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3. Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap

Author

Joseph Davey, Dvora L, Bekker, Linda-Gail, Bukusi, Elizabeth A, Chi, Benjamin H, Delany-Moretlwe, Sinead, Goga, Ameena, Lyerly, Anne Drapkin, Mgodi, Nyaradzo M, Mugo, Nelly, Myer, Landon, Noguchi, Lisa M, Stranix-Chibanda, Lynda, Slack, Catherine, and Pintye, Jillian

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, HIV/AIDS, Clinical Trials and Supportive Activities, Clinical Research, Prevention, Infectious Diseases, Mental Health, Pediatric, Anti-HIV Agents, Breast Feeding, Female, HIV Infections, Humans, Pre-Exposure Prophylaxis, Pregnancy, Tenofovir, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

Pregnant and breastfeeding populations are at substantial risk of acquiring HIV in some settings, yet are underrepresented in clinical trials of new pre-exposure prophylaxis (PrEP) agents. Several PrEP formulations are in development (eg, vaginal rings, long-acting injectables, and other modalities). Pregnant and breastfeeding populations are typically excluded from initial clinical trials. We identified 14 PrEP trials of novel agents in non-pregnant or non-breastfeeding populations, and six phase 1-3 trials and open label extensions among pregnant and breastfeeding populations, that are currently ongoing or complete. A framework shift is needed to consider the ethical costs of excluding pregnant and breastfeeding populations at risk for HIV in PrEP clinical trials and promote inclusion to maximise the benefits from PrEP tools in the pipeline. Research on new PrEP agents should include pregnant and breastfeeding populations to avoid delays in reaching those who could benefit from PrEP after efficacy is established.

Published
2022

4. Impact of catch-up human papillomavirus vaccination on cervical cancer incidence in Kenya: A mathematical modeling evaluation of HPV vaccination strategies in the context of moderate HIV prevalence

Author

Liu, Gui, Mugo, Nelly R, Bayer, Cara, Rao, Darcy White, Onono, Maricianah, Mgodi, Nyaradzo M, Chirenje, Zvavahera M, Njoroge, Betty W, Tan, Nicholas, Bukusi, Elizabeth A, and Barnabas, Ruanne V

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Research, Prevention, Vaccine Related, Cancer, Sexually Transmitted Infections, Cervical Cancer, Infectious Diseases, Immunization, HIV/AIDS, 3.4 Vaccines, Prevention of disease and conditions, and promotion of well-being, Infection, Good Health and Well Being, HPV vaccination, HIV, Cervical cancer, Mathematical model, HPV, Clinical sciences, Health services and systems, Public health
Abstract

BackgroundCervical cancer incidence is high in Kenya due to HIV and limited access to cancer prevention services. Human papillomavirus (HPV) has been shown to increase HIV acquisition; however, the potential impact of HPV vaccination on HIV is unknown. We modeled the health impact of HPV vaccination in the context of the HIV epidemiology in Kenya.MethodsUsing a validated compartmental transmission model of HIV and HPV set in Kenya, we evaluated five scenarios of nonavalent HPV vaccination: single-age-vaccination of 10-year-old girls at 90% coverage; multi-age-cohort (MAC) vaccination of 10-14-year-old girls at 90% coverage; MAC plus moderate-coverage (50%) catch-up vaccination of 15-24-year-old women; MAC plus high-coverage (80%) catch-up of 15-24-year-old women; and MAC plus catch-up of 15-44-year-old women at 80% coverage (HPV-FASTER). We compared cervical cancer incidence, HIV prevalence, and cumulative cervical cancer and HIV cases averted after 50 years to a baseline scenario without vaccination. In all scenarios, we assumed the UNAIDS 90-90-90 goal for HIV treatment is attained by 2030.FindingsIn 2021, model-estimated cervical cancer incidence is 44/100,000 and HIV prevalence among women is 6·5%. In 2070, projected cancer incidence declines to 27/100,000 and HIV prevalence reaches 0·3% without vaccination. With single-age-vaccination, cancer incidence in 2070 is reduced by 68%, averting 64,529 cumulative cancer cases. MAC vaccination reduces cancer incidence by 75%, averting 206,115 cancer cases. Moderate and high-coverage catch-up and HPV-FASTER reduce cancer incidence by 80%, 82%, and 84%, averting 254,930, 278,690, and 326,968 cancer cases, respectively. In all scenarios, HIV prevalence in 2070 is reduced by a relative 8-11%, with 15,609-34,981 HIV cases averted after 50 years.InterpretationHPV vaccination can substantially reduce cervical cancer incidence in Kenya in the next 50 years, particularly if women up to age 24 are vaccinated. HIV treatment scale-up can also alleviate cervical cancer burden. However, HPV vaccination has modest additional impact on HIV when antiretroviral therapy coverage is high.FundingNational Institutes of Health, Bill and Melinda Gates Foundation.

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. Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01

Author

Huang, Yunda, Zhang, Lily, Karuna, Shelly, Andrew, Philip, Juraska, Michal, Weiner, Joshua A., Angier, Heather, Morgan, Evgenii, Azzam, Yasmin, Swann, Edith, Edupuganti, Srilatha, Mgodi, Nyaradzo M., Ackerman, Margaret E., Donnell, Deborah, Gama, Lucio, Anderson, Peter L., Koup, Richard A., Hural, John, Cohen, Myron S., Corey, Lawrence, McElrath, M. Juliana, Gilbert, Peter B., and Lemos, Maria P.

