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

Author

Montgomery, Elizabeth T, Roberts, Sarah T, Nel, Annalene, Malherbe, Mariette, Torjesen, Kristine, Bunge, Katherine, Singh, Devika, Baeten, Jared M, Marrazzo, Jeanne, Chirenje, Z Mike, Kabwigu, Samuel, Beigi, Richard, Riddler, Sharon A, Gaffour, Zakir, Reddy, Krishnaveni, Mansoor, Leila E, Nair, Gonasagrie, Woeber, Kusbashni, Moodley, Jayajothi, Jeenarain, Nitesha, Siva, Samantha, Naidoo, Logashvari, Govender, Vaneshree, and Palanee-Phillips, Thesla

Subjects
Biomedical and Clinical Sciences, Health Services and Systems, Public Health, Health Sciences, Clinical Sciences, Topical Microbicides, Behavioral and Social Science, HIV/AIDS, Prevention, Clinical Research, Infectious Diseases, Mental Health, Patient Safety, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Africa South of the Sahara, Anti-HIV Agents, Double-Blind Method, Ethics, Research, Female, HIV Infections, Humans, Intimate Partner Violence, Male, Patient Participation, Prospective Studies, Safety, Vaginal Creams, Foams, and Jellies, Africa, HIV, microbicide, social harms, women, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology, Biomedical and clinical sciences, Health sciences
Abstract

ObjectivesAssessment of safety is an integral part of real-time monitoring in clinical trials. In HIV prevention research, safety of investigational products and trial participation has been expanded to include monitoring for 'social harms', generally defined as negative consequences of trial participation that may manifest in social, psychological, or physical ways. Further research on social harms within HIV prevention research is needed to understand the potential safety risks for women and advance the implementation of prevention methods in real-world contexts.MethodsSecondary analysis of quantitative data from three randomized, double-blind, placebo-controlled trials of microbicide candidates in sub-Saharan Africa was conducted. Additionally, we assessed data from two prospective cohort studies that included participants who became HIV-positive or pregnant during parent trials.ResultsSocial harms reporting was low across the largest and most recent microbicide studies. Social harm incidence per 100 person-years ranged from 1.10 (95% CI 0.78-1.52) to 3.25 (95% CI 2.83-3.74) in the phased trials. Reporting differed by dosing mechanism (e.g. vaginal gel, oral tablet, ring) and study, most likely as a function of measurement differences. Social harms were most frequently associated with male partners, rather than, for example, experiences of stigma in the community.ConclusionMeasurement and screening for social harms is an important component of conducting ethical research of novel HIV prevention methods. To date, social harm incidence reported in microbicide trials has been relatively low (

Published
2019

2. Factors associated with uptake and acceptability of cervical cancer screening among female sex workers in Northeastern Uganda: A cross-sectional study.

Author

Opito, Ronald, Tiyo Ayikobua, Emmanuel, Akurut, Hellen, Alwedo, Susan, Ssentongo, Saadick Mugerwa, Erabu, Walter Drake, Oucul, Lazarus, Kirya, Musa, Bukenya, Lameck Lumu, Ekwamu, Elly, Oluka, Abraham Ignatius, Kabwigu, Samuel, Othieno, Emmanuel, and Mwaka, Amos Deogratius

Abstract

Background: Cervical cancer screening program in Uganda is opportunistic and focuses mainly on women aged 25–49 years. Female sex workers (FSWs) are at increased risk of developing invasive cervical cancer. There is limited data regarding the uptake and acceptability of cervical cancer screening among FSWs in Uganda. This study aimed at identifying factors associated with uptake and acceptability of cervical cancer screening among FSWs in Eastern Uganda. Methods: This was a cross-sectional study conducted among 423 FSWs aged 18–49 years attending care at six health facilities serving Key Populations (FSWs, Men who have sex with men, transgender people, people who inject drugs and people in prisons) in the Teso sub-region. Data was collected using structured investigator administered questionnaire and analyzed using Stata statistical software version 15.0 (Stata Corp, Texas, USA). The primary outcome was uptake of cervical cancer screening measured as the proportion of female sex workers who have ever been screened for cervical cancer. Chi-square test was used to compare the differences in uptake of cervical cancer screening by HIV status. Modified Poisson regression model with a robust variance estimator was used to determine association between the outcome variables and selected independent variables including demographic characteristics. Prevalence ratios (PR) with accompanying 95% confidence intervals have been reported. Statistical significance was considered at two-sided p-values ≤ 0.05. Results: The mean age of the participants was 28.1 (±SD = 6.6) years. The self-reported HIV prevalence was 21.5% (n = 91). There were 138 (32.6%) participants who had ever been screened for cervical cancer (uptake), while 397 (93.9%) were willing to be screened (acceptability). There was a significant difference in cervical cancer screening uptake between women living with HIV (WLHIV) and those who were HIV negative, 59.3% vs 26.9% respectively (P < 0.001). The significant factors associated with uptake of cervical cancer screening included living with HIV, adjusted prevalence ratio (aPR) = 1.53 (95%CI: 1.15–2.07), increasing number of biological children, aPR = 1.14 (1.06–1.24) living near a private not for profit (PNFP) facility, aPR = 2.84 (95% CI; 1.68–4.80) and availability of screening services at the nearest health facility, aPR = 1.83 (95% CI, 1.30–2.57). Factors significantly associated with acceptability of cervical cancer screening included being 40 years or older, aPR = 1.22 (95%CI: 1.01–1.47), having a family history of cervical cancer, aPR = 1.05 (1.01–1.10), and living near a PNFP facility, aPR = 1.17 (95% CI, 1.09–1.27) and having ever screened before, aPR = 0.92 (0.86–0.98). Conclusion: Female sex workers living with HIV are more likely to screen for cervical cancer than the HIV negative clients. Cervical cancer screening uptake is relatively low among the female sex workers. However, majority of the FSWs are willing to be screened for cervical cancer if the services are provided in the nearby healthcare facilities. There is need to make cervical cancer screening services available to all eligible women especially the female sex workers and integrate the services with sexual reproductive health services in general and not just HIV/ART clinics services. [ABSTRACT FROM AUTHOR]

Published
2025
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3. Female Genital Tract Host Factors and Tenofovir and Lamivudine Active Metabolites.

