown, Elizabeth R., Palanee-Phillips, Thesla, Reddy, Krishnaveni, Naidoo, Logashvari, Jeenarain, Nitesha, Nair, Gonasagrie, Husnik, Marla J., Singh, Devika, Scheckter, Rachel, Soto-Torres, Lydia, Baeten, Jared M., and van der Straten, Ariane
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- 2022
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21. Digital tools for youth health promotion: principles, policies and practices in sub-Saharan Africa.
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Ferretti, Agata, Adjei, Kwame K, Ali, Joseph, Atuire, Caesar, Ayuk, Betrand Tambe, Banougnin, Boladé Hamed, Cengiz, Nezerith, Gichoya, Judy, Jjingo, Daudi, Juma, Damian Omari, Kotze, Wiaan, Krubiner, Carleigh, Littler, Katherine, McCradden, Melissa D, Moodley, Keymanthri, Naidoo, Meshandren, Nair, Gonasagrie, Obeng-Kyereh, Kingsley, Oliver, Kedebone, and Ralefala, Dimpho
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SAFETY ,AUTONOMY (Psychology) ,HUMAN services programs ,DIGITAL health ,HEALTH policy ,RESPONSIBILITY ,ADULT education workshops ,HEALTH promotion ,HEALTH equity - Abstract
Although digital health promotion (DHP) technologies for young people are increasingly available in low- and middle-income countries (LMICs), there has been insufficient research investigating whether existing ethical and policy frameworks are adequate to address the challenges and promote the technological opportunities in these settings. In an effort to fill this gap and as part of a larger research project, in November 2022, we conducted a workshop in Cape Town, South Africa, entitled 'Unlocking the Potential of Digital Health Promotion for Young People in Low- and Middle-Income Countries'. The workshop brought together 25 experts from the areas of digital health ethics, youth health and engagement, health policy and promotion and technology development, predominantly from sub-Saharan Africa (SSA), to explore their views on the ethics and governance and potential policy pathways of DHP for young people in LMICs. Using the World Café method, participants contributed their views on (i) the advantages and barriers associated with DHP for youth in LMICs, (ii) the availability and relevance of ethical and regulatory frameworks for DHP and (iii) the translation of ethical principles into policies and implementation practices required by these policies, within the context of SSA. Our thematic analysis of the ensuing discussion revealed a willingness to foster such technologies if they prove safe, do not exacerbate inequalities, put youth at the center and are subject to appropriate oversight. In addition, our work has led to the potential translation of fundamental ethical principles into the form of a policy roadmap for ethically aligned DHP for youth in SSA. [ABSTRACT FROM AUTHOR]
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- 2024
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22. An Empiric HIV Risk Scoring Tool to Predict HIV-1 Acquisition in African Women
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Balkus, Jennifer E, Brown, Elizabeth, Palanee, Thesla, Nair, Gonasagrie, Gafoor, Zakir, Zhang, Jingyang, Richardson, Barbra A, Chirenje, Zvavahera M, Marrazzo, Jeanne M, and Baeten, Jared M
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Public Health ,Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Infectious Diseases ,HIV/AIDS ,Clinical Research ,Prevention ,Behavioral and Social Science ,4.2 Evaluation of markers and technologies ,Detection ,screening and diagnosis ,Infection ,Good Health and Well Being ,Adult ,Africa ,Empirical Research ,Female ,HIV Infections ,HIV-1 ,Humans ,Incidence ,Male ,Predictive Value of Tests ,Randomized Controlled Trials as Topic ,Risk Assessment ,Risk Factors ,Sexual Partners ,HIV-1 acquisition ,African women ,clinical prediction rules ,AIDS ,risk score ,Public Health and Health Services ,Virology ,Clinical sciences ,Epidemiology ,Public health - Abstract
ObjectiveTo develop and validate an HIV risk assessment tool to predict HIV acquisition among African women.DesignData were analyzed from 3 randomized trials of biomedical HIV prevention interventions among African women (VOICE, HPTN 035, and FEM-PrEP).MethodsWe implemented standard methods for the development of clinical prediction rules to generate a risk-scoring tool to predict HIV acquisition over the course of 1 year. Performance of the score was assessed through internal and external validations.ResultsThe final risk score resulting from multivariable modeling included age, married/living with a partner, partner provides financial or material support, partner has other partners, alcohol use, detection of a curable sexually transmitted infection, and herpes simplex virus 2 serostatus. Point values for each factor ranged from 0 to 2, with a maximum possible total score of 11. Scores ≥5 were associated with HIV incidence >5 per 100 person-years and identified 91% of incident HIV infections from among only 64% of women. The area under the curve (AUC) for predictive ability of the score was 0.71 (95% confidence interval [CI]: 0.68 to 0.74), indicating good predictive ability. Risk score performance was generally similar with internal cross-validation (AUC = 0.69; 95% CI: 0.66 to 0.73) and external validation in HPTN 035 (AUC = 0.70; 95% CI: 0.65 to 0.75) and FEM-PrEP (AUC = 0.58; 95% CI: 0.51 to 0.65).ConclusionsA discrete set of characteristics that can be easily assessed in clinical and research settings was predictive of HIV acquisition over 1 year. The use of a validated risk score could improve efficiency of recruitment into HIV prevention research and inform scale-up of HIV prevention strategies in women at highest risk.
