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2. After their wives have delivered, a lot of men like going out: Perceptions of HIV transmission risk and support for HIV prevention methods during breastfeeding in sub‐Saharan Africa

Author

Valerie L. Flax, Imogen Hawley, Julia Ryan, Miria Chitukuta, Florence Mathebula, Rita Nakalega, Linly Seyama, Frank Taulo, Ariane van derStraten, and MTN‐041/MAMMA Study Team

Subjects
breast milk, breastfeeding, HIV prevention, qualitative, sub‐Saharan Africa, Pediatrics, RJ1-570, Gynecology and obstetrics, RG1-991, Nutritional diseases. Deficiency diseases, RC620-627
Abstract

Abstract Female‐initiated HIV prevention methods, such as oral pre‐exposure prophylaxis (PrEP) and the vaginal ring, may be important risk reduction strategies for breastfeeding women. Given their novelty, information about the sociocultural context and how it influences perceptions of and support for their use during breastfeeding is lacking. To address this gap, we conducted 23 focus group discussions separately with pregnant and breastfeeding women, male partners and grandmothers (N = 196) and 36 in‐depth interviews with key informants in Malawi, South Africa, Uganda and Zimbabwe. We analysed the data using a framework analysis method. Overall, breastfeeding was the norm, and participants described the transference of health (e.g., nutrition) and disease (e.g., HIV) to children through breast milk. Participants considered the early breastfeeding period as one of high HIV transmission risk for women. They explained that male partners tend to seek outside sexual partners during this period because women need time to recover from delivery, women focus their attention on the child, and some men are disgusted by breast milk. Participants highlighted concerns about the drugs in oral PrEP transferring to the child through breast milk, but fewer worried about the effects of the vaginal ring because the drug is localized. Women, grandmothers and key informants were supportive of women using these HIV prevention methods during breastfeeding, while male partners had mixed opinions. These findings can be used to tailor messages for promoting the use of PrEP or the vaginal ring during breastfeeding in sub‐Saharan Africa.

Published
2021
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3. Acceptability of the dapivirine vaginal ring for HIV-1 prevention among women reporting engagement in transactional sex

Author

Erica N. Browne, Kristine Torjesen, Brenda Gati Mirembe, Thesla Palanee-Phillips, Nitesha Jeenarain, Miria Chitukuta, Marie C. D. Stoner, Leila E. Mansoor, Krishnaveni Reddy, Thelma T. Tauya, Logashvari Naidoo, Samantha Siva, Barbra Richardson, Sufia Dadabhai, Linly Seyama, Lydia Soto-Torres, and Ariane van der Straten

Subjects
Health (social science), Social Psychology, Public Health, Environmental and Occupational Health
Published
2023
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4. Sexual Attitudes, Beliefs, Practices, and HIV Risk During Pregnancy and Post-delivery: A Qualitative Study in Malawi, South Africa, Uganda, and Zimbabwe

Author

Julia H, Ryan, Alinda, Young, Petina, Musara, Krishnaveni, Reddy, Nicole, Macagna, Victor, Guma, Linly, Seyama, Jeanna, Piper, and Ariane, van der Straten

Subjects
Male, Zimbabwe, Health Knowledge, Attitudes, Practice, Malawi, Social Psychology, Public Health, Environmental and Occupational Health, Mothers, HIV Infections, South Africa, Infectious Diseases, Attitude, Pregnancy, Humans, Female, Uganda
Abstract

Women who acquire HIV during the pregnancy and breastfeeding periods have a higher risk of transmitting the virus to their child than women who become infected with HIV before pregnancy. We explore the context of sexual beliefs and practices that may shape both HIV risk and willingness to use HIV prevention products during pregnancy and postpartum in Malawi, South Africa, Uganda and Zimbabwe. Twenty-three single sex focus group discussions and 36 in-depth interviews took place between May and November 2018 with recently pregnant or breastfeeding women, men, mothers and mothers-in-law of pregnant or breastfeeding women, and key informants. Participants across study groups and sites (N = 232) reported various perceived benefits and harms of sex during pregnancy and postpartum. Participants discussed reasons why men might seek sex outside of the relationship. There is a critical need for alternative prevention options to protect pregnant and breastfeeding women from HIV.