Author

Lantz, Alyssa M, Matovu, Flavia Kiweewa, Johnson, Reilly, Isingel, Esther, Nakalega, Rita, Kabwigu, Samuel, Beksinska, Mags E, and Nicol, Melanie R

Subjects
COPPER intrauterine contraceptives, GENITALIA, HIV, T helper cells, BIOMARKERS
Abstract

Background We previously reported the effect of contraception on cervical tenofovir concentrations in Ugandan women with human immunodeficiency virus (HIV). Here we explored the role of cervicovaginal cytokines and drug metabolizing enzymes and transporters (DMETs) to elucidate female genital tract (FGT) drug disposition in a Ugandan cohort. Methods Cervicovaginal fluid and cervical biopsies were collected from Ugandan women with HIV receiving tenofovir/lamivudine-based therapy and intramuscular depot medroxyprogesterone acetate (n = 25), copper intrauterine device (cuIUD; n = 12), or condoms (n = 13) as contraception. Cytokines were measured in cervicovaginal fluid (CVF). Ectocervical tenofovir diphosphate (TFVdp), lamivudine triphosphate (3TCtp), and deoxyadenosine triphosphate (dATP)/deoxycytidine triphosphate (dCTP) concentrations and immune marker/DMET gene expression were measured in cervical biopsies. Results Cervical 3TCtp was not correlated with any CVF cytokines. Cervical TFVdp was correlated with IL-10, IL-7, and IL-17 in CVF. CCR5 mRNA expression in cervical biopsies was higher in cuIUD users versus condom users. Using multivariable linear regression, CVF IL-17, tissue dATP, plasma estradiol, and plasma tenofovir were all significant predictors of cervical TFVdp. Tissue dCTP and plasma lamivudine were significant predictors of cervical 3TCtp. Conclusions TFVdp concentrations in cervix appear to be influenced by local inflammation. In contrast, 3TCtp FGT exposure was not affected by genital inflammation or DMETs. CuIUD users have more immune cells present, which may in turn influence local TFVdp disposition. Main Finding We investigated changes in tenofovir diphosphate and lamivudine triphosphate due to the microbiome and inflammation. While lamivudine triphosphate was not affected by either, tenofovir diphosphate appeared to be affected by local inflammation. Specifically, Th17 cells may influence tenofovir disposition. [ABSTRACT FROM AUTHOR]

Published
2024
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4. 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

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2021
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9. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study