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- 2016
23. Stakeholders' experiences of ethical challenges in cluster randomized trials in a limited resource setting: a qualitative analysis.
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Mtande, Tiwonge K, Lombard, Carl, Nair, Gonasagrie, and Rennie, Stuart
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CLUSTER randomized controlled trials ,INTEGRITY ,MEDICAL personnel ,PUBLIC health ethics ,DUTY ,MIDDLE-income countries ,DATA management - Abstract
Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design. [ABSTRACT FROM AUTHOR]
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- 2024
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24. Acquisition of Sexually Transmitted Infections among Women Using a Variety of Contraceptive Options: A prospective Study among High-risk African Women
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Kiweewa, Flavia Matovu, Brown, Elizabeth, Mishra, Anu, Nair, Gonasagrie, Palanee-Phillips, Thesla, Mgodi, Nyaradzo, Nakabiito, Clemensia, Chakhtoura, Nahida, Hillier, Sharon L., and Baeten, Jared M.
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Sexually transmitted diseases -- Patient outcomes ,HIV infections -- Risk factors ,Disease susceptibility -- Analysis ,Medical research ,Contraceptives -- Usage ,Health - Abstract
Introduction: In many African settings, women concurrently face substantial risk of human immunodeficiency virus type 1 (HIV-1) infection, sexually transmitted infections (STIs) and unintended pregnancies. Few studies have evaluated STI risk among users of hormonal implants and copper intrauterine devices (IUDs) although these long-acting reversible contraceptive methods are being promoted widely because of their benefits. Within a prospective study of women at risk for HIV-1, we compared the risk of acquisition of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis among women using different contraceptive methods. Methods: MTN-020/ASPIRE was a randomized trial of the dapivirine vaginal ring for HIV-1 prevention among 2629 women aged 18 to 45 years from Malawi, South Africa, Uganda and Zimbabwe, of whom 2264 used copper IUDs or progestin-based injectables or implants during follow-up. Screening for the above STIs occurred semi-annually. Results: Over 3440 person-years of follow-up, 408 cases of C. trachomatis (incidence 11.86/100 person-years), 196 of N. gonorrhoeae (5.70/100 person-years) and 213 cases of T. vaginalis (6.19/100 person-years) were detected. C. trachomatis and N. gonorrhoeae incidence were not significantly different across contraceptive methods. T. vaginalis incidence was significantly higher for copper IUD users compared to depot medroxyprogesterone acetate (DMPA), implant and norethisterone enanthate users. Conclusion: Among African women at high HIV-1 risk, STIs were common. Risk of cervical infections did not differ across contraceptive methods. Significantly higher rates of T. vaginalis were observed among progestin-based methods compared to copper IUD users. Overall, these findings call for more intensive routine screening for STIs, and they support current World Health Organization guidance that women should have a wide range of contraceptive options. Keywords: hormonal contraception; sexually transmitted diseases; chlamydia; gonorrhoea; trichomoniasis, 1 | INTRODUCTION The World Health Organization (WHO) estimates that 357 million adults acquire one of four curable sexually transmitted infections (STIs: Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum and Trichomonas [...]
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- 2019
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25. Risk of HIV-1 acquisition among South African women using a variety of contraceptive methods in a prospective study
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Palanee-Phillips, Thesla, Brown, Elizabeth R., Szydlo, Daniel, Matovu Kiweewa, Flavia, Pather, Arendevi, Harkoo, Ishana, Nair, Gonasagrie, Soto-Torres, Lydia, Hillier, Sharon L., and Baeten, Jared M.
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- 2019
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26. Baseline preferences for oral pre-exposure prophylaxis (PrEP) or dapivirine intravaginal ring for HIV prevention among adolescent girls and young women in South Africa, Uganda and Zimbabwe (MTN-034/IPM-045 study).
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Ngure, Kenneth, Friedland, Barbara A., Szydlo, Daniel W., Roberts, Sarah T., Garcia, Morgan, Levy, Lisa, Akello, Carolyne A., Reddy, Krishnaveni, Palanee-Phillips, Thesla, Macdonald, Pippa, Siziba, Bekezela, Soto-Torres, Lydia, Hosek, Sybil, Hillier, Sharon L., Nair, Gonasagrie, Celum, Connie, and van der Straten, Ariane
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TEENAGE girls ,HIV prevention ,YOUNG women ,PRE-exposure prophylaxis ,SEXUALLY transmitted diseases ,HIV - Abstract
Introduction: Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation. Methods: AGYW aged 16–21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to summarize demographic and behavioral data while multinomial analysis was used to determine predictors of stated product preference (ring or oral PrEP). Results: Of the 247 AGYW enrolled in REACH, 34% were aged 16–17 and 89% had a primary partner.The median age of sexual debut was 16 years and 40% had ever been pregnant. At screening, 35% of participants were diagnosed with a sexually transmitted infection (STI), 39% had an AUDIT-C score associated with harmful drinking and 11% reported intimate partner violence in the past 6 months. Overall, 28% of participants, had CESD-10 scores suggestive of depressive symptoms (≥12) in the past week. At baseline, similar proportions stated a preference for the ring and oral PrEP (38.1% and 40.5% respectively), with 19% of participants stating they preferred both products equally. Only study site was significantly associated with product preference (P<0.05) with AGYW from Johannesburg having higher odds of preferring the ring and those from Kampala having higher odds of preferring both options equally. Conclusions: We successfully enrolled African AGYW with a clear unmet need for HIV prevention. The balanced preference between the two products suggests that multiple biomedical prevention options may be appealing to this age group and could address their prevention needs. [ABSTRACT FROM AUTHOR]
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- 2023
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27. Impact of Partner-Related Social Harms on Womenʼs Adherence to the Dapivirine Vaginal Ring During a Phase III Trial
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Palanee-Phillips, Thesla, Roberts, Sarah T., Reddy, Krishnaveni, Govender, Vaneshree, Naidoo, Logashvari, Siva, Samantha, Gafoor, Zakir, Pather, Arendevi, Matovu, Flavia, Hlahla, Kudzai, Makanani, Bonus, Nair, Gonasagrie, Schwartz, Katie, Torjesen, Kristine, Brown, Elizabeth, Soto-Torres, Lydia, Baeten, Jared, and Montgomery, Elizabeth T.
