Verapol Chandeying

Safety of multiple daily applications of COL-1492, a nonoxynol-9 vaginal gel, among female sex workers

RationaleCOL-1492 is a nonoxynol-9 (N-9)-containing vaginal gel and may be a potential microbicide. As part of an effectiveness trial, an initial toxicity study was conducted. ObjectivesThe main objective of the reported study was the assessment of the toxicity of a 52.5 mg N-9 gel, COL-1492, when used a number of times each day by female sex workers. MethodsThis was a randomized, placebo-controlled triple-blinded trial among female sex workers. The participants were asked to use the product for each vaginal sexual act. At each monthly visit a gynaecological examination with sexually transmitted disease sampling and colposcopy was performed. Venous blood was drawn for syphilis and HIV serology. All women received intensive counselling on condom use. Male condoms and sexually transmitted disease treatment were given free of charge. ResultsOnly blinded results on the colposcopic examinations are reported. The incidence of lesions with or without an epithelial disruption was low: 0.06 and 0.29, respectively, per 100 woman–days in group A; 0.09 and 0.26 respectively per 100 woman–days in group B. There was no significant difference between the two arms. ConclusionThe multiple daily use of COL-1492 by female sex workers did not show an increase of local toxicity over that of a placebo. Colposcopy was discontinued in the autumn of 1997 in accordance with a Data Safety Monitoring Board decision. In the currently ongoing effectiveness trial the assessment of the products toxicity continues to be monitored by simple visual examination.

Challenges in the conduct of vaginal microbicide effectiveness trials in the developing world.

Conducting a phase III trial of a vaginal microbicide in a developing country poses several important and complex ethical challenges. As part of a process to bridge the gap between ethical theory and practice, we share our experiences in performing a phase III trial of Col 1492 (Advantage S) among female sex workers at four sites world-wide; Durban, Abidjan, Cotonou and Hat Yai. The ethical challenges included: (i) difficulties in obtaining informed consent. Participants were unable to grasp the concepts of a clinical trial for several weeks to months. In Cotonou, 30% of the women did not know the gel was tested for HIV prevention. Only 25% understood what a placebo was. In Durban, 70% of the women did not fully understand the study after 3 months; (ii) in sustaining the use of known HIV prevention strategies. Participants at the Durban site had difficulty in sustaining condom use due to financial and client preferences. Sex without condoms was worth more (

Toxoplasmosis-Serological Evidence and Associated Risk Factors among Pregnant Women in Southern Thailand

20) than sex with condoms (

Acceptability of the female condom among sex workers in Thailand: results from a prospective study.

10); (iii) in maintaining the confidentiality of the subjects HIV status. Novel approaches such as role plays and emphasis on other exclusion criteria were needed to maintain the confidentiality of women not included in the trial due to their HIV status; (iv) in providing care and support to the subjects who became infected with HIV during the trial. Women could only be offered routine sexually transmitted disease treatment and counselling. Anti-retrovirals were not offered. The successes and failures of the solutions attempted are described.

Perceptions and acceptability of the female condom [Femidom] amongst commercial sex workers in the Songkla province, Thailand.

Toxoplasma gondii is an important parasite in pregnant women. This case-controlled study assessed the seroprevalence of toxoplasmosis in 640 pregnant women in southern Thailand and identified their associated risk factors. The overall seroprevalence of toxoplasmosis was 181 (28.3%). Of this, 138 (21.6%) were positive for only anti-Toxoplasma immunoglobulin G (IgG) antibody, 43 (6.7%) were positive for both IgG and IgM antibodies, and none were positive for IgM antibody. Multivariate analysis revealed that increasing age (adjusted odds ratio [OR] = 1.64, 95% confidence interval [CI] = 1.01-2.67), living outside Songkhla province (adjusted OR = 1.56, 95% CI = 1.08-2.24), parity (adjusted OR = 1.65, 95% CI = 1.01-2.68), contact with cats (adjusted OR = 1.70, 95% CI = 1.20-2.43), and drinking of unclean water (adjusted OR = 1.70, 95% CI = 1.08-2.68) were factors associated with Toxoplasma seroprevalence. On the basis of the results obtained, a health surveillance program should be initiated as a primary preventive measure for congenital toxoplasmosis and focus on educating women of the child-bearing age group to avoid contact with cats and to strictly practice personal hygiene.

