Sexually transmitted infections and reproductive health morbidity in a cohort of female sex workers screened for a microbicide feasibility study in Nellore, India.

UNLABELLED: Women constitute 38% of India's 2.4 million HIV-infected persons. Microbicides are potential HIV-prevention products currently undergoing clinical trials for efficacy. A four-month placebo vaginal gel trial was conducted in Nellore, India to determine the feasibility of recruiting a suitable cohort of female sex workers (FSWs) for a future vaginal microbicide efficacy trial. We report on the HIV and STI prevalence and reproductive health (RH) morbidity of FSWs screened for the trial.   RESULTS: 529 FSWs completed screening procedures; of those 33.6% were found ineligible.  The mean age was 30.9 years; 68.6% women were married and 57.5% were home-based FSWs.  Self-reported symptoms included abnormal vaginal discharge (31.6%), genital itching (3.4%), uterine mass/prolapse (3%) and painful intercourse (2.6%).  Gynecological surgery was reported by 73.2% of participants; of those 10.5% had undergone a hysterectomy. Female sterilization was the most commonly reported contraceptive method. Pelvic examination showed vaginal discharge (50.7%), cervical discharge (5.3%), uterine/vaginal wall prolapse (2.6%), and cervical mass/nodule/vesicles/genital warts (4.2%). Common epithelial findings included erythema (79.1%) and vesicles/bullae (6%); 46% of participants had Papanicolaou tests graded as inflammatory and 1.1% as malignant. HSV-2 was the mostly commonly detected STI (60.7%) followed by HIV (5.3%), syphilis (2.8%), chlamydia (2.2%), gonorrhoea (0.7%) and trichomoniasis (15.5%).  RTIs were more common: bacterial vaginosis (27.8%) and candidiasis (18.9%). CONCLUSIONS:  The low HIV prevalence and high RH morbidity in the population makes this site unsuitable for a future phase 2 or 3 microbicide efficacy trial.  HIV prevention programs targeting this population should include access to RH services.

An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India.

Female sex workers (FSWs) were recruited for a 4-month placebo vaginal gel trial in Nellore, India. Two experiments explored if prior knowledge of biomarkers for unprotected sex and insertion of gel applicators would yield more accurate self-reports. A third experiment compared self-reports of gel use and adherence levels between FSWs randomly assigned to interactive voice response survey (IVRS) and those assigned to paper diaries. Prior knowledge of biomarkers did not improve accuracy of self-reported condom or gel use, nor did it affect actual adherence. Of those who tested positive for the presence of semenogelin in the vagina, 76% reported no unprotected sex in the previous 48 h. Overall, women reported using gel on 90% of days whereas the biomarker indicated gel use on fewer than 50% of days. Compliance to IVRS was low, despite familiarity with mobile phone technology. Additional explorations with other populations are needed.