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- 2018
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28. Risk of HIV-1 acquisition among women who use different types of injectable progestin contraception in South Africa: a prospective cohort study
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Noguchi, Lisa M, Richardson, Barbra A, Baeten, Jared M, Hillier, Sharon L, Balkus, Jennifer E, Chirenje, Z Mike, Bunge, Katherine, Ramjee, Gita, Nair, Gonasagrie, Palanee-Phillips, Thesla, Selepe, Pearl, van der Straten, Ariane, Parikh, Urvi M, Gomez, Kailazarid, Piper, Jeanna M, Watts, D Heather, and Marrazzo, Jeanne M
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- 2015
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29. Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial
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Beesham, Ivana, Welch, Julia D., Heffron, Renee, Pleaner, Melanie, Kidoguchi, Lara, Palanee?Phillips, Thesla, Ahmed, Khatija, Baron, Deborah, Bukusi, Elizabeth A., Louw, Cheryl, Mastro, Timothy D., Smit, Jennifer, Batting, Joanne R., Malahleha, Mookho, Bailey, Veronique C., Beksinska, Mags, Donnell, Deborah, Baeten, Jared M., Kiarie, James, Mugo, Nelly R., Rees, Helen, Justman, Jessica, Nhlabatsi, Zelda, Onono, Maricianah, Bekker, Linda?Gail, Nair, Gonasagrie, Hofmeyr, G Justus, Singata?Madliki, Mandisa, Sibiya, Sydney, Stringer, Jeffrey, Gichangi, Peter B., Heller, Kate B., Mbandazayo, Nomthandazo, Morrison, Charles S., Nanda, Kavita, Scoville, Caitlin W., Shears, Kathleen, Steyn, Petrus S., Taylor, Douglas, Thomas, Katherine K., Selepe, Raesibe Agnes Pearl, and Kasaro, Margaret Phiri
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Women -- Health aspects ,Antiviral agents -- Dosage and administration ,Sexually transmitted diseases -- Prevention ,Oral contraceptives -- Usage -- Health aspects ,HIV infection -- Risk factors -- Prevention ,Health - Abstract
: Introduction: Global guidelines emphasize the ethical obligation of investigators to help participants in HIV‐endpoint trials reduce HIV risk by offering an optimal HIV prevention package. Oral pre‐exposure prophylaxis (PrEP) has increasingly become part of state‐of‐the‐art HIV prevention. Here we describe the process of integrating oral PrEP delivery into the HIV prevention package of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial. Methods: ECHO was an open‐label randomized clinical trial that compared HIV incidence among women randomized to one of three effective contraceptives. In total, 7830 women aged 16 to 35 years from 12 sites in four African countries (Eswatini, Kenya, South Africa and Zambia) were enrolled and followed for 12 to 18 months, from 2015 to 2018. Part‐way through the course of the trial, oral PrEP was provided to study participants either off‐site via referral or on site via trained trial staff. PrEP uptake was compared between different contraceptive users using Chi‐squared tests or t‐tests. HIV seroincidence rates were compared between participants who never versus ever initiated PrEP using exact Poisson regression. Results: PrEP access in ECHO began through public availability in Kenya in May 2017 and was available at all sites by June 2018. When PrEP became available, 3626 (46.3%) eligible women were still in follow‐up in the study, and of these, 622 (17.2%) initiated PrEP. Women initiating PrEP were slightly older; more likely to be unmarried, not living with their partner, having multiple partners; and less likely to be earning their own income and receiving financial support from partners (all p < 0.05). PrEP initiation did not differ across study randomized groups (p = 0.7). Two‐thirds of PrEP users were continuing PrEP at study exit. Conclusions: There is a need for improved HIV prevention services in clinical trials with HIV endpoints, especially trials among African women. PrEP as a component of a comprehensive HIV prevention package provided to women in a large clinical trial is practical and feasible. Provision of PrEP within clinical trials with HIV outcomes should be standard of prevention., Introduction Within the context of clinical trials in which incident HIV infection is a primary study outcome, global guidelines emphasize an ethical imperative to assist participants reduce HIV risk by [...]
