Supaporn Chaikummao

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.

A Randomized, Placebo-controlled Trial to Assess the Safety and Acceptability of Use of Carraguard Vaginal Gel by Heterosexual Couples in Thailand

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.

Leaving sex work: barriers, facilitating factors and consequences for female sex workers in northern Thailand.

Factors facilitating or inhibiting womens ability to leave sex work are still poorly characterized, and little is known about womens lives after they leave the profession. This paper presents findings from a qualitative study about factors affecting womens ability to leave sex work and influencing their lives after leaving. We interviewed 42 current and former female sex workers (FSWs) drawn from a cohort study of 500 FSWs in northern Thailand. All but one of the participants had quit sex work at least once. The majority experienced one or more quit-re-entry-quit cycles. Womens ability and decisions to leave sex work were determined primarily by four factors: economic situation, relationship with a steady partner, attitudes towards sex work and HIV/AIDS experience. Economic concerns, ranging from survival needs to materialistic desires, had the strongest influence. Most women perceived their risk for HIV infection to be lower after leaving sex work, but three of the 17 HIV-infected women acquired infection after having left, presumably from their steady partners. Prevention efforts should guide women as they transition out of commercial sex work. Interventions aimed at assisting women wanting to leave sex work need to address the role of economic factors.

Sex frequency and sex planning among men who have sex with men in Bangkok, Thailand: implications for pre- and post-exposure prophylaxis against HIV infection

BackgroundDaily HIV antiretroviral pre-exposure prophylaxis (PrEP) is being evaluated in clinical trials among men who have sex with men (MSM). However, daily PrEP may not be congruent with sexual exposure profiles of MSM. Here, we investigate sex frequency and sex planning to identify and inform appropriate PrEP strategies for MSM.MethodsWe evaluated sex frequency and sex planning in a cohort of HIV-negative MSM in Bangkok, Thailand. Chi-squared test was used to compare reports of sex on different weekdays; logistic regression was used to identify predictors of sex frequency and sex planning.ResultsOf 823 MSM (with a mean age of 28.3 years), 86% reported having sex on two days per week or less, and 65% reported their last sex to have been planned. Sex on the weekend (~30%) was more often reported than sex on weekdays (~23%). In multivariate analysis, use of alcohol, erectile dysfunction drugs, group sex, sex with a foreigner, buying and selling sex, and a history of HIV testing were associated with having sex on three days or more per week. Being aged 22 to 29 years, not identifying as homosexual, having receptive anal intercourse, and not engaging in group sex were associated with unplanned sex.ConclusionsIntermittently dosed PrEP (as opposed to daily) may be a feasible HIV prevention strategy and should be considered for evaluation in clinical trials. Risk factors for sex frequency and sex planning may help to identify those in need for daily PrEP and those who may not be able to take a timely pre-exposure dose.

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.

No Increase in Cervicovaginal Proinflammatory Cytokines After Carraguard Use in a Placebo-controlled Randomized Clinical Trial

Background:Assessment of cervicovaginal cytokine levels may be helpful to evaluate subclinical epithelial inflammation during safety evaluations of candidate microbicides. Methods:Fifty-five HIV-seronegative Thai women were enrolled in a safety trial of the candidate microbicide Carraguard and were randomized to use Carraguard or placebo gel before vaginal sex. Cervicovaginal lavages were collected at baseline and after 1 month of gel use; levels of interleukin (IL)-1β, IL-6, IL-8, and secretory leukocyte protease inhibitor (SLPI) were measured using microwell plate-based enzyme immunoassays. Median levels were compared between the baseline and 1-month follow-up visits using paired t tests; the median change between groups was compared using Wilcoxon rank sum tests. Women were examined for the presence of genital findings; the association between genital findings and cytokine levels was studied. Results:No increase in levels of proinflammatory cytokines after use of Carraguard gel or placebo gel was observed during the study. The median change from the baseline to 1 month of follow-up was not significantly different between Carraguard and placebo groups (IL-1β: −0.3 pg/mL vs. −3.93 pg/mL; P = 0.4, IL-6: −0.3 pg/mL vs. 0 pg/mL; P = 0.3, IL-8: −40.1 pg/mL vs. −53.2 pg/mL; P = 0.8, and SLPI: −26.5 pg/mL vs. 12.6 pg/mL; P = 0.07). Genital findings with intact epithelium were found in 16 (29%) women; these women tended to have somewhat higher IL-6 levels than those with normal epithelium (14.9 pg/mL vs. 8.8 pg/mL; P = 0.08). Conclusion:We found no increase in proinflammatory cytokines after Carraguard and placebo gel use, suggesting that neither gel causes inflammation. Further studies to assess the role of cytokines in microbicide safety studies are warranted.

Rapid whole-blood finger-stick test for HIV antibody: performance and acceptability among women in northern Thailand.