Published
2023
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7. Safety and immunogenicity of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120 vaccine boost adjuvanted with MF59 or alum in healthy adults without HIV (HVTN 107): A phase 1/2a randomized trial

Author

Moodie, Zoe, Andersen-Nissen, Erica, Grunenberg, Nicole, Dintwe, One B., Omar, Faatima Laher, Kee, Jia J., Bekker, Linda-Gail, Laher, Fatima, Naicker, Nivashnee, Jani, Ilesh, Mgodi, Nyaradzo M., Hunidzarira, Portia, Sebe, Modulakgota, Miner, Maurine D., Polakowski, Laura, Ramirez, Shelly, Nebergall, Michelle, Takuva, Simbarashe, Sikhosana, Lerato, Heptinstall, Jack, Seaton, Kelly E., De Rosa, Stephen, Diazgranados, Carlos A., Koutsoukos, Marguerite, Van Der Meeren, Olivier, Barnett, Susan W., Kanesa-thasan, Niranjan, Kublin, James G., Tomaras, Georgia D., McElrath, M. Juliana, Corey, Lawrence, Mngadi, Kathryn, and Goepfert, Paul

Subjects
United States. National Institutes of Health, HIV (Viruses) -- Comparative analysis -- Usage, Vaccination -- Usage -- Comparative analysis, Immune response -- Usage -- Comparative analysis, Immunoglobulin A -- Comparative analysis -- Usage, Clinical trials -- Usage -- Comparative analysis, Adults -- Comparative analysis -- Usage, Immunoglobulin G -- Usage -- Comparative analysis, AIDS vaccines -- Usage -- Product development, Biological sciences
Abstract

Background Adjuvants are widely used to enhance and/or direct vaccine-induced immune responses yet rarely evaluated head-to-head. Our trial directly compared immune responses elicited by MF59 versus alum adjuvants in the RV144-like HIV vaccine regimen modified for the Southern African region. The RV144 trial of a recombinant canarypox vaccine vector expressing HIV env subtype B (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost adjuvanted with alum is the only trial to have shown modest HIV vaccine efficacy. Data generated after RV144 suggested that use of MF59 adjuvant might allow lower protein doses to be used while maintaining robust immune responses. We evaluated safety and immunogenicity of an HIV recombinant canarypox vaccine vector expressing HIV env subtype C (ALVAC-HIV) prime followed by ALVAC-HIV plus a bivalent gp120 protein vaccine boost (gp120) adjuvanted with alum (ALVAC-HIV+gp120/alum) or MF59 (ALVAC-HIV+gp120/MF59) or unadjuvanted (ALVAC-HIV+gp120/no-adjuvant) and a regimen where ALVAC-HIV+gp120 adjuvanted with MF59 was used for the prime and boost (ALVAC-HIV+gp120/MF59 coadministration). Methods and findings Between June 19, 2017 and June 14, 2018, 132 healthy adults without HIV in South Africa, Zimbabwe, and Mozambique were randomized to receive intramuscularly: (1) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/MF59 (months 3, 6, and 12), n = 36; (2) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/alum (months 3, 6, and 12), n = 36; (3) 4 doses of ALVAC-HIV+gp120/MF59 coadministered (months 0, 1, 6, and 12), n = 36; or (4) 2 priming doses of ALVAC-HIV (months 0 and 1) followed by 3 booster doses of ALVAC-HIV+gp120/no adjuvant (months 3, 6, and 12), n = 24. Primary outcomes were safety and occurrence and mean fluorescence intensity (MFI) of vaccine-induced gp120-specific IgG and IgA binding antibodies at month 6.5. All vaccinations were safe and well-tolerated; increased alanine aminotransferase was the most frequent related adverse event, occurring in 2 (1.5%) participants (1 severe, 1 mild). At month 6.5, vaccine-specific gp120 IgG binding antibodies were detected in 100% of vaccinees for all 4 vaccine groups. No significant differences were seen in the occurrence and net MFI of vaccine-specific IgA responses between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/alum-prime-boost groups or between the ALVAC-HIV+gp120/MF59-prime-boost and ALVAC-HIV+gp120/MF59 coadministration groups. Limitations were the relatively small sample size per group and lack of evaluation of higher gp120 doses. Conclusions Although MF59 was expected to enhance immune responses, alum induced similar responses to MF59, suggesting that the choice between these adjuvants may not be critical for the ALVAC+gp120 regimen. Trial registration HVTN 107 was registered with the South African National Clinical Trials Registry (DOH-27-0715-4894) and ClinicalTrials.gov (NCT03284710)., Author(s): Zoe Moodie 1,*, Erica Andersen-Nissen 1,2, Nicole Grunenberg 1, One B. Dintwe 1,2, Faatima Laher Omar 2, Jia J. Kee 1, Linda-Gail Bekker 3, Fatima Laher 4, Nivashnee Naicker [...]

