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2. Attitudes and perceptions towards developing a health educational video to enhance optimal uptake of malaria preventive therapy among pregnant women in Uganda: a qualitative study involving pregnant women, health workers, and Ministry of health officials

Author

Nakalega, Rita, Nabisere-Arinaitwe, Ruth, Mukiza, Nelson, Kuteesa, Cynthia Ndikuno, Mawanda, Denis, Natureeba, Paul, Kasirye, Ronnie, Nakabiito, Clemensia, Nabakooza, Jane, Mulumba, Emmie, Nabukeera, Josephine, Ggita, Joseph, Kakuru, Abel, Atuyambe, Lynn, Musoke, Philippa, Fowler, Mary Glenn, and Lukyamuzi, Zubair

Published
2024
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3. Metabolomic profiling of preterm birth in pregnant women living with HIV

Author

Tobin, Nicole H, Murphy, Aisling, Li, Fan, Brummel, Sean S, Fowler, Mary Glenn, Mcintyre, James A, Currier, Judith S, Chipato, Tsungai, Flynn, Patricia M, Gadama, Luis A, Saidi, Friday, Nakabiito, Clemensia, Koos, Brian J, and Aldrovandi, Grace M

Subjects
Medical Biochemistry and Metabolomics, Reproductive Medicine, Biomedical and Clinical Sciences, Paediatrics, Pregnancy, Pediatric, Women's Health, Prevention, Maternal Health, Infectious Diseases, Clinical Research, Preterm, Low Birth Weight and Health of the Newborn, HIV/AIDS, Perinatal Period - Conditions Originating in Perinatal Period, Sexually Transmitted Infections, 5.1 Pharmaceuticals, 2.1 Biological and endogenous factors, Infection, Reproductive health and childbirth, Good Health and Well Being, Infant, Child, Infant, Newborn, Female, Humans, HIV Infections, Zidovudine, Premature Birth, Pregnant Women, Pregnancy Complications, Infectious, Anti-HIV Agents, Pilot Projects, Metabolomics, Protease Inhibitors, Preterm birth, Women living with HIV, Plasma, Dried blood spots, IMPAACT 1077BF/1077FF PROMISE Study Team, Analytical Chemistry, Biochemistry and Cell Biology, Clinical Sciences, Biochemistry and cell biology, Medical biochemistry and metabolomics, Analytical chemistry
Abstract

BackgroundPreterm birth is a leading cause of death in children under the age of five. The risk of preterm birth is increased by maternal HIV infection as well as by certain antiretroviral regimens, leading to a disproportionate burden on low- and medium-income settings where HIV is most prevalent. Despite decades of research, the mechanisms underlying spontaneous preterm birth, particularly in resource limited areas with high HIV infection rates, are still poorly understood and accurate prediction and therapeutic intervention remain elusive.ObjectivesMetabolomics was utilized to identify profiles of preterm birth among pregnant women living with HIV on two different antiretroviral therapy (ART) regimens.MethodsThis pilot study comprised 100 mother-infant dyads prior to antiretroviral initiation, on zidovudine monotherapy or on protease inhibitor-based antiretroviral therapy. Pregnancies that resulted in preterm births were matched 1:1 with controls by gestational age at time of sample collection. Maternal plasma and blood spots at 23-35 weeks gestation and infant dried blood spots at birth, were assayed using an untargeted metabolomics method. Linear regression and random forests classification models were used to identify shared and treatment-specific markers of preterm birth.ResultsClassification models for preterm birth achieved accuracies of 95.5%, 95.7%, and 80.7% in the untreated, zidovudine monotherapy, and protease inhibitor-based treatment groups, respectively. Urate, methionine sulfone, cortisone, and 17α-hydroxypregnanolone glucuronide were identified as shared markers of preterm birth. Other compounds including hippurate and N-acetyl-1-methylhistidine were found to be significantly altered in a treatment-specific context.ConclusionThis study identified previously known as well as novel metabolomic features of preterm birth in pregnant women living with HIV. Validation of these models in a larger, independent cohort is necessary to ascertain whether they can be utilized to predict preterm birth during a stage of gestation that allows for therapeutic intervention or more effective resource allocation.

