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

July 26, 2023 updated by: Fred Ssewamala, Washington University School of Medicine

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

702

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Masaka, Uganda
        • International Center for Child Health and Asset Development
  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University in St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suubi+Adherence

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
Behavioral: Suubi+Adherence
  • 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
  • Medical Event Monitoring System

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
Active Comparator: Bolstered Standard of Care

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
Behavioral: Bolstered Standard of Care

-Medical Event Monitoring System

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to follow-up assessments of adherence to HIV treatment
Time Frame: Every year for 10 years
Adherence to HIV treatment regimen outcomes for HIV-positive adolescents, including participants' ability to access and refill prescribed HIV antiretroviral therapy and adhere to prescribed daily HIV medication routines.
Every year for 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protective Health Behaviors
Time Frame: Every year for 10 years
Using a series of standardized and pre-tested instruments, potential mechanisms of protective health behaviors, knowledge, and beliefs, including: 1) financial/economic stability, 2) sexual risk-taking behavior, 3) personal beliefs about HIV medication, 4) hopelessness, 5) future plans and aspirations, and 6) adherence self-efficacy, will be measured during a structured interview at baseline and at every subsequent follow-up assessment.
Every year for 10 years
Cost-Effectiveness Analyses
Time Frame: Every year for 10 years
Cost-effectiveness analyses measure the cost of achieving an agreed upon benefit, such as an additional year of schooling, employment, or a reduction in a disease. Costs will be measured on a per person basis. The costs of the intervention will include all program costs. Research costs will not be included.
Every year for 10 years
Cognitive functioning
Time Frame: Every year in years 6 to 10
Using a series of standardized and pre-tested instruments, cognitive functioning will be measured during a structured interview at wave 6 and at every subsequent follow-up assessment.
Every year in years 6 to 10
Substance misuse
Time Frame: Every year in years 6 to 10
Using a series of standardized and pre-tested instruments, substance misuse will be measured during a structured interview at wave 6 and at every subsequent follow-up assessment.
Every year in years 6 to 10
Social transitions
Time Frame: Every year in years 6 to 10
Using a series of standardized and pre-tested instruments, social transitions will be measured during a structured interview at wave 6 and at every subsequent follow-up assessment.
Every year in years 6 to 10
HIV stigma
Time Frame: Every year in years 6 to 10
Using a series of standardized and pre-tested instruments, HIV stigma will be measured during a structured interview at wave 6 and at every subsequent follow-up assessment.
Every year in years 6 to 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Fred M Ssewamala, MSW, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2013

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimated)

February 13, 2013

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAAK3852
  • 1R01HD074949-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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