Author

Baeten, Jared M, primary, Palanee-Phillips, Thesla, additional, Mgodi, Nyaradzo M, additional, Mayo, Ashley J, additional, Szydlo, Daniel W, additional, Ramjee, Gita, additional, Gati Mirembe, Brenda, additional, Mhlanga, Felix, additional, Hunidzarira, Portia, additional, Mansoor, Leila E, additional, Siva, Samantha, additional, Govender, Vaneshree, additional, Makanani, Bonus, additional, Naidoo, Logashvari, additional, Singh, Nishanta, additional, Nair, Gonasagrie, additional, Chinula, Lameck, additional, Parikh, Urvi M, additional, Mellors, John W, additional, Balán, Iván C, additional, Ngure, Kenneth, additional, van der Straten, Ariane, additional, Scheckter, Rachel, additional, Garcia, Morgan, additional, Peda, Melissa, additional, Patterson, Karen, additional, Livant, Edward, additional, Bunge, Katherine, additional, Singh, Devika, additional, Jacobson, Cindy, additional, Jiao, Yuqing, additional, Hendrix, Craig W, additional, Chirenje, Zvavahera M, additional, Nakabiito, Clemensia, additional, Taha, Taha E, additional, Jones, Judith, additional, Torjesen, Kristine, additional, Nel, Annalene, additional, Rosenberg, Zeda, additional, Soto-Torres, Lydia E, additional, Hillier, Sharon L, additional, Brown, Elizabeth R, additional, Aanyu, Dorothy, additional, Abima, John, additional, Abullarade, Janne, additional, Agarwal, Priyanka, additional, Ahluwalia, Surabhi, additional, Akasiima, Simon Africa, additional, Akello, Carolyne Agwau, additional, Albert, Samuel, additional, Alphale, Motsamai, additional, Alphonse, Calins, additional, Apeduno, Lucy, additional, Aranda, Sara, additional, Aridor, Orly, additional, Arnolds, Shakeera, additional, Asiimwe, Prossy, additional, Atujuna, Millicent, additional, Atwebembere, Didas, additional, Baboolall, Lakshmi, additional, Badana, Kiran, additional, Baeten, Jared M., additional, Balamusani, David, additional, Balán, Iván C., additional, Banda, Gabriel, additional, Banda, Towera Whitney, additional, Baugh, Jennifer, additional, Baziira, James Amos, additional, Beamer, May, additional, Bebeza, Sivuyisiwe Asanda, additional, Bekker, Linda-Gail, additional, Bell, Ian, additional, Bemer, Meagan, additional, Berman, Richard, additional, Berthiaume, Jennifer, additional, Bezak, Linda, additional, Bhagwandin, Yashveer, additional, Bhayat, Hassen Anwar, additional, Bhengu, Nokulunga, additional, Bhengu, Sonto, additional, Bhoola, Aruna, additional, Biira, Florence Asiimwe, additional, Bittoni, Daniel, additional, Black, Roberta, additional, Blose, Nombuso Jacqueline, additional, Boks, Pearl, additional, Bolton, Stephen Gordon, additional, Botya, Phathiswa, additional, Brown, Amanda, additional, Brown, Elizabeth, additional, Brown, Helen, additional, Bruce, Robyn Helen, additional, Bukenya, Luke Erismus, additional, Bukirwa, Aidah, additional, Bunts, Lisa, additional, Buthelezi, Fezile, additional, Buthelezi, Mbongeleni William, additional, Buthelezi, Samkelisiwe Dumisile, additional, Byogero, Rose, additional, Byroo, Samiksha, additional, Byuma, Robert, additional, Carstens, Johanna Albertha, additional, Carter, Allison, additional, Cassim, Nazneen, additional, Cebekhulu, Busisiwe, additional, Cele, Bongekile, additional, Cele, Dolly Judith, additional, Cele, Phindile, additional, Cele, Simangele, additional, Cele, Sithabile, additional, Chadza, Mary, additional, Chakhtoura, Nahida, additional, Chapdu, Claire, additional, Chareka, Gift Tafadzwa, additional, Chasakara, Charles, additional, Chatani-Gada, Manju, additional, Chetty, Diana, additional, Chidanyika, Mary, additional, Chifambi, Tafadzwa Tariro Lisa, additional, Chihota, Emelder, additional, Chikono, Sungano, additional, Chikonyora, Anesu, additional, Chikukwa, Brett Dzidzai, additional, Chin, Craig, additional, Chindevu, Mary, additional, Chinyanda, Tendai Blessing, additional, Chirenda, Thandiwe Hilda, additional, Chirenje, Zvavahera Mike, additional, Chirisa, Chiedza, additional, Chisale, Patience, additional, Chishanga, Angela, additional, Chitambo, Tobias, additional, Chitema, Fred, additional, Chithila, Flora, additional, Chitowa, Tinei Helen, additional, Chitsinde, Catherine, additional, Chitsulo, Gladys, additional, Chitukuta, Miria, additional, Chiveso, Spiwe, additional, Chome, Nelecy, additional, Chonco, Phumelele Fortune, additional, Christopher, Emily, additional, Chunderduri, Kerusha, additional, Cibi, Vutomi, additional, Cleland, Naana, additional, Coba, Thobeka, additional, Cobbing, Mandy Rae, additional, Collins, Clare, additional, Comer, Kim, additional, Cozzi, Shameen, additional, Crida, Danielle, additional, Dadabhai, Sufia, additional, Daki, Thembakazi, additional, Danster, Nwabisa, additional, Dassaye, Reshmi, additional, David, Renita, additional, Davis, Jontraye M., additional, Dawood, Sumaya, additional, Deb, Pallabi, additional, Degnam, Leslie, additional, Derrick, Tiffany Sharron, additional, Devlin, Bríd Teresa, additional, Dezzutti, Charlene, additional, Dhlakama, Patricia Mae, additional, Dias, Lorna, additional, Dimairo, Jean Chivoniso, additional, Dinnie, Elaine, additional, Dlabanta, Avile, additional, Dladla, Msizi, additional, Dladla, Thandeka Immaculate, additional, Dlungele, Andile Princess, additional, Dolezal, Curtis, additional, Donaty, Kristine, additional, Dott, Clare, additional, Dubbs, Jenna, additional, Dubula-Majola, Vuyiseka, additional, Dukwe, Pamella, additional, Duma, Cebo Ivan, additional, Duma, Portia Ignatia Makhosazana, additional, Duma, Promise, additional, Duncan, Vimbai Kudzanai, additional, Duran, Luis, additional, Dyabeni, Lindelwa, additional, Edwards, Andrew, additional, Etikala, Radhika, additional, Etima, Juliane, additional, Fairlie, Lee, additional, Fischer, Henry, additional, Fitzpatrick, Jacqueline, additional, Fleurs, Llewellyn, additional, Fowler, Mary Glenn, additional, Freeman, Lester, additional, Gaffoor, Zakir, additional, Gama, Lizzy, additional, Garg, Anita, additional, Gatsi, Vanesa Margret, additional, Gcwensa, Clifford, additional, Gebashe, Emmanuel Lwandile, additional, Geduld, Samantha, additional, Gelant, Jennipher, additional, Germuga, Donna, additional, Ggita, Joseph, additional, Giguere, Rebecca, additional, Godo, Lucy, additional, Goetz, B. Jay, additional, Gogo, Litha, additional, Goliati, Esther, additional, Gondwe, Daniel Kondwani, additional, Gordon, Kelley C., additional, Goreraza, Rodney, additional, Gounden, Jayandree, additional, Govender, Dhevium, additional, Govender, Justin Sivalingum, additional, Govender, Nerusha, additional, Govender, Subramonien, additional, Gqwara, Nonkululeko Nosipho, additional, Gravelle, Anisa (Tracy), additional, Guga, Phindile, additional, Guma, Victor, additional, Gumede, Delisile Zilungile, additional, Gumede, Sibusiso, additional, Gumede, Thembelihle, additional, Gumede, Thobeka Winifred, additional, Gundani, Orgrah, additional, Gunnam, Ravi, additional, Gupta, Rahul, additional, Gwande, Mirriam, additional, Gxako, Xolani, additional, Hall, Kim, additional, Hall, Wayne, additional, Hargrave, Perry, additional, Harkoo, Ishana, additional, Harrell, Tanya, additional, Heaps, Amy L., additional, Hendricks, Simone Lara, additional, Hendrix, Craig W., additional, Hlabisa, Bongeka, additional, Hlabisa, Lungile Bongeka, additional, Hlahla, Kudzai, additional, Hlela, Thulebona Martin, additional, Hobongwana, Thandiwe, additional, Horn, Eva, additional, Howard, Ridley, additional, Huang, Haixiao, additional, Hunidzairia, Portia, additional, Hurbans, Nivriti, additional, Husnik, Marla, additional, Hwehwe, Tendai Doreen, additional, Imamdin, Rabia, additional, Ismail, Amina, additional, Jacobs, Ebrahiema, additional, Jacques, Ashleigh Catherine, additional, Jamabya, Jane, additional, James, Grace, additional, Janse van Rensburg, Karla, additional, Jaya, Ziningi Nobuhle, additional, Jeenarain, Nitesha, additional, Jennings, Lauren, additional, Jiang, Haoping, additional, Jiang, Ning, additional, Jijana, Nwabisa Laurianne, additional, Jokoniya, Godfrey, additional, Kabasonga, Mildred, additional, Kabenge, Daniel