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191 results on '"Makanani, Bonus"'

1. Self-reported Antiretroviral Adherence: Association With Maternal Viral Load Suppression in Postpartum Women Living With HIV-1 From Promoting Maternal and Infant Survival Everywhere, a Randomized Controlled Trial in Sub-Saharan Africa and India

Author

Nevrekar, Neetal, Butler, Kevin, Shapiro, David E, Atuhaire, Patience, Taha, Taha E, Makanani, Bonus, Chinula, Lameck, Owor, Maxensia, Moodley, Dhayendre, Chipato, Tsungai, McCarthy, Katie, Flynn, Patricia M, Currier, Judith, Fowler, Mary Glenn, Gupta, Amita, and Suryavanshi, Nishi

Subjects
Biomedical and Clinical Sciences, Public Health, Health Sciences, Clinical Trials and Supportive Activities, Clinical Research, Behavioral and Social Science, Pediatric, Infection, Reproductive health and childbirth, Good Health and Well Being, Female, Infant, Humans, Viral Load, HIV-1, Self Report, HIV Infections, Mothers, Africa South of the Sahara, Clinical Sciences, Public Health and Health Services, Virology, Clinical sciences, Epidemiology, Public health
Abstract

IntroductionOptimal adherence to antiretroviral therapy (ART) is crucial to promoting maternal-infant health.SettingFourteen sites in 7 countries within sub-Saharan Africa and India.MethodsThe multicomponent, open-label strategy PROMISE trial enrolled breastfeeding mother-infant pairs not meeting in-country criteria for maternal ART (mART) initiation in the postpartum component within 5 days of delivery. Randomization was to mART versus infant NVP (iNVP) prophylaxis. Infants in the mART arm also received 6 weeks of iNVP. Self-reported adherence was assessed in a secondary analysis. Time-to-event analyses were performed to explore the association between adherence and maternal viral load (mVL) in the mART arm.ResultsTwo thousand four hundred thirty-one mother-infant pairs were enrolled between 2011 and 2014; the baseline maternal median CD4 was 686 (IQR 553-869), and the median mVL was 322 copies/mL (IQR 40-1422). Self-reported adherence was lower in the mART arm compared with the iNVP arm (no missed doses within 4 weeks of all study visits: 66% vs 83%; within 2 weeks: 71% vs 85%; P < 0.0001). The iNVP adherence at week 6 was high in both arms: 97% in mART arm; 95% in iNVP arm. Time-to-event analyses showed that adherence to mART was associated with time to first mVL ≥400 copies/mL ( P < 0.0001). Missing 1 full day of doses over 3 days was associated with a 66% risk of mVL ≥1000 copies/mL (HR: 1.66; 95% CI: 1.37, 1.99).ConclusionsPostpartum women were less adherent to their own ART than mothers providing their infant's nevirapine prophylaxis. The self-reported missed mART doses were associated with high mVL. Strategies to optimize postpartum mART adherence are urgently needed.Clinical trial numberClinicalTrials.gov: NCT01061151; closed to follow-up.

Published
2023

2. 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

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

Author

Reddy, Krishnaveni, Kelly, Cliff, Brown, Elizabeth R, Jeenarain, Nitesha, Naidoo, Logashvari, Siva, Samantha, Bekker, Linda-Gail, Nair, Gonasagrie, Makanani, Bonus, Chinula, Lameck, Mgodi, Nyaradzo, Chirenje, Zvavahera, Kiweewa, Flavia Matovu, Marrazzo, Jeanne, Bunge, Katherine, Soto-Torres, Lydia, Piper, Jeanna, Baeten, Jared M, and Palanee-Phillips, Thesla

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Topical Microbicides, Prevention, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Anti-HIV Agents, Contraceptive Devices, Female, Double-Blind Method, Female, HIV Infections, HIV Seropositivity, HIV-1, Humans, Pyrimidines, Vagina, Young Adult, cytology, dapivirine, preexposure prophylaxis, vaginal ring, MTN-020/ASPIRE and MTN-003/VOICE Study Teams, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveWe aimed to determine if the dapivirine vaginal ring and the ring device alone (flexible silicone matrix polymer) was associated with the development of cervical cytology abnormalities.DesignSecondary analysis comparing cervical cytology results between two randomized controlled microbicide trials (MTN-020/ASPIRE and MTN-003/VOICE).MethodsData from ASPIRE, a phase III, placebo-controlled trial of the dapivirine vaginal ring, were used in this analysis. Cervical cytology smears were evaluated at baseline and at the final visit with product use. We compared cytology results between women randomized to dapivirine versus placebo vaginal ring. We further assessed for the effect of the vaginal ring device on cervical cytology by comparing results with data from the oral placebo arm of VOICE, a prior HIV-1 prevention trial conducted in a similar population.ResultsCervical cytology results for 2394 women from ASPIRE (1197 per study arm) were used in this analysis; median time between baseline and final visit with product use was 22.1 months. Cytology smear findings were comparable between dapivirine and placebo vaginal ring arms: at final visit, normal: 90.6 versus 91.5%, ASC-US//LSIL: 7.8 versus 7.4%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 1.7 versus 1.1%, P = 0.44. Cytology data from VOICE had findings (normal: 87.8%, ASC-US/LSIL: 9.8%, ASC-H/HSIL/AGC/AGC-favor neoplastic: 2.4%) comparable with that of both dapivirine (P = 0.93) and placebo vaginal ring arms (P = 0.24).ConclusionThese findings indicate that neither use of the dapivirine vaginal ring nor the vaginal ring device alone, over a period of 2 years, is associated with development of cervical cytology abnormalities that could lead to precancerous or cancerous lesions.