Published
2023

4. HIV genotypic resistance among pregnant women initiating ART in Uganda: a baseline evaluation of participants in the Option B+ clinical trial

Author

Amone, Alexander, Wavamunno, Priscilla, Gabagaya, Grace, Rukundo, Gordon, Namale-Matovu, Joyce, Malamba, Samuel S, Lubega, Irene, Homsy, Jaco, King, Rachel, Nakabiito, Clemensia, Nolan, Monica, Fowler, Mary Glenn, and Musoke, Philippa

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Research, Infectious Diseases, Clinical Trials and Supportive Activities, HIV/AIDS, Antimicrobial Resistance, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Reproductive health and childbirth, Infection, Good Health and Well Being, Female, Humans, Pregnancy, Anti-HIV Agents, Drug Resistance, Viral, HIV Infections, HIV-1, Infectious Disease Transmission, Vertical, Mutation, Pregnancy Complications, Infectious, Prenatal Care, Uganda, Viral Load, Clinical Sciences, Tropical Medicine, Clinical sciences, Health services and systems, Public health
Abstract

BackgroundPre-treatment HIV drug resistance is a threat to elimination of mother to child HIV transmission and could lead to virological failure among HIV-positive pregnant women. We analysed genotypic HIV drug resistance (HIVDR) of baseline samples of participants enrolled in the Option B+ clinical trial in Uganda.MethodsHIV-infected pregnant women attending antenatal care were enrolled from Uganda's National Referral Hospital (Mulago) and Mityana District general hospital and surrounding health centers (HCs). Genotypic HIV testing was performed on blood samples from the first 135 enrolled women out of a subset of 136 participants (25%) who had a baseline VL>1000 copies/mL as one sample failed to amplify.Results159/540 (29.4%) had a VL < 1000 copies/ml and 381/540 (70.6%) had a VL >1,000 copies/ml. Of the women with VL>1000 copies/ml, 32 (23.7%) had resistance mutations including 29/135 (21.5%) NNRTI mutations, 6/135 (4.4%) NRTI mutations and 3/135 (2.2%) had both NNRTI and NRTI mutations. The most common NNRTI resistance mutations were: K103KN (5), K103N (5), V179T (4) and E138A (4).ConclusionsOne quarter of the HIV-infected pregnant women in this trial at baseline had NNRTI genotypic resistance mutations. Our findings support new WHO guidelines for first-line ART that were changed to dolutegravir-based regimens.

Published
2022

5. 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

6. Prevalence of undetectable and suppressed viral load in HIV-infected pregnant women initiating Option B+ in Uganda: an observational study nested within a randomized controlled trial

Author

Gabagaya, Grace, Rukundo, Gordon, Amone, Alexander, Wavamunno, Priscilla, Namale-Matovu, Joyce, Lubega, Irene, Nakabiito, Clemensia, Namukwaya, Zikulah, Nolan, Monica, Malamba, Samuel S, King, Rachel, Homsy, Jaco, Fowler, Mary Glenn, and Musoke, Philippa

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Pediatric, Mental Health, Infectious Diseases, Pediatric Research Initiative, Clinical Research, HIV/AIDS, Pediatric AIDS, Clinical Trials and Supportive Activities, Infection, Good Health and Well Being, Anti-HIV Agents, Female, HIV Infections, Humans, Pregnancy, Pregnancy Complications, Infectious, Pregnant Women, Prevalence, Uganda, Viral Load, HIV, Viral load, Viral or virological suppression, HIV transmission, Option B plus, Antiretroviral therapy, Option B+, Microbiology, Clinical sciences, Medical microbiology, Public health
Abstract

