Long-term consistent use of a vaginal microbicide gel among HIV-1 sero-discordant couples in a phase III clinical trial (MDP 301) in rural south-west Uganda

Abstract

BackgroundA safe and effective vaginal microbicide could substantially reduce HIV acquisition for women. Consistent gel use is, however, of great importance to ensure continued protection against HIV infection, even with a safe and effective microbicide. We assessed the long-term correlates of consistent gel use in the MDP 301 clinical trial among HIV-negative women in sero-discordant couples in south-west Uganda.MethodsHIV-negative women living with an HIV-infected partner were enrolled between 2005 and 2008, in a three-arm phase III microbicide trial and randomized to 2% PRO2000, 0.5% PRO2000 or placebo gel arms. Follow-up visits continued up to September 2009. The 2% arm was stopped early due to futility and the 229 women enrolled in this arm were excluded from this analysis. Data were analyzed on 544 women on the 0.5% and placebo arms who completed at least 52 weeks of follow-up, sero-converted or became pregnant before 52 weeks. Consistent gel use was defined as satisfying all of the following three conditions: (i) reported gel use at the last sex act for at least 92% of the 26 scheduled visits or at least 92% of the visits attended if fewer than 26; (ii) at least one used applicator returned for each visit for which gel use was reported at the last sex act; (iii) attended at least 13 visits (unless the woman sero-converted or became pregnant during follow-up). Logistic regression models were fitted to investigate factors associated with consistent gel use.ResultsOf the 544 women, 473 (86.9%) were followed for at least 52 weeks, 29 (5.3%) sero-converted and 42 (7.7%) became pregnant before their week 52 visit. Consistent gel use was reported by 67.8%. Women aged 25 to 34 years and those aged 35 years or older were both more than twice as likely to have reported consistently using gel compared to women aged 17 to 24 years. Living in a household with three or more rooms used for sleeping compared to one room was associated with a twofold increase in consistent gel use.ConclusionIn rural Uganda younger women and women in houses with less space are likely to require additional support to achieve consistent microbicide gel use.Trial registrationProtocol Number ISRCTN64716212

Baseline Predictors of High Adherence to a Coitally Dependent Microbicide Gel Based on an Objective Marker of Use: Findings from the Carraguard Phase 3 Trial

“…The results of this analysis differ from the findings of Abaasa et al [ 27 ], who found that older age and living in a household with more rooms for sleeping were associated with more consistent gel use at the Uganda MDP 301 trial site. The differences between the sites (rural Uganda in MDP 301 versus peri-urban South Africa in the Carraguard trial) and cohorts (discordant couples in Uganda versus sexually active women from the general population in South Africa), which tested similar broad-spectrum gels, both to be used within 1 hour of each sex act, highlights the importance of understanding the influence of contextual issues on adherence [ 17 , 43 ].…”

“…In two small studies, one among women considered to be at high risk of HIV in the US (N = 96) who used a commercial lubricant for 2 weeks as a proxy for a microbicide [ 25 ], and another among female sex workers in Madagascar (N = 192) who used a diaphragm with or without a microbicide for 4 weeks [ 26 ], less “relationship power” (measured by partner resistance or violence related to suggested condom use) was associated with higher rates of adherence. By contrast, age (older women) and privacy (more than one room for sleeping) were associated with more consistent gel use among women enrolled with their HIV-positive partners (N = 544) at the Uganda site of MDP 301, a Phase 3 efficacy trial of Pro-2000 gel [ 27 ]. In a six-month study among monogamous Zimbabwean women (N = 117) using a microbicide gel with or without a diaphragm, positive partnership dynamics (partner approving of product use, consistent condom use) were predictors of consistent use [ 28 ], whereas no association was found between psychosocial variables (such as couple harmony, HIV risk perception) and consistent gel use among married women (N = 100) from the Pune, India, site of HPTN 059, a Phase 2 trial of tenofovir gel [ 29 ].…”

Optimizing HIV prevention for women: a review of evidence from microbicide studies and considerations for gender‐sensitive microbicide introduction

“…In many areas, men are the primary decision-makers about sexuality; thus, women cannot always control or predict the circumstances of their sex lives. Women participating in microbicide trials, their male partners and people interviewed about potential microbicide use in Benin, India, Malawi, South Africa, Thailand, Uganda, the United States and Zimbabwe noted that women's lack of privacy to insert the gel [ 16 , 28 , 38 , 44 , 57 , 58 ] and limited ability to control the timing of sex (and thus the ability to apply the gel before sex) [ 13 , 34 , 38 , 41 , 44 , 59 , 60 ] may interfere with women's adherence to a coitally dependent microbicide regimen. A hypothetical study among adolescent girls, their parents and other community leaders in Kenya found the timing of gel insertion would likely be a challenge among adolescent girls, whose sex lives were described as unpredictable, rushed and illicit [ 56 ].…”

Women and Sexually Transmitted Infections in Africa

“…In SSA, women comprise 60% of adults living with HIV infection [78]. Sexual transmission is the main route of HIV infection, with an increased risk of infection in women in comparison to men [79].…”