Published
2021
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5. The Influence of Perceived Dapivirine Vaginal Ring Effectiveness on Social Disclosure and Ring Adherence

Author

Linly Seyama, Logashvari Naidoo, Carolyne Akello, Ariane van der Straten, Mtn Aspire, Tchangani Tembo, M Hope study teams, Nitesha Jeenarain, Miria Chitukuta, Nyaradzo Mgodi, Portia Hunidzarira, Elizabeth R. Brown, Thesla Palanee-Phillips, Leila E. Mansoor, Marie C D Stoner, and Gonasagrie Nair

Subjects
Ring (mathematics), medicine.medical_specialty, Social Psychology, Anti-HIV Agents, Public health, Dapivirine, Public Health, Environmental and Occupational Health, Contraceptive Devices, Female, HIV Infections, Disclosure, Vaginal ring, Article, Ring protection, Social support, Health psychology, Pyrimidines, Infectious Diseases, Hope trial, medicine, Humans, Female, Psychology, Social psychology
Abstract

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

Published
2021
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6. Acceptability of the Dapivirine Vaginal Ring for HIV-1 Prevention and Association with Adherence in a Phase III Trial

Author

Prisca Mutero, Erica N Browne, Jared M. Baeten, Kristine Torjesen, Thesla Palanee-Phillips, Miria Chitukuta, Krishnaveni Reddy, Tchangani Tembo, Elizabeth T. Montgomery, Nitesha Jeenarain, Ariane van der Straten, Thelma Tonderai Tauya, Mtn, Ashley J Mayo, Lydia Soto-Torres, Brenda Gati Mirembe, Elizabeth R. Brown, Linly Seyama, Aspire Study Team, Kubashni Woeber, and Ishana Harkoo

Subjects
medicine.medical_specialty, Activities of daily living, Social Psychology, Anti-HIV Agents, HIV prevention, Dapivirine, Psychological intervention, HIV Infections, Vaginal ring, symbols.namesake, Acceptability, medicine, Humans, Poisson regression, Original Paper, Sub-Saharan Africa, business.industry, Public health, Public Health, Environmental and Occupational Health, Contraceptive Devices, Female, Hiv 1 prevention, Pyrimidines, Infectious Diseases, Willingness to use, Adherence, HIV-1, symbols, Female, business, Demography
Abstract

We evaluated the acceptability of the 25 mg dapivirine vaginal ring (DVR) as an HIV prevention intervention and its influence on DVR adherence in the MTN-020/ASPIRE phase III trial. Acceptability measures were captured using ACASI at month 3 and end of product use (median 24 months, IQR 15–30). Monthly returned rings were classified as nonadherent if dapivirine release rate was ≤ 0.9 mg/month. Associations between acceptability measures and nonadherence were estimated using Poisson regression models with robust standard errors. At month 3 (N = 2334), 88% reported DVR was comfortable, 80% were unaware of it during daily activities, and 74% never felt it during sex. At exit, 66% were ‘very likely’ to use DVR in the future. Acceptability was found to differ significantly by country across several measures including wearing the ring during sex, during menses, partner acceptability, impact on sexual pleasure and willingness to use the ring in the future. Risk of nonadherence at month 12 was elevated if DVR was felt during sex at month 3 (aRR 1.67, 95% CI 1.26, 2.23). Risk of nonadherence in the last year of study participation was elevated if, at exit, participants minded wearing during sex (aRR 2.08, 95% CI 1.52, 2.85), during menses (aRR 1.57, 95% CI 1.06, 2.32), reported a problematic change to the vaginal environment (aRR 1.57, 95% CI 1.12, 2.21), and were not “very likely” to use DVR in the future (aRR 1.31, 95% CI 1.02, 1.68). DVR acceptability was overall high yet varied by country. Addressing perceived ring interference with sex, menses, or problematic changes to the vaginal environment in future interventions could help improve adherence, as could embracing sex-positive messaging related to ring use and increased pleasure. Trial Registration ClinicalTrials.gov Identifier: NCT01617096. Supplementary Information The online version contains supplementary material available at 10.1007/s10461-021-03205-z.