BackgroundViral load (VL) testing is key in monitoring adherence to antiretroviral therapy (ART) and documenting HIV treatment response. As per HIV treatment guidelines in Uganda, the first VL test is recommended 6 months after initiation of ART. Undetectable VL (uVL) at ART initiation may be helpful in detecting elite controllers in the absence of previous ART use. We investigated viral suppression at ART initiation among a cohort of HIV-positive pregnant women enrolled in the Friends for Life Circles (FLC) for Option B+ randomized controlled trial (RCT).MethodsPregnant women ≥ 18 years of age testing positive for HIV at their first antenatal care visit and starting on ART Option B+ as per the National PMTCT Program guidelines were enrolled into the FLC for Option B+ RCT in urban Kampala and rural Mityana districts of Uganda. Each participant had whole blood samples collected at enrolment to assess baseline VL. Plasma HIV-1 RNA was quantified using COBAS Ampliprep /COBAS Taqman. Baseline VL below 400 RNA copies/ml was considered as viral suppression while baseline VL below 20 RNA copies/ml was considered uVL.ResultsThe mean duration from the date of ART initiation to time of sample collection for baseline VL assessment was 4.4 days (SD 3.6). Of the 532 HIV-positive pregnant women enrolled in the FLC for Option B+ study and newly starting Option B+ without a self-reported history of prior ART use, 29 (5.5%) had uVL and 113 (21.4%) had suppressed VL at baseline. There was no association between participants' age, gravidity, marital status, mean monthly income, educational level, disclosure of HIV status to partner, and uVL or viral suppression at baseline. However, non-disclosure of HIV status to any other person was associated with decreased odds of viral suppression at baseline (OR 0.640; 0.416-0.982).ConclusionTwenty-one percent of HIV-positive Ugandan pregnant women initiating ART (Option B+) showed virological suppression at baseline and were presumed to be "elite controllers" or to have misreported being ART-naive. Further studies are needed to better understand the biologic mechanisms of elite controllers among pregnant women as well as to differentiate elite controllers from concealed ART use. Trial Registration The trial was registered as NCT02515370 (04/08/2015) on Clinicaltrials.gov.

Published
2021

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. 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

9. 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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11. Couples’ Preferences for “2 in 1” Multipurpose Prevention Technologies to Prevent Both HIV and Pregnancy: Results of a Discrete Choice Experiment in Uganda and Zimbabwe

Author

Minnis, Alexandra M., Etima, Juliane, Musara, Petina, Browne, Erica N., Mutero, Prisca, Kemigisha, Doreen, Mgodi, Nyaradzo M., Nakabiito, Clemensia, Shapley-Quinn, Mary Kate, Stoner, Marie C. D., Hartmann, Miriam, Macagna, Nicole, Piper, Jeanna, and van der Straten, Ariane

Published
2022
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12. 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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13. Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial

Author

Akello, Carolyne A, Bunge, Katherine E, Nakabiito, Clemensia, Mirembe, Brenda G, Fowler, Mary Glenn, Mishra, Anupam, Marrazzo, Jeanne, Chirenje, Zvavahera M, Celum, Connie, and Balkus, Jennifer E

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Contraception/Reproduction, HIV/AIDS, Prevention, Clinical Trials and Supportive Activities, Comparative Effectiveness Research, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Adult, Chemoprevention, Contraception, Contraception Behavior, Contraceptives, Oral, Combined, Female, HIV Infections, Humans, Incidence, Medroxyprogesterone Acetate, Middle Aged, Outcome Assessment, Health Care, Pregnancy, Proportional Hazards Models, Uganda, Young Adult, hormonal contraception, contraceptive initiation, DMPA, oral contraception, HIV prevention, Medical and Health Sciences, Public Health, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundRecent HIV prevention trials required use of effective contraceptive methods to fulfill eligibility for enrollment. We compared pregnancy rates in a subset of participants enrolled in the Microbicide Trials Network protocol (MTN-003), a randomized trial of chemoprophylaxis to prevent HIV acquisition among women aged 18-45 years who initiated depot medroxyprogesterone acetate (DMPA) or combined oral contraceptives (COCs) at enrollment, relative to those already using DMPA or COCs.MethodsData were analyzed from MTN-003 participants from Uganda. Before enrollment, information on contraceptive type and initiation date was obtained. Urine pregnancy tests were performed at monthly follow-up visits. Cox proportional hazards models were used to compare pregnancy incidence among new users (initiated ≤60 days before enrollment) and established users (initiated >60 days before enrollment).ResultsOf 322 women enrolled, 296 were COC or DMPA users, 82 (28%) were new users, and 214 (72%) were established users. Pregnancy incidence was higher among new contraceptive users compared to established users (20.70% vs. 10.55%; adjusted hazard ratio [HR] = 1.66; 95% confidence interval [95% CI] 0.93-2.96). Among DMPA users, pregnancy incidence was 10.20% in new users versus 3.48% in established users (HR = 2.56; 95% CI 0.86-7.65). Among new COC users, pregnancy incidence was 42.67% in new users versus 23.67% in established COC users (adjusted HR = 1.74; 95% CI 0.87-3.48).ConclusionsNew contraceptive users, regardless of method, at the Uganda MTN-003 site had an increased pregnancy risk compared to established users, which may be due to contraceptive initiation primarily for trial eligibility. New users may benefit from intensive contraceptive counseling and additional contraceptive options, including longer acting reversible contraceptives.