Published
2024
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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. How Presentation of Drug Detection Results Changed Reports of Product Adherence in South Africa, Uganda and Zimbabwe

Author

Musara, Petina, Montgomery, Elizabeth T, Mgodi, Nyaradzo M, Woeber, Kubashni, Akello, Carolyne A, Hartmann, Miriam, Cheng, Helen, Levy, Lisa, Katz, Ariana, Grossman, Cynthia I, Chirenje, Z Mike, van der Straten, Ariane, Mensch, Barbara, and On behalf of the Microbicide Trials Network-003D Study Team

Subjects
Public Health, Health Sciences, Infectious Diseases, HIV/AIDS, Sexually Transmitted Infections, Clinical Trials and Supportive Activities, Prevention, Clinical Research, 7.1 Individual care needs, Good Health and Well Being, Adult, Anti-HIV Agents, Female, HIV Infections, Humans, Medication Adherence, Pre-Exposure Prophylaxis, Qualitative Research, Self Report, South Africa, Uganda, Zimbabwe, Drug detection results, Adherence measures, Pre-exposure prophylaxis, Microbicides, HIV prevention, Microbicide Trials Network-003D Study Team, Public Health and Health Services, Social Work, Public health
Abstract

Accurate estimates of study product use are critical to understanding and addressing adherence challenges in HIV prevention trials. The VOICE trial exposed a significant gap between self-reported adherence and drug detection. The VOICE-D qualitative study was designed to better understand non-adherence during VOICE, and was conducted in 2 stages: before (stage 1) and after (stage 2) drug detection results were provided to participants. Transcripts from 44 women who participated in both stages were analysed to understand the effect of presenting drug detection data on narratives of product use. Thirty-six women reported high adherence in stage 1, yet admitted non-use in stage 2, three reported high adherence in both stages (contrary to their drug detection results) and five had consistent responses across both stages and drug results. Presenting objective measures of use may facilitate more accurate product use reporting and should be evaluated in future prevention trials.

Published
2018

13. Advancing the use of Long‐Acting Extended Delivery formulations for HIV prevention in sub‐Saharan Africa: challenges, opportunities, and recommendations

Author

Mgodi, Nyaradzo M., Murewanhema, Grant, Moyo, Enos, Samba, Chesterfield, Musuka, Godfrey, Dzinamarira, Tafadzwa, and Brown, Joelle M.

Subjects
HIV infection -- Prevention, Health
Abstract

: Introduction: The burden of HIV in sub‐Saharan Africa (SSA) remains unacceptably high, and disproportionately affects girls and women. While the introduction of oral HIV pre‐exposure prophylaxis (PrEP) in 2012 revolutionized HIV prevention, its effectiveness is dependent on user adherence and its implementation in SSA has faced numerous challenges. Patient‐level, interpersonal and structural barriers, including, for example, daily pill burden, side effects, lack of partner support, testing and disclosure, and costs have been found to reduce adherence to oral PrEP. Discussion: Long‐acting extended delivery (LAED) formulations for PrEP, such as injectable long‐acting cabotegravir (CAB‐LA) and dapivirine vaginal ring (DPV‐VR) are critical additions to the HIV prevention toolkit and are especially important for populations such as adolescent girls and young women (AGYW) and other key populations who remain at significant risk of HIV acquisition while facing substantial barriers to preventive services. These LAED formulations have been shown to result in better adherence and fewer side effects, with CAB‐LA being superior to oral PrEP in reducing the risk of HIV acquisition. They can be used to overcome user burden and adherence challenges. However, the successful rollout of the DPV‐VR and CAB‐LA may be hampered by issues such as a shortage of healthcare providers (HCPs), inadequate parenteral medication infrastructure, increased workload for HCPs, patient concerns, the price of the medications and the possibility of drug resistance. Conclusions: SSA must develop laboratory capabilities for monitoring patients on LAED formulations and enhance research on developing more non‐injectable LAED formulations. There is a need to train and retain more HCPs, implement task shifting, invest in healthcare infrastructure and integrate healthcare services. To reduce costs and improve availability, the region must advocate for patent license waivers for LAED formulations and procure drugs collectively as a region., INTRODUCTION The burden of HIV in sub‐Saharan Africa Despite major advances in HIV prevention and treatment, the global burden of HIV remains unacceptably high. Approximately 38 million people are currently [...]

Published
2023
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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. Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlled, cross-over studies in South Africa and Zimbabwe

Author

Friedland, Barbara A, primary, Mgodi, Nyaradzo M, additional, Palanee-Phillips, Thesla, additional, Mathur, Sanyukta, additional, Plagianos, Marlena G, additional, Bruce, Irene V, additional, Lansiaux, Maud, additional, Murombedzi, Caroline, additional, Musara, Petina, additional, Dandadzi, Adlight, additional, Reddy, Krishnaveni, additional, Ndlovu, Nkosiphile, additional, Zulu, Sihle K, additional, Shale, Lerato R, additional, Zieman, Brady, additional, and Haddad, Lisa B, additional

Published
2024
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16. 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

18. Infusion reactions after receiving the broadly neutralizing antibody VRC01 or placebo to reduce HIV-1 acquisition: Results from the phase 2b Antibody Mediated Prevention (AMP) randomized trials