Acceptability of COL-1492, a vaginal gel, among sex workers in one Asian and three African cities

Background The female condom may provide women with the first female-controlled barrier method that is effective against sexually transmitted diseases, including HIV infection. Goal This study evaluated the acceptability of the female condom among sex workers in Thailand. Study Design Data on use and acceptability of the female condom were collected using a structured questionnaire during an 8-week follow-up. Results Analyses included 148 women who were still in follow-up at week 8. Sex workers used, on average, 2.8 female condoms per week. The overall satisfaction rate with the female condom was 68%, although, among users, 31% had difficulties in device insertion, 37% had pain from the inner ring, and 22% reported itching sensations. The main reason for using the female condom in the future was its perceived safety, and the main reason for not using it would be the client’s refusal. Conclusion Two-thirds of the sex workers were satisfied with the female condom. Difficulties at insertion, discomfort during use, and clients’ attitude were potential obstacles to the use of the female condom in the future.

Prevalence of sexually transmitted infections among clients of female commercial sex workers in Thailand.

In a prospective descriptive study on the perceptions and acceptability of the female condom in a group of Thai commercial sex workers (CSWs) in the Songkla province, we invited CSWs from selected brothels to participate. Those who used the female condom were interviewed after one week and 16 weeks of use. Focus group discussions were also conducted at the end of the study period to obtain additional information. The group comprised 56 CSWs. Only 34% of them had heard of the female condom prior to this study and none had ever used one. A high proportion of CSWs reported positive experiences and perceptions. There were no signi® cant changes in perceptions and experiences during the study. Eighty per cent of participants said they were satis® ed with the female condom and would use it again in the future and would recommend it to their friends. However, the female condom was used in only 29% of the total number of sexual acts reported, and 98% of CSWs said they would prefer to use a male condom for sex work. Many of the women were concerned that the physical appearance of the condom would reduce its acceptability to their clients. This was the most frequently cited reason for not using the female condom in the future. While a promising device, the female condom must also become more acceptable to men if it is to enable women to be in control of their own protection from pregnancy and STD/HIV.In a prospective descriptive study on the perceptions and acceptability of the female condom in a group of Thai commercial sex workers (CSWs) in the Songkla province, we invited CSWs from selected brothels to participate. Those who used the female condom were interviewed after one week and 16 weeks of use. Focus group discussions were also conducted at the end of the study period to obtain additional information. The group comprised 56 CSWs. Only 34% of them had heard of the female condom prior to this study and none had ever used one. A high proportion of CSWs reported positive experiences and perceptions. There were no significant changes in perceptions and experiences during the study. Eighty per cent of participants said they were satisfied with the female condom and would use it again in the future and would recommend it to their friends. However, the female condom was used in only 29% of the total number of sexual acts reported, and 98% of CSWs said they would prefer to use a male condom for sex work. Many of the women were concerned that the physical appearance of the condom would reduce its acceptability to their clients. This was the most frequently cited reason for not using the female condom in the future. While a promising device, the female condom must also become more acceptable to men if it is to enable women to be in control of their own protection from pregnancy and STD/HIV.

Toxoplasma infection in pregnant women: a current status in Songklanagarind hospital, southern Thailand

Objectives: To evaluate the acceptability of COL-1492, a vaginal gel containing 52.5 mg nonoxynol-9, in an HIV prevention trial. Methods: Sex workers participating in a phase II/III triple blind, randomised trial in Benin, Côte d’Ivoire, South Africa, and Thailand were interviewed on the gel’s acceptability at monthly scheduled clinic visits. Safer sex counselling, male condoms, and study gels were given at each monthly visit; a gynaecological examination and HIV test were performed. Phase III interviews considered the participants’ appreciation of the gel. On the first, second, and fifth follow up visits, the study volunteers completed more extensive questionnaires. Results: Responses were similar between treatment arms. Women indicated not liking their gel in 1.8% of the visits; 98.1% of the women found the gel easy to apply; 30.1% said that it affected sexual intercourse. These effects were mostly improvements (92.6%) by facilitating intercourse (73.6%). Intercourse was more often affected in women reporting painful sexual intercourse (OR: 2.59 (95% CI 1.63 to 4.12)) and in older women. The latter effect differed among centres. Conclusion: Most participants found their assigned gel acceptable and the vast majority of reported effects on intercourse were favourable. The type of gel had no significant impact on the findings.

