A group-based intervention to increase condom use among HIV serodiscordant couples in India, Thailand, and Uganda.

This study assessed the feasibility of a group-based couples intervention to increase condom use in HIV serodiscordant couples in three countries (India, Thailand and Uganda). The intervention focused on communication, problem solving, and negotiation skills. Forty-three couples enrolled in the intervention (15 in India, 14 in Thailand, and 14 in Uganda) and 40 couples completed all study activities. Participants were interviewed at baseline and at one and three months post- intervention. The intervention consisted of two same sex sessions and two couples sessions with 'homework' to practice skills between sessions. The same intervention modules were used at each site, tailored for local appropriateness. Participants at each site were enthusiastic about the intervention, citing information about HIV serodiscordancy and the opportunity to meet couples 'like us' as important features. Participants reported increased comfort discussing sex and condoms with their partner, although some participants remain concerned about situations when condoms might not be used (e.g. when drunk). At three-month follow up 90% of the participants reported having been able to use the skills from the intervention with their partner. Our results highlight the feasibility of this couples group-based intervention and the need for ongoing support for discordant couples.

The reliability and validity of the Modified Condom Outcome Expectancy Scale (MCOES) among an international sample of HIV-negative partners of people living with HIV/AIDS.

Safer sexual behaviour is vital in curbing the HlV epidemic in many developing countries where the epidemic is primarily transmitted through heterosexual sex. Reliable and valid assessment of factors related to HIV risk behaviours are important in testing behavioural theories as well as informing effective AIDS prevention programmes. The current study tests the reliability and validity of a modified version of the Condom Outcome Expectancy Scale (COES) among a sample of HI'-negative sexual partners (n = 100) of HIV-infected individuals in Pune, India, Chang Mai,Thailand and Kampala, Uganda. Internal consistency reliability was measured using Cronbach's alpha coefficient, which had a value of 0.80 for the entire sample, with site-specific values of. 0.78 for India; 0.75 for Thailand; and 0.79 for Uganda. Test-retest reliability was conducted to test the scale's stability over time with 60% of the sample, resulting in a Cronbach's alpha coefficient of 0.70. The scale's structure was explored by analyzing response scores on the items using principal components analysis, which yielded a two-factor solution. The study indicates the utility of a modified version of the widely tested COES across international settings. Such research is necessary in understanding intervention targets across international settings.

Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites.

AIM: To evaluate the safety of BufferGel (ReProtect LLC, Baltimore, MD), a spermicidal microbicide that acidifies semen and maintains the protective acidity of the vagina, in a high-dose tolerance trial. METHODS: HIV/STD negative, sexually abstinent, and sexually active women in India, Thailand, Malawi, and Zimbabwe were asked to insert one applicator ( approximately 5 ml) of BufferGel vaginally twice per day for 14 days. Sexually active women agreed to have sex (while using BufferGel and nonlubricated condoms) at least twice per week. RESULTS: In total, 98 women (30 sexually abstinent and 68 sexually active) were enrolled. Overall compliance with product use was 93%. Epithelial abnormalities detected by pelvic examination or colposcopy were uncommon (8 cases in 271 examinations). Irritation was reported by approximately one quarter of the women (0.58 events per woman-week) but was generally mild and of short duration. The prevalence of bacterial vaginosis (BV) fell significantly, from 30% at enrollment to 6% at one week, and 7% at two weeks of BufferGel use. Thirty-two women acquired microscopically detectable yeast during BufferGel exposure, but only 3 developed symptomatic vaginitis. CONCLUSION: BufferGel appears to be safe and well tolerated by the cervicovaginal epithelium. Its effect on BV and yeasts merits further study.

Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States.

BufferGel (ReProtect, LLC) is a vaginal gel with an acidic buffering action that was designed to prevent vaginal neutralization by semen. The purpose of this study was to evaluate the safety and tolerability of BufferGel (ReProtect, Limited Liability Company) applied vaginally either once or twice daily by 27 women who were at low risk for acquisition of human immunodeficiency virus (HIV). Participants initially used the product once daily for 14 days and then twice daily for 14 days; they underwent colposcopy before and after product exposure. BufferGel was well tolerated, although two-thirds of the participants reported at least 1 mild or moderate adverse experience. The most common adverse events were irritative genitourinary symptoms. Product use was discontinued after 3 adverse events. BufferGel was well tolerated in women at low risk for acquisition of HIV; toxicity was limited and occurred at frequencies similar to those in women who did not use any vaginal product and at levels lower than in women who used detergent-based microbicides.

Acceptability of a novel vaginal microbicide during a safety trial among low-risk women.

CONTEXT: The increasing recognition that women who are unable or unwilling to discuss or use condoms with their sexual partners need female-controlled methods for preventing sexually transmitted diseases (STDs), including HIV, has led to considerable focus on the development of vaginal microbicides. While many such products are being tested for safety and effectiveness, clinical trials generally overlook another key factor in a product's impact on infection rates-its acceptability to users. METHODS: A Phase I clinical trial of a microbicidal gel included an assessment of the product's acceptability among 27 low-risk participants. Information on acceptability was gathered from structured interviews, participants' daily diaries and unstructured exit interviews. RESULTS: Participants reported only minor side effects of product use, such as itching, burning and difficulty urinating; two women developed candida infections while participating in the study. None of the side effects could be conclusively linked to use of the gel. Some women noted product discharge and messiness as drawbacks of the method, but this experience varied according to how often the women applied the gel. For example, one-third of those who used it once daily said that at least some of the time, it was too "wet or drippy," compared with two-thirds of women who inserted the gel twice a day. However, participants considered these "nuisance factors" that could be outweighed by the potential protective characteristics of the product. The majority reported that they would use the product if it were available and proven efficacious, and if they perceived that they were at risk of STD infection. CONCLUSIONS: Additional testing of this product is urgently needed. Furthermore, as other products approach Phase I testing, acceptability assessments should be a key component of clinical trials.