title: Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention.
abstract: BACKGROUND
  Women in sub-Saharan Africa are a priority population for evaluation of new biomedical HIV-1 prevention strategies. Antiretroviral pre-exposure prophylaxis is a promising prevention approach; however, clinical trials among young women using daily or coitally-dependent products have found low adherence. Antiretroviral-containing vaginal microbicide rings, which release medication over a month or longer, may reduce these adherence challenges.
  
  
  METHODS
  ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) is a phase III, randomized, double-blind, placebo-controlled trial testing the safety and effectiveness of a vaginal ring containing the non-nucleoside reverse transcriptase inhibitor dapivirine for prevention of HIV-1 infection. We describe the baseline characteristics of African women enrolled in the ASPIRE trial.
  
  
  RESULTS
  Between August 2012 and June 2014, 5516 women were screened and 2629 HIV-1 seronegative women between 18-45 years of age were enrolled from 15 research sites in Malawi, South Africa, Uganda, and Zimbabwe. The median age was 26 years (IQR 22-31) and the majority (59%) were unmarried. Nearly 100% of participants reported having a primary sex partner in the prior three months but 43% did not know the HIV-1 status of their primary partner; 17% reported additional concurrent partners. Nearly two-thirds (64%) reported having disclosed to primary partners about planned vaginal ring use in the trial. Sexually transmitted infections were prevalent: 12% had Chlamydia trachomatis, 7% Trichomonas vaginalis, 4% Neisseria gonorrhoeae, and 1% syphilis.
  
  
  CONCLUSIONS
  African HIV-1 seronegative women at risk of HIV -1 infection were successfully enrolled into a phase III trial of dapivirine vaginal ring for HIV-1 prevention.
authors.affiliation: Wits Reproductive Health and HIV Research Institute, University of the Witswatersrand, School of Clinical Medicine, Johannesburg, South Africa.
authors.forename: Thesla
authors.initials: T
authors.lastname: Palanee-Phillips
authors.affiliation: FHI 360, Durham, NC, United States of America.
authors.forename: Katie
authors.initials: K
authors.lastname: Schwartz
authors.affiliation: Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Brown
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
authors.forename: Vaneshree
authors.initials: V
authors.lastname: Govender
authors.affiliation: University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF) Research Collaboration, Harare, Zimbabwe.
authors.forename: Nyaradzo
authors.initials: N
authors.lastname: Mgodi
authors.affiliation: Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
authors.forename: Flavia Matovu
authors.initials: FM
authors.lastname: Kiweewa
authors.affiliation: Centre for AIDS Programme of Research in SA (CAPRISA), Durban, South Africa.
authors.forename: Gonasagrie
authors.initials: G
authors.lastname: Nair
authors.affiliation: University of Zimbabwe-University of California San Francisco Collaborative Research Program (UZ-UCSF) Research Collaboration, Harare, Zimbabwe.
authors.forename: Felix
authors.initials: F
authors.lastname: Mhlanga
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
authors.forename: Samantha
authors.initials: S
authors.lastname: Siva
authors.affiliation: Desmond Tutu HIV Foundation Clinical Research Site, Cape Town, South Africa.
authors.forename: Linda-Gail
authors.initials: LG
authors.lastname: Bekker
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
authors.forename: Nitesha
authors.initials: N
authors.lastname: Jeenarain
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
authors.forename: Zakir
authors.initials: Z
authors.lastname: Gaffoor
authors.affiliation: UNC Lilongwe Clinical Research Site, Lilongwe, Malawi.
authors.forename: Francis
authors.initials: F
authors.lastname: Martinson
authors.affiliation: College of Medicine-John Hopkins University Research Project Queen Elizabeth Central Hospital, Blantyre, Malawi.
authors.forename: Bonus
authors.initials: B
authors.lastname: Makanani
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
authors.forename: Sarita
authors.initials: S
authors.lastname: Naidoo
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
authors.forename: Arendevi
authors.initials: A
authors.lastname: Pather
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.
authors.forename: Jessica
authors.initials: J
authors.lastname: Phillip
authors.affiliation: Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America.
authors.forename: Marla J
authors.initials: MJ
authors.lastname: Husnik
authors.affiliation: RTI International, San Francisco, CA, United States of America.
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
authors.affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Mental Health, and Eunice Shriver Kennedy, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States of America.
authors.forename: Lydia
authors.initials: L
authors.lastname: Soto-Torres
authors.affiliation: Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA, United States of America.
authors.forename: Jared
authors.initials: J
authors.lastname: Baeten
mesh_terms: D000293:Adolescent; D000328:Adult; D017954:Africa South of the Sahara; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D015497:HIV-1; D006801:Humans; D008875:Middle Aged; D011743:Pyrimidines / Q000008:administration & dosage*; D014621:Vagina; D055815:Young Adult
chemical_list: D011743:Pyrimidines; C481671:Dapivirine