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Researchers have raised concerns that microbicide use during clinical trials would displace condom use. We sought to understand whether condom use changed for participants in a microbicide clinical trial in Pune, India, to understand whether condom shifts were a legitimate concern. We hypothesize that women participating in a microbicide clinical trial in Pune, India, were more likely, on average, to report condom use at follow-up. We further hypothesize that men, whose female partners participated in a microbicide clinical trial were more likely, on average, to report condom use at follow-up. The outcome measure for reported condom use was a dichotomous variable to indicate whether or not the participant had used a male or female condom with a sexual partner since 2 months before enrollment or since the last survey, depending on the visit. Data are from semi-structured interviews at baseline, 2 months, 4 months, and 6 months with HPTN 059 clinical trial participants (100 women and 57 male partners). We used generalized estimating equations with a logit link function, exchangeable correlation, and a binomial family to model condom use. The odds of condom use for clinical trial women increased from baseline to 6 months by a factor of 3.7 (95% CI: 1.84–7.63) and the change in odds of condom use for clinical trial men from baseline to 6 months increased by a factor of 2.58 (95% CI: 1.37–4.85). We found concerns about microbicide use displacing condom use were not merited in this study population. The percent of participants reporting condom use declined from 4 to 6 months, suggesting that increases in condom use may only be during active study participation. Information about clinical trial factors that enabled these men and women to enact this important HIV prevention behavior is needed to develop interventions. [ABSTRACT FROM PUBLISHER]

Research suggests that the HIV/AIDS epidemic has spread to monogamous women in India. Gender inequalities prevent women from asserting control over the circumstances that increase their vulnerability to infection. Men control most of the sexual decision-making. The present study explores views on use of microbicides by men and circumstances in which they might find microbicide use with their wives acceptable. Progressive in-depth interviews were conducted among 15 consenting men from Pune, India. Men felt that women with identifiable HIV risk, such as being a sex worker, having an HIV infected husbands or being educated; were more likely to use microbicides. Most high-risk men would permit or force their wives to use microbicides and had a higher intention to use microbicides compared with low-risk men probably due to perceived susceptibility. The majority of men with previous experience of microbicide use mentioned that privacy was important for gel use. Most low-risk men believed that they would be angry with covert gel use by their wives. They felt that covert use was impossible since their wives were under their control and they would notice the gel due to a change in their sexual experience. Low-risk men also opined that husband's permission was not required if he was HIV-infected or having extra-marital sex. Some men stressed the need for exercising sexual control while women inserted gel before sex. Men's risk-perception, knowledge about their safety concerns, as well as their behavior may affect acceptability of gel use, hence men's involvement and cooperation is imperative for microbicide gel use by women in India.