Author

Takuva, Simbarashe, Karuna, Shelly T., Juraska, Michal, Rudnicki, Erika, Edupuganti, Srilatha, Anderson, Maija, De La Grecca, Robert, Gaudinski, Martin R., Sehurutshi, Alice, Orrell, Catherine, Naidoo, Logashvari, Valencia, Javier, Villela, Larissa M., Walsh, Stephen R., Andrew, Philip, Karg, Carissa, Randhawa, April, Hural, John, Gomez Lorenzo, Margarita M, Burns, David N., Ledgerwood, Julie, Mascola, John R., Cohen, Myron, Corey, Lawrence, Mngadi, Kathy, and Mgodi, Nyaradzo M

Published
2021
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19. Greater dapivirine release from the dapivirine vaginal ring is correlated with lower risk of HIV-1 acquisition: a secondary analysis from a randomized, placebo-controlled trial

Author

Brown, Elizabeth R., Hendrix, Craig W., van der Straten, Ariane, Kiweewa, Flavia M., Mgodi, Nyaradzo M., Palanee-Philips, Thesla, Marzinke, Mark A., Bekker, Linda-Gail, Soto-Torres, Lydia, Hillier, Sharon L., and Baeten, Jared M.

Subjects
Antiviral agents -- Dosage and administration -- Testing, HIV infection -- Risk factors -- Prevention -- Diagnosis, Health
Abstract

Introduction: A vaginal ring containing 25 mg of the antiretroviral dapivirine has demonstrated efficacy in reducing women's risk of sexually acquiring HIV-1; however, imperfect ring use likely diluted efficacy estimates in clinical trials. The amount of dapivirine remaining in returned rings may reflect the extent of product use, permitting estimation of HIV protection in the context of consistent use. Methods: We measured the amount of dapivirine in returned rings from a placebo-controlled trial of the dapivirine vaginal ring conducted between August 2012 and June 2015 among 2629 African women. Phase I/II studies established that greater than 4 mg of dapivirine on average is released from the ring when used consistently over 28 days and [less than or equal to]0.9 mg released suggested non-use. We assessed the relative risk reduction associated with levels of ring use using residual dapivirine in returned rings as a time-dependent covariate for HIV-1 infection in multivariable Cox models, including multiple exploratory analyses designed to estimate upper limits of efficacy given uncertainty in timing of HIV-1 acquisition. All models were adjusted for baseline covariates associated with HIV risk and adherence. Results: Residual dapivirine levels indicating at least some use (>0.9 mg released over a month) were associated with a 48% relative reduction in HIV-1 acquisition risk (95% confidence interval (CI): 21% to 66%; p = 0.002) compared to the placebo. Exploratory analyses accounting for potential misclassification in timing of HIV-1 acquisition estimated 75% to 91% HIV-1 risk reduction with> 4 mg released when compared to placebo. Results limited to the subgroup of women Conclusions: Residual dapivirine levels, an objective measure of adherence, were correlated with HIV-1 protection in a secondary analysis of a randomized trial. Periods of ring use were associated with approximately 50% protection, with exploratory analyses suggesting higher protection with more consistent use. The dapivirine vaginal ring is the first method to fulfil the promise of a fully reversible, long-acting, woman-initiated approach for discreet HIV-1 prevention. Keywords: adherence; clinical trials; HIV prevention; women; HIV prevention trials; Africa, 1 | INTRODUCTION Worldwide, nearly 870 000 women and girls are infected with HIV-1 every year [1] , with the vast majority of infections occurring in sub-Saharan Africa. New, effective [...]

Published
2020
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20. Adult Hematology and Clinical Chemistry Laboratory Reference Ranges in a Zimbabwean Population

Author

Samaneka, Wadzanai P, Mandozana, Gibson, Tinago, Willard, Nhando, Nehemiah, Mgodi, Nyaradzo M, Bwakura-Dangarembizi, Mutsawashe F, Munjoma, Marshall W, Gomo, Zvenyika AR, Chirenje, Zvavahera M, and Hakim, James G

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Hematology, Adolescent, Adult, Child, Child, Preschool, Clinical Chemistry Tests, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Reference Values, Young Adult, Zimbabwe, General Science & Technology
Abstract

BackgroundLaboratory reference ranges used for clinical care and clinical trials in various laboratories in Zimbabwe were derived from textbooks and research studies conducted more than ten years ago. Periodic verification of these ranges is essential to track changes over time. The purpose of this study was to establish hematology and chemistry laboratory reference ranges using more rigorous methods.MethodsA community-based cross-sectional study was carried out in Harare, Chitungwiza, and Mutoko. A multistage sampling technique was used. Samples were transported from the field for analysis at the ISO15189 certified University of Zimbabwe-University of California San Francisco Central Research Laboratory. Hematology and clinical chemistry reference ranges lower and upper reference limits were estimated at the 2.5th and 97.5th percentiles respectively.ResultsA total of 769 adults (54% males) aged 18 to 55 years were included in the analysis. Median age was 28 [IQR: 23-35] years. Males had significantly higher red cell counts, hemoglobin, hematocrit, and mean corpuscular hemoglobin compared to females. Females had higher white cell counts, platelets, absolute neutrophil counts, and absolute lymphocyte counts compared to males. There were no gender differences in eosinophils, monocytes, and absolute basophil count. Males had significantly higher levels of urea, sodium, potassium, calcium, creatinine, amylase, total protein, albumin and liver enzymes levels compared to females. Females had higher cholesterol and lipase compared with males. There are notable differences in the white cell counts, neutrophils, cholesterol, and creatinine kinase when compared with the currently used reference ranges.ConclusionData from this study provides new country specific reference ranges which should be immediately adopted for routine clinical care and accurate monitoring of adverse events in research studies.

