Randomized Controlled Trial to Enhance Dual Protection Among PLHIV in India

描述（由申请人提供）：耶鲁大学、康涅狄格大学和印度艾滋病毒/艾滋病患者网络（INP+）之间的这个合作项目为开展社会和行为科学研究提供了一个独特的机会，旨在扩大印度已婚艾滋病毒感染者（PLHIV）中双重避孕方法的使用（一贯使用避孕套和一贯使用另一种有效的避孕方法）。这将防止意外怀孕和艾滋病毒可能垂直传播给婴儿，防止从非一夫一妻制的配偶获得性传播感染，防止艾滋病毒传播给血清不一致的配偶，并防止耐药或更具致病性的艾滋病毒株在血清一致的配偶之间传播。该项目将基于信息-动机-行为技能（IMB）理论框架和动机性访谈技术，设计、实施和评估一种经过修改的、完全符合文化的干预措施，旨在降低艾滋病毒感染者的性风险。我们项目的具体目标是：1)设计、试点测试和完善一个理论驱动（IMB模式）、文化适应、同伴咨询师提供的干预措施，以帮助印度泰米尔纳德邦INP+的客户、在未来两年内不打算怀孕的已婚艾滋病毒感染者采用双重避孕方法。干预措施将针对已婚人士，而不是夫妻；2)开展一项组随机对照试验，比较在第一个特定目标中开发的干预措施与在印度泰米尔纳德邦获得INP+地区级服务的已婚艾滋病毒感染者的常规护理（UC）。随机化的单位是地区。干预将在18个月的时间内进行，并在6、12、18和24个月时进行评估。主要结果将是使用双重避孕方法。次要结果将是持续单独使用避孕套、怀孕、性传播感染症状、接受性传播感染治疗和IMB成分。假设：1)与接受UC的已婚hiv感染者相比，接受干预的已婚hiv感染者使用双重避孕方法的次数增加，婚姻中怀孕次数减少，性传播感染症状减少，性传播感染治疗减少；2)与UC组相比，干预组在24个月时将持续增加双重避孕方法的使用；(3)干预导致的双重避孕方法使用增加将通过干预对IMB模型所指定的避孕行为决定因素的影响来调节。据我们所知，这将是印度第一个以理论驱动的干预研究来推广双重避孕方法。如果这项研究证明有效，该干预措施将被纳入泰米尔纳德邦和整个印度的INP+常规护理中，并将在许多利用同伴外展工作者或同伴咨询师/教育者的印度环境中广泛适用。

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.