An Intervention for Male STD Patients in India / HIV Related

Investigator: Christina (Krysia) Lindan, MD, MSc
Sponsor: NIH National Institute of Allergy and Infectious Disease

Location(s): India


A randomized trial of a behavioral intervention compared to STI treatment/HIV testing and counseling alone, among male STI patients in Mumbai, India. Trial outcomes include HIV/STI incidence and self-reported risk behavior. The cumulative prevalence of HIV among men screened to date is 14%. We have recruited over half the total 1800 HIV negative men required for randomization, and have an excellent research infrastructure on site including data management, laboratory, and trained staff. Preliminary data indicate the primary risk factor for HIV is exposure to female sex workers (FSW) and HSV2 infection; preliminary analysis of trial results reveal a strong effect in both arms over time, and a difference in self-reported risk behavior between the two arms. We found a strong association of alcohol use during sex with FSW and increased HIV risk, HSV2, syphilis, and number of episodes of unprotected sex. In addition, many men have sex with both women and other high-risk men. To address this, we propose to expand our evaluation of MSM and the role of alcohol in risky sex among men being enrolled the study. Data from the trial will supplement information obtained from the large community based STI trials in Africa, which have shown differing results. It is possible that specific STI diagnosis and treatment including HSV2, if accompanied by HIV testing and quality counseling, is an affordable and effective prevention strategy in our setting. Overall goals of the study are to develop and evaluate a feasible, culturally appropriate intervention to reduce HIV transmission in India. To be widely effective, prevention programs in south Asia should be instituted within the public health system. For this reason, we implemented this trial within the public health structure, despite the inherent difficulties of this approach. The study has already succeeded in changing public health STI treatment guidelines. Additional time and funding are required due to a short initial 4-year funding period, time required to perform such a trial in India, and slower than anticipated recruitment of subjects due to demographic shifts in the high risk population. To address these issues, we propose to add an additional recruitment site and evening follow-up clinics to enhance enrollment and retention.