Title |
Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention
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Published in |
PLOS ONE, June 2015
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DOI | 10.1371/journal.pone.0128857 |
Pubmed ID | |
Authors |
Thesla Palanee-Phillips, Katie Schwartz, Elizabeth R. Brown, Vaneshree Govender, Nyaradzo Mgodi, Flavia Matovu Kiweewa, Gonasagrie Nair, Felix Mhlanga, Samantha Siva, Linda-Gail Bekker, Nitesha Jeenarain, Zakir Gaffoor, Francis Martinson, Bonus Makanani, Sarita Naidoo, Arendevi Pather, Jessica Phillip, Marla J. Husnik, Ariane van der Straten, Lydia Soto-Torres, Jared Baeten |
Abstract |
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. 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. 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. 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 2 | 40% |
Unknown | 3 | 60% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 5 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 1 | <1% |
Spain | 1 | <1% |
United States | 1 | <1% |
Brazil | 1 | <1% |
Unknown | 143 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 22 | 15% |
Student > Ph. D. Student | 21 | 14% |
Researcher | 17 | 12% |
Student > Bachelor | 12 | 8% |
Other | 9 | 6% |
Other | 25 | 17% |
Unknown | 41 | 28% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 43 | 29% |
Nursing and Health Professions | 16 | 11% |
Social Sciences | 10 | 7% |
Pharmacology, Toxicology and Pharmaceutical Science | 9 | 6% |
Agricultural and Biological Sciences | 6 | 4% |
Other | 18 | 12% |
Unknown | 45 | 31% |