Published
2016

21. Infusion Reactions After Receiving the Broadly Neutralizing Antibody VRC01 or Placebo to Reduce HIV-1 Acquisition: Results From the Phase 2b Antibody-Mediated Prevention Randomized Trials

Author

Takuva, Simbarashe, Karuna, Shelly T., Juraska, Michal, Rudnicki, Erika, Edupuganti, Srilatha, Anderson, Maija, De La Grecca, Robert, Gaudinski, Martin R., Sehurutshi, Alice, Orrell, Catherine, Naidoo, Logashvari, Valencia, Javier, Villela, Larissa M., Walsh, Stephen R., Andrew, Philip, Karg, Carissa, Randhawa, April, Hural, John, Gomez Lorenzo, Margarita M., Burns, David N., Ledgerwood, Julie, Mascola, John R., Cohen, Myron, Corey, Lawrence, Mngadi, Kathy, and Mgodi, Nyaradzo M.

Published
2022
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24. A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection in Women in Sub-Saharan Africa: Baseline Findings

Author

Mgodi, Nyaradzo M., Takuva, Simbarashe, Edupuganti, Srilatha, Karuna, Shelly, Andrew, Philip, Lazarus, Erica, Garnett, Precious, Shava, Emily, Mukwekwerere, Pamela G., Kochar, Nidhi, Marshall, Kyle, Rudnicki, Erika, Juraska, Michal, Anderson, Maija, Karg, Carissa, Tindale, India, Greene, Elizabeth, Luthuli, Nandisile, Baepanye, Kagisho, Hural, John, Gomez Lorenzo, Margarita M., Burns, David, Miner, Maurine D., Ledgerwood, Julie, Mascola, John R., Donnell, Deborah, Cohen, Myron S., and Corey, Lawrence

Published
2021
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25. Assessing Per-Sex-Act HIV-1 Risk Reduction Among Women Using the Dapivirine Vaginal Ring.

Author

Stalter, Randy M, Dong, Tracy Q, Hendrix, Craig W, Palanee-Phillips, Thesla, van der Straten, Ariane, Hillier, Sharon L, Kiweewa, Flavia M, Mgodi, Nyaradzo M, Marzinke, Mark A, Bekker, Linda-Gail, Soto-Torres, Lydia, Baeten, Jared M, Brown, Elizabeth R, and Team, for the MTN-020/ASPIRE Study

Subjects
HIV, CLINICAL trial registries, HUMAN sexuality, AT-risk behavior, GROUP rings
Abstract

Background Confounding introduced by individuals' sexual risk behavior is potentially a significant source of bias in HIV-1 prevention intervention studies. To more completely account for sexual behaviors when assessing the efficacy of the monthly dapivirine ring, a new longer-acting HIV-1 prevention option for women, we estimated per-sex-act risk reduction associated with product use. Methods We conducted a secondary analysis of data from MTN-020/ASPIRE, a phase 3, randomized, placebo-controlled efficacy trial of the dapivirine ring that recruited HIV-uninfected, African women aged 18–45 years. With cumulative sex acts as the time scale, we used multivariable Cox regression with inverse probability of censoring weights to estimate HIV-1 risk reduction associated with a rate of dapivirine release indicative of consistent product use. Results Women in the dapivirine ring group (n = 1187) had an estimated incidence rate of 2.3 (95% confidence interval [CI], 1.8–3.1) HIV-1 acquisition events per 10 000 sex acts versus 3.6 (95% CI, 2.9–4.4) per 10 000 acts in the placebo group (n = 1187). Dapivirine release indicative of consistent ring use was associated with a 63% (95% CI, 33%–80%) per-sex-act HIV-1 risk reduction. Conclusions These results support the efficacy of the dapivirine vaginal ring for HIV-1 prevention and help to inform decision-making for women, providers, and policymakers regarding product use. Clinical Trials Registration NCT01617096. [ABSTRACT FROM AUTHOR]

Published
2024
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27. Understanding the role of men in women's use of the vaginal ring and oral PrEP during pregnancy and breastfeeding: multi-stakeholder perspectives

Author

Musara, Petina, primary, Hartmann, Miriam, additional, Ryan, Julia H, additional, Reddy, Krishnaveni, additional, Ggita, Joseph, additional, Mutero, Prisca, additional, Macagna, Nicole, additional, Taulo, Frank, additional, Mgodi, Nyaradzo M, additional, Piper, Jeanna, additional, and van der Straten, Ariane, additional

Published
2022
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28. 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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30. 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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31. Impact of catch-up human papillomavirus vaccination on cervical cancer incidence in Kenya: A mathematical modeling evaluation of HPV vaccination strategies in the context of moderate HIV prevalence

Author

Liu, Gui, primary, Mugo, Nelly R, additional, Bayer, Cara, additional, Rao, Darcy White, additional, Onono, Maricianah, additional, Mgodi, Nyaradzo M, additional, Chirenje, Zvavahera M, additional, Njoroge, Betty W, additional, Tan, Nicholas, additional, Bukusi, Elizabeth A, additional, and Barnabas, Ruanne V, additional