Kizza, additional, Kabwigu, Samuel, additional, Kachale, Evans, additional, Kachenjera, Lonely, additional, Kachingamire, Fiona, additional, Kachipapa, Emma, additional, Kadiwa, Mary, additional, Kadyamusuma, McLoddy, additional, Kafufu, Bosco, additional, Kagwa, Mary Mukasa, additional, Kajura-Manyindo, Clare, additional, Kakayi, Brenda Catherine, additional, Kaliwo, Victoria, additional, Kalonji, Dishiki Jenny, additional, Kamanga, Nyasha Elizabeth, additional, Kamira, Betty, additional, Kampangire, Zerif, additional, Kamwana, Getrude, additional, Kamya, Justine, additional, Kapa, La-Donna, additional, Karugaba, Patrick, additional, Kasambara, Khumbo, additional, Kassim, Priya, additional, Kassim, Sheetal, additional, Katana, Milly, additional, Katongole, Francis, additional, Katongole, Sulaiman, additional, Katsis, Alexis, additional, Katumbi, Chaplain, additional, Katz, Ariana W.K., additional, Kawanje, Edmore, additional, Kawuma, Caroline Nassozi, additional, Kayongo, Sowedi, additional, Kekana, Emily, additional, Kemigisha, Doreen, additional, Khanyile, Siphosihle, additional, Khanyisile, Nombuso Happiness, additional, Khaya, Babalwa, additional, Khiya, Noluthando, additional, Khoza, Norah Ntombikayise, additional, Khumalo, Thembisile, additional, Khwela, Christina, additional, Khwela, Zamo, additional, Kibiribiri, Edith, additional, Kibirige, Ismael, additional, Kiiza, Beatrice, additional, Kikonyogo, Florence Sempa, additional, Kin, Melissa, additional, Kirkwood, Catherine, additional, Kistnasami, Girisha, additional, Kiweewa, Flavia Matovu, additional, Kiweewa, Max, additional, Konatham, Deepika, additional, Kubheka, Lungile, additional, Kufakunesu, Terrence, additional, Kumwenda, Phaleda, additional, Kumwenda, Wiza Wisdom Isaac, additional, Kush, Maura, additional, Kutner, Bryan A., additional, Kwatsha, Ntomboxolo, additional, Kwedza, Rosper, additional, Kyomukama, Erinah, additional, Lands, Debra, additional, Langa, Phumelele Nokuthula, additional, Lebeta, Kalkidan, additional, Lentz, Cody, additional, Leremi, Brendley Tebogo, additional, Leszczewski, Michelle, additional, Levy, Lisa, additional, Livant, Ted, additional, Lukas, Irene, additional, Mabanga, Lungile Pearl, additional, Mabaso, Nomusa, additional, Machisa, Vimbainashe, additional, Maddox, Toni M., additional, Madlala, Bernadette, additional, Magobiane, Nocwaka, additional, Magolela, Melda, additional, Maguramhinga, Fungai, additional, Magwaza, Phumzile Desiree, additional, Maharaj, Keshnee, additional, Mahed, Ferial, additional, Mahlase, Tankiso Vuyiswa, additional, Maila, Moshukutjoane Lebogang, additional, Makala, Yvonne, additional, Makamure, Patrick, additional, Makgoka, Kgabo Phineas, additional, Makhamba, Pamela, additional, Makhanya, Nompumelelo, additional, Makondo, Rulani, additional, Makoni, Rujeko, additional, Makooka, Henry, additional, Makunganya, Jennie, additional, Makwenda, Sibongile, additional, Malan, Gakiema, additional, Malemia, Agnes, additional, Malherbe, Mariette, additional, Malunga, Faith, additional, Mamba Nhassengo, Temantfulini, additional, Mampa, Mogau, additional, Mamvura, Tendai Karen, additional, Manengamambo, Elmah, additional, Mangove, Loreen Zandile, additional, Mangxilana, Nomvuyo Thelma, additional, Manjera, Tsungai Patience, additional, Mans, Winifred Elizabeth, additional, Mansoor, Leila, additional, Maoko, Memory, additional, Mapfunde, Annie, additional, Maphumulo, Nonhlanhla Yvonne, additional, Martinson, Francis E.A., additional, Maruwo, Abel, additional, Marx, Emmerentia Yvonne, additional, Marzinke, Mark A., additional, Masango, Moira, additional, Mashego, Mmathabo Nnana, additional, Mashinini, Gwendoline Thotele Refilwe, additional, Masuko, Shingirayi Irene, additional, Matambanadzo, Kudzai Viviana, additional, Mathebula, Florence Tintswalo, additional, Mathipa, Matheus, additional, Matsa, Jacob Munyaradzi, additional, Matta, Eleanor Agnes, additional, Matubu, Allen Taguma, additional, Mavundla, Ayanda Comfort, additional, Mavundla, Sandile, additional, Mawindo, Billy, additional, Mayani, Josiah, additional, Mayanja, Emmanuel, additional, Mayekiso, Nombongo, additional, Mayisela, Nonkululeko Precious, additional, Mayo, Ashley J., additional, Mbabali, Mary Speciosa, additional, Mbanjwa, Nonhlakanipho Masibonge Gciniwe, additional, Mbatha, Constance Seanokeng, additional, Mbatha, Nomcedo Janice, additional, Mbewe, Dorica, additional, Mbichila, Tinkhani, additional, Mbilizi, Yamikani Rose, additional, Mbokazi, Sithokoza, additional, Mbwerera, Mwandifitsa, additional, Mchunu, Zethu, additional, McKinstry, Laura, additional, Mdlongwa, Bongiwe, additional, Mellors, John W., additional, Meyiwa, Sihle Perfect, additional, Mgodi, Nyaradzo Mavis, additional, Mhizha, Erasmus Samuel, additional, Mhlanga, Nomsa Sibongile, additional, Mirembe, Brenda Gail, additional, Mirembe, Dorothy, additional, Mkandawire, Fumbani, additional, Mkhabela, Ntombizethu Hazel, additional, Mkhize, Baningi, additional, Mkhize, Princess Hlengiwe, additional, Mkhize, Zaba, additional, Mlangeni, Elizabeth Gugu, additional, Mlingo, Margaret, additional, Mngqebisa, Bukiwe, additional, Mngxekeza, Noluxolo, additional, Mninzi, Anele, additional, Mnqonywa, Nonzwakazi, additional, Mogkoro, Mammekwa, additional, Mogodiri, Thembisile Wilmah, additional, Mohuba, Rebone Frengelina, additional, Mokoena, Maseponki Cecilia, additional, Mona, Noxolo, additional, Montoya, Deidra, additional, Monyethabeng, Willie, additional, Moodley, Jayajothi, additional, Moodley, Jeeva, additional, Moodley, Kerushini, additional, Moonsamy, Suri, additional, Morar, Neetha Shagan, additional, Morudu, Sophie Nomsa, additional, Mpekula, Angela, additional, Mphisa, Gerald Thsepo, additional, Mpofu, Jayne, additional, Mposula, Hlengiwe Theodora, additional, Mqadi, Avril, additional, Msiska, Emmie, additional, Msumba, Lusungu, additional, Mtambo, Nana, additional, Mthalane, Emmanuel Sinothi, additional, Mthembu, Thabisile Susan, additional, Mthethi, Zanoxolo, additional, Mthethwa, Magdeline Judith, additional, Mthethwa, Ntokozo Zabathethwa, additional, Mthimkhulu, Sicelo Samuel, additional, Mtlokoa, Itsepheng, additional, Mubiru, Michael Charles, additional, Mudavanhu, Mary, additional, Mufumisi, Anna Zvirevo, additional, Mugagga, Agnes Mary, additional, Muganga, Joanita, additional, Mugava, Michelle, additional, Mugenyi, Margaret, additional, Mugocha, Caroline, additional, Mugodhi, Faith, additional, Mugwagwa, Norma, additional, Muhlanga, Felix Godwin Sivhukile, additional, Mukaka, Shorai, additional, Mukasa, Dick, additional, Mukasa, Restituta, additional, Mukatipa, Mathews, additional, Mukova, Shedina, additional, Mulebeke, Sarah, additional, Mulima, Joyce, additional, Muller, Julio, additional, Mulumba, Faith, additional, Mupamombe, Tsitsi, additional, Murandu, Constance, additional, Murefu, Tarisai, additional, Murewa, Fungai, additional, Muringayi, Kudakwashe, additional, Murombedzi, Caroline, additional, Musara, Petina, additional, Musisi, Jane Nsubuga, additional, Musisi, Mary Maria, additional, Musoke, Philippa, additional, Mutebo, Joseph, additional, Mutero, Prisca, additional, Mutiti, Kudzai Santana, additional, Mutizira, Shadreck, additional, Mutsvunguma, Sharon, additional, Muungani, Netsai, additional, Muvunzi, Tariro, additional, Muwawu, Rosemary, additional, Mvelase, Samkelisiwe, additional, Mvinjelwa, Priscilla Pamela, additional, Mvuyane, Goodness Zoh, additional, Mwafulirwa, Liness, additional, Mwagomba, Pokiwe, additional, Mwakhwawa, Thoko Gift, additional, Mwebaza, Deborah, additional, Mwenda, Wezi Longwe, additional, Myeni, Nqobile, additional, Mzolo, Angeline Doreen Nonhlanhla, additional, Nabatanzi, Regina Bukenya, additional, Nabisere, Joselyne, additional, Nabukeera, Josephine, additional, Nagawa, Christine Valerie, additional, Naicker, Cherise, additional, Naicker, Kumari, additional, Naicker, Vimla, additional, Naidoo, Ishana, additional, Naidoo, Jason, additional, Naidoo, Jayganthie, additional, Naidoo, Kalendri, additional, Naidoo, Renissa, additional, Naidoo, Sandy, additional, Naidu, Nalini, additional, Nair, Gonasagrie