Published
2017

14. 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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15. 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, Sexually Transmitted Infections, HIV/AIDS, Prevention, Clinical Trials and Supportive Activities, Women's Health, Clinical Research, Infectious Diseases, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, 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

16. Bone Mineral Density Changes Among Young, Healthy African Women Receiving Oral Tenofovir for HIV Preexposure Prophylaxis

Author

Mirembe, Brenda G, Kelly, Clifton W, Mgodi, Nyaradzo, Greenspan, Susan, Dai, James Y, Mayo, Ashley, Piper, Jeanna, Akello, Carolyne A, Kiweewa, Flavia M, Magure, Tsitsi, Nakabiito, Clemensia, Marrazzo, Jeanne M, Chirenje, Z Mike, and Riddler, Sharon A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Osteoporosis, Prevention, Clinical Research, HIV/AIDS, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Musculoskeletal, Adolescent, Adult, Anti-HIV Agents, Bone Density, Female, HIV Infections, Humans, Pre-Exposure Prophylaxis, Tenofovir, Uganda, Young Adult, Zimbabwe, tenofovir, bone density, preexposure prophylaxis, HIV prevention, African women, MTN-003B Protocol Team, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

BackgroundLimited data exist on effect of tenofovir disoproxil fumarate (TDF) when used for preexposure prophylaxis (PrEP) on bone mineral density (BMD) in HIV-negative women. We evaluated the effect of daily oral TDF and emtricitabine/TDF compared with placebo on BMD among women enrolled in an HIV-1 PrEP trial.MethodsHIV-uninfected women in Uganda and Zimbabwe had BMD measurements of lumbar spine (LS) and total hip (TH) by dual-energy x-ray absorptiometry at baseline and every 24 weeks for 48 weeks of active treatment and for 48 weeks after discontinuation of study medication. Plasma tenofovir levels were assessed every 12 weeks for the first 48 weeks.ResultsOf 518 women enrolled, 432 had dual-energy x-ray absorptiometry results at baseline and week 48. In the primary analysis, no significant differences in percent BMD change in hip or spine between arms observed, likely because of low product adherence. Among the subset with tenofovir detection in 75%-100% of plasma samples, the mean percent BMD change from baseline to week 48 in the LS was 1.4% lower for TDF or emtricitabine/TDF recipients than for placebo (P = 0.002) and TH BMD was 0.9% lower (P = 0.018). BMD changes from end of active treatment to 48 weeks were significantly greater in the active arm participants compared with placebo participants with a net difference of approximately +0.9% at the LS (P = 0.007) and +0.7% (P = 0.003) at the TH.ConclusionsTDF-containing oral PrEP resulted in small but significant reversible decreases in hip and spine BMD among young African women.

Published
2016

18. Ethical considerations for involving adolescents in biomedical HIV prevention research

Author

Nakalega, Rita, Akello, Carolyne, Gati, Brenda, Nakabiito, Clemensia, Nolan, Monica, Kamira, Betty, Etima, Juliane, Nakyanzi, Teopista, Kemigisha, Doreen, Nanziri, Sophie C., Nanyonga, Stella, Nambusi, Maria Janine, Mulumba, Emmie, Biira, Florence, Nabunya, Hadijah Kalule, Akasiima, Simon Afrika, Nansimbe, Joselyne, Maena, Joel, Babirye, Juliet Allen, Ngure, Kenneth, and Mujugira, Andrew

Published
2021
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19. Enhanced peer-group strategies to support the prevention of mother-to-child HIV transmission leads to increased retention in care in Uganda: A randomized controlled trial.