Although use of rapid HIV antibody tests of finger-stick blood specimens could expand voluntary counseling and testing in areas where fear of venipuncture and delays in learning test results are barriers, there is little information on performance and acceptability of these tests in Asia. We used the Hema. Strip HIV-1/2 test (Saliva Diagnostic Systems, Vancouver, WA) in a prospective cohort study of HIV seroincidence among women in northern Thailand from 1998 to 1999. Nurses obtained whole-blood specimens by finger-stick testing and provided test results and counseling at each visit. Acceptability of the rapid test was assessed at the first 6-month follow-up visit. HIV-1 seroprevalence among the 804 women screened at enrollment was 3.1%. Positive rapid test results from 25 women were confirmed by enzyme immunoassay and Western blot analysis using serum obtained by venipuncture. Of the 741 women who returned for follow-up, 56% preferred specimen collection by finger-stick testing to venipuncture, 80% preferred immediate rather than delayed test results, 79% preferred the rapid test method to typical testing methods, and 97% were satisfied with the test method used. Results from this study demonstrate the utility and acceptability of the rapid finger-stick test for HIV antibody among women in northern Thailand.

Temporal trends in HIV-1 incidence and risk behaviours in men who have sex with men in Bangkok, Thailand, 2006-13: An observational study

BACKGROUND HIV-1 incidence in men who have sex with men (MSM) is often difficult to estimate. We therefore assessed temporal trends in HIV-1 incidence and behavioural risk factors in MSM in Bangkok, Thailand, from 2006 to 2013. METHODS In this observational study, we used data for clients attending the Silom Community Clinic for voluntary counselling and testing (VCT) services and from the Bangkok MSM Cohort Study (BMCS) to investigate trends in HIV incidence per 100 person-years per quarter in both cohorts. During VCT, basic demographic data were gathered at registration. However, no behavioural risk data were gathered. In the BMCS, we gathered demographic and behavioural data at baseline and at regular study visits using audio computer-assisted self-interviewing. Questions were included about potential risk factors such as drug use, sexual practices, and how often condoms were used. We also analysed behavioural risk factors in the BMCS cohort, using a restricted cubic spline function for time. FINDINGS From 2006 to 2013, 8176 MSM came for VCT; 1999 (24%) clients were initially seronegative and returned for another test. 235 (12%) individuals seroconverted. The overall HIV-1 incidence was 5.5 per 100 person-years (95% CI 4.8-6.3), with an increasing trend (adjusted p=0.02). In the BMCS, 1372 people were seronegative at baseline; 1259 (92%) had more than one follow-up test and 238 (17%) seroconverted. The overall HIV-1 incidence was 5.3 per 100 person-years (95% CI 4.7-6.1), with an increase and then a decline (inverted U-shaped curve, p=0.0001). Individuals aged 21 years and younger were at significantly higher risk of HIV infection than were those aged 30 years and older in the in the VCT (rate ratio 2.29, 95% CI 1.88-2.78, p<0.0001) and BMCS cohorts (1.99, 1.50-2.65, p<0.0001). Overall, drug use (p=0.03), drug use to enhance sex (p=0.0006), use of drugs for erectile dysfunction (p<0.0001), and 100% condom use (p<0.0001) increased over time, whereas the proportion of individuals reporting receptive anal intercourse decreased (p=0.004). INTERPRETATION With a sustained high HIV-1 incidence and increasing drug use in MSM in Bangkok, we urgently need innovative and acceptable HIV prevention interventions, especially for young MSM. FUNDING US Centers for Disease Control and Prevention.

Incidence of HIV-1 infection and effects of clinic-based counseling on HIV preventive behaviors among married women in northern Thailand.

&NA; To determine the incidence of and risk factors for HIV‐1 infection among married women in northern Thailand, we enrolled 779 seronegative women from family planning clinics and a postpartum ward in Chiang Rai, Thailand, from 1998 through 1999. Women were tested for HIV antibodies at 6 and 12 months after enrollment. They received HIV prevention counseling at enrollment and at each follow‐up visit. Counseling covered partner communication, partner HIV testing, and condom use by steady partners. Effects of counseling were measured using standardized questionnaires. Follow‐up rates were 94% at 6 months and 92% at 12 months. Only 1 woman seroconverted during the follow‐up period, yielding an overall HIV incidence of 0.14 per 100 person‐years. After receiving counseling, women reported significantly increased communication with husbands concerning HIV risk, HIV testing, and condom use during the first 6 months after enrollment; communication remained high for 6 to 12 months. Women reported a modest increase in HIV testing and consistent condom use by husbands. The risk for HIV transmission to women in steady relationships is low in northern Thailand. Although HIV prevention counseling promoted partner communication, its effects on HIV preventive behaviors were limited.

High Rates of Pregnancy among Vocational School Students: Results of Audio Computer-Assisted Self-Interview Survey in Chiang Rai, Thailand.

Unplanned pregnancy among young people can lead to adverse social, psychological, and health outcomes, particularly when it results in abortion. In 1999, we examined the prevalence of and factors associated with pregnancy and abortion among 1725 consenting vocational school students in northern Thailand. Results from an audio computer-assisted self-interview showed that 48% of the male and 43% of the female students reported ever having had sexual intercourse. Among those who had had intercourse, 27% of the women and 17% of the men said they or their partner had ever been pregnant. Among the last reported pregnancies that resulted in delivery or abortion, 95% were aborted. Age, current contraceptive use, early initiation of sexual intercourse (</=16 years), alcohol and drug use, and sexual coercion were associated with self or partner pregnancy. The high rates of pregnancy and abortion in this population indicate the need for better sexual health education and access to effective contraceptive methods.