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1. Likely clinical depression and HIV-related decline in antiretroviral therapy untreated women who seroconverted during participation in microbicide trials in sub-Saharan Africa

Author

Rael, Christine T, Roberts, Sarah, Ibitoye, Mbolaji, Gorbach, Pamina M, Palanee-Phillips, Thesla, Harkoo, Ishana, Mbilizi, Yamikani, Panchia, Ravindre, Siva, Samantha, Tembo, Tchangani, Akello, Carolyne Agwau, Balkus, Jennifer, Riddler, Sharon, and Carballo-Diéguez, Alex

Subjects
Infectious Diseases, HIV/AIDS, Clinical Research, Behavioral and Social Science, Depression, Clinical Trials and Supportive Activities, Brain Disorders, Mental Health, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Anti-HIV Agents, Anti-Infective Agents, Cross-Sectional Studies, Female, HIV Infections, Humans, Male, Viral Load, Clinical Sciences, Medical Microbiology, Public Health and Health Services, Public Health
Abstract

Depression worsens HIV outcomes in populations treated with antiretroviral therapy (ART) medications. Data are limited on the relationship between depression and HIV in untreated populations in sub-Saharan Africa. We aimed to identify associations between likely clinical depression, alcohol use, social support by partners, and HIV viral load (VL) among ART untreated women who recently became HIV positive and enrolled in the Microbicide Trials Network (MTN)-015 study. Analyses used cross-sectional data collected at baseline in MTN-015. Participants in this analysis (N = 190) enrolled from other MTN trials were not receiving ART and provided data on their HIV disclosure status to their husband or male partner and alcohol use behavior. The dependent variable, VL, was categorized as: low (≤400 RNA copies/mL; 9.1% of participants), medium (401-20,000 RNA copies/mL; 48.8%), and high (>20,000 RNA copies/mL; 42.0%). Depression was assessed using eight items from Hopkins Symptom Checklist; a cutoff of ≥1.75 indicated likely clinical depression. Independent variables with a significance of p ≤ 0.05 in unadjusted regressions were included in a regression adjusted for age, education, and time since seroconversion. Depressive symptoms were positively associated with high VL, in the adjusted regression (OR = 1.80; 95% CI = 1.07-3.01). Results suggest that likely having clinical depression may have a biological relationship with HIV disease progression.

Published
2021

2. 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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3. Integrating Gender-Based Violence Screening and Support into the Research Clinic Setting: Experiences from an HIV Prevention Open-Label Extension Trial in Sub-Saharan Africa

Author

Garcia, Morgan, Roberts, Sarah T., Mayo, Ashley J., Scheckter, Rachel, Mansoor, Leila E., Palanee-Phillips, Thesla, Reddy, Krishnaveni, Naidoo, Yuthika, Akello, Carolyne Agwau, Gaffoor, Zakir, Siva, Samantha, Rushwaya, Chenai, Hlahla, Kudzai, Jambaya, Jane, Makoni, Rujeko, Kachale, Evans, Ndovie, Margret, Zuma, Jabulisile, and Montgomery, Elizabeth T.

Published
2023
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4. 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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5. 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

6. 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

8. 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

9. 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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10. 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

12. 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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14. Feasibility and acceptability of peer-delivered HIV self-testing and PrEP for young women in Kampala, Uganda

Author

Nakalega, Rita, primary, Mukiza, Nelson, additional, Menge, Robert, additional, Kizito, Samuel, additional, Babirye, Juliet Allen, additional, Kuteesa, Cynthia Ndikuno, additional, Mawanda, Denis, additional, Mulumba, Emmie, additional, Nabukeera, Josephine, additional, Ggita, Joseph, additional, Nakanjako, Lydia, additional, Akello, Carolyne, additional, Mirembe, Brenda Gati, additional, Lukyamuzi, Zubair, additional, Nakaye, Catherine, additional, Kataike, Hajira, additional, Maena, Joel, additional, Etima, Juliane, additional, Nabunya, Hadijah Kalule, additional, Biira, Florence, additional, Nagawa, Christine, additional, Heffron, Renee, additional, Celum, Connie, additional, Gandhi, Monica, additional, and Mujugira, Andrew, additional

Published
2023
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16. 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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17. Baseline preferences for oral pre-exposure prophylaxis (PrEP) or dapivirine intravaginal ring for HIV prevention among adolescent girls and young women in South Africa, Uganda and Zimbabwe (MTN-034/IPM-045 study).