Author

Amone, Alexander, Gabagaya, Grace, Wavamunno, Priscilla, Rukundo, Gordon, Namale-Matovu, Joyce, Malamba, Samuel S., Lubega, Irene, Homsy, Jaco, King, Rachel, Nakabiito, Clemensia, Namukwaya, Zikulah, Fowler, Mary Glenn, and Musoke, Philippa

Subjects
HIV, HIV infection transmission, INFANTS, ORPHANS, RANDOMIZED controlled trials, HIV prevention, HIV-positive women, HEALTH facilities
Abstract

Introduction: Despite the scale-up of Option B+, long-term retention of women in HIV care during pregnancy and the postpartum period remains an important challenge. We compared adherence to clinic appointments and antiretroviral therapy (ART) at 6 weeks, 6, and and 24 months postpartum among pregnant women living with HIV and initiating Option B+. Women were randomized to a peer group support, community-based drug distribution and income-generating intervention called "Friends for Life Circles" (FLCs) versus the standard of care (SOC). Our secondary outcome was infant HIV status and HIV-free survival at 6 weeks and 18 months postpartum. Methods: Between 16 May 2016 and 12 September 2017, 540 ART-naïve pregnant women living with HIV at urban and rural health facilities in Uganda were enrolled in the study at any gestational age. Participants were randomized 1:1 to the unblinded FLC intervention or SOC at enrolment and assessed for adherence to the prevention of mother-to-child HIV transmission (PMTCT) clinic appointments at 6 weeks, 12, and 24 months postpartum, self-reported adherence to ART at 6 weeks, 6 and 24 months postpartum and supported by plasma HIV-1 RNA viral load (VL) measured at the same time points, retention in care through the end of study, and HIV status and HIV-free survival of infants at 18 months postpartum. The FLC groups were formed during pregnancy within 4 months of enrollment and held monthly meetings in their communites, and were followed up until the last group participant reached 24 months post delivery. We used Log-rank and Chi-Square p-values to test the equality of Kaplan-Meier survival probabilities and hazard rates (HR) for failure to retain in care for any reason by study arm. Results: There was no significant difference in adherence to PMTCT clinic visits or to ART or in median viral loads between FLC and SOC arms at any follow-up time points. Retention in care through the end of study was high in both arms but significantly higher among participants randomized to FLC (86.7%) compared to SOC (79.3%), p = 0.022. The adjusted HR of visit dropout was 2.4 times greater among participants randomized to SOC compared to FLC (aHR = 2.363, 95% CI: 1.199–4.656, p = 0.013). Median VL remained < 400 copies/ml in both arms at 6 weeks, 6, and 24 months postpartum. Eight of the 431 infants tested at 18 months were HIV positive (1.9%), however, this was not statistically different among mothers enrolled in the FLC arm compared to those in the SOC arm. At 18 months, HIV-free survival of children born to mothers in the FLC arm was significantly higher than that of children born to mothers in the SOC arm. Conclusions: Our findings suggest that programmatic interventions that provide group support, community-based ART distribution, and income-generation activities may contribute to retention in PMTCT care, HIV-free survival of children born to women living with HIV, and ultimately, to the elimination of mother-to-child HIV transmission (EMTCT). Trial registration: NCT02515370 (04/08/2015) on ClinicalTrials.gov. [ABSTRACT FROM AUTHOR]

Published
2024
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21. 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
Analysis, Usage, Risk factors, Patient outcomes, Sexually transmitted diseases -- Patient outcomes, HIV infections -- Risk factors, Disease susceptibility -- Analysis, Medical research, Contraceptives -- Usage
Abstract

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 [...], 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

Published
2019
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22. DELIVER: A Safety Study of a Dapivirine Vaginal Ring and Oral PrEP for the Prevention of HIV During Pregnancy

Author

Bunge, Katherine, primary, Balkus, Jennifer E., additional, Fairlie, Lee, additional, Mayo, Ashley J., additional, Nakabiito, Clemensia, additional, Mgodi, Nyaradzo, additional, Gadama, Luis, additional, Matrimbira, Moleen, additional, Chappell, Catherine Anne, additional, Piper, Jeanna, additional, Chakhtoura, Nahida, additional, Szydlo, Daniel w., additional, Richardson, Barbra, additional, and Hillier, Sharon L., additional