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- 2020
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30. Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial
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Husnik, Marla J., Brown, Elizabeth R., Marzinke, Mark, Livant, Edward, Palanee-Phillips, Thesla, Hendrix, Craig W., Matovu Kiweewa, Flavia, Nair, Gonasagrie, Soto-Torres, Lydia E., Schwartz, Katie, Hillier, Sharon L., and Baeten, Jared M.
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- 2017
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31. Ethics and regulatory complexities posed by a pragmatic clinical trial: a case study from Lilongwe, Malawi.
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Mtande, Tiwonge Kumwenda, Nair, Gonasagrie, and Rennie, Stuart
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- 2022
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32. The Effect of Contraception on Genital Cytokines in Women Randomized to Copper Intrauterine Device, Depot Medroxyprogesterone Acetate, or Levonorgestrel Implant.
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Tanko, Ramla F, Bunjun, Rubina, Dabee, Smritee, Jaumdally, Shameem Z, Onono, Maricianah, Nair, Gonasagrie, Palanee-Phillips, Thesla, Harryparsad, Rushil, Happel, Anna Ursula, Gamieldien, Hoyam, Qumbelo, Yamkela, Sinkala, Musalula, Scoville, Caitlin W, Heller, Kate, Baeten, Jared M, Bosinger, Steven E, Burgener, Adam, Heffron, Renee, Jaspan, Heather B, and Passmore, Jo Ann S
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HIV infections ,CONTRACEPTION ,CYTOKINES ,RESEARCH ,MEDROXYPROGESTERONE ,GENITALIA ,INTRAUTERINE contraceptives ,EVALUATION research ,AMINES ,LEVONORGESTREL ,COMPARATIVE studies ,RANDOMIZED controlled trials ,RESEARCH funding ,CONTRACEPTIVE drugs - Abstract
Background: The ECHO trial randomized women to intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel implant (LNG-implant), or copper intrauterine device (Cu-IUD). In a substudy of the ECHO trial, we tested the hypothesis that contraceptives influence genital inflammation by comparing cervicovaginal cytokine changes following contraception initiation. In addition, we compared cytokine profiles in women who acquired HIV (cases) versus those remaining HIV negative (controls).Methods: Women (n = 251) from South Africa and Kenya were included. Twenty-seven cervicovaginal cytokines were measured by Luminex at baseline, and 1 and 6 months after contraceptive iTanko et alnitiation. In addition, cytokines were measured preseroconversion in HIV cases (n = 25) and controls (n = 100).Results: At 6 months after contraceptive initiation, women using Cu-IUD had increased concentrations of 25/27 cytokines compared to their respective baseline concentrations. In contrast, women initiating DMPA-IM and LNG-implant did not experience changes in cervicovaginal cytokines. Preseroconversion concentrations of IL-1β, IL-6, and TNF-α, previously associated with HIV risk, correlated with increased HIV risk in a logistic regression analysis, although not significantly after correcting for multiple comparisons. Adjusting for contraceptive arm did not alter these results.Conclusions: Although Cu-IUD use broadly increased cervicovaginal cytokine concentrations at 6 months postinsertion, these inflammatory changes were found not to be a significant driver of HIV risk.Clinical Trials Registration: NCT02550067. [ABSTRACT FROM AUTHOR]- Published
- 2022
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33. Tenofovir-Based Preexposure Prophylaxis for HIV Infection among African Women
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Marrazzo, Jeanne M., Ramjee, Gita, Richardson, Barbra A., Gomez, Kailazarid, Mgodi, Nyaradzo, Nair, Gonasagrie, Palanee, Thesla, Nakabiito, Clemensia, van der Straten, Ariane, Noguchi, Lisa, Hendrix, Craig W., Dai, James Y., Ganesh, Shayhana, Mkhize, Baningi, Taljaard, Marthinette, Parikh, Urvi M., Piper, Jeanna, Mâsse, Benoît, Grossman, Cynthia, Rooney, James, Schwartz, Jill L., Watts, Heather, Marzinke, Mark A., Hillier, Sharon L., McGowan, Ian M., and Chirenje, Mike Z.
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- 2015
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34. Revisiting community engagement methods in the context of data science research and big data use in South Africa.
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Nair, Gonasagrie, Burgess, Theresa L., Obasa, Adetayo E., Kling, Sharon, and Singh, Shenuka
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The article focuses on the ethical implications and challenges associated with big data research in the context of health data science. Topics include the blurring boundaries between clinical care and research, the need for community engagement to build trust and address participation barriers, and the limitations in current frameworks for community engagement in data science research.
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- 2023
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35. The role of an ethics advisory committee in data science research in sub-Saharan Africa.
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Kling, Sharon, Singh, Shenuka, Burgess, Theresa L., and Nair, Gonasagrie
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The article focuses on the ethical implications of data science research, particularly in the context of big data and its use in healthcare. Topics discussed include the need for ethics review in data science research, challenges related to bias and privacy, the establishment of ethics advisory committees, and suggested reforms to improve the ethics review process.
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- 2023
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36. High HIV incidence among young women in South Africa: Data from a large prospective study.
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Palanee-Phillips, Thesla, Rees, Helen V., Heller, Kate B., Ahmed, Khatija, Batting, Joanne, Beesham, Ivana, Heffron, Renee, Justman, Jessica, Makkan, Heeran, Mastro, Timothy D., Morrison, Susan A., Mugo, Nelly, Nair, Gonasagrie, Kiarie, James, Philip, Neena M., Pleaner, Melanie, Reddy, Krishnaveni, Selepe, Pearl, Steyn, Petrus S., and Scoville, Caitlin W.