Published
2021
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7. After their wives have delivered, a lot of men like going out: Perceptions of HIV transmission risk and support for HIV prevention methods during breastfeeding in sub-Saharan Africa

Author

Imogen Hawley, Julia Ryan, Florence Mathebula, Rita Nakalega, Mtn, Ariane van der Straten, Mamma Study Team, Linly Seyama, Frank Taulo, Valerie L. Flax, and Miria Chitukuta

Subjects
0301 basic medicine, Male, Malawi, breastfeeding, Breastfeeding, HIV Infections, Disease, South Africa, 0302 clinical medicine, Pregnancy, Medicine, Uganda, 030212 general & internal medicine, Hiv transmission, Child, lcsh:RC620-627, media_common, Nutrition and Dietetics, lcsh:RJ1-570, Obstetrics and Gynecology, Vaginal ring, lcsh:Nutritional diseases. Deficiency diseases, Breast Feeding, breast milk, Female, Original Article, Zimbabwe, medicine.medical_specialty, Anti-HIV Agents, media_common.quotation_subject, HIV prevention, Breast milk, lcsh:Gynecology and obstetrics, 03 medical and health sciences, Perception, Humans, Spouses, lcsh:RG1-991, 030109 nutrition & dietetics, business.industry, Public Health, Environmental and Occupational Health, Social environment, lcsh:Pediatrics, Original Articles, Focus group, Family medicine, Pediatrics, Perinatology and Child Health, qualitative, business, sub‐Saharan Africa
Abstract

Female‐initiated HIV prevention methods, such as oral pre‐exposure prophylaxis (PrEP) and the vaginal ring, may be important risk reduction strategies for breastfeeding women. Given their novelty, information about the sociocultural context and how it influences perceptions of and support for their use during breastfeeding is lacking. To address this gap, we conducted 23 focus group discussions separately with pregnant and breastfeeding women, male partners and grandmothers (N = 196) and 36 in‐depth interviews with key informants in Malawi, South Africa, Uganda and Zimbabwe. We analysed the data using a framework analysis method. Overall, breastfeeding was the norm, and participants described the transference of health (e.g., nutrition) and disease (e.g., HIV) to children through breast milk. Participants considered the early breastfeeding period as one of high HIV transmission risk for women. They explained that male partners tend to seek outside sexual partners during this period because women need time to recover from delivery, women focus their attention on the child, and some men are disgusted by breast milk. Participants highlighted concerns about the drugs in oral PrEP transferring to the child through breast milk, but fewer worried about the effects of the vaginal ring because the drug is localized. Women, grandmothers and key informants were supportive of women using these HIV prevention methods during breastfeeding, while male partners had mixed opinions. These findings can be used to tailor messages for promoting the use of PrEP or the vaginal ring during breastfeeding in sub‐Saharan Africa.

Published
2020

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

Author

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

Subjects
0301 basic medicine, Adult, Zimbabwe, medicine.medical_specialty, Malawi, Epidemiology, Anti-HIV Agents, Immunology, Dapivirine, HIV Infections, Placebo, Article, 03 medical and health sciences, South Africa, 0302 clinical medicine, Virology, Internal medicine, Microbicide, medicine, Humans, Uganda, 030212 general & internal medicine, Tenofovir, business.industry, Surrogate endpoint, Incidence (epidemiology), Contraceptive Devices, Female, 030112 virology, Vaginal ring, Clinical trial, Administration, Intravaginal, Infectious Diseases, Clinical research, Pyrimidines, Treatment Outcome, Seroconversion, HIV-1, Patient Compliance, Female, Patient Safety, business
Abstract

Two 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.We 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.Between 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; p0·0001). HIV-1 incidence was 2·7 per 100 person-years (95% CI 1·9-3·8, 35 infections), compared with an expected incidence of 4·4 per 100 person-years (3·2-5·8) among a population matched on age, site, and presence of a sexually transmitted infection from the placebo group of ASPIRE. No serious adverse events or grade 3 or higher adverse events observed were assessed as related to the DVR.High uptake and persistent use in this open-label extension study support the DVR as an HIV-1 prevention option for women. With an increasing number of HIV-1 prophylaxis choices on the horizon, these results suggest that the DVR will be an acceptable and practical option for women in Africa.The Microbicide Trials Network and the National Institute of Allergy and Infectious Diseases, The Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health, all components of the US National Institutes of Health.