Published
2020

4. The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes—A randomized clinical trial

Author

Atuhaire, Patience, S. Brummel, Sean, Mmbaga, Blandina Theophil, Angelidou, Konstantia, Fairlie, Lee, Violari, Avy, Theron, Gerhard, Mukuzunga, Cornelius, Mawlana, Sajeeda, Mubiana-Mbewe, Mwangelwa, Naidoo, Megeshinee, Makanani, Bonus, Mandima, Patricia, Nematadzira, Teacler, Suryavanshi, Nishi, Mbengeranwa, Tapiwa, Loftis, Amy, Basar, Michael, McCarthy, Katie, Currier, Judith S, and Fowler, Mary Glenn

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Public Health, Health Sciences, Prevention, Pregnancy, HIV/AIDS, Clinical Research, Infectious Diseases, Women's Health, Clinical Trials and Supportive Activities, Sexually Transmitted Infections, Maternal Health, 6.1 Pharmaceuticals, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, Infection, Reproductive health and childbirth, Good Health and Well Being, Aged, Algorithms, Antiretroviral Therapy, Highly Active, Area Under Curve, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Models, Biological, Outcome Assessment, Health Care, ROC Curve, Reproducibility of Results, Time Factors, 1077BF/1077FF PROMISE Team, General Science & Technology
Abstract

BackgroundGiven well documented challenges faced by pregnant women living with HIV taking lifetime ART, it is critical to understand the impact of short-term ART exposure followed by treatment interruption on maternal health outcomes.MethodsHIV+ breastfeeding (BF) and Formula Feeding (FF) women with CD4 counts > 350 cells/mm3, enrolled in the 1077BF/1077FF PROMISE trial were followed to assess the effect of ART during pregnancy and breastfeeding respectively. The first analysis compared ART use limited to the antepartum period (AP-only) relative to women randomized to Zidovudine. The second analysis included women with no pregnancy combination ART exposure; and compared women randomized to either ART or no ART during postpartum (PP-only). Both analyses included follow-up time beyond breastfeeding period. The primary outcome was progression to AIDS and/or death. Secondary outcomes included adverse events and HIV-related events.Results3490 and 1137 HIV+ women were enrolled from 14 sites in Africa and India from April 2011 through September 2014 in cohort AP-only and PP-only, respectively. Most were Black African (96%); median age was 27 years; 97% were WHO Clinical Stage I; and most had a screening CD4 count ≥500 cells/mm3 (78%). The rate of progression to AIDS and/or death was similar and low across all comparison arms (AP comparison, HR = 1.14, 95%CI (0.44, 2.96), p-value = 0.79). In the PP-only cohort, the rate of WHO stage 2-3 events was lower for women randomized to ART(HR = 0.65, 95% CI 0.42, 1.01, p-value = 0.05).ConclusionThe incidence of AIDS and/or death was low in pregnant/postpartum HIV+ women with highCD4 cell counts for all comparison arms. This provides some reassurance that there were limited consequences for short term ART interruption in this group of asymptomatic HIV+ women during up to 4 years of follow up; and underscores that even short term ART exposure postpartum may reduce the risk of WHO grade 2-3 disease progression.

Published
2020

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

Author

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

Subjects
Reproductive Medicine, Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Pediatric, HIV/AIDS, Clinical Trials and Supportive Activities, Infectious Diseases, Prevention, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Reproductive health and childbirth, Infection, Adolescent, Adult, Africa, Southern, Age Factors, Double-Blind Method, Drug Resistance, Viral, Female, HIV Infections, HIV-1, Humans, Incidence, Middle Aged, Patient Compliance, Pyrimidines, Reverse Transcriptase Inhibitors, Vagina, Young Adult, MTN-020–ASPIRE Study Team, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundAntiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection.MethodsWe conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe.ResultsAmong the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0.046) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P=0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P

Published
2016

9. Long-term follow-up of HIV seroconverters in microbicide trials – rationale, study design, and challenges in MTN-015

Author

Riddler, Sharon A, Husnik, Marla, Gorbach, Pamina M, Levy, Lisa, Parikh, Urvi, Livant, Edward, Pather, Arendevi, Makanani, Bonus, Muhlanga, Felix, Kasaro, Margaret, Martinson, Francis, Elharrar, Vanessa, Balkus, Jennifer E, and Network, on Behalf of the MTN-015 Protocol Team for the Microbicide Trials

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Behavioral and Social Science, HIV/AIDS, Infectious Diseases, Prevention, Topical Microbicides, Clinical Research, Infection, Good Health and Well Being, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Clinical Protocols, Female, HIV Infections, HIV-1, Humans, Longitudinal Studies, Male, Pre-Exposure Prophylaxis, Pregnancy, Pregnancy Outcome, Research Design, Treatment Outcome, Viral Load, HIV, clinical trial design, cohort Study, prevention, microbicides, pre-exposure prophylaxis, seroconversion, drug resistance, MTN-015 Protocol Team for the Microbicide Trials Network, Virology, Clinical sciences
Abstract

BackgroundAs the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort.MethodsInitiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing.ResultsMTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness.ConclusionsEnrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.

Published
2016

10. Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial.