Published
2023
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24. Enhanced Peer-Group strategies to support prevention of Mother-to-Child HIV transmission leads to increased retention in care in Uganda: A Randomized controlled trial

Author

Amone, Alexander, primary, Gabagaya, Grace, additional, Wavamunno, Priscilla, additional, Rukundo, Gordon, additional, Matovu, Joyce Namale, additional, Malamba, Samuel S, additional, Lubega, Irene, additional, Homsy, Jaco, additional, King, Rahcel, additional, Nakabiito, Clemensia, additional, Namukwaya, Zikulah, additional, Fowler, Mary Glenn, additional, and Musoke, Philippa, additional

Published
2023
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28. Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial

Author

Coovadia, Hoosen M, Brown, Elizabeth R, Fowler, Mary Glenn, Chipato, Tsungai, Moodley, Dhayendre, Manji, Karim, Musoke, Philippa, Stranix-Chibanda, Lynda, Chetty, Vani, Fawzi, Wafaie, Nakabiito, Clemensia, Msweli, Lindiwe, Kisenge, Roderick, Guay, Laura, Mwatha, Anthony, Lynn, Diana J, Eshleman, Susan H, Richardson, Paul, George, Kathleen, Andrew, Philip, Mofenson, Lynne M, Zwerski, Sheryl, and Maldonado, Yvonne

Published
2012
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29. 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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31. Couples’ decision making regarding the use of multipurpose prevention technology (MPT) for pregnancy and HIV prevention

Author

Stoner, Marie C.D., primary, Browne, Erica N, additional, Etima, Juliane, additional, Musara, Petina, additional, Hartmann, Miriam, additional, Shapley-Quinn, Mary Kate, additional, Kemigisha, Doreen, additional, Mutero, Prisca, additional, Mgodi, Nyaradzo M., additional, Nakabiito, Clemensia, additional, Bhushan, Nivedita L., additional, Piper, Jeanna, additional, van der Straten, Ariane, additional, and Minnis, Alexandra M., additional

Published
2022
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33. 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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34. Intramuscular depot medroxyprogesterone acetate accentuates bone loss associated with tenofovir disoproxil fumarate-containing antiretroviral therapy initiation in young women living with HIV (the BONE: CARE study): a prospective cohort study in Uganda

Author

Kiweewa Matovu, Flavia, primary, Kiwanuka, Noah, additional, Nabwana, Martin, additional, Scholes, Delia, additional, Musoke, Philippa, additional, Glenn Fowler, Mary, additional, Beksinska, Mags E, additional, Pettifor, John M, additional, Brown, Todd T, additional, Kiweewa, Flavia Matovu, additional, Nakabiito, Clemensia, additional, Nawagi, Faith, additional, Kamira, Betty, additional, Isingel, Esther, additional, Bule, Stephen, additional, Kukundakwe, Violet, additional, Kateregga, Andrew, additional, Musisi, Mary (Maria), additional, Namayanja, Paula Mubiru, additional, Mirembe, Dorothy, additional, Mbabali, Mary Speciosa, additional, Mulebeke, Sarah, additional, Nabisere, Joselyne, additional, Nakakande, Joyce, additional, Matovu, Nicholas, additional, Nakaye, Dorah, additional, Wynne, Joshua, additional, Mulumba, Faith, additional, Mukasa, Restituta, additional, Ssewanyana, Masitula, additional, Nabunya, Hadijah Kalule, additional, Biira, Florence Asiimwe, additional, Kyomukama, Erinah, additional, Nampiira, Suzan, additional, Zalwago, Aisha, additional, Namuganga, Margaret l, additional, Mwebaza, Deborah, additional, Namuli, Prossy Ethel, additional, Tulina, Caroline, additional, Kikonyogo, Florence Sempa, additional, Nabatanzi, Regina Bukenya, additional, Muwawu, Rosemary, additional, Musisi, Jane Nsubuga, additional, Saava, Margaret Nakato, additional, Najjemba, Mary Mukasa Kagwa, additional, Kaahwa, Winfred, additional, Mukalazi, Rose Namwanje, additional, Takhuli, Miriam Magomu, additional, Sawsan, Osman, additional, Mugenyi, Margaret, additional, Mugagga, Mary Agnes, additional, Sserugo, Francis, additional, Namuddu, Agnes, additional, Kemigisha, Doreen, additional, Nakyeyune, Justine, additional, Nassozi, Caroline Kawuma, additional, Asello, Juliet, additional, Nakawungu, Zaam Zinda, additional, Kaboggoza, Olivia Higiro, additional, Ssebabi, Sarah Babirye, additional, Birungi, Bertha, additional, Ssentogo, Ruth Lutabi, additional, Mubiru, Michael Charles, additional, Nansamba, Winnie, additional, Kalungi, Stella Nalusiba, additional, Bukenya, Luke Erismus, additional, Asiimwe, Prossy, additional, Bazira, James Amos, additional, Katongole, Sulaiman, additional, Twinomujuni, Wenceslaus, additional, Nakacwa, Susan, additional, Baddokwaya, Joanita Nankya, additional, Elwana, Alice Margaret, additional, Nanyonjo, Juliet, additional, Adikini, Susan, additional, Nalwoga, Justine, additional, Rwanzogyera, Godfrey, additional, Okello, Fabian, additional, Kiiza, Daniel Kabenge, additional, Mayanja, Emmanuel, additional, Katongole, Francis, additional, Kiwewa, Max, additional, Onen, Francis, additional, Mutebo, Joseph, additional, Mukasa, Dick, additional, Tamale, Joshua, additional, and Kibirige, Ismael, additional

