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1. Correlates of Adherence to Oral and Vaginal Pre-exposure Prophylaxis (PrEP) Among Adolescent Girls and Young Women (AGYW) Participating in the MTN-034/REACH Trial

Author: Ngure, Kenneth, Browne, Erica N., Reddy, Krishnaveni, Friedland, Barbara A., van der Straten, Ariane, Palanee-Phillips, Thesla, Nakalega, Rita, Gati, Brenda, Kalule, Hadijah N., Siziba, Bekezela, Soto-Torres, Lydia, Nair, Gonasagrie, Garcia, Morgan, Celum, Connie, and Roberts, Sarah T.
Published: 2024
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2. Update on the Impact of Depot Medroxyprogesterone Acetate on Vaginal Mucosal Endpoints and Relevance to Sexually Transmitted Infections

Author: 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
Published: 2023
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3. Copper intrauterine device increases vaginal concentrations of inflammatory anaerobes and depletes lactobacilli compared to hormonal options in a randomized trial

Author: 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.
Published: 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

Author: 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
Subjects: 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.
Published: 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

Author: 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.
Published: 2023
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6. Correlates of Dapivirine Vaginal Ring Acceptance among Women Participating in an Open Label Extension Trial

Author: 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.
Published: 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

Author: 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
Published: 2023
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8. Prevalence and Incidence of Sexually Transmitted Infection in Injectable Progestin Contraception Users in South Africa

Author: 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
Subjects: 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.
Published: 2021

9. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

Author: 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
Subjects: 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
Published: 2021

10. Use of the dapivirine vaginal ring and effect on cervical cytology abnormalities.

Author: 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
Subjects: 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.
Published: 2020

11. Social harms in female-initiated HIV prevention method research: state of the evidence.

Author: 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
Subjects: 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 (
Published: 2019

12. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

Author: 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
Published: 2021
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13. Ethics and governance challenges related to genomic data sharing in southern Africa: the case of SARS-CoV-2

Author: Moodley, Keymanthri, Cengiz, Nezerith, Domingo, Aneeka, Nair, Gonasagrie, Obasa, Adetayo Emmanuel, Lessells, Richard John, and de Oliveira, Tulio
Published: 2022
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14. Digital tools for youth health promotion: principles, policies and practices in sub-Saharan Africa

Author: Ferretti, Agata, primary, Adjei, Kwame K, additional, Ali, Joseph, additional, Atuire, Caesar, additional, Ayuk, Betrand Tambe, additional, Banougnin, Boladé Hamed, additional, Cengiz, Nezerith, additional, Gichoya, Judy, additional, Jjingo, Daudi, additional, Juma, Damian Omari, additional, Kotze, Wiaan, additional, Krubiner, Carleigh, additional, Littler, Katherine, additional, McCradden, Melissa D, additional, Moodley, Keymanthri, additional, Naidoo, Meshandren, additional, Nair, Gonasagrie, additional, Obeng-Kyereh, Kingsley, additional, Oliver, Kedebone, additional, Ralefala, Dimpho, additional, Toska, Elona, additional, Wekesah, Frederick M, additional, Wright, Jonty, additional, and Vayena, Effy, additional
Published: 2024
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15. Complex decisions: correlates of injectable contraceptive discontinuation following HIV-1 seroconversion in an HIV prevention trial

Author: Caplan, Margaret R, Landovitz, Raphael J, Palanee-Phillips, Thesla, Nair, Gonasagrie, Mhlanga, Felix, Balkus, Jennifer E, Riddler, Sharon A, and Gorbach, Pamina M
Subjects: 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.
Published: 2019

16. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial

Author: 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
Published: 2022
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17. Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study

Author: 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
Published: 2021
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18. Patterns of Adherence to a Dapivirine Vaginal Ring for HIV-1 Prevention Among South African Women in a Phase III Randomized Controlled Trial

Author: 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
Published: 2022
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19. 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

