Testing the Efficacy of 2 Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV: Protocol for a Randomized Controlled Trial.

BACKGROUND: Rural people living with HIV in the United States have higher mortality rates and lower rates of HIV suppression compared to nonrural people living with HIV. In addition, compared to younger people living with HIV, older people living with HIV face numerous challenges to maintaining health and well-being. However, few interventions have targeted health or quality-of-life outcomes in rural older people living with HIV.

OBJECTIVE: This randomized controlled trial will evaluate the efficacy of 2 remotely delivered interventions-supportive-expressive peer social support groups and strengths-based case management-to improve viral suppression, medication adherence, quality of life, and depressive symptoms in people living with HIV aged >50 years in rural counties in the southern United States.

METHODS: We will enroll 352 rural older (aged >50 y) people living with HIV and test the interventions using a 2 (social support groups: yes or no) × 2 (strengths-based case management: yes or no) factorial design. Supportive-expressive peer social support groups aim to increase social support and lower HIV stigma, thereby improving HIV health outcomes and quality of life. Trained facilitators will deliver the 8 weekly sessions with a set curriculum to groups of 8 to 12 participants via videoconference. Strengths-based case management is an individual-level, individually tailored intervention delivered by trained staff. Over 5 sessions, the participant-staff duo selects a barrier impacting HIV care or quality of life and identifies short-term goals to overcome the barrier, focusing on the process of incremental problem-solving while recognizing accomplishments. We will assess HIV viral load-using participant-collected dried blood spot samples-at baseline and 8 and 12 months after the intervention. Using surveys, we will assess adherence, quality of life, depressive symptoms, and secondary outcomes at baseline and 4, 8, and 12 months after the intervention. We hypothesize that participants randomly assigned to each intervention will be more likely to be virally suppressed and adherent to antiretroviral therapy and have higher quality of life and fewer depressive symptoms at follow-up than those not assigned to each intervention. Secondary hypotheses are that, compared to those not receiving each intervention, participants in each intervention will report greater social support, self-efficacy, and likelihood of accessing needed services; less loneliness and internalized HIV stigma; and fewer structural barriers. Data will be analyzed using generalized linear mixed models.

RESULTS: Funded in April 2023, the study began enrollment in April 2024, with 177 participants having given consent by July 2025. Data collection will run through 2027 followed by analysis and publication by 2028.

CONCLUSIONS: This study will evaluate 2 remotely delivered interventions for rural older people living with HIV for their effects on HIV health outcomes, quality of life, and depressive symptoms. If effective, these scalable interventions could improve outcomes for this growing population.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06269081; https://www.clinicaltrials.gov/study/NCT06269081.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71429.