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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: Suubi+Adherence
* Behavioral: Bolstered Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suubi+Adherence<br>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<br>* 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<br>|
| Active Comparator: Bolstered Standard of Care<br>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<br>* -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<br>|

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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suubi, Adolescents, Poverty, Economic empowerment interventions, Adherence to HIV antiretroviral therapy, Wisepill, HIV/AIDS infected Children, Medical event monitoring system, Uganda