Author: 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
Published: 2021
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20. Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial

Author: 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
Subjects: 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.
Published: 2017

21. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Author: 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
Subjects: 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
Published: 2016

22. An Empiric HIV Risk Scoring Tool to Predict HIV-1 Acquisition in African Women

Author: 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
Subjects: 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.
Published: 2016

23. Stakeholders’ experiences of ethical challenges in cluster randomized trials in a limited resource setting: a qualitative analysis

Author: Mtande, Tiwonge K, primary, Lombard, Carl, additional, Nair, Gonasagrie, additional, and Rennie, Stuart, additional
Published: 2023
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24. Stakeholders' experiences of ethical challenges in cluster randomized trials in a limited resource setting: a qualitative analysis.

Author: Mtande, Tiwonge K, Lombard, Carl, Nair, Gonasagrie, and Rennie, Stuart
Subjects: 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]
Published: 2024
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25. The role of an ethics advisory committee in data science research in sub-Saharan Africa

Author: Kling, Sharon, primary, Singh, Shenuka, primary, Burgess, Theresa L., primary, and Nair, Gonasagrie, primary
Published: 2023
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26. Revisiting community engagement methods in the context of data science research and big data use in South Africa

Author: Nair, Gonasagrie, primary, Burgess, Theresa L., primary, Obasa, Adetayo E., primary, Kling, Sharon, primary, and Singh, Shenuka, primary
Published: 2023
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27. Acquisition of Sexually Transmitted Infections among Women Using a Variety of Contraceptive Options: A prospective Study among High-risk African Women

Author: 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.
Subjects: 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 [...]
Published: 2019
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28. Risk of HIV-1 acquisition among South African women using a variety of contraceptive methods in a prospective study

Author: 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.
Published: 2019
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29. 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

Author: Deese, Jennifer, primary, Chen, Pai Lien, additional, Gao, Xiaoming, additional, Heffron, Renee, additional, Hobbs, Marcia, additional, Lapple, Dana, additional, Jaspan, Heather, additional, Miller, Ashley, additional, Nair, Gonasagrie, additional, Onono, Maricianah, additional, Palanee-Phillips, Thesla, additional, Reddy, Krishnaveni, additional, and Steiner, Markus J., additional
Published: 2022
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30. Ethics and regulatory complexities posed by a pragmatic clinical trial: a case study from Lilongwe, Malawi

Author: Mtande, Tiwonge Kumwenda, Nair, Gonasagrie, and Rennie, Stuart
Subjects: real world data, pragmatic clinical trials, research oversight, research participants, guidelines, research ethics committee, PRECIS-2 tool, HIV, antiretroviral treatment, Malawi, Pragmatic Clinical Trials as Topic, Organizational Case Studies, Humans, General Medicine, Delivery of Health Care
Abstract: Background Pragmatic clinical trials generally rely on real world data and have the potential to generate real world evidence. This approach arose from concerns that many trial results did not adequately inform real world practice. However, maintaining the real world setting during the conduct of a trial and ensuring adequate protection for research participants can be challenging. Best practices in research oversight for pragmatic clinical trials are nascent and underdeveloped, especially in developing countries. Methods We use the PRECIS-2 tool to present a case study from Lilongwe in Malawi to describe ethical and regulatory challenges encountered during the conduct of a pragmatic trial and suggest possible solutions. Results In this article, we highlight the following six issues: (1) one public facility hosting several pragmatic trials within the same period; (2) research participants refusing financial incentives; (3) inadequate infrastructure and high workload to conduct research; (4) silos among partner organisations involved in delivery of health care; (5) individuals influencing the implementation of revised national guidelines; (6) difficulties with access to electronic medical records. Conclusion Multiple stakeholder engagement is critical to the conduct of pragmatic trials, and even with careful stakeholder engagement, continuous monitoring by gatekeepers is essential. In the Malawian context, active engagement of the district research committees can complement the work of the research ethics committees (RECs).
Published: 2022

31. 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).

