Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study. Issue 2 (February 2021)

• Record Type: Journal Article
• Authors: Baeten, Jared M; Palanee-Phillips, Thesla; Mgodi, Nyaradzo M; Mayo, Ashley J; Szydlo, Daniel W; Ramjee, Gita; Gati Mirembe, Brenda; Mhlanga, Felix; Hunidzarira, Portia; Mansoor, Leila E; Siva, Samantha; Govender, Vaneshree; Makanani, Bonus; Naidoo, Logashvari; Singh, Nishanta; Nair, Gonasagrie; Chinula, Lameck; Parikh, Urvi M; Mellors, John W; Balán, Iván C; Ngure, Kenneth; van der Straten, Ariane; Scheckter, Rachel; Garcia, Morgan; Peda, Melissa; Patterson, Karen; Livant, Edward; Bunge, Katherine; Singh, Devika; Jacobson, Cindy; Jiao, Yuqing; Hendrix, Craig W; Chirenje, Zvavahera M; Nakabiito, Clemensia; Taha, Taha E; Jones, Judith; Torjesen, Kristine; Nel, Annalene; Rosenberg, Zeda; Soto-Torres, Lydia E; Hillier, Sharon L; Brown, Elizabeth R; Aanyu, Dorothy; Abima, John; Abullarade, Janne; Agarwal, Priyanka; Ahluwalia, Surabhi; Akasiima, Simon Africa; Akello, Carolyne Agwau; Albert, Samuel; Alphale, Motsamai; Alphonse, Calins; Apeduno, Lucy; Aranda, Sara; Aridor, Orly; Arnolds, Shakeera; Asiimwe, Prossy; Atujuna, Millicent; Atwebembere, Didas; Baboolall, Lakshmi; Badana, Kiran; 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; 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;
• Is Part Of: Lancet. Volume 8:Issue 2(2021)
• Page Start: e87
• Page End: e95
• Publication Date: 2021-02
• Subjects: HIV (Viruses) -- Periodicals; HIV infections -- Periodicals; AIDS (Disease) -- Periodicals; 616.9792
• DOI: 10.1016/S2352-3018(20)30304-0
• Languages: English
• ISSNs: 2405-4704

Abstract

Summary: Background: 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. Methods: 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 . Findings: 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; p<0·0001). 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. Interpretation: 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. Funding: 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.