Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT01790373

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

HIV

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Center for Child Health and Asset Development, Masaka, Uganda

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suubi+Adherence

Behavioral
  • 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

Bolstered Standard of Care

Behavioral

-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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2013
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.