A Double-Blind, Adjuvant-Controlled Trial of Human Immunodeficiency Virus Type 1 (HIV-1) Immunogen (Remune) Monotherapy in Asymptomatic, HIV-1-Infected Thai Subjects with CD4-Cell Counts of >300

Background: Clients of commercial sex workers are considered at high risk for the acquisition and transmission of sexually transmitted diseases (STDs). Identification and treatment of infections in this group could help to reduce the transmission of STDs. Goal: To ascertain the prevalence of sexually transmitted organisms in male clients of female sex workers in Thailand by analysis of seminal fluid collected after intercourse. Study Design: Used condoms were collected from 291 male clients attending a brothel in Hat Yai, Thailand during a 7‐day period. Nucleic acid was extracted from seminal fluid and tested by polymerase chain reaction for the presence of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, herpes simplex virus (HSV) and HIV sequences. Results: Overall, 17 (6%), 47 (16%), and 2 (1%) of specimens were positive for C trachomatis, N gonorrhoeae and T vaginalis respectively. HSV sequences were found in 24 (8%) of the specimens: 14 specimens (5%) with HSV type 1, and 11 specimens (4%) with HSV type 2. HIV RNA was detected in two samples (1%). Overall, 75 specimens (26%) were positive for one or more infections, and more than one pathogen was detected in 16 specimens (5%). Conclusion: This study reports a high rate of STDs among clients of female sex workers in Thailand. Consequently, this population is a significant risk for transmitting STDs to commercial sex workers and to other noncommercial partners. Strategies that target this population of men are needed to reduce STD and HIV transmission.

Delayed progression to AIDS in volunteers treated with long-term HIV-1 Immunogen (REMUNE®) therapy in Thailand

BackgroundToxoplasmosis, being one of the TORCH’s infections in pregnant women, is caused by Toxoplasma gondii, an obligate intracellular protozoan parasite. This parasitic infection in pregnancy congenitally causes severe outcomes to their fetus and newborn. This study aimed to determine the seroprevalence and stages of Toxoplasma infection in pregnant women and its associated risks exposures.MethodsThe study was conducted within the pregnant women attending the antenatal clinic (ANC) at Songklanagarind hospital, Hat Yai, Songkhla province, Thailand. The sera of a total of 760 consecutive pregnant women were screened using standard commercial ELISA kits for detection of anti-Toxoplasma IgG and IgM antibodies. IgG avidity in the seropositive for both anti-Toxoplasma IgG and IgM antibodies were also assessed. The pregnant women’s socio-demographic, obstetrics and risk factors associated with Toxoplasma seropositivity data were analyzed using univariate and multivariate analyses.ResultsFrom the total 760 pregnant women, 190 (25%, 95% CI = 22.05-28.20) were positive for anti-Toxoplasma antibodies. Of these, 167 (22.0%, 95% CI = 19.0-25.0) were positive for only anti-Toxoplasma IgG antibody and 23 (3.0%, 95% CI = 2.0-4.0) were positive for both anti-Toxoplasma IgG and IgM antibodies. All these samples were high avidity, indicated the infection occured prior to four to five months. By applying statistical univariate analysis, age group, occupation and sources of drinking water showed a significant association with Toxoplasma seropositivity (p < 0.05). Multivariate logistic regression analysis further indicated that the significant factors associated with Toxoplasma seropositivity are age ≥26 (OR = 1.65, 95% CI = 1.11-2.44), working as laborer (OR = 1.57, 95% CI = 1.13-2.18) and drinking unclean (piped/tap/rain) water (OR = 1.75, 95% CI = 1.08-2.84).ConclusionThe pregnant women in the active age group, working as laborers and exposure to unclean drinking water from various sources were at higher risk of Toxoplasma infection. Therefore, health education and the awareness of risk exposures regarding this parasitic disease are required to minimize the effects of this parasitic infection in pregnant women as well as in the general population.