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YOUNG women ,SEXUALLY transmitted diseases ,COPPER intrauterine contraceptives ,HIV infections ,PROPORTIONAL hazards models ,HIV prevention ,SOUTH Africans - Abstract
Introduction: South Africa has the highest national burden of HIV globally. Understanding drivers of HIV acquisition in recently completed, prospective studies in which HIV was an endpoint may help inform the strategy and investments in national HIV prevention efforts and guide the design of future HIV prevention trials. We assessed HIV incidence and correlates of incidence among women enrolled in ECHO (Evidence for Contraceptive Options and HIV Outcomes), a large, open-label randomized clinical trial that compared three highly effective. reversible methods of contraception and rates of HIV acquisition. Methods: During December 2015 to October 2018, ECHO followed sexually active, HIV-seronegative women, aged 16–35 years, seeking contraceptive services and willing to be randomized to one of three contraceptive methods (intramuscular depot medroxyprogesterone acetate, copper intrauterine device, or levonorgestrel implant) for 12–18 months at nine sites in South Africa. HIV incidence based on prospectively observed HIV seroconversion events. Cox proportional hazards regression models were used to define baseline cofactors related to incident HIV infection. Results: 5768 women were enrolled and contributed 7647 woman-years of follow-up. The median age was 23 years and 62.5% were ≤24 years. A total of 345 incident HIV infections occurred, an incidence of 4.51 per 100 woman-years (95%CI 4.05–5.01). Incidence was >3 per 100 woman-years at all sites. Age ≤24 years, baseline infection with sexually transmitted infections, BMI≤30, and having new or multiple partners in the three months prior to enrollment were associated with incident HIV. Conclusions: HIV incidence was high among South African women seeking contraceptive services. Integration of diagnostic management of sexually transmitted infections alongside delivery of HIV prevention options in health facilities providing contraception services are needed to mitigate ongoing risks of HIV acquisition for this vulnerable population. Clinical trial registration: ClinicalTrials.gov, number NCT02550067 was the main Clinical Trial from which this secondary, non-randomized / observational analysis was derived with data limited to just South African sites. [ABSTRACT FROM AUTHOR]
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- 2022
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37. Feasibility, Performance, and Acceptability of the Wisebag™ for Potential Monitoring of Daily Gel Applicator Use in Durban, South Africa
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van der Straten, Ariane, Montgomery, Elizabeth, Pillay, Diantha, Cheng, Helen, Naidoo, Anushka, Cele, Zakhele, Naidoo, Kalendri, Hartmann, Miriam, Piper, Jeanna, and Nair, Gonasagrie
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- 2013
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38. Timing of initiation of antiretroviral drugs during tuberculosis therapy
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Karim, Salim S. Abdool, Naidoo, Kogieleum, Grobler, Anneke, Padayatchi, Nesri, Baxter, Cheryl, Gray, Andrew, Gengiah, Tanuja, Nair, Gonasagrie, Bamber, Sheila, Singh, Aarthi, Khan, Munira, Pienaar, Jacqueline, El-Sadr, Wafaa, Friedland, Gerald, and Karim, Quarraisha Abdool
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Antiviral agents -- Usage ,Antiviral agents -- Health aspects ,Tuberculosis -- Care and treatment - Abstract
A study was conducted to evaluate whether timely initiation of antiretroviral drugs during tuberculosis therapy was effective in reducing mortality and improving survival rates among patients with tuberculosis and human immunodeficiency virus (HIV). Results indicated that the use of such therapy greatly improved survival rates among such patients.
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- 2010
39. P159: Prevalence And Incidence of Human Papillomavirus Infection Among African Women Randomized to Depot Medroxyprogesterone Acetate, Copper Intrauterine Device, or Levonorgestrel Implant for Contraception.
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Happel, Anna-Ursula, Achilles, Sharon L., Budiawan, Elvira, Dabee, Smritee, Heffron, Renee, Heuvel, Janine, Innes, Steve, Jaspan, Heather, Kappa, La-Donna, Kellow-Webb, Sarah, Mkhize, Zandile, Mugo, Nelly R., Nair, Gonasagrie, Ongere, Joan, Onono, Maricianah, Palanee-Phillips, Thesla, Passmore, Jo-Ann, Rakiep, Adeebah, Scoville, Caitlin, and Sigcu, Mpumpie
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- 2024
40. Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives.
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Nair, Gonasagrie, Kabanda, Siti M., Jacobs-Alfred, Meagan M. M., Obasa, Adetayo E. A., McCaul, Michael G., and Moodley, Keymanthri
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The article discusses the benefits of the electronic consent in a COVID-19 vaccine implementation trial in South Africa. Topics include participation of healthcare professionals (HCPs) in an online survey to explore their experiences of providing electronic consent for enrolment into the largest implementation trial of a COVID vaccine in South Africa; training of HCPs with access to electronic devices and data; and the use of descriptive analysis to characterise respondents.