Author

Ngure, Kenneth, Friedland, Barbara A., Szydlo, Daniel W., Roberts, Sarah T., Garcia, Morgan, Levy, Lisa, Akello, Carolyne A., Reddy, Krishnaveni, Palanee-Phillips, Thesla, Macdonald, Pippa, Siziba, Bekezela, Soto-Torres, Lydia, Hosek, Sybil, Hillier, Sharon L., Nair, Gonasagrie, Celum, Connie, and van der Straten, Ariane

Subjects
TEENAGE girls, HIV prevention, YOUNG women, PRE-exposure prophylaxis, SEXUALLY transmitted diseases, HIV
Abstract

Introduction: Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation. Methods: AGYW aged 16–21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to summarize demographic and behavioral data while multinomial analysis was used to determine predictors of stated product preference (ring or oral PrEP). Results: Of the 247 AGYW enrolled in REACH, 34% were aged 16–17 and 89% had a primary partner.The median age of sexual debut was 16 years and 40% had ever been pregnant. At screening, 35% of participants were diagnosed with a sexually transmitted infection (STI), 39% had an AUDIT-C score associated with harmful drinking and 11% reported intimate partner violence in the past 6 months. Overall, 28% of participants, had CESD-10 scores suggestive of depressive symptoms (≥12) in the past week. At baseline, similar proportions stated a preference for the ring and oral PrEP (38.1% and 40.5% respectively), with 19% of participants stating they preferred both products equally. Only study site was significantly associated with product preference (P<0.05) with AGYW from Johannesburg having higher odds of preferring the ring and those from Kampala having higher odds of preferring both options equally. Conclusions: We successfully enrolled African AGYW with a clear unmet need for HIV prevention. The balanced preference between the two products suggests that multiple biomedical prevention options may be appealing to this age group and could address their prevention needs. [ABSTRACT FROM AUTHOR]

Published
2023
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19. Integrating Gender-based Violence Screening and Support Into the Research Clinic Setting: Experiences From an HIV Prevention Open-label Extension Trial in Sub-saharan Africa

Author

Garcia, Morgan, primary, Roberts, Sarah T, additional, Mayo, Ashley J, additional, Scheckter, Rachel, additional, Mansoor, Leila E, additional, Palanee-Phillips, Thesla, additional, Reddy, Krishnaveni, additional, Naidoo, Yuthika, additional, Akello, Carolyne Agwau, additional, Gaffoor, Zakir, additional, Siva, Samantha, additional, Rushwaya, Chenai, additional, Hlahla, Kudzai, additional, Jambaya, Jane, additional, Makoni, Rujeko, additional, Kachale, Evans, additional, Ndovie, Margret, additional, Zuma, Jabulisile, additional, and Montgomery, Elizabeth T, additional

Published
2022
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22. The Influence of Perceived Dapivirine Vaginal Ring Effectiveness on Social Disclosure and Ring Adherence.

Author

Stoner, Marie C. D., Brown, Elizabeth R., Palanee-Phillips, Thesla, Mansoor, Leila E., Tembo, Tchangani, Nair, Gonasagrie, Akello, Carolyne, Seyama, Linly, Jeenarain, Nitesha, Naidoo, Logashvari, Mgodi, Nyaradzo, Hunidzarira, Portia, Chitukuta, Miria, van der Straten, Ariane, for the MTN-020 ASPIRE and M-025 HOPE study teams, Baeten, Jared, Brown, Elizabeth, Soto-Torres, Lydia, Schwartz, Katie, and Mayo, Ashley

Subjects
HIV prevention, SOCIAL support, CERVICAL caps
Abstract

We analyzed data from 1428 users of the dapivirine vaginal ring, who participated in the MTN-020/ASPIRE phase III trial and subsequent open-label extension MTN-025/HOPE trial, to examine relationships between perceived ring protection, social disclosures, and self-reported ring adherence. In HOPE, 77% perceived the ring to be highly effective, and this view was associated with speaking: (a) to a greater number of people about the study, (b) with other participants, (c) to more people who were in favor of the ring, and (d) to more people whose opinions were valued. Reported adherence was not directly associated with perceived protection but was associated with disclosing to someone who was in favor of the ring. These findings suggest the importance of women's internalized ideas about the protective benefits of the DVR in sharing information about the ring and the importance of social support on adherence. [ABSTRACT FROM AUTHOR]

Published
2021
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23. Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring.