Lulu, additional, Nakacwa, Susan, additional, Nakakande, Joyce Gladys, additional, Nakalega, Rita, additional, Nakalema, Maria Gorreti, additional, Nakibuka, Jesca, additional, Nakyanzi, Teopista, additional, Nakyeyune, Justine, additional, Nalusiba, Stella, additional, Namakula, Rhoda, additional, Namalueso, Felix, additional, Namayanja, Paula Mubiru, additional, Nampala, Christine Tapuwa, additional, Nampiira, Suzan Nkalubo, additional, Namuddu, Agnes, additional, Nandundu, Norah, additional, Nansamba, Winnie, additional, Nanyonga, Stella, additional, Nanziri, Sophie Clare, additional, Nassoma, Zainab Nakivumbi, additional, Ncube, Duduzile Ethel, additional, Ncube, Eva, additional, Ncube, Sithabile, additional, Ndadziyira, Pepukayi, additional, Ndamase, Pamella Pumla, additional, Nderecha, Walter Seth Taurayi, additional, Ndhlovu-Forde, Zanele, additional, Ndimande, Thembelihle Cynthia, additional, Ndlovu, Bukekile, additional, Ndlovu, Grecenia, additional, Ndlovu, James, additional, Ndlovu, Nontokozo Happiness, additional, Ndlovu, Thakisile Nontokozo, additional, Ndlovu, Zodwa, additional, Ndovie, Margret, additional, Nemasango, Beauty, additional, Neradilek, Blazej, additional, Ngani, Susan, additional, Ngcebethsha, Nokwanda Queeneth, additional, Ngcobela, Lizbon, additional, Ngcobo, Nolwazi, additional, Ngcobo, Nompumelelo, additional, Ngcobo, Sindisiwe Promise, additional, Ngcukana, Nidleka, additional, Ngo, Julie, additional, Ngqabe, Nontshukumo, additional, Ngqame, Siyabonga, additional, Ngubane, Mduduzi Dawood, additional, Ngwenya, Nancy Nokuthula, additional, Nhkoma, Mugowe, additional, Nhlapho, Bongiwe Ntombizodwa, additional, Nhleko, Sibusiso, additional, Nkwanyana, Hlengiwe, additional, Noble, Heather, additional, Nobula, Lumka Lucia, additional, Nolan, Monica, additional, Nompondwana, Mluleki, additional, Notshokovu, Busiwe, additional, Ntanzi, Vukani Sandile, additional, Nursaye, Nishi, additional, Nutall, Jeremy Peter, additional, Nyabadza, Omega, additional, Nyaka, Evelesi, additional, Nyakudya, Sandra, additional, Nyakura, Envioletta Chiedza, additional, Nyamadzawo, Shingayi, additional, Nyamuzihwa, Tsitsi, additional, Nyanzi, Zubayiri, additional, Nyathi, Angel Tinny, additional, Nyirenda, Fadire, additional, Nyirenda, Makandwe, additional, Nyirenda, Mary, additional, Nzama, Sinqobile Charity, additional, Nzuza, Lamec Sbongisomi, additional, O'Byrne, Bhavesha, additional, Okello, Fabian, additional, Okumu, Eunice, additional, Oluka, Emmanuel, additional, Onen, Francis, additional, Onyango, Carolyne Peris, additional, Ostbye, Katherine, additional, Padayachee, Kerusha, additional, Palichina, Victor, additional, Pan, Zhenyu, additional, Pappajohn, Colin, additional, Paramanund, Levanya, additional, Parikh, Urvi M., additional, Pearce, Nazmie, additional, Penrose, Kerri J., additional, Phahlamohlaka, Bathandekile Molly, additional, Phidane, Nokulunga Ruth, additional, Pillay, Omisha, additional, Premrajh, Anamika, additional, Prosad, Nikita, additional, Rabe, Lorna, additional, Rajman, Alishka, additional, Rampai, Keneoe Maphuti, additional, Rampyapedi, Hlalifi Sylvia, additional, Randhawa, April, additional, Rasmeni, Sabelo, additional, Rausch, Dianne, additional, Reddy, Avanita, additional, Reddy, Isayum, additional, Reddy, Jerusha, additional, Reddy, Krishnaveni, additional, Rees, Vera Helen, additional, Repetto, Andrea, additional, Richards, Cheryl, additional, Riddler, Sharon, additional, Rini, Nobubele, additional, Roeber, Brendon, additional, Rohan, Lisa, additional, Romer, Zachary, additional, Rose, Matthew, additional, Rosenberg, Zeda Fran, additional, Rossi, Lisa, additional, Ruch, Aviva, additional, Rullo, Christine, additional, Runeyi, Sinazo, additional, Rupemba, Olivia, additional, Rushwaya, Chenai, additional, Russell, Marisa, additional, Ruzive, Patience Sharai, additional, Rwanzogyera, Godfrey, additional, Saava, Margaret Nakato, additional, Sagela, Tshepo Jimmy, additional, Sakwa, Rebecca, additional, Sayed, Fathima, additional, Schille, Jennifer, additional, Scotch, Nokwayintombi, additional, Scott, William, additional, Scoville, Caitlin, additional, Sebagala, Richard, additional, Sebastian, Elaine, additional, Sedze, Natasha Tina, additional, Seedat, Nasreen Hoosen, additional, Semakula, Joseph, additional, Senn, Teri, additional, Serugo, Francis, additional, Seyama, Linly, additional, Shabalala, Bhekanani Khumulani, additional, Shangase, Charlotte Phumzile, additional, Shanhinga, Pamela Caroline, additional, Shaver, Jeremy, additional, Shen, Hanjie, additional, Shogole, Mogobalale Corlett, additional, Shonhiwa, Rachel, additional, Shozi, Claudia, additional, Sibanda, Marvelous, additional, Sibeko, Sylvia Sibongile, additional, Sibisi, Ncamisile Teressa, additional, Sibisi, Samuel Siphelele, additional, Sibiya, Brighty Zweni, additional, Sibiya, Happiness, additional, Sichali, Dorothy, additional, Sikosana, Phumzile Yvonne, additional, Silva, Craig, additional, Simelane, Ayanda Purity, additional, Simon, Melissa, additional, Sing, Triesha, additional, Sithole, Hailey Virginia, additional, Sitima, Edith, additional, Siyasiya, Alex, additional, Sizane, Vuyane, additional, Siziba, Bekezela, additional, Slezinger, Edward, additional, Smolinski, Daria, additional, Snapinn, Katie, additional, Sogoni, Olwethu, additional, Soko, Dean, additional, Solai, Leonard Nichiren, additional, Somga, Mandiphumle, additional, Song, Mei, additional, Song, Xiaoling, additional, Soobryan, Devarani, additional, Soto-Torres, Lydia, additional, Spence, Patrick Lawrence, additional, Spooner, Elizabeth, additional, Sseguya, Vincent, additional, Ssentongo, Augustine, additional, Ssenyonga, Mark, additional, Sseremba, Lawrence Lollian, additional, Stais, Michael, additional, Steytler, John, additional, Stockton, Sharon, additional, Stofel, Julie, additional, Stuurman, Tinyiko Reginah, additional, Sukazi, Sizakele, additional, Sukdao, Jasmin Lynn, additional, Swarna, Kranthi, additional, Szydlo, Daniel, additional, Tagliaferri Rael, Christine, additional, Taguta, Dorothy Rumbidzai, additional, Taha, Taha, additional, Tahuringana, Eunice, additional, Tamale, Joshua, additional, Tambama, Penelope, additional, Taulo, Edna, additional, Taulo, Frank, additional, Tauya, Thelma Tonderai, additional, Tegha, Gerald, additional, Tembe, Sindisiwe Lucia, additional, Tembo, Tchangani, additional, Thatelo, Constance Lebo, additional, Thobela, Pinky Mery, additional, Thom, Annie, additional, Thompson, Christine, additional, Thompson, Monica, additional, Thusi, Linda, additional, Tock, Lauri, additional, Tofile, Thandokazi, additional, Tranfaglia, Carol, additional, Tseng, Jenny, additional, Tshabalala, Themba, additional, Tshongoyi, Nomvuselelo, additional, Tsidya, Mercy, additional, Tsikiwa, Wendy Rufaro, additional, Tuswa-Haynes, NoCamagu, additional, Tutshana, Bomkazi Onini, additional, Twala, Andile Premrose, additional, Udith, Ashvir Viren, additional, Unten, Christine, additional, van Niekerk, Neliette, additional, Varela, Amanda, additional, Vatsha, Nangamso, additional, Vijayendran, Gayathri, additional, Vuma, Amukelani California, additional, Wabwire, Deo Ogema, additional, Walani, Madalo, additional, Wanda, Bhekisisa, additional, Wasberg, Lisa, additional, White, Rhonda R., additional, Windle, Kathleen Marie, additional, Woeber, Kubashni, additional, Wright, Danica, additional, Wright, Tiffanee, additional, Xaba, Thembalethu Nontokozo, additional, Yambira, Makanaka Jean Savie, additional, Yola, Ntando, additional, Zaca, Sindisiwe Lydia, additional, Zalwango, Aisha, additional, Zemanek, Jullian, additional, Zimba, Chifundo, additional, Zinyengere, Tsitsi, additional, Zinyongo, Margaret, additional, Zondi, Thabile Goodness, additional, Zou, Chun, additional, Zuma, Jabulisile, additional, Zungu, Nokuthula Princess, additional, and Zungu, Nompumelelo, additional