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- 2022
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41. The Immune Reconstitution Inflammatory Syndrome After Antiretroviral Therapy Initiation in Patients With Tuberculosis: Findings From the SAPiT Trial
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Naidoo, Kogieleum, Yende-Zuma, Nonhlanhla, Padayatchi, Nesri, Naidoo, Kasavan, Jithoo, Niraksha, Nair, Gonasagrie, Bamber, Sheila, Gengiah, Santhana, El-Sadr, Wafaa M., Friedland, Gerald, and Abdool Karim, Salim
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- 2012
42. Comparison of Female Genital Tract Cytokine and Microbiota Signatures Induced by Initiation of Intramuscular DMPA and NET-EN Hormonal Contraceptives - a Prospective Cohort Analysis.
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Dabee, Smritee, Tanko, Ramla F., Brown, Bryan P., Bunjun, Rubina, Balle, Christina, Feng, Colin, Konstantinus, Iyaloo N., Jaumdally, Shameem Z., Onono, Maricianah, Nair, Gonasagrie, Palanee-Phillips, Thesla, Gill, Katherine, Baeten, Jared M., Bekker, Linda-Gail, Passmore, Jo-Ann S., Heffron, Renee, Jaspan, Heather B., and Happel, Anna-Ursula
- Subjects
HUMAN microbiota ,GENITALIA ,CONTRACEPTION ,SEXUALLY transmitted diseases ,CYTOKINES - Abstract
Background: Cervicovaginal inflammation, bacterial microbiota and hormonal contraceptives all influence sexual and reproductive health. To date, the effects of intramuscular depo-medroxyprogesterone acetate (DMPA-IM) versus injectable norethisterone enanthate (NET-EN) on vaginal microbiota or cytokines have not been compared back-to-back, although in-vitro data suggest that DMPA-IM and NET-EN have different pharmacokinetic and biologic activities. This study aimed at comparing the effects of DMPA-IM versus NET-EN initiation on cervicovaginal cytokines and microbiota in women at high risk for sexually transmitted infections (STIs) assigned to the respective contraceptives. Methods: We collected socio-demographic characteristics and vaginal samples from women initiating DMPA-IM (ECHO Trial; n = 53) and NET-EN (UChoose Trial; n = 44) at baseline and after two consecutive injections to assess cytokine concentrations by Luminex, vaginal microbiota by 16S rRNA gene sequencing, STIs, bacterial vaginosis (BV) and candidiasis. Results: Cytokine concentrations did not change significantly after initiating DMPA-IM or NET-EN, although NET-EN versus DMPA-IM-associated profiles were distinct. While the abundance of bacterial taxa associated with optimal and non-optimal microbiota fluctuated with DMPA-IM use, overall community composition did not significantly change with either contraceptive. HSV-2 serology, chlamydial infection, gonorrhoea and candidiasis did not influence the associations between contraceptive type and cervicovaginal cytokines or microbiota. Conclusions: Both DMPA-IM and NET-EN use did not lead to broad inflammatory or microbiota changes in the female genital tract of sub-Saharan African women. This suggests that NET-EN is likely a viable option for contraception in African women at high risk of BV and STIs. [ABSTRACT FROM AUTHOR]
- Published
- 2021
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43. The Influence of Perceived Dapivirine Vaginal Ring Effectiveness on Social Disclosure and Ring Adherence.
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Stoner, Marie C. D., Brown, Elizabeth R., Palanee-Phillips, Thesla, Mansoor, Leila E., Tembo, Tchangani, Nair, Gonasagrie, Akello, Carolyne, Seyama, Linly, Jeenarain, Nitesha, Naidoo, Logashvari, Mgodi, Nyaradzo, Hunidzarira, Portia, Chitukuta, Miria, van der Straten, Ariane, for the MTN-020 ASPIRE and M-025 HOPE study teams, Baeten, Jared, Brown, Elizabeth, Soto-Torres, Lydia, Schwartz, Katie, and Mayo, Ashley
- Subjects
HIV prevention ,SOCIAL support ,CERVICAL caps - Abstract
We analyzed data from 1428 users of the dapivirine vaginal ring, who participated in the MTN-020/ASPIRE phase III trial and subsequent open-label extension MTN-025/HOPE trial, to examine relationships between perceived ring protection, social disclosures, and self-reported ring adherence. In HOPE, 77% perceived the ring to be highly effective, and this view was associated with speaking: (a) to a greater number of people about the study, (b) with other participants, (c) to more people who were in favor of the ring, and (d) to more people whose opinions were valued. Reported adherence was not directly associated with perceived protection but was associated with disclosing to someone who was in favor of the ring. These findings suggest the importance of women's internalized ideas about the protective benefits of the DVR in sharing information about the ring and the importance of social support on adherence. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF
44. Integration of Antiretroviral Therapy with Tuberculosis Treatment
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Abdool Karim, Salim S., Naidoo, Kogieleum, Grobler, Anneke, Padayatchi, Nesri, Baxter, Cheryl, Gray, Andrew L., Gengiah, Tanuja, Gengiah, Santhanalakshmi, Naidoo, Anushka, Jithoo, Niraksha, Nair, Gonasagrie, El-Sadr, Wafaa M., Friedland, Gerald, and Abdool Karim, Quarraisha
- Published
- 2011
45. Timing of Initiation of Antiretroviral Drugs during Tuberculosis Therapy
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Abdool Karim, Salim S, Naidoo, Kogieleum, Grobler, Anneke, Padayatchi, Nesri, Baxter, Cheryl, Gray, Andrew, Gengiah, Tanuja, Nair, Gonasagrie, Bamber, Sheila, Singh, Aarthi, Khan, Munira, Pienaar, Jacqueline, El-Sadr, Wafaa, Friedland, Gerald, and Karim, Quarraisha Abdool
- Published
- 2010
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46. Impact of Male Partner Involvement on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial.