Published
2020

9. Safety of a killed oral cholera vaccine (Shanchol) in pregnant women in Malawi: an observational cohort study

Author

Mohammad, Ali, Allyson, Nelson, Francisco J, Luquero, Andrew S, Azman, Amanda K, Debes, Maurice Mwesawina, M'bang'ombe, Linly, Seyama, Evans, Kachale, Kingsley, Zuze, Desire, Malichi, Fatima, Zulu, Kelias Phiri, Msyamboza, Storn, Kabuluzi, and David A, Sack

Subjects
Adult, Malawi, Incidence, Administration, Oral, Mothers, Cholera Vaccines, Article, Cholera, Vaccines, Inactivated, Pregnancy, Humans, Female, Safety, Fetal Death, Retrospective Studies
Abstract

Pregnancy increases the risk of harmful effects from cholera for both mothers and their fetuses. A killed oral cholera vaccine, Shanchol (Shantha Biotechnics, Hydrabad, India), can protect against the disease for up to 5 years. However, cholera vaccination campaigns have often excluded pregnant women because of insufficient safety data for use during pregnancy. We did an observational cohort study to assess the safety of Shanchol during pregnancy.This observational cohort study was done in two adjacent districts (Nsanje and Chikwawa) in Malawi. Individuals older than 1 year in Nsanje were offered oral cholera vaccine during a mass vaccination campaign between March 30 and April 30, 2015, but no vaccines were administered in Chikwawa. We enrolled women who were exposed to oral cholera vaccine during pregnancy in Nsanje district, and women who were pregnant in Chikwawa district (and thus not exposed to oral cholera vaccine) during the same period. The primary endpoint of our analysis was pregnancy loss (spontaneous miscarriage or stillbirth), and the secondary endpoints were neonatal deaths and malformations. We evaluated these endpoints using log-binomial regression, adjusting for the imbalanced baseline characteristics between the groups. This study is registered with ClinicalTrials.gov, number NCT02499172.We recruited 900 women exposed to oral cholera vaccine and 899 women not exposed to the vaccine between June 16 and Oct 10, 2015, and analysed 835 in each group. 361 women exposed to the vaccine and 327 not exposed to the vaccine were recruited after their pregnancies had ended. The incidence of pregnancy loss was 27·54 (95% CI 18·41-41·23) per 1000 pregnancies among those exposed to the vaccine and 21·56 (13·65-34·04) per 1000 among those not exposed. The adjusted relative risk for pregnancy loss among those exposed to oral cholera vaccine was 1·24 (95% CI 0·64-2·43; p=0·52) compared with those not exposed to the vaccine. The neonatal mortality rate was 11·78 (95% CI 5·92-23·46) per 1000 livebirths for infants whose mothers were exposed to oral cholera vaccine versus 8·91 (4·02-19·77) per 1000 livebirths for infants whose mothers were not exposed to the vaccine (crude relative risk 1·32, 95% CI 0·46-3·84; p=0·60). Only three newborn babies had malformations, two in the vaccine exposure group and one in the no-exposure group, yielding a relative risk of 2·00 (95% CI 0·18-22·04; p=0·57), although this estimate is unreliable because of the small number of outcomes.Our study provides evidence that fetal exposure to oral cholera vaccine confers no significantly increased risk of pregnancy loss, neonatal mortality, or malformation. These data, along with findings from two retrospective studies, support use of oral cholera vaccine in pregnant women in cholera-affected regions.BillMelinda Gates Foundation.

Published
2016

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