Published
2021
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10. Depot Medroxyprogesterone Acetate and the Vaginal Microbiome as Modifiers of Tenofovir Diphosphate and Lamivudine Triphosphate Concentrations in the Female Genital Tract of Ugandan Women: Implications for Tenofovir Disoproxil Fumarate/Lamivudine in Preexposure Prophylaxis

Author

Nicol, Melanie R, primary, Eneh, Prosperity, primary, Nakalega, Rita, primary, Kaiser, Thomas, primary, Kabwigu, Samuel, primary, Isingel, Esther, primary, Beksinska, Mags, primary, Sykes, Craig, primary, Fowler, Mary Glenn, primary, Brown, Todd T, primary, Staley, Christopher, primary, and Kiweewa Matovu, Flavia, primary

Published
2019
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11. Impact of Male Partner Involvement on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial.

Author

Roberts, Sarah T., Nair, Gonasagrie, Baeten, Jared M., Palanee-Philips, Thesla, Schwartz, Katie, Reddy, Krishnaveni, Kabwigu, Samuel, Matovu Kiweewa, Flavia, Govender, Vaneshree, Gaffoor, Zakir, Singh, Nishanta, Siva, Samantha, Naidoo, Kalendri, and Montgomery, Elizabeth T.

Subjects
HIV prevention, CERVICAL caps, CONCEPTUAL structures, CONFIDENCE intervals, HEALTH behavior, SECONDARY analysis, SOCIAL support, RELATIVE medical risk, NON-nucleoside reverse transcriptase inhibitors, SEXUAL partners, DESCRIPTIVE statistics
Abstract

Although vaginal microbicides for HIV prevention are designed to be female-initiated, male partner influence has been identified as one of the most significant factors impacting women's willingness and ability to use them. As a result, research teams have sought to increase male partner involvement by encouraging disclosure of product use to male partners, promoting male partner engagement in the study through attendance at the study clinic, and helping women to garner male partner support for product use. This paper aims to assess the impact of these three elements of male partner involvement on women's adherence to the dapivirine vaginal ring during MTN-020/ASPIRE, a phase III randomized placebo-controlled clinical trial involving 2629 women in Malawi, South Africa, Uganda, and Zimbabwe. During the study, 64–80% of participants reported disclosure of ring use at each quarterly visit, and 13% reported that their partners had attended the study clinic at some point during the study. At study exit, 66% reported that their partner was supportive, 18% unsupportive, and 17% were unsure. After adjusting for age, site and time in study, women were more likely to have low ring adherence if they had an unsupportive male partner (aRR 1.29, 95% CI 1.03–1.62). Neither disclosure nor clinic attendance directly predicted ring adherence, but disclosure increased the probability of having a supportive partner (aRRR 24.17, 95% CI 16.38–35.66) or an unsupportive partner (aRRR 4.10, 95% CI 2.70–6.24), relative to an unknown level of partner support. Women were also more likely to have a supportive partner if their partner had attended the clinic (aRRR 3.77, 95% CI 1.36–10.42). This study suggests that although the vaginal ring is relatively discreet, lack of support from male partners remains a relevant barrier to use. Though both disclosure and clinic attendance may increase partner support, disclosure may also increase partner opposition. Interventions to reduce male partner opposition are needed to maximize the potential impact of the ring and other PrEP products for HIV prevention. [ABSTRACT FROM AUTHOR]

