16th International AIDS Conference Toronto, Canada - August 13 - 18, 2006

THE IMPACT OF A RANDOMIZED CONTROLLED TRIAL OF AN STI/BEHAVIORAL PREVENTION INTERVENTION ON HIV AND STI INCIDENCE AMONG HIGH RISK MEN IN MUMBAI, INDIA

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. TuAc0502

C. Lindan¹, M. Ekstrand², M. Mathur³, M. McGuire⁴, A. Hernandez⁵, S. Gregorich⁶, J. Moncada⁷, J. Klausner⁸, L. Borges⁹, H. Jerajani^10
1 University of California San Francisco (UCSF), Institute for Global Health (IGH), San Francisco, United States, ² UCSF, CAPS, San Francisco, United States, ³ LTMG Hospital and Medical School, Microbiology, Mumbai, India, ⁴ UCSF, CAPS-Mumbai Project, Mumbai, India, ⁵ UCSF, IGH, San Francisco, United States, ⁶ UCSF, Epidemiology and Biostatistics, San Francisco, United States, ⁷ UCSF Chlamydia Research Laboratory, San Francisco, United States, ⁸ SF Department of Public Health, STI Control, San Francisco, United States, ⁹ Mumbai District AIDS Control Society, Mumbai, India, ¹⁰ LTMG Hospital and Medical School, Dermatology and Venerealogy, Mumbai, India

BACKGROUND: The role of STI intervention and treatment on HIV acquisition remains controversial. We report results of a randomized controlled trial of a behavioral intervention (plus STI care and HIV C&T) on HIV/STI incidence among high risk men in India. Behavioral outcomes are presented elsewhere.

METHODS: 3345 men were enrolled from 2 public clinics; most were poor, long-term migrant workers (70%). Baseline (BL) screening and testing were performed for HIV, syphilis, HSV2, H. ducreyi, C. trachomatis, N. gonorrhea, NGU. 14% were HIV+. Only HIV negative men were randomized (N=2144), 31% of whom had an STI. Both arms received etiologically specific STI treatment(including acyclovir for symptomatic HSV2) and HIV C&T at BL and followup. The intervention group also received a daylong skills building session with boosters. Men were evaluated every 3 months for a year.

RESULTS: There was a slight difference in HIV incidence between arms (1.7% ppy control vs 0.7% ppy intervention) but was not statistically significant (RR 2.5; 95% CI: 0.60,14.5). There were 235 new STIs but no difference between groups (21.9% ppy control vs 19.5% ppy). STI incidence in both arms was significantly reduced compared to an estimated BL STI incidence (100% ppy) (RR = 0.5, p<.001). BL incidence assumed acute STIs were acquired within the prior 3 months. New HIV infections were associated with HSV2 (RR = 6.2) or having any STI (RR = 5.4) (p<.01). We also evaluated and present associations between reductions in self reported risk behavior, condom use, and incident HIV/STIs.

CONCLUSIONS: Both arms showed a significant reduction in STIs and low HIV incidence, accompanied by changes in sexual risk. These results support the use of etiologically based STI treatment and individualized counseling to reduce new infections. These basic services should be incorporated into existing clinics and programs in India. The addition of a behavioral intervention did not further improve biological outcomes.

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2006-08-13
TuAc0502

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