- Author
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Roberts, Sarah T., Nair, Gonasagrie, Baeten, Jared M., Palanee-Philips, Thesla, Schwartz, Katie, Reddy, Krishnaveni, Kabwigu, Samuel, Matovu Kiweewa, Flavia, Govender, Vaneshree, Gaffoor, Zakir, Singh, Nishanta, Siva, Samantha, Naidoo, Kalendri, and Montgomery, Elizabeth T.
- Subjects
HIV prevention ,CERVICAL caps ,CONCEPTUAL structures ,CONFIDENCE intervals ,HEALTH behavior ,SECONDARY analysis ,SOCIAL support ,RELATIVE medical risk ,NON-nucleoside reverse transcriptase inhibitors ,SEXUAL partners ,DESCRIPTIVE statistics - Abstract
Although vaginal microbicides for HIV prevention are designed to be female-initiated, male partner influence has been identified as one of the most significant factors impacting women's willingness and ability to use them. As a result, research teams have sought to increase male partner involvement by encouraging disclosure of product use to male partners, promoting male partner engagement in the study through attendance at the study clinic, and helping women to garner male partner support for product use. This paper aims to assess the impact of these three elements of male partner involvement on women's adherence to the dapivirine vaginal ring during MTN-020/ASPIRE, a phase III randomized placebo-controlled clinical trial involving 2629 women in Malawi, South Africa, Uganda, and Zimbabwe. During the study, 64–80% of participants reported disclosure of ring use at each quarterly visit, and 13% reported that their partners had attended the study clinic at some point during the study. At study exit, 66% reported that their partner was supportive, 18% unsupportive, and 17% were unsure. After adjusting for age, site and time in study, women were more likely to have low ring adherence if they had an unsupportive male partner (aRR 1.29, 95% CI 1.03–1.62). Neither disclosure nor clinic attendance directly predicted ring adherence, but disclosure increased the probability of having a supportive partner (aRRR 24.17, 95% CI 16.38–35.66) or an unsupportive partner (aRRR 4.10, 95% CI 2.70–6.24), relative to an unknown level of partner support. Women were also more likely to have a supportive partner if their partner had attended the clinic (aRRR 3.77, 95% CI 1.36–10.42). This study suggests that although the vaginal ring is relatively discreet, lack of support from male partners remains a relevant barrier to use. Though both disclosure and clinic attendance may increase partner support, disclosure may also increase partner opposition. Interventions to reduce male partner opposition are needed to maximize the potential impact of the ring and other PrEP products for HIV prevention. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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- View/download PDF
47. Preventive Misconception and Risk Behaviors in a Multinational HIV Prevention Trial.
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Sugarman, Jeremy, Lin, Li, Baeten, Jared M., Palanee-Phillips, Thesla, Brown, Elizabeth R., Matovu Kiweewa, Flavia, Mgodi, Nyaradzo M., Nair, Gonasagrie, Siva, Samantha, Seils, Damon M., and Weinfurt, Kevin P.
- Subjects
RISK-taking behavior ,HIV infections ,HIV prevention ,CONDOM use ,HUMAN research subjects - Abstract
Background: Some HIV prevention research participants may hold a "preventive misconception" (PM), an overestimate of the probability or level of personal protection afforded by trial participation. However, these reports typically rely upon small, retrospective qualitative assessments that did not use a standardized approach. Methods: We administered a measure of PM called PREMIS, during Microbicide Trials Network 020—A Study to Prevent Infection with a Ring for Extended Use, a large, multicenter, placebo-controlled, phase III trial evaluating the safety and efficacy of a dapivirine vaginal ring among women at risk for HIV infection in Malawi, South Africa, Uganda, and Zimbabwe. The maximum follow-up period was 2.6 years. Results: One thousand two hundred sixty-one respondents completed PREMIS at their month 3 visit (M3); 2085 at their month 12 visit (M12); and 1010 at both visits. Most participants expressed high expectations of personal benefit (EPB) and that at least one of the rings used in the trial would reduce the risk of getting HIV (expectation of maximum aggregate benefit or EMAB). There was a moderate positive correlation between EPB and EMAB at M3 (r =.43, 95% CI:.37,.47) and M12 (r =.44, 95% CI:.40,.48). However, there was variability among sites in the strength of the relationship. There was no relationship between either expectation variable and condom use, adherence, or HIV infection. Conclusions: A majority of trial participants expressed some belief that their risk of HIV infection would be reduced by using a vaginal ring, which may signal PM. However, such beliefs were not associated with adherence, condom use, or subsequent HIV infection, and there was variability across sites. Further work is needed to understand these findings. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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48. Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing.
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Justman, Jessica E., Nair, Gonasagrie (Lulu), Hendrix, Craig W., Piper, Jeanna M., Marzinke, Mark A., Dai, James Y., Pan, Zhenyu, Galaska, Beth, Levy, Lisa, Schwartz, Jill L., Balar, Bhavna, Ayudhya, Ratiya P. Kunjara Na, Mushamiri, Ivy, McGowan, Ian, and Dezzutti, Charlene S.