Author: 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
Subjects: 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]
Published: 2023
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32. Impact of Partner-Related Social Harms on Womenʼs Adherence to the Dapivirine Vaginal Ring During a Phase III Trial

Author: 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.
Published: 2018
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33. Risk of HIV-1 acquisition among women who use different types of injectable progestin contraception in South Africa: a prospective cohort study

Author: 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
Published: 2015
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34. Correlates of Dapivirine Vaginal Ring Acceptance among Women Participating in an Open Label Extension Trial

Author: Mirembe, Brenda Gati, primary, Cabrera, Maria Valdez, additional, van der Straten, Ariane, additional, Nakalega, Rita, additional, Cobbing, Mandy, additional, Mgodi, Nyaradzo M., additional, Palanee-Phillips, Thesla, additional, Mayo, Ashley J., additional, Dadabhai, Sufia, additional, Mansoor, Leila E., additional, Siva, Samantha, additional, Nair, Gonasagrie, additional, Chinula, Lameck, additional, Akello, Carolyne A., additional, Nakabiito, Clemensia, additional, Soto-Torres, Lydia E., additional, Baeten, Jared M., additional, and Brown, Elizabeth R., additional
Published: 2022
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35. Initiating Intramuscular Depot Medroxyprogesterone Acetate Increases Frequencies of Th17-like Human Immunodeficiency Virus Target Cells in the Genital Tract of Women in South Africa: A Randomized Trial

Author: Bunjun, Rubina, primary, Ramla, Tanko F, additional, Jaumdally, Shameem Z, additional, Noël-Romas, Laura, additional, Ayele, Hossaena, additional, Brown, Bryan P, additional, Gamieldien, Hoyam, additional, Harryparsad, Rushil, additional, Dabee, Smritee, additional, Nair, Gonasagrie, additional, Onono, Maricianah, additional, Palanee-Phillips, Thesla, additional, Scoville, Catilin W, additional, Heller, Kate B, additional, Baeten, Jared M, additional, Bosinger, Steven E, additional, Burgener, Adam, additional, Passmore, Jo-Ann S, additional, Jaspan, Heather, additional, and Heffron, Renee, additional
Published: 2022
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36. Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial

Author: 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
Subjects: 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 [...]
Published: 2020
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37. Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives

Author: Nair, Gonasagrie, primary, Kabanda, Siti M., additional, Jacobs-Alfred, Meagan M.M., additional, Obasa, Adetayo E.A., additional, McCaul, Michael G., additional, and Moodley, Keymanthri, additional
Published: 2022
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38. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial

