Randomized Controlled Trial to Enhance Dual Protection Among PLHIV in India

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DESCRIPTION (provided by applicant): This collaborative project between Yale University, the University of Connecticut, and the Indian Network for People Living with HIV/AIDS (INP+) in India provides a unique opportunity to conduct social and behavioral science research aimed at expanding the use of dual contraceptive methods (consistent condom use in combination with consistent use of another effective contraceptive method) among married people living with HIV (PLHIV) in India. This will prevent unintended pregnancies and possible vertical transmission of HIV to the infant, prevent acquisition of sexually transmitted infections from a non-monogamous spouse, prevent transmission of HIV to a serodiscordant spouse, and prevent transmission of drug resistant or more pathogenic HIV strains between seroconcordant spouses. The project will design, implement, and evaluate a modified, completely culturally-adapted version of a previously validated intervention aimed at sexual risk reduction for PLHIV based upon the Information-Motivation-Behavioral Skills (IMB) theoretical framework and Motivational Interviewing techniques. The specific aims of our project are: 1) To design, pilot test, and refine a theory-driven (IMB model), culturally-adapted, peer-counselor-delivered intervention to assist married men and women living with HIV who are clients of INP+ in Tamil Nadu, India, and who do not intend to initiate a pregnancy in the next two years, to adopt dual contraceptive methods. The intervention will be delivered to married individuals, not couples; and 2) To conduct a group-randomized controlled trial to compare the intervention developed in the first specific aim with usual care (UC) among married men and women living with HIV who are accessing district-level services from INP+ in Tamil Nadu, India. The unit of randomization will be the district. The intervention will be delivered over an 18-month period and will be evaluated at 6, 12, 18, and 24 months. The primary outcome will be use of dual contraceptive methods. Secondary outcomes will be consistent use of condoms alone, pregnancy, STI symptoms, having received treatment for an STI, and IMB components. Hypotheses are: 1) Married PLHIV who receive the intervention will have increased use of dual contraceptive methods, fewer pregnancies in the marriage, fewer STI symptoms, and less STI treatment compared with married PLHIV who receive UC; 2) Increased use of dual contraceptive methods will be sustained at 24 months in the intervention group compared to the UC group; and 3) Intervention-induced increased use of dual contraceptive methods will be mediated by intervention effects on the determinants of contraceptive behavior specified by the IMB model. To our knowledge, this would be the first theory-driven intervention study among PLHIV in India to promote dual contraceptive methods. If this research demonstrates efficacy, the intervention will be integrated into INP+ usual care in Tamil Nadu and throughout India, and will also have wide applicability in many Indian settings that utilize peer outreach workers or peer counselors/educators.