Leveraging Randomized Controlled Trial Design: HIV and Wellness Interventions with Marginalized Populations

Abstract

Treatment as usual has historically been used as control arms for randomized controlled trials (RCTs), but utilizing wellness interventions as active comparison conditions can advance the evidence base of such interventions while increasing access to health promotion content. We use the results from the CONNECT 2 RCT's wellness intervention control arm as a case example of active comparison conditions that can control for dosage or attentional effects in future research. We summarized existing studies on wellness control HIV RCT interventions, introduced CONNECT 2, and discussed recruitment, randomization, and the intervention. Overall, Wellness Promotion participants were more likely to engage in physical activity, eat healthier, and do more vigorous exercise when compared with HIV Risk Reduction. CONNECT 2 Wellness intervention results solidify why wellness interventions can play an important role in treatment guidelines. Developing and implementing this model can be a more ethical, equitable, and holistic approach among underserved communities.