Suubi+Adherence Study Protocol: A family economic empowerment intervention addressing HIV treatment adherence for perinatally infected adolescents

Abstract Background Globally, 1.8 million children Methods Suubi+Adherence was evaluated via a two-arm cluster randomized-controlled trial design in 39 health clinics, with a total enrollment of 702 HIV+ adolescents (ages 10-16 at enrollment). The study addresses two primary outcomes: 1) adherence to HIV treatment regimen and 2) HIV knowledge and attitudes. Secondary outcomes include family functioning, sexual risk-taking behavior, and financial savings behavior. For potential scale-up, cost effectiveness analysis was employed to compare the relative costs and outcomes associated with each study arm: family economic strengthening comprising matched savings accounts, financial management training and small business development, all intended for family economic security versus bolstered usual care (SOC) comprising enhanced adherence sessions to ensure more standardized and sufficient adherence counseling. Discussion This study aims to advance knowledge and inform the development of the next generation of programs aimed at increasing adherence to HIV treatment for HIV+ adolescents in low-resource regions such as SSA. To our knowledge, the proposed study is the first to integrate and test family economic empowerment and stability-focused interventions for HIV+ adolescents in Uganda (and much of SSA)—so families would have the necessary finances to manage HIV/AIDS as a chronic illness. The study would provide crucial evidence about the effects of an economic empowerment program on short and long-term impact, which is essential if such interventions are to be taken to scale. Trial registration This trial was registered with ClinicalTrials.gov (registration number: NCT01790373) on 13 February 2013.