Published
2020
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12. Depot Medroxyprogesterone Acetate and the Vaginal Microbiome as Modifiers of Tenofovir Diphosphate and Lamivudine Triphosphate Concentrations in the Female Genital Tract of Ugandan Women: Implications for Tenofovir Disoproxil Fumarate/Lamivudine in Preexposure Prophylaxis

Author

Nicol, Melanie R, Eneh, Prosperity, Nakalega, Rita, Kaiser, Thomas, Kabwigu, Samuel, Isingel, Esther, Beksinska, Mags, Sykes, Craig, Fowler, Mary Glenn, Brown, Todd T, Staley, Christopher, and Matovu, Flavia Kiweewa

Subjects
HIV prevention, BIOPSY, HUMAN microbiota, CLINICAL trials, CONTRACEPTIVE drugs, DNA, DRUG interactions, FEMALE reproductive organs, LACTOBACILLUS, LIQUID chromatography, MASS spectrometry, PREVENTIVE medicine, MEDROXYPROGESTERONE, RNA, VAGINA, WOMEN'S health, TREATMENT effectiveness, LAMIVUDINE, TENOFOVIR, SEQUENCE analysis, MANN Whitney U Test, PHARMACODYNAMICS
Abstract

Background Effective concentrations of antiretrovirals in the female genital tract (FGT) are critical for suppression of viral shedding or effective preexposure prophylaxis. The disposition of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in the FGT have been previously described. Despite widespread use, however, lamivudine triphosphate (3TC-TP) exposure in the FGT is unknown. Depot medroxyprogesterone acetate (DMPA) and vaginal dysbiosis have been implicated in increased risk of human immunodeficiency virus (HIV) acquisition, but whether they alter TFV-DP or 3TC-TP exposure, and therefore compromise prevention efficacy, is unknown. Methods Fifty premenopausal women living with HIV in Kampala, Uganda, and receiving daily tenofovir disoproxil fumarate/lamivudine were recruited. Ectocervical biopsies were obtained for quantification of TFV-DP and 3TC-TP using liquid chromatography–mass spectrometry. 16S ribosomal RNA gene sequencing was performed on DNA extracted from vaginal swabs. Wilcoxon rank-sum was used to test for differences between contraceptive groups. Results 3TC-TP concentrations were on average 17-fold greater than TFV-DP concentrations in cervical tissues. TFV-DP concentrations in cervical biopsies were 76% greater in DMPA users compared with women using nonhormonal contraception (n = 23 per group). Abundance of Lactobacillus in vaginal swabs was correlated with 3TC-TP concentrations in cervical tissues. Conclusions We found that TFV-DP concentrations were significantly greater in DMPA users compared with women using nonhormonal contraception, suggesting that prevention efficacy is unlikely to be compromised by DMPA use. Similar to reports of FTC-TP, 3TC-TP exposure was significantly greater than TFV-DP in cervical tissue and was correlated with abundance of Lactobacillus. These data support lamivudine as an option for preexposure prophylaxis. Clinical Trials Registration NCT03377608. [ABSTRACT FROM AUTHOR]

Published
2020
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14. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials

Author

Mhlanga, Felix G., primary, Noguchi, Lisa, additional, Balkus, Jennifer E., additional, Kabwigu, Samuel, additional, Scheckter, Rachel, additional, Piper, Jeanna, additional, Watts, Heather, additional, O’Rourke, Colin, additional, Torjesen, Kristine, additional, Brown, Elizabeth R., additional, Hillier, Sharon L., additional, and Beigi, Richard, additional

Published
2017
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15. HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial

Author

Riddler, Sharon A., primary, Husnik, Marla, additional, Ramjee, Gita, additional, Premrajh, Anamika, additional, Tutshana, Bomkazi Onini, additional, Pather, Arendevi, additional, Siva, Samantha, additional, Jeenarain, Nitesha, additional, Nair, Gonasagrie, additional, Selepe, Pearl, additional, Kabwigu, Samuel, additional, Palanee-Phillips, Thesla, additional, Panchia, Ravindre, additional, Mhlanga, Felix, additional, Levy, Lisa, additional, Livant, Edward, additional, Patterson, Karen, additional, Elharrar, Vanessa, additional, and Balkus, Jennifer, additional

Published
2017
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19. The MTN-016 Pregnancy Registry: Baseline Characteristics of Enrollees from the VOICE Study and Reasons for Non-enrollment of Eligible Women

Author

Kabwigu, Samuel, primary, Noguchi, Lisa, additional, Moodley, Jothi, additional, Palanee, Thes, additional, Kintu, Kenneth, additional, Nair, Lulu, additional, Panchia, R, additional, Selepe, Pearl, additional, Balkus, Jennifer E., additional, Torjesen, Kristine, additional, Piper, Jeanna, additional, Scheckter, Rachel, additional, Hazra, Rohan, additional, and Beigi, Richard, additional

Published
2014
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22. Hematologic and Chemistry Normal Laboratory Values among Healthy Ugandan Women Screened for a Pre-exposure Prophylaxis Trial: The MTN-003(VOICE) Study

Author

Kiweewa, Flavia Matovu, primary, Gundacker, Holly M., additional, Mubiru, Mike, additional, Kamira, Betty, additional, Gati, Brenda Mirembe, additional, Ojok, David, additional, Kabwigu, Samuel, additional, Musoke, Philippa, additional, Nakabiito, Clemensia, additional, and Fowler, Mary Glenn, additional

Published
2014
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26. Recruitment for Retention in Biomedical HIV Prevention Studies: Strategies, Challenges, Lessons Learned from MTN-020 (ASPIRE) Study, at Kampala Site

Author

Nanziri, Sophie Clare, primary, Ndawula, Patrick, additional, Nakyanzi, Teopista, additional, Gati, Brenda, additional, Matovu, Flavia K., additional, Etima, Juliane, additional, Kabwigu, Samuel, additional, Kemigisha, Doreen, additional, Nanyonga, Stella, additional, and Nakabiito, Cleemensia, additional

Published
2014
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27. Obstetric and Infant Outcomes Following Planned Maternal Third Trimester Exposure to Tenofovir 1% Vaginal Gel.