Published
2022
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32. 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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33. 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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34. Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition

Author

Corey, Lawrence, primary, Gilbert, Peter B., additional, Juraska, Michal, additional, Montefiori, David C., additional, Morris, Lynn, additional, Karuna, Shelly T., additional, Edupuganti, Srilatha, additional, Mgodi, Nyaradzo M., additional, deCamp, Allan C., additional, Rudnicki, Erika, additional, Huang, Yunda, additional, Gonzales, Pedro, additional, Cabello, Robinson, additional, Orrell, Catherine, additional, Lama, Javier R., additional, Laher, Fatima, additional, Lazarus, Erica M., additional, Sanchez, Jorge, additional, Frank, Ian, additional, Hinojosa, Juan, additional, Sobieszczyk, Magdalena E., additional, Marshall, Kyle E., additional, Mukwekwerere, Pamela G., additional, Makhema, Joseph, additional, Baden, Lindsey R., additional, Mullins, James I., additional, Williamson, Carolyn, additional, Hural, John, additional, McElrath, M. Juliana, additional, Bentley, Carter, additional, Takuva, Simbarashe, additional, Gomez Lorenzo, Margarita M., additional, Burns, David N., additional, Espy, Nicole, additional, Randhawa, April K., additional, Kochar, Nidhi, additional, Piwowar-Manning, Estelle, additional, Donnell, Deborah J., additional, Sista, Nirupama, additional, Andrew, Philip, additional, Kublin, James G., additional, Gray, Glenda, additional, Ledgerwood, Julie E., additional, Mascola, John R., additional, and Cohen, Myron S., additional

Published
2021
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35. Infusion Reactions in Persons Receiving the Broadly Neutralizing Antibody VRC01 or Placebo for Reduction of HIV-1 Acquisition: Results From the Phase 2b Antibody Mediated Prevention (AMP) Randomized Trials

Author

Takuva, Simbarashe, primary, Karuna, Shelly T., additional, Juraska, Michal, additional, Rudnicki, Erika, additional, Edupuganti, Srilatha, additional, Anderson, Maija, additional, De La Grecca, Robert, additional, Gaudinski, Martin R., additional, Sehurutshi, Alice, additional, Orrell, Catherine, additional, Naidoo, Logashvari, additional, Valencia, Javier, additional, Villela, Larissa M., additional, Walsh, Stephen R., additional, andrew, philip, additional, Karg, Carissa, additional, Randhawa, April, additional, Hural, John, additional, Gomez Lorenzo, Margarira M., additional, Barnes, David N., additional, Ledgerwood, Julie, additional, Mascola, John R., additional, Cohen, Myron, additional, Lawrence, Corey, additional, Mngadi, Kathy, additional, and Mgodi, Nyaradzo M., additional

Published
2021
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36. Impact of Catch-Up Human Papillomavirus Vaccination on Cervical Cancer Incidence in Kenya: A Mathematical Modeling Evaluation of HPV Vaccination Strategies in the Context of Moderate HIV Prevalence

Author

Liu, Gui, primary, Mugo, Nelly R., additional, Bayer, Cara J., additional, Rao, Darcy W., additional, Onono, Maricianah, additional, Mgodi, Nyaradzo M., additional, Chirenje, Zvavahera M., additional, Njoroge, Betty W., additional, Tan, Nicolas, additional, Bukusi, Elizabeth A., additional, and Barnabas, Ruanne V., additional

Published
2021
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37. Client-Centered Adherence Counseling with Adherence Measurement Feedback to Support Use of the Dapivirine Ring in MTN-025 (The HOPE Study)

Author

Balán, Iván C., primary, Giguere, Rebecca, additional, Lentz, Cody, additional, Kutner, Bryan A., additional, Kajura-Manyindo, Clare, additional, Byogero, Rose, additional, Asiimwe, Florence Biira, additional, Makala, Yvonne, additional, Jambaya, Jane, additional, Khanyile, Nombuso, additional, Chetty, Diane, additional, Soto-Torres, Lydia, additional, Mayo, Ashley, additional, Mgodi, Nyaradzo M., additional, Palanee-Phillips, Thesla, additional, and Baeten, Jared M., additional

Published
2020
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38. 1272. Feasibility and Successful Enrollment in Proof-of-Concept Trials to Assess Safety and Efficacy of a Broadly Neutralizing Monoclonal Antibody, VRC01, to Prevent HIV-1 Acquisitionin in Uninfected Individuals

Author

Edupuganti, Srilatha, primary, Mgodi, Nyaradzo M, additional, Karuna, Shelly, additional, Andrew, Philip, additional, Kochar, Nidhi, additional, Marshall, Kyle, additional, Decamp, Allan, additional, Takuva, Simbarashe, additional, Anderson, Maija, additional, De La Grecca, Robert, additional, Gomez Lorenzo, Margarita, additional, Burns, David, additional, Goepfert, Paul, additional, McElrath, Julie, additional, Casapia, Martin, additional, Sanchez, Jorge, additional, Mukwekwerere, Pamela G, additional, Shava, Emily, additional, Lazarus, Erica M, additional, Hural, John, additional, Mascola, John R, additional, Cohen, Myron, additional, and Corey, Lawrence, additional