Author

Balkus, Jennifer, Brown, Elizabeth, Hillier, Sharon, Coletti, Anne, Ramjee, Gita, Mgodi, Nyaradzo, Makanani, Bonus, Reid, Cheri, Martinson, Francis, Soto-Torres, Lydia, Abdool Karim, Salim, and Chirenje, Zvavahera

Subjects
HIV infection, Hormonal contraception, Injectables, Oral contraceptive pills, Southern Africa, Women, Adult, Condoms, Contraceptive Agents, Female, Contraceptives, Oral, Hormonal, Delayed-Action Preparations, HIV Infections, Humans, Incidence, Injections, Intramuscular, Malawi, Proportional Hazards Models, Prospective Studies, Risk Factors, South Africa, Sterilization, Tubal, Young Adult, Zambia, Zimbabwe
Abstract

OBJECTIVE: To assess the effect of oral and injectable contraceptive use compared to nonhormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial. STUDY DESIGN: This is a prospective cohort study using data from women enrolled in HIV Prevention Trials Network protocol 035. At each quarterly visit, participants were interviewed about self-reported contraceptive use and sexual behaviors and underwent HIV testing. Cox proportional hazards regression was used to assess the effect of injectable and oral hormonal contraceptive use on HIV acquisition. RESULTS: The analysis included 2830 participants, of whom 106 became HIV infected (4.07 per 100 person-years). At baseline, 1546 (51%) participants reported using injectable contraceptives and 595 (21%) reported using oral contraceptives. HIV incidence among injectable, oral and nonhormonal contraceptive method users was 4.72, 2.68 and 3.83 per 100 person-years, respectively. Injectable contraceptive use was associated with a nonstatistically significant increased risk of HIV acquisition [adjusted hazard ratio (aHR)=1.17; 95% confidence interval (CI) 0.70, 1.96], while oral contraceptive use was associated with a nonstatistically significant decreased risk of HIV acquisition (aHR=0.76; 95% CI 0.37,1.55). CONCLUSION: In this secondary analysis of randomized trial data, a marginal, but nonstatistically significant, increase in HIV risk among women using injectable hormonal contraceptives was observed. No increased HIV risk was observed among women using oral contraceptives. Our findings support the World Health Organizations recommendation that women at high risk for acquiring HIV, including those using progestogen-only injectable contraception, should be strongly advised to always use condoms and other HIV prevention measures. IMPLICATIONS: Among Southern African women participating in an HIV prevention trial, women using injectable hormonal contraceptives had a modest increased risk of HIV acquisition; however, this association was not statistically significant. Continued research on the relationship between widely used hormonal contraceptive methods and HIV acquisition is essential.

Published
2016

14. Impact of Partner-Related Social Harms on Womenʼs Adherence to the Dapivirine Vaginal Ring During a Phase III Trial

Author

Palanee-Phillips, Thesla, Roberts, Sarah T., Reddy, Krishnaveni, Govender, Vaneshree, Naidoo, Logashvari, Siva, Samantha, Gafoor, Zakir, Pather, Arendevi, Matovu, Flavia, Hlahla, Kudzai, Makanani, Bonus, Nair, Gonasagrie, Schwartz, Katie, Torjesen, Kristine, Brown, Elizabeth, Soto-Torres, Lydia, Baeten, Jared, and Montgomery, Elizabeth T.

Published
2018
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16. Self-reported Antiretroviral Adherence: Association With Maternal Viral Load Suppression in Postpartum Women Living With HIV-1 From Promoting Maternal and Infant Survival Everywhere, a Randomized Controlled Trial in Sub-Saharan Africa and India

Author

Nevrekar, Neetal, primary, Butler, Kevin, additional, Shapiro, David E., additional, Atuhaire, Patience, additional, Taha, Taha E., additional, Makanani, Bonus, additional, Chinula, Lameck, additional, Owor, Maxensia, additional, Moodley, Dhayendre, additional, Chipato, Tsungai, additional, McCarthy, Katie, additional, Flynn, Patricia M., additional, Currier, Judith, additional, Fowler, Mary Glenn, additional, Gupta, Amita, additional, and Suryavanshi, Nishi, additional

Published
2022
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18. Additional file 3 of Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

Author

Baltrusaitis, Kristin, Makanani, Bonus, Tierney, Camlin, Fowler, Mary Glenn, Moodley, Dhayendre, Theron, Gerhard, Nyakudya, Lynette H., Tomu, Musunga, Fairlie, Lee, George, Kathleen, Heckman, Barbara, Knowles, Kevin, Browning, Renee, Siberry, George K., Taha, Taha E., and Stranix-Chibanda, Lynda

Abstract

Additional file 3: Additional Baseline Characteristics.

Published
2022
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19. Additional file 1 of Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

Author

Baltrusaitis, Kristin, Makanani, Bonus, Tierney, Camlin, Fowler, Mary Glenn, Moodley, Dhayendre, Theron, Gerhard, Nyakudya, Lynette H., Tomu, Musunga, Fairlie, Lee, George, Kathleen, Heckman, Barbara, Knowles, Kevin, Browning, Renee, Siberry, George K., Taha, Taha E., and Stranix-Chibanda, Lynda

Abstract

Additional file 1: PROMISE Study Design.