- Abstract
Background: Evidence is lacking regarding whether vaginal preexposure prophylaxis with topical tenofovir (TFV) reduces the risk of rectal HIV acquisition. Setting: Bronx, NY. Methods: MTN-014 was a phase 1, cross-over, randomized sequence trial comparing the cross-compartment pharmacokinetics and pharmacodynamics of daily TFV reduced-glycerin 1% gel after 14 days each of rectal and vaginal application, with directly observed dosing and a 6-week washout period between phases. Results: Fourteen HIV-uninfected women enrolled; 91% of doses were observed and 13 women completed all study procedures. TFV and TFV diphosphate (TFV-DP) were detected in most samples collected from the dosing compartment. After vaginal dosing, TFV was detected in 10/14 samples of rectal fluid (RF) (median 4.4 ng/sponge) and 1/13 rectal tissue samples (0.2 ng/mg); TFV-DP was detected in 2/13 rectal tissue samples at 59.8 and 76.5 fmol/mg. After rectal dosing, TFV was detected in 9/14 samples of vaginal fluid (median 1.1 ng/swab) and in 6/ 14 vaginal tissue samples (median below limit of quantification); TFVDP was detected in 3/14 vaginal tissue samples at 17.3, 87.6, and 77.1 fmol/mg. Neither cervicovaginal lavage fluid nor RF collected 24 hours after rectal or vaginal dosing resulted in a statistically significant suppression of viral replication. Conclusions: In this study of 14 days each of vaginal and rectal application of TFV reduced-glycerin 1% gel, we found only a small degree of cross-compartment distribution of TFV in RF and vaginal fluids and no pharmacodynamic activity in ex vivo testing. Although high TFV concentrations in the dosing compartment may be protective, low cross-compartment tissue concentrations are not likely to be protective. [ABSTRACT FROM AUTHOR]
- Published
- 2018
- Full Text
- View/download PDF
49. HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial.
- Author
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Riddler, Sharon A., Husnik, Marla, Ramjee, Gita, Premrajh, Anamika, Tutshana, Bomkazi Onini, Pather, Arendevi, Siva, Samantha, Jeenarain, Nitesha, Nair, Gonasagrie, Selepe, Pearl, Kabwigu, Samuel, Palanee-Phillips, Thesla, Panchia, Ravindre, Mhlanga, Felix, Levy, Lisa, Livant, Edward, Patterson, Karen, Elharrar, Vanessa, and Balkus, Jennifer
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HIV prevention ,TENOFOVIR ,SEROCONVERSION ,DISEASE progression ,RANDOMIZED controlled trials ,LONGITUDINAL method ,THERAPEUTICS - Abstract
Background: Little is known regarding HIV disease outcomes among individuals who become infected with HIV while receiving antiretroviral medications for prevention. We compared HIV disease parameters among women who seroconverted while receiving tenofovir-containing oral or vaginal pre-exposure prophylaxis (PrEP) to placebo. Methods: Participants with HIV seroconversion in a randomized placebo-controlled trial of oral tenofovir, oral tenofovir/emtricitabine, and vaginal tenofovir gel (MTN-003) were followed in a longitudinal cohort study (MTN-015). The effect of oral and vaginal tenofovir-containing PrEP on HIV disease progression was compared to placebo using linear mixed effects and Cox proportional hazard models, as appropriate. Additional analyses were performed to compare the outcomes among participants with detectable tenofovir or emtricitabine in plasma at the first quarterly visit in MTN-003. Results: A total of 224 participants were included in the analysis; 93% from South Africa and 94% clade C virus. No differences in HIV RNA at steady state or the trajectory over 12 months were observed for each active arm compared to placebo; tenofovir gel recipients had higher CD4
+ T cell counts (722 vs 596 cells/mm3 ; p = 0.02) at 90 days after estimated HIV seroconversion and higher average rates of change over 12 months compared to placebo (-181 vs -92 cells/mm3 per year; p = 0.08). With a median follow-up of 31 months, no significant differences were observed for time to CD4+ T cell count ≤350 cells/mm3 , or the composite endpoint of CD4+ T cells ≤350 cells/mm3 , initiation of antiretroviral therapy or death for each active arm compared to placebo. Additionally, there were no significant differences in the HIV RNA or CD4+ T cell counts at baseline, the change to month 12, or any disease progression outcomes among participants with oral drug detected and no oral drug detected compared to placebo. Conclusions: No clinically significant differences in HIV seroconversion outcomes were observed among women randomized to tenofovir-containing oral or vaginal PrEP regimens, however low overall adherence limits the generalizability of these findings. [ABSTRACT FROM AUTHOR]- Published
- 2017
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50. Age-Disparate Partnerships and Risk of HIV-1 Acquisition Among South African Women Participating in the VOICE Trial.
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Balkus, Jennifer E., Nair, Gonasagrie, Montgomery, Elizabeth T., Mishra, Anu, Palanee-Phillips, Thesla, Ramjee, Gita, Panchia, Ravindre, Selepe, Pearl, Richardson, Barbra A., Chirenje, Zvavahera M., and Marrazzo, Jeanne M.
- Published
- 2015
- Full Text
- View/download PDF
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