Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence

The Washington University

Status: Active, not recruiting

Conditions: HIV

Treatments: Behavioral: Bolstered Standard of Care; Behavioral: Suubi+Adherence

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01790373

AAAK3852

1R01HD074949-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of Suubi+Adherence is to examine the impact and cost associated with an innovative intervention to increase adherence to HIV treatment for HIV-infected adolescents. Multiple intervention studies by our team in Rakai and Masaka Districts of southern Uganda with AIDS-orphaned adolescents have revealed that if given an opportunity to participate in economic empowerment interventions, youth and their caregivers take full advantage of these interventions to save and invest in their future, show improvements in family financial outcomes, future aspirations, health functioning, sexual-risk taking behaviors, and mental health. The Suubi+Adherence study capitalizes on this prior work, positing that economic empowerment may be a missing, yet critical ingredient to HIV treatment adherence interventions for adolescents and young people. Suubi+Adherence incorporates an economic empowerment design, with a savings-led income generating component, to promote economic stability, and apply it to adherence to HIV treatment regimens for HIV-positive adolescents in a region of southern Uganda with the highest HIV incidence and prevalence in the country.

Enrollment: 702 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HIV-positive adolescents confirmed by medical report
• Prescribed antiretroviral therapy
• Enrolled in care at one of 40 medical clinics within study region
• 10-16 years of age at the time of enrollment
• Living within a family (not necessarily with biological parent(s))

Exclusion criteria

• Not HIV-positive
• HIV-positive but not prescribed antiretroviral therapy
• Not enrolled in care at one of 40 medical clinics within study region
• Younger than 10 years and older than 16 years
• Not living within a family

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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702 participants in 2 patient groups

Suubi+Adherence

Experimental group

Description:

Suubi+Adherence intervention arm provides: Matched savings accounts/child development accounts (CDAs) for the adolescents held in a local bank. Financial education and workshops on asset-building, future planning, and protection from risks Mentorship from a young adult/near-peer Family-based microenterprise development training Bolstered Standard of Care: Adherence Counseling Practices -Four to six counseling sessions to review HIV, ART, resistance, and adherence. Medical Standard of Care: -Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda Psychosocial Standard of Care: -Psychosocial support provided by lay counselors trained in standardized ART adherence counseling

Treatment:

Behavioral: Suubi+Adherence

Bolstered Standard of Care

Active Comparator group

Description:

Bolstered Standard of Care: Adherence Counseling Practices -Four to six counseling sessions to review HIV, ART, resistance, and adherence. Medical Standard of Care: -Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda Psychosocial Standard of Care: -Psychosocial support provided by lay counselors trained in standardized ART adherence counseling

Treatment:

Behavioral: Bolstered Standard of Care