Published
2022
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20. Additional file 4 of Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

Author

Baltrusaitis, Kristin, Makanani, Bonus, Tierney, Camlin, Fowler, Mary Glenn, Moodley, Dhayendre, Theron, Gerhard, Nyakudya, Lynette H., Tomu, Musunga, Fairlie, Lee, George, Kathleen, Heckman, Barbara, Knowles, Kevin, Browning, Renee, Siberry, George K., Taha, Taha E., and Stranix-Chibanda, Lynda

Abstract

Additional file 4: Table S1. PROMISE Study Follow-up Time and Tenofovir Disoproxil Fumarate (TDF) Exposure for Women Eligible for TDF Randomization.

Published
2022
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21. Additional file 2 of Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial

Author

Baltrusaitis, Kristin, Makanani, Bonus, Tierney, Camlin, Fowler, Mary Glenn, Moodley, Dhayendre, Theron, Gerhard, Nyakudya, Lynette H., Tomu, Musunga, Fairlie, Lee, George, Kathleen, Heckman, Barbara, Knowles, Kevin, Browning, Renee, Siberry, George K., Taha, Taha E., and Stranix-Chibanda, Lynda

Abstract

Additional file 2: Comparison of the ZDV ART and the ZDV Alone arms.

Published
2022
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24. Pooled Prevalence of Adverse Pregnancy and Neonatal Outcomes in Malawi, South Africa, Uganda, and Zimbabwe: Results From a Systematic Review and Meta-Analyses to Inform Trials of Novel HIV Prevention Interventions During Pregnancy

Author

Lokken, Erica M., primary, Mathur, Anya, additional, Bunge, Katherine E., additional, Fairlie, Lee, additional, Makanani, Bonus, additional, Beigi, Richard, additional, Noguchi, Lisa, additional, and Balkus, Jennifer E., additional

Published
2021
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26. HPTN 035 phase II/IIb randomised safety and effectiveness study of the vaginal microbicides BufferGel and 0.5% PRO 2000 for the prevention of sexually transmitted infections in women

Author

Guffey, M Bradford, Richardson, Barbra, Husnik, Marla, Makanani, Bonus, Chilongozi, David, Yu, Elmer, Ramjee, Gita, Mgodi, Nyaradzo, Gomez, Kailazarid, Hillier, Sharon L, Karim, Salim Abdool, Black, R, Soto-Torres, L, Estep, S, Profy, A, Moench, T, Karim, SA, Taha, T, Kumwenda, N, Makanani, B, Hurst, S, Nkhoma, C, Kachale, E, Ramjee, G, Govinden, R, Coumi, N, Dladla-Qwabe, N, Ganesh, S, Morar, N, Chirenje, ZM, Padian, N, van der Straten, A, Magure, T, Mlingo, M, Mgodi, N, Hoffman, I, Martinson, F, Tembo, T, Chinula, L, Mvalo, T, Parham, G, Kapina, M, Reid, C, Kasaro, M, Brahmi, A, Maslankowski, L, Prince, J, Tustin, N, Whittington, S, Yu, E, Cates, W, Coletti, A, Gomez, K, White, R, Cianciola, M, Kelly, C, Miller, C, Mâsse, B, Richardson, B, Fleming, T, Hillier, S, Piwowar-Manning, E, and Rabe, L

Published
2014
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29. Pregnancy Outcomes of Women Conceiving on Antiretroviral Therapy (ART) Compared to Those Commenced on ART During Pregnancy

Author

Theron, Gerhard, primary, Brummel, Sean, additional, Fairlie, Lee, additional, Pinilla, Mauricio, additional, McCarthy, Katie, additional, Owor, Maxensia, additional, Chinula, Lameck, additional, Makanani, Bonus, additional, Violari, Avy, additional, Moodley, Dhayendre, additional, Chakhtoura, Nahida, additional, Browning, Renee, additional, Hoffman, Risa, additional, and Fowler, Mary Glenn, additional

Published
2020
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32. Association of Maternal Viral Load and CD4 Count With Perinatal HIV-1 Transmission Risk During Breastfeeding in the PROMISE Postpartum Component.

Author

Flynn, Patricia M., Taha, Taha E., Cababasay, Mae, Butler, Kevin, Fowler, Mary G., Mofenson, Lynne M., Owor, Maxensia, Fiscus, Susan, Stranix-Chibanda, Lynda, Coutsoudis, Anna, Gnanashanmugam, Devasena, Chakhtoura, Nahida, McCarthy, Katie, Frenkel, Lisa, Beck, Ingrid, Mukuzunga, Cornelius, Makanani, Bonus, Moodley, Dhayendre, Nematadzira, Teacler, and Kusakara, Bangani

Published
2021
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33. Correlates of Adherence to the Dapivirine Vaginal Ring for HIV-1 Prevention.

Author

Husnik, Marla J., Brown, Elizabeth R., Dadabhai, Sufia S., Gaffoor, Zakir, Jeenarain, Nitesha, Kiweewa, Flavia Matovu, Livant, Edward, Mansoor, Leila E., Mirembe, Brenda Gati, Palanee-Phillips, Thesla, Singh, Devika, Siva, Samantha, Soto-Torres, Lydia, van der Straten, Ariane, Baeten, Jared M., for the M. T. N.-020/ASPIRE Study Team, Baeten, Jared, Brown, Elizabeth, Schwartz, Katie, and Makanani, Bonus

Subjects
HIV prevention, MEDICAL equipment reliability, CONFIDENCE intervals, REVERSE transcriptase inhibitors, HUMAN sexuality, RANDOMIZED controlled trials, DRUGS, CERVICAL caps, PREVENTIVE medicine, PATIENT compliance, STATISTICAL sampling, ODDS ratio
Abstract