Author

Biggio, Joseph, Bunge, Katherine, Dai, James, Isaacs, Karen, Torjesen, Kristine, Kabwigu, Samuel, Schwartz, Jill, Vargas, Juan, Scaglia, Fernando, Jacobson, Cindy, Watts, D H., Piper, Jeanna M., and Beigi, Richard H.

Abstract

An abstract of the article "Obstetric and Infant Outcomes Following Planned Maternal Third Trimester Exposure to Tenofovir 1% Vaginal Gel" by Lisa M. Noguchi and colleagues is presented.

Published
2014
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28. Maximizing Participant Retention in a Phase2 B HIV Prevention Trial in Kampala, Uganda: The MTN-003 (VOICE Study).

Author

Kiweewa, Flavia M., Kapaata, Fred B., Kikonyogo, Florence, Bukenya, Regina, Musisi, Jane, Kaggwa, Mary, Saava, Margaret, Kabwigu, Samuel, and Nakabiito, Clemensia

Abstract

An abstract of the article "Maximizing Participant Retention in a Phase2 B HIV Prevention Trial in Kampala, Uganda: The MTN-003 (VOICE Study)" by Flavia M. Kiweewa, Fred B. Kapaata and colleagues is presented.

Published
2014
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29. Why Women at High Risk for HIV-1 Infection Did Not Join the VOICE Study in Uganda: A Qualitative Community Study.

Author

Kabwigu, Samuel, Kemigisha, Doreen, Nanziri, Sophie C., Ndawula, Patrick, Nanyonga, Stella, Etima, Juliane, Kiweewa, Flavia M., White, Rhonda, Noguchi, Lisa, and Nakabiito, Clemensia

Abstract

An abstract of the article "Why Women at High Risk for HIV-1 Infection Did Not Join the VOICE Study in Uganda: A Qualitative Community Study" by Teopista Nakyanzi, Samuel Kabwigu, Doreen Kemigisha and colleagues is presented.

Published
2014
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30. How Community Education Tools Facilitated Understanding of the ASPIRE Vaginal Ring Study: Kampala Experience.

Author

Nakyanzi, Teopista, Etima, Juliane, Kabwigu, Samuel, Matovu, Flavia K., Nanziri, Sophie C., Kemigisha, Doreen, Nanyonga, Stella, White, Rhonda, Cokley, Cheryl, and Nakabiito, Clemesia

Abstract

An abstract of the article "How Community Education Tools Facilitated Understanding of the ASPIRE Vaginal Ring Study: Kampala Experience" by Patrick Ndawula and colleagues is presented.

Published
2014
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31. Hematologic and Chemistry Normal Laboratory Values among Healthy Ugandan Women Screened for a Pre-exposure Prophylaxis Trial: The MTN-003(VOICE) Study.

Author

Gundacker, Holly M., Mubiru, Mike, Kamira, Betty, Gati, Brenda Mirembe, Ojok, David, Kabwigu, Samuel, Musoke, Philippa, Nakabiito, Clemensia, and Fowler, Mary Glenn

Abstract

An abstract of the article "Hematologic and Chemistry Normal Laboratory Values among Healthy Ugandan Women Screened for a Pre-exposure Prophylaxis Trial: The MTN- 003(VOICE) Study" by Flavia Matovu Kiweewa, Holly M. Gundacker and colleagues is presented.

Published
2014
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32. 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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33. Recruitment for Retention in Biomedical HIV Prevention Studies: Strategies, Challenges, Lessons Learned from MTN-020 (ASPIRE) Study, at Kampala Site.

Author

Ndawula, Patrick, Nakyanzi, Teopista, Gati, Brenda, Matovu, Flavia K., Etima, Juliane, Kabwigu, Samuel, Kemigisha, Doreen, Nanyonga, Stella, and Nakabiito, Cleemensia

Abstract

An abstract of the article "Recruitment for Retention in Biomedical HIV Prevention Studies: Strategies, Challenges, Lessons Learned from MTN-020 (ASPIRE) Study, at Kampala Site" by Sofie Clare Nanziri and colleagues is presented.

Published
2014
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34. Strategies for Successful Promotion and Implementation of Contraceptive Method Mix in MTN-020/ASPIRE: The Why and How at Kampala Site.

Author

Nakabiito, Clemensia, Nsangi, Justine Kamya, Nabisere, Joselyne, Nagawa, Christine, Kabwigu, Samuel, Kapaata, Fred, and Matovu, Flavia K.

Abstract

An abstract of the article "Strategies for Successful Promotion and Implementation of Contraceptive Method Mix in MTN-020/ASPIRE: The Why and How at Kampala Site" by Betty Kamira, Clemensia Nakabiito, Justine Kamya Nsangi and colleagues is presented.

Published
2014
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35. 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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36. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials.

Author

Mhlanga FG, Noguchi L, Balkus JE, Kabwigu S, Scheckter R, Piper J, Watts H, O'Rourke C, Torjesen K, Brown ER, Hillier SL, and Beigi R

Subjects
Anti-HIV Agents adverse effects, Cohort Studies, Female, HIV Infections drug therapy, Humans, Infant, Infant, Newborn, Internationality, Pregnancy, Pregnancy Complications, Infectious drug therapy, Anti-HIV Agents administration & dosage, Anti-HIV Agents pharmacology, HIV Infections prevention & control, Pregnancy Complications, Infectious prevention & control, Registries
Abstract

Background: Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials., Methods: The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation., Results: To date, participants from two phase I studies and two effectiveness trials have participated in MTN-016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit., Conclusion: In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.

Published
2018
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37. Case Study: Converting Paper-based Case Report Forms to an Electronic Format (e-CRF) with ACASI Self-Report Integration.

Author

Mierzwa S, Souidi S, Akello C, Etima J, Ssebagala R, Nolan M, Kabwigu S, and Nakablito C

Abstract

This paper will discuss the integration of electronic Case Report Forms (e-CRFs) into an already existing Android-based Audio Computer-Assisted Self-Interview (ACASI) software solution that was developed for a public health project in Kampala, Uganda, the technical outcome results, and lessons learned that may be useful to other projects requiring or considering such a technology solution. The developed product can function without a connection to the Internet and allows for synchronizing collected data once connectivity is possible. Previously, only paper-based CRFs were utilized at the Uganda project site. A subset or select group of CRFs were targeted for integration with ACASI in order to test feasibility and success. Survey volume, error rate, and acceptance of the system, as well as the operational and technical design of the solution, will be discussed.

Published
2017
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