Effectiveness and Implementation of Adapted Physical Activity Delivery Strategies for Older Adults Living With HIV in Ivory Coast: Protocol for a Type 2 Hybrid Randomized Controlled Trial.

BACKGROUND: With improved access to antiretroviral treatment, HIV infection has become a chronic disease, and the proportion of people living with HIV aged 50 years or older 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 people living with HIV. 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 2 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 prior formative research that provides information on the context and guides the implementation. Conducted in Ivory Coast, the study aims to randomize 180 people living with HIV aged 50 years or older, receiving antiretroviral treatment and presenting moderate functional limitations or disabilities into the following 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 Emerging Infectious Disease, which is also the study sponsor. It received ethical approval from the National Ethical Committee of Ivory Coast (00231 3124/MSHPCMU/CNESVS-km). As of manuscript submission, the baseline formative research has been completed, participants have been randomized, and they have 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. TRIAL REGISTRATION: ClinicalTrial.gov NCT06139497; https://clinicaltrials.gov/study/NCT06139497. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/84677.