Understanding characteristics associated with adherence to pre-exposure prophylaxis (PrEP) methods for HIV-1 prevention may assist with optimizing implementation efforts. The dapivirine vaginal ring is a novel topical PrEP delivery method. Using data from a randomized, double-blind, placebo-controlled, phase III trial of the dapivirine vaginal ring conducted in four African countries, generalized estimating equation models were used to evaluate correlates of ring adherence. Two levels of quarterly dapivirine blood plasma, and dapivirine released from returned rings defined measures of adherence for recent and cumulative use, respectively. Time on study, calendar time, primary partner knowledge that the participant was taking part in the study, and use of long-acting contraceptive methods were associated with ring adherence whereas younger age, ring worries, condom use, episodes of menstrual bleeding and vaginal washing were associated with non-adherence. These findings may be useful for recruitment into future clinical studies and dapivirine ring implementation efforts. [ABSTRACT FROM AUTHOR]

Published
2021
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34. Elevated Risk of Bacterial Vaginosis Among Users of the Copper Intrauterine Device: A Prospective Longitudinal Cohort Study.

Author

Peebles, Kathryn, Kiweewa, Flavia M, Palanee-Phillips, Thesla, Chappell, Catherine, Singh, Devika, Bunge, Katherine E, Naidoo, Logashvari, Makanani, Bonus, Jeenarain, Nitesha, Reynolds, Doerieyah, Hillier, Sharon L, Brown, Elizabeth R, Baeten, Jared M, Balkus, Jennifer E, and team, MTN-020/ASPIRE study

Subjects
PATIENT aftercare, BACTERIAL vaginitis, CONFIDENCE intervals, INTRAUTERINE contraceptives, DESCRIPTIVE statistics, TERMINATION of treatment, LONGITUDINAL method, SECONDARY analysis, CONTRACEPTIVE drugs, DISEASE risk factors
Abstract

Background Limited evidence suggests that the nonhormonal contraceptive copper intrauterine device (Cu-IUD) may increase bacterial vaginosis (BV) risk, possibly due to increased volume and duration of menses, a common side effect of Cu-IUD use. Although increases in bleeding typically resolve within 6–12 months following initiation, evaluations of the association between Cu-IUD and BV have not included more than 6 months of follow-up. Methods This secondary analysis of a human immunodeficiency virus type 1 prevention trial included 2585 African women ages 18–45 followed for up to 33 months. Women reported contraceptive use each month. BV was evaluated by Nugent score in 6-monthly intervals and, if clinically indicated, by Amsel criteria. Andersen-Gill proportional hazards models were used to (1) evaluate BV risk among Cu-IUD users relative to women using no/another nonhormonal contraceptive and (2) test changes in BV frequency before, while using, and following Cu-IUD discontinuation. Results BV frequency was highest among Cu-IUD users at 153.6 episodes per 100 person-years (95% confidence interval [CI]: 145.2, 162.4). In adjusted models, Cu-IUD users experienced 1.28-fold (95% CI: 1.12, 1.46) higher BV risk relative to women using no/another nonhormonal contraception. Compared to the 6 months prior to initiation, BV risk was 1.52-fold (95% CI: 1.16, 2.00) higher in the first 6 months of Cu-IUD use and remained elevated over 18 months of use (P  < .05). Among women who discontinued Cu-IUD, BV frequency was similar to pre-initiation rates within 1 year. Conclusions Cu-IUD users experienced elevated BV risk that persisted throughout use. Women and their providers may wish to consider BV risk when discussing contraceptive options. [ABSTRACT FROM AUTHOR]

Published
2021
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35. Pregnancy Outcomes of Women Conceiving on Antiretroviral Therapy (ART) Compared to Those Commenced on ART During Pregnancy.

Author

Theron, Gerhard, Brummel, Sean, Fairlie, Lee, Pinilla, Mauricio, McCarthy, Katie, Owor, Maxensia, Chinula, Lameck, Makanani, Bonus, Violari, Avy, Moodley, Dhayendre, Chakhtoura, Nahida, Browning, Renee, Hoffman, Risa, and Fowler, Mary Glenn

Subjects
HIV infections, HIV-positive persons, CONFIDENCE intervals, CONCEPTION, MISCARRIAGE, PREGNANT women, HIGHLY active antiretroviral therapy, PREGNANCY outcomes, RANDOMIZED controlled trials, LOW birth weight, PERINATAL death, BREASTFEEDING, STATISTICAL sampling, PREGNANCY
Abstract

Background Globally, the number of infected women of childbearing age living with human immunodeficiency virus (HIV) and conceiving on antiretroviral therapy (ART) is increasing. Evidence of ART safety at conception and during pregnancy and adverse pregnancy outcomes remains conflicting. The Promoting Maternal and Infant Survival Everywhere (PROMISE) 1077 breastfeeding (BF) and formula feeding (FF) international multisite trials provide an opportunity to examine the impact of ART at conception on pregnancy outcomes with subsequent pregnancies. Methods The PROMISE 1077BF/1077FF trials were designed to address key questions in the management of HIV-infected women who did not meet clinical guidelines for ART treatment during the time of the trials. After the period of risk of mother-to-child transmission was over, women were randomized to either continue or discontinue ART. We compared subsequent pregnancy outcomes of nonbreastfeeding women randomized to continue ART following delivery, or breastfeeding women randomized to continue ART following breastfeeding cessation who conceived while on ART to women randomized to discontinue ART, who restarted ART after pregnancy was diagnosed. Results Pregnancy outcomes of 939 subsequent pregnancies of 826 mothers were recorded. The intention-to-treat analyses showed increased incidence of low birth weight (<2500 g) for women who conceived while on ART (relative risk, 2.65 [95% confidence interval {CI}, 1.20–5.81]), and also a higher risk of spontaneous abortion, stillbirth, or neonatal death (hazard ratio, 1.40 [95% CI,.99–1.98]) compared to women who restarted ART after they were found to be pregnant during trial follow-up. Conclusions We found an increased risk for adverse pregnancy outcomes in women conceiving on ART, emphasizing the need for improved obstetric and neonatal care for this group. Clinical Trials Registration NCT01061151. [ABSTRACT FROM AUTHOR]