Author: Delany-Moretlwe, Sinead, primary, Hughes, James P, additional, Bock, Peter, additional, Ouma, Samuel Gurrion, additional, Hunidzarira, Portia, additional, Kalonji, Dishiki, additional, Kayange, Noel, additional, Makhema, Joseph, additional, Mandima, Patricia, additional, Mathew, Carrie, additional, Spooner, Elizabeth, additional, Mpendo, Juliet, additional, Mukwekwerere, Pamela, additional, Mgodi, Nyaradzo, additional, Ntege, Patricia Nahirya, additional, Nair, Gonasagrie, additional, Nakabiito, Clemensia, additional, Nuwagaba-Biribonwoha, Harriet, additional, Panchia, Ravindre, additional, Singh, Nishanta, additional, Siziba, Bekezela, additional, Farrior, Jennifer, additional, Rose, Scott, additional, Anderson, Peter L, additional, Eshleman, Susan H, additional, Marzinke, Mark A, additional, Hendrix, Craig W, additional, Beigel-Orme, Stephanie, additional, Hosek, Sybil, additional, Tolley, Elizabeth, additional, Sista, Nirupama, additional, Adeyeye, Adeola, additional, Rooney, James F, additional, Rinehart, Alex, additional, Spreen, William R, additional, Smith, Kimberly, additional, Hanscom, Brett, additional, Cohen, Myron S, additional, Hosseinipour, Mina C, additional, Asmelash, Aida, additional, Sehurutshi, Alice, additional, Baguma, Allan, additional, Marais, Anita, additional, Kawoozo, Barbarah, additional, Malinga, Bongiwe Prudence, additional, Mirembe, Brenda Gati, additional, Okech, Brenda, additional, Esterhuizen, Bryan, additional, Murombedzi, Caroline, additional, Gadama, Daphne, additional, Hwengwere, Eldinah, additional, Roos, Elizabeth, additional, Magada, Elizabeth S, additional, Shava, Emily, additional, Piwowar-Manning, Estelle, additional, Tahuringana, Eunice, additional, Muhlanga, Felix GS, additional, Conradie, Francesca, additional, Angira, Frank, additional, Nanyonjo, Gertrude, additional, Kistnasami, Girisha, additional, Mvula, Hazzie, additional, Naidoo, Ishana, additional, Horak, Jaco, additional, Jere, Jane, additional, Moodley, Jeeva, additional, Shin, Katie, additional, Nel, Kerry, additional, Bokoch, Kevin, additional, Birungi, Lilian, additional, Emel, Lynda, additional, Monametsi, Maletsatsi, additional, Sibanda, Marvelous, additional, Mutambanengwe, Mercy, additional, Chitukuta, Miria, additional, Matimbira, Moleen, additional, Bhondai-Mhuri, Muchaneta, additional, Sibisi, Ncamsile, additional, Morar, Neetha, additional, Mudzonga, Netsai, additional, Natureeba, Paul, additional, Richardson, Paul, additional, Musara, Petina, additional, Macdonald, Pippa, additional, Nkambule, Rejoice, additional, Mosime, Repelang, additional, White, Rhonda, additional, Berhanu, Ribka, additional, Ncube-Sihlongonyane, Ritha, additional, Sekabira, Rogers, additional, Siva, Samantha, additional, Pillay, Saresha, additional, Govender, Shamelle, additional, Bamweyana, Sheiala, additional, Nzimande, Siyabonga, additional, Innes, Steve, additional, Dadabhai, Sufia, additional, Samandari, Taraz, additional, Tembo, Tchangani, additional, Lungu Mabedi, Thandie, additional, Chirenda, Thandiwe, additional, Chidemo, Tinashe, additional, Mudhune, Victor, additional, Naidoo, Vikesh, additional, Samaneka, Wadzanai, additional, Agyei, Yaw, additional, Musodza, Yeukai, additional, Fourie, Yolandie, additional, and Gaffoor, Zakir, additional
Published: 2022
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39. Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial

Author: 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.
Published: 2017
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40. Characterization of Human Immunodeficiency Virus (HIV) Infections in Women Who Received Injectable Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention: HPTN 084

Author: Eshleman, Susan H, primary, Fogel, Jessica M, additional, Piwowar-Manning, Estelle, additional, Chau, Gordon, additional, Cummings, Vanessa, additional, Agyei, Yaw, additional, Richardson, Paul, additional, Sullivan, Philip, additional, Haines, Casey D, additional, Bushman, Lane R, additional, Petropoulos, Christos, additional, Persaud, Deborah, additional, Kofron, Ryan, additional, Hendrix, Craig W, additional, Anderson, Peter L, additional, Farrior, Jennifer, additional, Mellors, John, additional, Adeyeye, Adeola, additional, Rinehart, Alex, additional, St Clair, Marty, additional, Ford, Susan, additional, Rooney, James F, additional, Mathew, Carrie-Anne, additional, Hunidzarira, Portia, additional, Spooner, Elizabeth, additional, Mpendo, Juliet, additional, Nair, Gonasagrie, additional, Cohen, Myron S, additional, Hughes, James P, additional, Hosseinipour, Mina, additional, Hanscom, Brett, additional, Delany-Moretlwe, Sinead, additional, and Marzinke, Mark A, additional
Published: 2022
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41. The Effect of Contraception on Genital Cytokines in Women Randomized to Copper Intrauterine Device, Depot Medroxyprogesterone Acetate, or Levonorgestrel Implant

