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

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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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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