Published
2021
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36. Factors associated with unsuppressed viremia in women living with HIV on lifelong ART in the multi-country US-PEPFAR PROMOTE study: A cross-sectional analysis

Author

Atuhaire, Patience, primary, Hanley, Sherika, additional, Yende-Zuma, Nonhlanhla, additional, Aizire, Jim, additional, Stranix-Chibanda, Lynda, additional, Makanani, Bonus, additional, Milala, Beteniko, additional, Cassim, Haseena, additional, Taha, Taha, additional, and Fowler, Mary Glenn, additional

Published
2019
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37. Factors associated with unsuppressed viremia in women living with HIV on lifelong ART in a multi-country cohort study: US-PEPFAR PROMOTE study

Author

Atuhaire, Patience, primary, Hanley, Sherika, additional, Yende-Zuma, Nonhlanhla, additional, Aizire, Jim, additional, Stranix-Chibanda, Lynda, additional, Makanani, Bonus, additional, Milala, Beteniko, additional, Cassim, Haseena, additional, Taha, Taha, additional, and Fowler, Mary Glenn, additional

Published
2019
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38. Experiences with simultaneous use of contraception and the vaginal ring for HIV prevention in sub-Saharan Africa.

Author

Leslie, Jonah, Kiweewa, Flavia, Palanee-Phillips, Thesla, Bunge, Katherine, Mhlanga, Felix, Kamira, Betty, Baeten, Jared, Katz, Ariana, Hillier, Sharon, Montgomery, Elizabeth, for the MTN-020/ASPIRE Study Team, Brown, Elizabeth, Soto-Torres, Lydia, Schwartz, Katie, Makanani, Bonus, Martinson, Francis, Bekker, Linda-Gail, Govender, Vaneshree, Siva, Samantha, and Gaffoor, Zakir

Subjects
HIV prevention, CONTRACEPTION, VAGINAL rings (Contraceptives), WOMEN'S attitudes, FOCUS groups, ANTI-HIV agents, HIV infections, RESEARCH funding, CERVICAL caps
Abstract

Background: Clinical trials have found that a monthly dapivirine vaginal ring was well-tolerated and reduced HIV-1 risk among women in sub-Saharan Africa. However, in order for the ring or other novel prevention methods to have optimal impact, it is necessary to understand and address women's challenges to uptake and adherence. This paper provides insight into a few key challenges noted by women using the ring and contraceptives simultaneously.Methods: The qualitative portion of the MTN-020/ASPIRE study consisted of data collection using single in-depth interviews, serial in-depth interviews, and focus group discussions, conducted with 214 participants across 15 sites in Malawi, South Africa, Uganda and Zimbabwe. A coding team used qualitative analysis software to identify themes within the interviews.Results: The primary qualitative themes among participant data pertained to side effects. Participants reported negative side effects related to menses, in some cases attributing these effects to their contraceptives and in others to the vaginal ring. Participants also expressed concern over the long-term impact of contraception and ring use on fertility, including the reversibility of the contraceptive, especially among nulliparous women.Conclusions: Women's attitudes toward contraceptives can impact their willingness to concurrently use and adhere to a novel HIV prevention product. To optimize the potential of both prevention products, researchers should pre-emptively address concerns about contraceptive impact on fertility and counsel women about the expected side effects of contraceptives versus the ring. Clinical trials identifier NCT01617096. Registered on 6-12-2012 at clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT01617096. [ABSTRACT FROM AUTHOR]

Published
2021
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39. Assessing pregnancy and neonatal outcomes in Malawi, South Africa, Uganda, and Zimbabwe: Results from a systematic chart review.

Author

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

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

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

Published
2021
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40. Relationship Type and Use of the Vaginal Ring for HIV-1 Prevention in the MTN 020/ASPIRE Trial.

Author

Pleasants, E., Tauya, T., Reddy, K., Mirembe, B. G., Woeber, K., Palanee-Phillips, T., Zimba, C., Atujuna, M., Montgomery, E. T., the MTN-020/ASPIRE Study Team, Baeten, Jared, Palanee-Phillips, Thesla, Brown, Elizabeth, Soto-Torres, Lydia, Makanani, Bonus, Martinson, Francis, Bekker, Linda-Gail, Govender, Vaneshree, Siva, Samantha, and Gaffoor, Zakir

Subjects
HIV prevention, CERVICAL caps, HEALTH behavior, HEALTH promotion, INTIMACY (Psychology), POWER (Social sciences), PSYCHOLOGY of women, QUALITATIVE research, SECONDARY analysis
Abstract

