Abstract
Short Summary: Four-month placebo vaginal gel trial conducted to determine the feasibility of recruiting FSWs for future Phase 2/3 microbicide trials. RH morbidity and HIV and STI prevalence are reported.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 trichomoniasis (15.5%), HIV (5.3%), syphilis (2.8%), chlamydia (2.2%) and gonorrhoea (0.7%). 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.
Highlights
India has an estimated 2.4 million adults living with Human Immunodeficiency Virus (HIV) with a national prevalence of 0.31%; women constitute 38% of this population (UNAIDS, 2010)
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
Summary
India has an estimated 2.4 million adults living with HIV with a national prevalence of 0.31%; women constitute 38% of this population (UNAIDS, 2010). Recent data indicate that 90% of HIV-positive women in India were infected within long-term relationships, highlighting the need for HIV prevention methods that women could use to protect themselves (UNAIDS, 2010). Products applied to the vaginal or rectal mucosa, are being developed to reduce the sexual transmission of HIV and other infections (Minces & McGowan, 2010); this has the potential to be an ideal prevention product for women in India. HIV prevalence is significantly higher among FSWs than in the general female population (4.9% vs 0.3%), despite recent data indicating declining prevalence in FSWs. FSWs would be a logical population for a vaginal microbicide effectiveness trial in India (NACO, 2011; Joshi, Solomon, Mayer, & Mehendale, 2005). Obtaining suitable cohorts for microbicide trials is often challenging
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