Author: Tanko, Ramla F, primary, Bunjun, Rubina, additional, Dabee, Smritee, additional, Jaumdally, Shameem Z, additional, Onono, Maricianah, additional, Nair, Gonasagrie, additional, Palanee-Phillips, Thesla, additional, Harryparsad, Rushil, additional, Happel, Anna Ursula, additional, Gamieldien, Hoyam, additional, Qumbelo, Yamkela, additional, Sinkala, Musalula, additional, Scoville, Caitlin W, additional, Heller, Kate, additional, Baeten, Jared M, additional, Bosinger, Steven E, additional, Burgener, Adam, additional, Heffron, Renee, additional, Jaspan, Heather B, additional, and Passmore, Jo Ann S, additional
Published: 2022
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42. Cabotegravir for Prevention of HIV-1 in Women: Results From HPTN 084, a Phase III, Randomised Controlled Trial

Author: Delany-Moretlwe, Sinead, primary, Hughes, James P., additional, Bock, Peter, additional, Ouma, Samuel Gurrion, additional, Hunidzarira, Portia, additional, Kalonji, Dishiki, additional, Kayange, Noel, additional, Makhema, Joseph, additional, Mandima, Patricia, additional, Mathew, Carrie, additional, Spooner, Elizabeth, additional, Mpendo, Juliet, additional, Mukwekwerere, Pamela, additional, Mgodi, Nyaradzo M., additional, Ntege, Patricia Nahirya, additional, Nair, Gonasagrie, additional, Nakabiito, Clemensia, additional, Nuwagaba-Biribonwoha, Harriet, additional, Panchia, Ravindre, additional, Singh, Nishanta, additional, Siziba, Bekezela, additional, Farrior, Jennifer, additional, Rose, Scott, additional, Berhanu, Rebecca, additional, Anderson, Peter L, additional, Agyei, Yaw, additional, Eshleman, Susan H., additional, Marzinke, Mark A., additional, Piwowar-Manning, Estelle, additional, Hendrix, Craig W., additional, Asmelash, Aida, additional, Conradie, Francesca, additional, Moorhouse, Michelle, additional, Richardson, Paul, additional, Beigel-Orme, Stephanie, additional, Emel, Lynda, additional, Bokoch, Kevin, additional, White, Rhonda, additional, Hosek, Sybil, additional, Tolley, Elizabeth, additional, Sista, Nirupama, additional, Shin, Katherine, additional, Adeyeye, Adeola, additional, Rooney, James, additional, Rinehart, Alex R., additional, Spreen, William R, additional, Smith, Kimberly, additional, Hanscom, Brett, additional, Cohen, Myron S., additional, and Hosseinipour, Mina C., additional
Published: 2022
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43. Comparison of Female Genital Tract Cytokine and Microbiota Signatures Induced by Initiation of Intramuscular DMPA and NET-EN Hormonal Contraceptives - a Prospective Cohort Analysis

Author: Dabee, Smritee, primary, Tanko, Ramla F., additional, Brown, Bryan P., additional, Bunjun, Rubina, additional, Balle, Christina, additional, Feng, Colin, additional, Konstantinus, Iyaloo N., additional, Jaumdally, Shameem Z., additional, Onono, Maricianah, additional, Nair, Gonasagrie, additional, Palanee-Phillips, Thesla, additional, Gill, Katherine, additional, Baeten, Jared M., additional, Bekker, Linda-Gail, additional, Passmore, Jo-Ann S., additional, Heffron, Renee, additional, Jaspan, Heather B., additional, and Happel, Anna-Ursula, additional
Published: 2021
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44. Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study