Author

Riddler, Sharon A, Balkus, Jennifer E, Parikh, Urvi M, Mellors, John W, Akello, Carolyne, Dadabhai, Sufia, Mhlanga, Felix, Ramjee, Gita, Mayo, Ashley J, Livant, Edward, Heaps, Amy L, O'Rourke, Colin, and Baeten, Jared M

Subjects
HIV prevention, HIV infection risk factors, REVERSE transcriptase inhibitors, CERVICAL caps, RISK assessment, RNA, WOMEN'S health, VIRAL load, RANDOMIZED controlled trials, TREATMENT effectiveness, DISEASE progression, LOG-rank test, THERAPEUTICS
Abstract

Background A vaginal ring containing dapivirine, a non-nucleoside human immunodeficiency virus (HIV)-1 reverse transcriptase inhibitor (NNRTI), was safe and effective in preventing HIV-1 infection in African women. We examined the impact of dapivirine ring use at the time of HIV-1 acquisition on subsequent HIV-1 disease progression and responses to NNRTI-containing antiretroviral therapy (ART). Methods HIV-1 disease progression and virologic failure following initiation of ART were assessed among women who acquired HIV-1 while participating in Microbicide Trials Network–020, a randomized, placebo-controlled trial of a monthly, dapivirine vaginal ring. Results Among the 158 participants who acquired HIV-1 (65 dapivirine, 93 placebo), no differences between dapivirine and placebo participants were observed in CD4+ cell counts or plasma HIV-1 RNA over the first year after infection (prior to ART). During follow-up, 100/158 (63%) participants initiated NNRTI-containing ART (dapivirine: 39/65; placebo: 61/93); the median time to HIV-1 RNA <200 copies/ml was approximately 90 days for both dapivirine and placebo ring recipients (log-rank P =.40). Among the 81 participants with at least 6 months of post-ART follow-up, 19 (24%) experienced virologic failure (dapivirine: 6/32, 19%; placebo: 13/39, 27%; P =.42). Conclusions The acquisition of HIV-1 infection during dapivirine or placebo treatment in ASPIRE did not lead to differences in HIV-1 disease progression. After the initiation of NNRTI-containing ART, dapivirine and placebo participants had similar times to virologic suppression and risks of virologic failure. These results provide reassurance that NNRTI-based ART regimens are effective among women who acquired HIV-1 while receiving the dapivirine vaginal ring. Clinical Trials Registration NCT016170096 and NCT00514098. [ABSTRACT FROM AUTHOR]

Published
2019
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25. Bone Mineral Density Changes among Healthy African Pre-menopausal Women Participating in a Tenofovir-based HIV PrEP Study: The MTN-003B Study

Author

Mirembe, Brenda G., primary, Kelly, Cliff, additional, Nyaradzo, Mgodi, additional, Greenspan, Suzan, additional, Dai, James, additional, Bragg, Vivian, additional, Piper, Jeanna, additional, Akello, Carolyne A., additional, Kiweewa, Flavia M., additional, Tsitsi, Magure, additional, Nakabiito, Clemensia, additional, and Riddler, Sharon, additional

Published
2014
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28. Bone Mineral Density Changes among Healthy African Pre-menopausal Women Participating in a Tenofovir-based HIV PrEP Study: The MTN-003B Study.

Author

Kelly, Cliff, Nyaradzo, Mgodi, Greenspan, Suzan, Dai, James, Bragg, Vivian, Piper, Jeanna, Akello, Carolyne A., Kiweewa, Flavia M., Tsitsi, Magure, Nakabiito, Clemensia, and Riddler, Sharon

Abstract

An abstract of the article "Bone Mineral Density Changes among Healthy African Pre-menopausal Women Participating in a Tenofovirbased HIV PrEP Study: The MTN-003B Study" by Brenda G. Mirembe, Cliff Kelly, Mgodi Nyaradzo, and colleagues is presented.

Published
2014
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29. To Give or Not to Give PK Results: An Ethical Dilemma for Researchers & Regulators in Uganda.

Author

Nakabiito, Clemensia, Akello, Carolyne A., Kabwigu, Samuel, Nakyanzi, Teopista, Nabukeera, Josephine, Hartmann, Miriam, Montgomery, Elizabeth, Mensch, Barbara, and Van der Straten, Ariane

Abstract

An abstract of the article "To Give or Not to Give PK Results: An Ethical Dilemma for Researchers & Regulators in Uganda" by Juliane Etima, Clemensia Nakabiito, Carolyne A. Akello and colleagues is presented.

Published
2014
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30. Impact of DSMB Outcomes on Participation in HIV Prevention Trials: The VOICE Study Experience in Kampala, Uganda.

Author

Nakyanzi, Teopista, Kabwigu, Samuel, Kiweewa, Flavia M., Mirembe, Brenda G., Akello, Carolyne A., Rossi, Lisa, and Nakabiito, Clemensia

Abstract

An abstract of the article "Impact of DSMB Outcomes on Participation in HIV Prevention Trials: The VOICE Study Experience in Kampala, Uganda" by Juliane Etima, Teopista Nakyanzi, Samuel Kabwigu and colleagues is presented.

Published
2014
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