Published
2022
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35. 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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37. 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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38. 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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40. Analysis of HIV Tropism in Ugandan Infants

Author

Church, Jessica D., Huang, Wei, Mwatha, Anthony, Musoke, Philippa, Jackson, Brooks J., Bagenda, Danstan, Omer, Saad B., Donnell, Deborah, Nakabiito, Clemensia, Eure, Chineta, Guay, Laura A., Taylor, Allan, Bakaki, Paul M., Matovu, Flavia, McConnell, Michelle, Fowler, Mary Glenn, and Eshleman, Susan H.

Published
2010

45. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial

Author

Jackson, J Brooks, Musoke, Philippa, Fleming, Thomas, Guay, Laura A, Bagenda, Danstan, Allen, Melissa, Nakabiito, Clemensia, Sherman, Joseph, Bakaki, Paul, Owor, Maxensia, Ducar, Constance, Deseyve, Martina, Mwatha, Anthony, Emel, Lynda, Duefield, Corey, Mirochnick, Mark, Fowler, Mary Glenn, Mofenson, Lynne, Miotti, Paolo, Gigliotti, Maria, Bray, Dorothy, and Mmiro, Francis

Published
2003
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46. Tenofovir Diphosphate Concentrations in Dried Blood Spots From Pregnant and Postpartum Adolescent and Young Women Receiving Daily Observed Pre-exposure Prophylaxis in Sub-Saharan Africa.

Author

Stranix-Chibanda, Lynda, Anderson, Peter L., Kacanek, Deborah, Hosek, Sybil, Sharon Huang, Nematadzira, Teacler G., Taulo, Frank, Korutaro, Violet, Nakabiito, Clemensia, Masenya, Maysebole, Lypen, Kathryn, Brown, Emily, Ibrahim, Mustafa E., Yager, Jenna, Wiesner, Lubbe, Johnston, Benjamin, Amico, K. Rivet, Rooney, James F., Chakhtoura, Nahida, and Spiegel, Hans M. L.

