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Not Yet Recruiting NCT05600621

Suubi+Adherence4Youth

Conditions: HIV

Sex: All
Ages: 11 Years – 17 Years
Phase: NA
Enrollment: 576
Sponsor: Washington University School of Medicine

Summary

The study will test four economic empowerment intervention components to identify the combination that best enhance viral suppression.The study design is a 2-to-the 4 factorial experiment. The 2 represents the level of each component:0 (receive) or (don't receive) four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Guided by the MOST framework, the study will test each of the four components' performance and their combinations on the primary outcome, viral suppression. Resulting in 16 unique conditions representing all possible combinations of the 4 components. The study will randomize at the level of health clinics (N=48). Clinics will be randomized to provide one of the 16 conditions, with 12 ALHIV (aged 11-17 years) enrolled per clinic, yielding main effects and interaction effects for the 4 components on sustained viral suppression. Sustained viral suppression is defined as an undetectable viral load on all 12-, 24- and 36-month follow-up assessments.

Eligibility Criteria

Inclusion Criteria:Adolescent:living with HIV (confirmed by medical report and aware of status)living within a familybeing 11-17 years of age (at enrollment)prescribed ARTenrolled in ART care at one of the 48 health clinics in the study districts.Health clinics would be eligible if they:have existing procedures tailored to adolescent adherence (including adolescent-specific clinic days and peer counselling)Accredited by the Uganda Ministry of Health as a provider of ART within the study districts.Exclusion Criteria:Includes an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or parent.If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05600621). StuddyBuddy aggregates publicly available trial information.