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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A randomized, placebo-controlled trial to assess the safety and acceptability of use of carraguard vaginal gel by heterosexual couples in Thailand
Sexually Transmitted Diseases, Volume 35, No. 3, Year 2008
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Description
OBJECTIVES: To determine the safety and acceptability of use of Carraguard, a carrageenan-derived candidate microbicide gel, during sexual intercourse in women and men. STUDY DESIGN: We conducted a 6-month randomized, placebo-controlled trial among sexually active, couples at relatively lower risk for HIV infection in northern Thailand. METHODS: Women inserted 1 applicator of study gel vaginally every time the couple had sex. Safety was assessed by symptom report and genital examination of both partners and by changes in vaginal flora. Acceptability was assessed by participant interview. RESULTS: Overall, 55 couples were randomized, 28 to Carraguard use and 27 to the methyl-cellulose placebo gel group. Retention and study gel use were similarly high in both study groups; use of gel without condoms was reported in more than 95% of vaginal sex acts. The 2 study groups were similar in the proportions of women and men with symptoms or with genital findings without epithelial disruption, of men with findings with epithelial disruption, and of women with abnormal genital flora, whereas more women in the placebo group had findings with epithelial disruption. Women and men in both groups reported that the gel and applicator were acceptable. CONCLUSIONS: Carraguard can safely be used an average of 2 to 3 times per week during sex and is acceptable to Thai women and men. © Copyright 2008 American Sexually Transmitted Diseases Association.
Authors & Co-Authors
Kilmarx, Peter H.
United States, Atlanta
National Center for Hiv, Viral Hepatitis, Std, and tb Prevention
Blanchard, Kelly
United States, New York
The Population Council, Inc.
Chaikummao, Supaporn
Thailand, Nontaburi
Thailand Ministry of Public Health
Friedland, Barbara A.
United States, New York
The Population Council, Inc.
Srivirojana, Nucharee
Thailand, Bangkok
Population Council
Connolly, Catherine Anne
South Africa, Tygerberg
South African Medical Research Council
Witwatwongwana, Paisit
Thailand, Chiang Rai
Chiang Rai Prachanukhro Hospital
Supawitkul, Somsak
Thailand, Chiang Rai
Chiang Rai Provincial Public Health Office
Mock, Philip A.
Thailand, Nontaburi
Thailand Ministry of Public Health
Chaowanachan, Thanyanan
Thailand, Nontaburi
Thailand Ministry of Public Health
Tappero, Jordan W.
United States, Atlanta
National Center for Hiv, Viral Hepatitis, Std, and tb Prevention
Thailand, Nontaburi
Thailand Ministry of Public Health
Statistics
Citations: 68
Authors: 11
Affiliations: 7
Identifiers
Doi:
10.1097/OLQ.0b013e31815d6e0d
ISSN:
01485717
Research Areas
Infectious Diseases
Sexual And Reproductive Health
Participants Gender
Male
Female