Acceptability of Carraguard vaginal gel use among Thai couples

Objectives: To evaluate the acceptability of candidate microbicide Carraguard among couples participating in a safety trial. Study Design: A 6-month randomized, placebo-controlled trial was conducted in sexually active, low-risk couples in Thailand. Methods: Couples who were monogamous, HIV uninfected, and not regular condom users were enrolled. Acceptability data were collected through structured questionnaires at repeated intervals. At the closing study visit, participants were asked questions about hypothetical product characteristics and future use. Compliance with gel use was assessed by questionnaires, coital diaries, and tracking of used and unused applicators. Results: Among 55 enrolled couples, follow up and adherence with gel use were high and sustained, with 80% of women using gel in over 95% of vaginal sex acts. Because acceptability results from Carraguard and placebo arms were similar, they were combined for this analysis. Overall, 92% of women and 83% of men liked the gel somewhat or very much; 66% of women and 72% of men reported increased sexual pleasure with gel use; and 55% of women and 62% of men reported increased frequency of intercourse. Only 15% of women but 43% of men thought that gel could be used without the man knowing. Although men and women had similar views overall, concordance within couples was low, with no kappa coefficients above 0.31. Conclusion: Carraguard gel use was acceptable to low-risk couples in northern Thailand. Reported associations between gel use and increased sexual pleasure and frequency suggest a potential to market microbicide products for both disease prevention and enhancement of pleasure

Acceptability of a carrageenan-based candidate vaginal microbicide and matching placebo: findings from a phase II safety trial among women in Chiang Rai, Thailand

To evaluate extended acceptability of vaginal use of a carrageenan-based candidate microbicide and placebo in northern Thai women. As part of a randomized, placebo-controlled, triple-blinded clinical trial, women were asked to insert gel with each vaginal sex act and at least three times per week for 1 year. Used applicators were collected monthly; acceptability questions were asked quarterly. One hundred sixty-five women were enrolled (83 microbicide, 82 placebo); 148 (90%) remained in the study for 12 months. Gel use was high, with > or =87% returning at least three used applicators per week at each visit. Although acceptability was generally high, some decline in positive reporting was noted in terms of ease of application, timing of gel insertion, and gel volume over time. Approximately one quarter reported gel use increased her sexual pleasure. Over one quarter reported that gel volume of 5 mL was too much. All women with a steady partner at 12 months reported talking to their partner about using the gel. Only 2 women spontaneously mentioned being able to use a product covertly as one of the most appealing attributes of a potential microbicide. Although women in this study generally reported high acceptability and use, some found 5 mL of gel to be too much. Focusing on enhanced sexual pleasure and lubrication may be beneficial for marketing proven microbicides. Development of products will need to balance lubrication and efficacy with perceptions of too much volume. The ability to use a product covertly was not a high priority in this populatio

Safety and acceptability of the candidate microbicide carraguard in Thai women: Findings from a Phase II clinical trial

Objective: To determine the safety and acceptability of vaginal application of Carraguard, a carrageenan-derived candidate microbicide gel. Design: A randomized, placebo-controlled, triple-blinded clinical trial was conducted in Chiang Rai, northern Thailand. Methods: Women were asked to insert one applicator of study gel vaginally at least three times per week (with or without sex) and to use gel with condoms every time they had sex. Safety was assessed by visual inspection of the vagina and cervix, changes in vaginal flora and self-reported symptoms at day 14, month 1 and then monthly for up to 1 year. Acceptability was assessed through reported use of the gel, return of used and unused applicators, and quarterly interviews. Results: One hundred sixty-five women were randomized: 83 to Carraguard and 82 to the placebo (methylcellulose gel) group. Study gel use was similarly high in both groups throughout the trial with an average of four applicators per week. Carraguard use was not associated with abnormal genital clinical findings, abnormal vaginal flora, Pap smear abnormalities or other abnormal clinical signs or symptoms. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Participants in both groups reported high acceptability. Conclusions: Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa

Implementation of a Test, Treat, and Prevent HIV program among men who have sex with men and transgender women in Thailand, 2015-2016

<div><p>Introduction</p><p>Antiretroviral therapy reduces the risk of serious illness among people living with HIV and can prevent HIV transmission. We implemented a Test, Treat, and Prevent HIV Program among men who have sex with men (MSM) and transgender women at five hospitals in four provinces of Thailand to increase HIV testing, help those who test positive start antiretroviral therapy, and increase access to pre-exposure prophylaxis (PrEP).</p><p>Methods</p><p>We implemented rapid HIV testing and trained staff on immediate antiretroviral initiation at the five hospitals and offered PrEP at two hospitals. We recruited MSM and transgender women who walked-in to clinics and used a peer-driven intervention to expand recruitment. We used logistic regression to determine factors associated with prevalent HIV infection and the decision to start antiretroviral therapy and PrEP.</p><p>Results</p><p>During 2015 and 2016, 1880 people enrolled. Participants recruited by peers were younger (p<0.0001), less likely to be HIV-infected (p<0.0001), and those infected had higher CD4 counts (p = 0.04) than participants who walked-in to the clinics. Overall, 16% were HIV-positive: 18% of MSM and 9% of transgender women; 86% started antiretroviral therapy and 46% of eligible participants started PrEP. A higher proportion of participants at hospitals with one-stop HIV services started antiretroviral therapy than other hospitals. Participants who started PrEP were more likely to report sex with an HIV-infected partner (p = 0.002), receptive anal intercourse (p = 0.02), and receiving PrEP information from a hospital (p<0.0001).</p><p>Conclusions</p><p>We implemented a Test, Treat, and Prevent HIV Program offering rapid HIV testing and immediate access to antiretroviral therapy and PrEP. Peer-driven recruitment reached people at high risk of HIV and people early in HIV illness, providing an opportunity to promote HIV prevention services including PrEP and early antiretroviral therapy. Sites with one-stop HIV services had a higher uptake of antiretroviral therapy and PrEP.</p></div

Results of logistic regression analysis evaluating characteristics of HIV-uninfected participants in the test, treat, and prevent HIV program at Lerdsin and Thammasat University Hospitals who chose to start HIV pre-exposure prophylaxis (PrEP), Thailand, 2015–2016.

<p>Results of logistic regression analysis evaluating characteristics of HIV-uninfected participants in the test, treat, and prevent HIV program at Lerdsin and Thammasat University Hospitals who chose to start HIV pre-exposure prophylaxis (PrEP), Thailand, 2015–2016.</p

Baseline characteristics of participants in the test, treat, and prevent HIV program, Thailand, 2015–2016.

<p>Baseline characteristics of participants in the test, treat, and prevent HIV program, Thailand, 2015–2016.</p

Results of logistic regression analysis to evaluate characteristics of participants in the test, treat, and prevent HIV program associated with prevalent HIV infection, Thailand, 2015–2016.

<p>Results of logistic regression analysis to evaluate characteristics of participants in the test, treat, and prevent HIV program associated with prevalent HIV infection, Thailand, 2015–2016.</p