Published
2019
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39. Prediction of VRC01 neutralization sensitivity by HIV-1 gp160 sequence features

Author

Magaret, Craig A., primary, Benkeser, David C., additional, Williamson, Brian D., additional, Borate, Bhavesh R., additional, Carpp, Lindsay N., additional, Georgiev, Ivelin S., additional, Setliff, Ian, additional, Dingens, Adam S., additional, Simon, Noah, additional, Carone, Marco, additional, Simpkins, Christopher, additional, Montefiori, David, additional, Alter, Galit, additional, Yu, Wen-Han, additional, Juraska, Michal, additional, Edlefsen, Paul T., additional, Karuna, Shelly, additional, Mgodi, Nyaradzo M., additional, Edugupanti, Srilatha, additional, and Gilbert, Peter B., additional

Published
2019
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40. Preferences and Acceptability of Vaginal Delivery Forms for HIV Prevention Among Women, Male Partners and Key Informants in South Africa and Zimbabwe: Qualitative Findings.

Author

Musara, Petina, Milford, Cecilia, Shapley-Quinn, Mary Kate, Weinrib, Rachel, Mutero, Prisca, Odoom, Enyonam, Mgodi, Nyaradzo M., Chirenje, Zvavahera M., Hanif, Homaira, Clark, Meredith R., Smit, Jenni, van der Straten, Ariane, and Montgomery, Elizabeth T.

Subjects
HIV prevention, ANTI-infective agents, ATTITUDE (Psychology), COMMERCIAL product evaluation, CONSUMER attitudes, DOSAGE forms of drugs, FOCUS groups, GENETIC techniques, INTERVIEWING, MEDICAL personnel, NEW product development, SEXUAL excitement, PSYCHOLOGY of Spouses, VAGINAL medication, QUALITATIVE research
Abstract

The attributes of an HIV microbicide may affect its acceptability, uptake and use. Quatro, a clinical study with a qualitative component, was conducted to elicit input from end-users and key informants (KIs) on four different placebo vaginal microbicide delivery forms; fast dissolving insert, ring, film and gel. In-depth interviews and focus group discussions were conducted with young women, their male partners and KIs, to explore acceptability and preferences of the four placebo products, with the intention of improving product attributes, adherence, and consequently, long term effectiveness. None of the four microbicide delivery forms stood well above others as the most preferred. Product attributes; long-action, ease of use, invisibility, female initiated and non-interference during sex were favourable in both countries. Despite preference for the long-action, on-demand products were the most liked by women. Qualitative data from the Quatro study provided rich feedback on specific attributes important to the acceptability of four HIV prevention product platforms currently in development, enabling more informed and guided product development efforts moving forward. [ABSTRACT FROM AUTHOR]

Published
2021
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41. Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence counseling intervention in a multi-site biomedical HIV prevention study.

Author

Balán, Iván C., Lentz, Cody, Giguere, Rebecca, Mayo, Ashley J., Rael, Christine Tagliaferri, Soto-Torres, Lydia, Palanee-Phillips, Thesla, Mgodi, Nyaradzo M., Hillier, Sharon, and Baeten, Jared M.

Subjects
HIV prevention, EVALUATION of medical care, CERVICAL caps, COUNSELING, MEDICAL cooperation, PREVENTIVE medicine, RESEARCH, VAGINAL medication, EVIDENCE-based medicine, PILOT projects, MOTIVATIONAL interviewing, TREATMENT effectiveness, HUMAN services programs, ANTI-HIV agents, DESCRIPTIVE statistics
Abstract

Pre-Exposure Prophylaxis (PrEP) trials often implement counseling to support product adherence. Counseling fidelity can vary significantly across providers and time. Fidelity monitoring can ensure that counseling is delivered as designed. We describe the process, feasibility, and outcomes of monitoring Options counseling fidelity in an open-label study of the dapivirine vaginal ring MTN-025/HOPE. After initial training, 63 counselors from 14 sites in Sub-Sahara Africa audio-recorded counseling sessions with study participants. Sessions were rated by a New York-based team that included bilingual emigres from the study countries. Completed session rating forms were sent to counselors to provide feedback and counseling difficulties were discussed during monthly calls. Of 1456 study participants, 85.7% consented to at least one session, and 20% to all sessions, being audio-recorded. Among 9926 study visits in which Options was expected to occur, 5366 (54.1%) Options sessions were audio-recorded, of which 1238 (23.1%) were reviewed; 1039 (83.9%) were rated as "good" or "fair." Eleven counselors who failed to consistently deliver the intervention were reassigned to back-up status. This study demonstrates the feasibility and benefits of monitoring counseling fidelity using audio-recordings in a multi-site, multi-language, multi-country PrEP trial. Given the investment necessary to conduct such trials, providing counseling oversight is highly warranted. [ABSTRACT FROM AUTHOR]

Published
2020
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42. Negative rumours about a vaginal ring for HIV-1 prevention in sub-Saharan Africa.

Author

Chitukuta, Miria, Duby, Zoe, Katz, Ariana, Nakyanzi, Teopista, Reddy, Krishnaveni, Palanee-Phillips, Thesla, Tembo, Tchangani, Etima, Juliane, Musara, Petina, Mgodi, Nyaradzo M., van der Straten, Ariane, and MTN-020/ASPIRE Study Team

Subjects
HIV prevention, FOCUS groups
Abstract

Copyright of Culture, Health & Sexuality is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2019
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43. Preventive Misconception and Risk Behaviors in a Multinational HIV Prevention Trial.

