Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 17, 2025
Date Accepted: Aug 28, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Testing the Efficacy of Two Interventions to Improve Health Outcomes and Quality of Life among Rural Older Adults Living with HIV: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Rural people living with HIV (PLH) in the US have higher mortality rates, lower rates of HIV suppression, and multiple social and practical challenges to achieving healthy outcomes compared to non-rural PLH. Compared with younger PLH, older PLH also face numerous challenges to maintaining their health and wellbeing. However, few interventions have targeted health or quality of life outcomes in rural older PLH.
Objective:
This randomized controlled trial (RCT) will evaluate the efficacy of two remotely-delivered interventions to improve viral suppression, medication adherence, quality of life, and depressive symptoms in PLH over age 50 living in rural counties in the Southern US.
Methods:
Building on preliminary work, this RCT will test two interventions to evaluate their effect on HIV viral suppression, antiretroviral medication adherence, quality of life, and depressive symptoms. We will enroll 352 rural older (aged 50+) PLH who live in the Southern US and use a 2 x 2 factorial design to test the interventions. Supportive-expressive peer social support groups aim to increase social support and lower HIV stigma, in turn improving HIV health outcomes and quality of life. Trained facilitators will deliver the 8 weekly online sessions, each with a planned curriculum, to groups of 8-12 older rural PLH via videoconference. Strengths-based case management is an individual-level, individually-tailored intervention delivered by trained staff. Over the course of 5 sessions, the participant-staff duo selects a barrier impacting HIV care or quality of life and identifies a series of short-term goals to overcome the barrier, focusing on the process of incremental problem-solving while recognizing accomplishments and newly acquired strengths and skills. We will assess HIV viral load—using participant-collected dried blood spot samples—at baseline and at 8 and 12 months following intervention participation. Using surveys, we will assess medication adherence, quality of life, depressive symptoms, and secondary outcomes at baseline and 4, 8, and 12 months post intervention.
Results:
Research activities began in April 2024 and are ongoing.
Conclusions:
This study will evaluate two-remotely delivered interventions for rural older PLH for their effects on HIV health outcomes, quality of life, and depressive symptoms. If found effective, these scalable interventions could help to improve outcomes for this growing population that faces health disparities. Clinical Trial: ClinicalTrials.gov NCT06269081; https://clinicaltrials.gov/ct2/show/study/NCT06269081
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