Gender roles and imbalances in sexual power contribute to the heightened HIV-1 risk faced by women in Sub-Saharan Africa. This has led prevention research to focus on the development of female controlled methods. Despite the design of products such as vaginal rings to be used autonomously by women, male partners and women's perceptions of relationships influence HIV prevention choices. To understand the influences that male partners and dyadic dynamics had on the use of the Dapivirine Vaginal Ring in the ASPIRE trial, this analysis of qualitative data explored the types of intimate partner relationships that women engaged in. This paper describes how partners facilitated or challenged women's ring use and how women dealt with these challenges within six different types of relationships characterized by power dynamics and commitment levels. We offer insights into how future use of female-initiated HIV prevention products can be promoted through recognition of different relationship types. [ABSTRACT FROM AUTHOR]

Published
2020
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41. Hygiene, Blood Flow, and Vaginal Overload: Why Women Removed an HIV Prevention Vaginal Ring During Menstruation in Malawi, South Africa, Uganda and Zimbabwe.

Author

Duby, Zoe, Katz, Ariana W. K., Browne, Erica N., Mutero, Prisca, Etima, Juliane, Zimba, Chifundo Colleta, Woeber, Kubashni, Atujuna, Millicent, Reddy, Krishnaveni, van der Straten, Ariane, the MTN-020/ASPIRE Study Team, Baeten, Jared, Palanee-Phillips, Thesla, Brown, Elizabeth, Soto-Torres, Lydia, Schwartz, Katie, Makanani, Bonus, Martinson, Francis, Bekker, Linda-Gail, and Govender, Vaneshree

Subjects
HIV prevention, BLOOD circulation, CERVICAL caps, HYGIENE, INTERVIEWING, MENSTRUATION, PATIENT compliance, SELF-evaluation, SURVEYS, TAMPONS, QUALITATIVE research, MEDICAL device removal
Abstract

We assessed the interference between vaginal ring use and menses among women who participated in the qualitative component of the MTN-020/ASPIRE vaginal ring trial in Malawi, South Africa, Uganda and Zimbabwe (N = 214). A common reason for imperfect ring adherence and premature removal of the vaginal ring cited by participants related to vaginal bleeding or menses. Whereas self-reporting via survey questions suggested that the majority (60%) of women did not mind wearing the ring while menstruating, and did not remove it (91%) during menses, in the qualitative interviews women frequently described removing the ring during menses. Their reasons included hygiene, beliefs that the ring blocked the flow of menstrual blood, fears that the ring would come out with blood or during tampon removal, and concerns around an 'overburdened' vagina. Examining women's narratives and subjective experiences related to menstruation helps build a better understanding of factors affecting ring use and adherence. [ABSTRACT FROM AUTHOR]

Published
2020
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42. The multi-country PROMOTE HIV antiretroviral treatment observational cohort in Sub-Saharan Africa: Objectives, design, and baseline findings

Author

Taha, Taha E., primary, Yende-Zuma, Nonhlanhla, additional, Aizire, Jim, additional, Chipato, Tsungai, additional, Wambuzi Ogwang, Lillian, additional, Makanani, Bonus, additional, Chinula, Lameck, additional, Nyati, Mandisa M., additional, Hanley, Sherika, additional, Brummel, Sean S., additional, and Fowler, Mary Glenn, additional

Published
2018
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44. Oral and injectable contraceptive use and HIV acquisition risk among women in 4 African countries: a secondary analysis of data from a microbicide trial

Author

Balkus, Jennifer E., Brown, Elizabeth R., Hillier, Sharon L., Coletti, Anne, Ramjee, Gita, Mgodi, Nyaradzo, Makanani, Bonus, Reid, Cheri, Martinson, Francis, Soto-Torres, Lydia, Karim, Salim S. Abdool, and Chirenje, Zvavahera M.

Subjects
Adult, Zimbabwe, Malawi, Sterilization, Tubal, Incidence, Zambia, HIV Infections, Injections, Intramuscular, Article, Contraceptives, Oral, Hormonal, Condoms, South Africa, Young Adult, Risk Factors, Delayed-Action Preparations, Contraceptive Agents, Female, Humans, Prospective Studies, Proportional Hazards Models
Abstract

To assess the effect of oral and injectable contraceptive use compared to nonhormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial.This is a prospective cohort study using data from women enrolled in HIV Prevention Trials Network protocol 035. At each quarterly visit, participants were interviewed about self-reported contraceptive use and sexual behaviors and underwent HIV testing. Cox proportional hazards regression was used to assess the effect of injectable and oral hormonal contraceptive use on HIV acquisition.The analysis included 2830 participants, of whom 106 became HIV infected (4.07 per 100 person-years). At baseline, 1546 (51%) participants reported using injectable contraceptives and 595 (21%) reported using oral contraceptives. HIV incidence among injectable, oral and nonhormonal contraceptive method users was 4.72, 2.68 and 3.83 per 100 person-years, respectively. Injectable contraceptive use was associated with a nonstatistically significant increased risk of HIV acquisition [adjusted hazard ratio (aHR)=1.17; 95% confidence interval (CI) 0.70, 1.96], while oral contraceptive use was associated with a nonstatistically significant decreased risk of HIV acquisition (aHR=0.76; 95% CI 0.37,1.55).In this secondary analysis of randomized trial data, a marginal, but nonstatistically significant, increase in HIV risk among women using injectable hormonal contraceptives was observed. No increased HIV risk was observed among women using oral contraceptives. Our findings support the World Health Organization's recommendation that women at high risk for acquiring HIV, including those using progestogen-only injectable contraception, should be strongly advised to always use condoms and other HIV prevention measures.Among Southern African women participating in an HIV prevention trial, women using injectable hormonal contraceptives had a modest increased risk of HIV acquisition; however, this association was not statistically significant. Continued research on the relationship between widely used hormonal contraceptive methods and HIV acquisition is essential.

