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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Appropriateness of hydroxyethylcellulose gel as a placebo control in vaginal microbicide trials: A comparison of the two control arms of HPTN 035
Journal of Acquired Immune Deficiency Syndromes, Volume 63, No. 1, Year 2013
Notification
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Description
OBJECTIVE: To compare the 2 control arms of HPTN 035 [a hydroxyethylcellulose (HEC) gel control arm and a no-gel control arm] to assess the behavioral effects associated with gel use and direct causal effects of the HEC gel on sexually transmitted infections (STIs), pregnancy, and genital safety. DESIGN: Randomized trial with 1 blinded (HEC gel) and 1 open-label (no-gel) control arms. METHODS: HIV-uninfected, sexually active women were randomized into the HEC gel arm (n = 771) and into the no-gel arm (n = 772) in 5 countries. Participants in the HEC gel arm were instructed to insert the study gel intravaginally <1 hour before each vaginal sex act. Data on sexual behavior, adherence, safety, pregnancy, and STIs were collected quarterly for 12-30 months of follow-up. RESULTS: During follow-up, mean reported condom use in the past week was significantly higher in the no-gel arm (81% versus 70%, P < 0.001). There were no significant differences, after adjusting for this differential condom use, between the 2 arms in the rates of genital safety events, pregnancy outcomes, or STIs, including HIV-1. CONCLUSIONS: In this large randomized trial, we found no significant differences between the no-gel and HEC gel arms in the rates of genital safety events, pregnancy outcomes, or STIs. These results aid interpretation of the results of previous vaginal microbicide trials that used the HEC gel as a control. The HEC gel is suitable as a control for ongoing and future vaginal microbicide studies. Copyright © 2013 by Lippincott Williams & Wilkins.
Authors & Co-Authors
Richardson, Barbra Ann
United States, Seattle
University of Washington
United States, Seattle
Fred Hutchinson Cancer Research Center
Kelly, Cliff
United States, Seattle
Fred Hutchinson Cancer Research Center
Ramjee, Gita A.
South Africa, Tygerberg
South African Medical Research Council
Fleming, Thomas R.
United States, Seattle
University of Washington
Makanani, Bonus S.
United Kingdom
Johns Hopkins University Research Project
Roberts, Sarah T.
United States, Birmingham
The University of Alabama at Birmingham
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Musara, Petina
Zimbabwe, Harare
Uz-ucsf Collaborative Research Programme
Mkandawire, Nkhafwire
Malawi, Lilongwe
Unc Project-malawi
Moench, Thomas Ray
United States, Baltimore
Reprotect Inc.
Coletti, Anne Schwartz
United States, Durham
Fhi 360
Soto-Torres, Lydia E.
United States, Bethesda
National Institute of Allergy and Infectious Diseases Niaid
Abdool Karim, Salim S.
South Africa, Durban
University of Kwazulu-natal
Statistics
Citations: 17
Authors: 12
Affiliations: 12
Identifiers
Doi:
10.1097/QAI.0b013e31828607c5
ISSN:
15254135
Research Areas
Infectious Diseases
Maternal And Child Health
Sexual And Reproductive Health
Study Design
Cohort Study
Participants Gender
Female