Abstract

Background. Intracellular tenofovir diphosphate (TFV-DP) concentration in dried blood spots (DBSs) is used to monitor cumulative pre-exposure prophylaxis (PrEP) adherence. We evaluated TFV-DP in DBSs following daily oral PrEP (emtricitabine 200 mg/tenofovir diphosphate 300 mg) among pregnant and postpartum adolescent girls and young women (AGYW). Methods. Directly observed PrEP was administered for 12 weeks in a pregnancy (14–24 weeks’ gestation, n = 20) and postpartum (6–12 weeks postpartum, n = 20) group of AGYW aged 16–24 years in sub-Saharan Africa. Weekly DBS TFV-DP was measured by validated liquid chromatography–tandem mass spectrometry assay. Week 12 TFV-DP distributions were compared between groups with Wilcoxon test. Population pharmacokinetic models were fit to estimate steady-state concentrations and create benchmarks for adherence categories. Baseline correlates of TFV-DP were evaluated. Results. Median age was 20 (IQR, 19–22) years. Of 3360 doses, 3352 (>99%) were directly observed. TFV-DP median (IQR) half-life was 10 (7–12) days in pregnancy and 17 (14–21) days postpartum, with steady state achieved by 5 and 8 weeks, respectively. Observed median (IQR) steady-state TFV-DP was 965 fmol/punch (691–1166) in pregnancy versus 1406 fmol/punch (1053–1859) postpartum (P = .006). Modeled median steady-state TFV-DP was 881 fmol/punch (667–1105) in pregnancy versus 1438 fmol/punch (1178–1919) postpartum. In pooled analysis, baseline creatinine clearance was associated with observed TFV-DP concentrations. Conclusions. TFV-DP in African AGYW was approximately one-third lower in pregnancy than postpartum. These Populationspecific benchmarks can be used to guide PrEP adherence support in pregnant/postpartum African women. [ABSTRACT FROM AUTHOR]

Published
2021
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47. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial

Author

Guay, Laura A, Musoke, Philippa, Fleming, Thomas, Bagenda, Danstan, Allen, Melissa, Nakabiito, Clemensia, Sherman, Joseph, Bakaki, Paul, Ducar, Constance, Deseyve, Martina, Emel, Lynda, Mirochnick, Mark, Fowler, Mary Glenn, Mofenson, Lynne, Miotti, Paolo, Dransfield, Kevin, Bray, Dorothy, Mmiro, Francis, and Jackson, J Brooks

Published
1999

50. Assessing pregnancy and neonatal outcomes in Malawi, South Africa, Uganda, and Zimbabwe: Results from a systematic chart review.

Author

Balkus, Jennifer E., Neradilek, Moni, Fairlie, Lee, Makanani, Bonus, Mgodi, Nyaradzo, Mhlanga, Felix, Nakabiito, Clemensia, Mayo, Ashley, Harrell, Tanya, Piper, Jeanna, and Bunge, Katherine E.

Subjects
PREGNANCY outcomes, PREGNANCY complications, NEONATAL death, PREMATURE labor, HIV prevention, CHILDBIRTH at home
Abstract

A systematic chart review was performed to estimate the frequency of pregnancy outcomes, pregnancy complications and neonatal outcomes at facilities in Blantyre, Malawi; Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza and Harare, Zimbabwe to provide comparisons with estimates from an ongoing clinical trial evaluating the safety of two biomedical HIV prevention interventions in pregnancy. A multi-site, cross-sectional chart review was conducted at Maternal Obstetric Units and hospitals where women participating in the ongoing clinical trial would be expected to deliver. All individuals delivering at the designated facilities or admitted for postpartum care within seven days of a delivery elsewhere (home, health clinic, etc.) were included in the review. Data were abstracted for pregnancy outcomes, pregnancy complications, maternal and neonatal death, and congenital anomalies. Data from 10,138 records were abstracted across all four sites (Blantyre n = 2,384; Johannesburg n = 1,888; Kampala n = 3,708; Chitungwiza and Harare n = 2,158), which included 10,426 pregnancy outcomes. The prevalence of preterm birth was 13% (range across sites: 10.4–20.7) and 4.1% of deliveries resulted in stillbirth (range: 3.1–5.5). The most commonly noted pregnancy complication was gestational hypertension, reported among 4.4% of pregnancies. Among pregnancies resulting in a live birth, 15.5% were low birthweight (range: 13.8–17.4) and 2.0% resulted in neonatal death (range:1.2–3.2). Suspected congenital anomalies were noted in 1.2% of pregnancies. This study provides systematically collected data on background rates of pregnancy outcomes, pregnancy complications and neonatal outcomes that can be used as a reference in support of ongoing HIV prevention studies. In addition, estimates from this study provide important background data for future studies of investigational products evaluated in pregnancy in these urban settings. [ABSTRACT FROM AUTHOR]

Published
2021
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