Published
2015

45. Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial.

Author

Balkus, Jennifer E, Balkus, Jennifer E, Brown, Elizabeth R, Hillier, Sharon L, Coletti, Anne, Ramjee, Gita, Mgodi, Nyaradzo, Makanani, Bonus, Reid, Cheri, Martinson, Francis, Soto-Torres, Lydia, Abdool Karim, Salim S, Chirenje, Zvavahera M, Balkus, Jennifer E, Balkus, Jennifer E, Brown, Elizabeth R, Hillier, Sharon L, Coletti, Anne, Ramjee, Gita, Mgodi, Nyaradzo, Makanani, Bonus, Reid, Cheri, Martinson, Francis, Soto-Torres, Lydia, Abdool Karim, Salim S, and Chirenje, Zvavahera M

Abstract

ObjectiveTo assess the effect of oral and injectable contraceptive use compared to nonhormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial.Study designThis is a prospective cohort study using data from women enrolled in HIV Prevention Trials Network protocol 035. At each quarterly visit, participants were interviewed about self-reported contraceptive use and sexual behaviors and underwent HIV testing. Cox proportional hazards regression was used to assess the effect of injectable and oral hormonal contraceptive use on HIV acquisition.ResultsThe analysis included 2830 participants, of whom 106 became HIV infected (4.07 per 100 person-years). At baseline, 1546 (51%) participants reported using injectable contraceptives and 595 (21%) reported using oral contraceptives. HIV incidence among injectable, oral and nonhormonal contraceptive method users was 4.72, 2.68 and 3.83 per 100 person-years, respectively. Injectable contraceptive use was associated with a nonstatistically significant increased risk of HIV acquisition [adjusted hazard ratio (aHR)=1.17; 95% confidence interval (CI) 0.70, 1.96], while oral contraceptive use was associated with a nonstatistically significant decreased risk of HIV acquisition (aHR=0.76; 95% CI 0.37,1.55).ConclusionIn this secondary analysis of randomized trial data, a marginal, but nonstatistically significant, increase in HIV risk among women using injectable hormonal contraceptives was observed. No increased HIV risk was observed among women using oral contraceptives. Our findings support the World Health Organization's recommendation that women at high risk for acquiring HIV, including those using progestogen-only injectable contraception, should be strongly advised to always use condoms and other HIV prevention measures.ImplicationsAmong Southern African women participating in an HIV prevention trial, women using injectable hormonal contraceptives had a modest increased risk of HIV

Published
2016

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

Author

Baeten, Jared, Baeten, Jared, Palanee-Phillips, Thesla, Brown, Elizabeth, Schwartz, Katie, Soto-Torres, Lydia, Govender, Vaneshree, Mgodi, Nyaradzo, 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, Parikh, Urvi, Mellors, John, Marzinke, Mark, Hendrix, Craig, van der Straten, Ariane, Ramjee, Gita, Nakabiito, Clemensia, Taha, Taha, 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, Montgomery, Elizabeth, Mensch, Barbara, Torjesen, Kristine, Grossman, Cynthia, Chakhtoura, Nahida, Nel, Annalene, Rosenberg, Zeda, McGowan, Ian, Hillier, Sharon, Chirenje, Zvavahera, Baeten, Jared, Baeten, Jared, Palanee-Phillips, Thesla, Brown, Elizabeth, Schwartz, Katie, Soto-Torres, Lydia, Govender, Vaneshree, Mgodi, Nyaradzo, 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, Parikh, Urvi, Mellors, John, Marzinke, Mark, Hendrix, Craig, van der Straten, Ariane, Ramjee, Gita, Nakabiito, Clemensia, Taha, Taha, 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, Montgomery, Elizabeth, Mensch, Barbara, Torjesen, Kristine, Grossman, Cynthia, Chakhtoura, Nahida, Nel, Annalene, Rosenberg, Zeda, McGowan, Ian, Hillier, Sharon, and Chirenje, Zvavahera

Abstract

BACKGROUND: Antiretroviral 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. METHODS: We 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. RESULTS: Among 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<0.001) but not among those 21 years of age or younger (-27%; 95% CI, -133 to 31; P=0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups. CONCLUSIONS: A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01617096 .).

Published
2016

48. 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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49. Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study

Author

Kasaro, Margaret P, primary, Husnik, Marla J, additional, Chi, Benjamin H, additional, Reid, Cheri, additional, Magure, Tsitsi, additional, Makanani, Bonus, additional, Tembo, Tchangani, additional, Ramjee, Gita, additional, Maslankowski, Lisa, additional, Rabe, Lorna, additional, and Brad Guffey, M, additional

Published
2016
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50. Corrigendum to “oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial” [Contraception 2016; 93 (1): 25–31]

Author

Balkus, Jennifer E., primary, Brown, Elizabeth R., additional, Hillier, Sharon L., additional, Coletti, Anne, additional, Ramjee, Gita, additional, Mgodi, Nyaradzo, additional, Makanani, Bonus, additional, Reid, Cheri, additional, Martinson, Francis, additional, Soto-Torres, Lydia, additional, Abdool Karim, Salim S., additional, and Chirenje, Zvavahera M., additional

Published
2016
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