2.1. Study Design and Sample Participants
AIDS, depression
AIDS
This study utilized longitudinal data from the parent study, ‘Alcohol and ART Adherence: Assessment, Intervention, and Modeling in India’, which was a randomized controlled clinical trial designed to evaluate and compare the efficacy of a multi-level and multi-factorial intervention to decrease alcohol consumption and related factors among male PLHW on ART who consume alcohol in Mumbai, India [Study design: The study design employed an intervention crossover design, in which three types of interventions, including individual counseling (IC), group intervention (GI), and collective advocacy (CA), were implemented against two control ART centers, with the sequence of interventions varying by site. The ATR site 1 sequence was GI–IC–CA; the ATR site 2 sequence was IC–CA–GI; and the ATR site 3 sequence was CA–GI–IC. The intervention content focused on promoting healthy living, reducing depression, tension, and stress, reducing alcohol consumption, maintaining ART adherence, as well as promoting positive relationships and social support. A total of 940 male PLWH consented to participate in the study, with 564 participants receiving the three interventions and 376 participants in the two control ART centers. Both intervention and control participants continued to receive routine care approved by the India National AIDS Control Organization at the ART center while they were enrolled in the study. This study design allowed for the comparison of the effectiveness of the interventions with the standard care received by the control group. Baseline survey and follow-up evaluation: The pre-intervention baseline assessment was conducted at Time 1 (T1), followed by a follow-up assessment within 80 to 120 days after the intervention (T2). Of the 941 participants interviewed at T1, 871 had complete data on all study variables at both T1 and T2. The baseline and follow-up surveys were administered after medication pick-up to all participants in all five ART centers. The data collection was conducted orally in Hindi and Marathi by trained research investigators, and the data were recorded digitally on tablets using an Android-based app. 