Author: Donnell, Deborah, primary, Beesham, Ivana, additional, Welch, Julia D, additional, Heffron, Renee, additional, Pleaner, Melanie, additional, Kidoguchi, Lara, additional, Palanee-Phillips, Thesla, additional, Ahmed, Khatija, additional, Baron, Deborah, additional, Bukusi, Elizabeth A, additional, Louw, Cheryl, additional, Mastro, Timothy D, additional, Smit, Jennifer, additional, Batting, Joanne R, additional, Malahleha, Mookho, additional, Bailey, Veronique C, additional, Beksinska, Mags, additional, Rees, Helen, additional, Baeten, Jared M, additional, Gichangi, Peter B, additional, Heller, Kate B, additional, Mbandazayo, Nomthandazo, additional, Morrison, Charles S, additional, Nanda, Kavita, additional, Scoville, Caitlin W, additional, Shears, Kathleen, additional, Steyn, Petrus S, additional, Taylor, Douglas, additional, Thomas, Katherine K, additional, Kiarie, James, additional, Justman, Jessica, additional, Nhlabatsi, Zelda, additional, Bekker, Linda-Gail, additional, Nair, Gonasagrie, additional, Hofmeyr, G Justus, additional, Singata-Madliki, Mandisa, additional, Selepe, Raesibe Agnes Pearl, additional, Sibiya, Sydney, additional, Phiri Kasaro, Margaret, additional, Stringer, Jeffrey, additional, and Mugo, Nelly R, additional
Published: 2021
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45. Prevalence and Incidence of Sexually Transmitted Infection in Injectable Progestin Contraception Users in South Africa

Author: Noguchi, Lisa M., primary, Marrazzo, Jeanne M., additional, Richardson, Barbara, additional, Hillier, Sharon L., additional, Balkus, Jennifer E., additional, Palanee-Phillips, Thesla, additional, Nair, Gonasagrie, additional, Panchia, Ravindre, additional, Piper, Jeanna, additional, Gomez, Kailazarid, additional, Ramjee, Gita, additional, and Chirenje, Z. Mike, additional
Published: 2021
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46. Prevalent human papillomavirus infection increases the risk of HIV acquisition in African women: advancing the argument for human papillomavirus immunization

Author: Liu, Gui, primary, Mugo, Nelly R., additional, Brown, Elizabeth R., additional, Mgodi, Nyaradzo M., additional, Chirenje, Zvavahera M., additional, Marrazzo, Jeanne M., additional, Winer, Rachel L., additional, Mansoor, Leila, additional, Palanee-Phillips, Thesla, additional, Siva, Samantha S., additional, Naidoo, Logashvari, additional, Jeenarain, Nitesha, additional, Gaffoor, Zakir, additional, Nair, Gonasagrie L., additional, Selepe, Pearl, additional, Nakabiito, Clemensia, additional, Mkhize, Baningi, additional, Mirembe, Brenda Gati, additional, Taljaard, Marthinette, additional, Panchia, Ravindre, additional, Baeten, Jared M., additional, Balkus, Jennifer E., additional, Hladik, Florian, additional, Celum, Connie L., additional, and Barnabas, Ruanne V., additional
Published: 2021
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47. Tenofovir-Based Preexposure Prophylaxis for HIV Infection among African Women

Author: 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.
Published: 2015
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48. High HIV incidence among young women in South Africa: Data from a large prospective study.

Author: 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.
Subjects: 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]
Published: 2022
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49. Feasibility, Performance, and Acceptability of the Wisebag™ for Potential Monitoring of Daily Gel Applicator Use in Durban, South Africa

Author: van der Straten, Ariane, Montgomery, Elizabeth, Pillay, Diantha, Cheng, Helen, Naidoo, Anushka, Cele, Zakhele, Naidoo, Kalendri, Hartmann, Miriam, Piper, Jeanna, and Nair, Gonasagrie
Published: 2013
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50. Timing of initiation of antiretroviral drugs during tuberculosis therapy

Author: 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
Subjects: 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.
Published: 2010

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