Comparison of the effectiveness of two adapted physical activity programs: Toward a protocol for a hybrid type 2 randomized controlled trial to improve the quality of life of older adults living with HIV in Côte d’Ivoire (Preprint)

BACKGROUND With improved access to antiretroviral treatment (ART), HIV infection has become a chronic disease, and the proportion of people living with HIV (PLWH) older than 50 years is increasing. However, the long-term evolution of this disease is associated with an increased risk of comorbidities and functional impairments, which negatively impact the social participation and quality of life of PLWH. In resource-limited countries, population aging is a new situation, and significant challenges remain unaddressed to respond to this demographic shift. Strong evidence supports the role of physical activity (PA) in improving health and decreasing functional limitations in many chronic conditions, including HIV. However, there is a lack of information on how to effectively implement this type of nondrug intervention in resource-limited contexts. OBJECTIVE This study aims to examine the effectiveness and implementation of two strategies to deliver an adapted PA program to older adults living with HIV. METHODS This is a prospective, randomized controlled, trial following a type 2 hybrid design, with a dual focus on intervention effectiveness and implementation outcomes. It also includes a prior formative research that provides information on the context and guides the implementation. Conducted in Côte d’Ivoire, the study aims to randomize 180 PLWH aged 50 years or older, receiving ART and presenting moderate functional limitations and/or disabilities into three arms: (1) a reference arm receiving a group-based PA program supervised by a coach, (2) an exploratory arm receiving a home-based PA program with remote supervision via phone calls and messaging apps, or (3) a control arm receiving health education sessions. The total follow-up period is planned for 12 months, with an initial 6-month active phase and then a 6-month maintenance phase. The primary effectiveness outcome is the increase in the number of steps in the 6-minute step-up test between baseline and 6 months. The secondary outcomes include changes in performance on other functional tests and improvements in cardiometabolic risk factors. The implementation outcomes include the acceptability, adoption, feasibility and sustainability of the intervention. RESULTS This study is funded by ANRS-MIE, which is also the study sponsor. It received ethical approval from the national ethical committee of Côte d’Ivoire (00231 3124/MSHPCMU/CNESVS-km). It is registred on the ClinicalTrials.gov website (NCT06139497). As of manuscript submission, the baseline formative research has been completed, participants have been randomized and started the PA activity program. Results dissemination will involve civil society and decision-makers through workshops and policy briefs. CONCLUSIONS This study builds on previous research on healthy aging while living with HIV. Its hybrid design allows for a comprehensive evaluation of implementation processes and outcomes alongside effectiveness outcomes. CLINICALTRIAL ClinicalTrial.gov NCT06139497