Author

Sugarman, Jeremy, Lin, Li, Baeten, Jared M., Palanee-Phillips, Thesla, Brown, Elizabeth R., Matovu Kiweewa, Flavia, Mgodi, Nyaradzo M., Nair, Gonasagrie, Siva, Samantha, Seils, Damon M., and Weinfurt, Kevin P.

Subjects
RISK-taking behavior, HIV infections, HIV prevention, CONDOM use, HUMAN research subjects
Abstract

Background: Some HIV prevention research participants may hold a "preventive misconception" (PM), an overestimate of the probability or level of personal protection afforded by trial participation. However, these reports typically rely upon small, retrospective qualitative assessments that did not use a standardized approach. Methods: We administered a measure of PM called PREMIS, during Microbicide Trials Network 020—A Study to Prevent Infection with a Ring for Extended Use, a large, multicenter, placebo-controlled, phase III trial evaluating the safety and efficacy of a dapivirine vaginal ring among women at risk for HIV infection in Malawi, South Africa, Uganda, and Zimbabwe. The maximum follow-up period was 2.6 years. Results: One thousand two hundred sixty-one respondents completed PREMIS at their month 3 visit (M3); 2085 at their month 12 visit (M12); and 1010 at both visits. Most participants expressed high expectations of personal benefit (EPB) and that at least one of the rings used in the trial would reduce the risk of getting HIV (expectation of maximum aggregate benefit or EMAB). There was a moderate positive correlation between EPB and EMAB at M3 (r =.43, 95% CI:.37,.47) and M12 (r =.44, 95% CI:.40,.48). However, there was variability among sites in the strength of the relationship. There was no relationship between either expectation variable and condom use, adherence, or HIV infection. Conclusions: A majority of trial participants expressed some belief that their risk of HIV infection would be reduced by using a vaginal ring, which may signal PM. However, such beliefs were not associated with adherence, condom use, or subsequent HIV infection, and there was variability across sites. Further work is needed to understand these findings. [ABSTRACT FROM AUTHOR]

Published
2019
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45. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women

Author

Baeten, Jared M., primary, Palanee-Phillips, Thesla, additional, Brown, Elizabeth R., additional, Schwartz, Katie, additional, Soto-Torres, Lydia E., additional, Govender, Vaneshree, additional, Mgodi, Nyaradzo M., additional, Kiweewa, Flavia Matovu, additional, Nair, Gonasagrie, additional, Mhlanga, Felix, additional, Siva, Samantha, additional, Bekker, Linda-Gail, additional, Jeenarain, Nitesha, additional, Gaffoor, Zakir, additional, Martinson, Francis, additional, Makanani, Bonus, additional, Pather, Arendevi, additional, Naidoo, Logashvari, additional, Husnik, Marla, additional, Richardson, Barbra A., additional, Parikh, Urvi M., additional, Mellors, John W., additional, Marzinke, Mark A., additional, Hendrix, Craig W., additional, van der Straten, Ariane, additional, Ramjee, Gita, additional, Chirenje, Zvavahera M., additional, Nakabiito, Clemensia, additional, Taha, Taha E., additional, Jones, Judith, additional, Mayo, Ashley, additional, Scheckter, Rachel, additional, Berthiaume, Jennifer, additional, Livant, Edward, additional, Jacobson, Cindy, additional, Ndase, Patrick, additional, White, Rhonda, additional, Patterson, Karen, additional, Germuga, Donna, additional, Galaska, Beth, additional, Bunge, Katherine, additional, Singh, Devika, additional, Szydlo, Daniel W., additional, Montgomery, Elizabeth T., additional, Mensch, Barbara S., additional, Torjesen, Kristine, additional, Grossman, Cynthia I., additional, Chakhtoura, Nahida, additional, Nel, Annalene, additional, Rosenberg, Zeda, additional, McGowan, Ian, additional, and Hillier, Sharon, additional

Published
2016
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46. Uptake of HBV Vaccination and Incident HBV Infection in Women of Reproductive Age and at Risk of HIV-1 Infection in the VOICE (MTN 003) Study

Author

Mgodi, Nyaradzo M., primary, Kelly, Cliff W., additional, Kakayi, Brenda, additional, Dai, James Y., additional, Nair, Gonasagrie, additional, Palanee, Thesla, additional, Gomez-Feliciano, Kailazarid, additional, Marrazzo, Jeanne, additional, Piper, Jeanna, additional, and Chirenje, Zvavahera Mike, additional

Published
2014
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47. The Effect of Presentation of Pharmacokinetic (PK) Drug Results on Self-reported Study Product Adherence among VOICE Participants in Zimbabwe

Author

Musara, Petina, primary, Munaiwa, Otillia, additional, Mahaka, Imelda, additional, Mgodi, Nyaradzo M., additional, Hartmann, Miriam, additional, Levy, Lisa, additional, Montgomery, Elizabeth T., additional, Grossmann, Cynthia I., additional, Chirenje, Zvavahera Mike, additional, van der Straten, Ariane, additional, and Mensch, Barbara, additional

Published
2014
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