Economic Empowerment for HIV Treatment Adherence

Recruiting at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Antiretroviral therapy

Disqualifiers: Not HIV-positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 years

702 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since it focuses on adherence to HIV treatment, you will likely need to continue your prescribed antiretroviral therapy.

What data supports the effectiveness of the treatment Suubi+Adherence for HIV treatment adherence?

Research shows that the Suubi+Adherence treatment, which includes economic empowerment strategies like savings accounts and financial training, improved adherence to HIV medication among adolescents in Uganda. Participants in the program also had better school enrollment and economic outcomes, which can contribute to overall health improvements. ^{1 2 3 4 5}

Is the Economic Empowerment intervention safe for humans?

The Economic Empowerment interventions, like Suubi+Adherence, have been tested in various studies with no reported safety concerns, suggesting they are generally safe for humans. ^{2 3 4 6 7}

What makes the Suubi+Adherence treatment unique for HIV treatment adherence?

The Suubi+Adherence treatment is unique because it combines economic empowerment strategies, like savings accounts and financial training, with mentorship and role model engagement to improve adherence to HIV treatment among adolescents. This approach addresses both economic and psychosocial barriers to treatment adherence, which is different from standard medical treatments that focus solely on medication. ^{1 2 4 5 7}

What is the purpose of this trial?

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.

Research Team

Fred M Ssewamala, MSW, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for HIV-positive adolescents aged 10-16 in southern Uganda, who are on antiretroviral therapy and enrolled at one of the specified 40 medical clinics. They must be living within a family setting, but not necessarily with biological parents.

Inclusion Criteria

Enrolled in care at one of 40 medical clinics within study region

Living within a family (not necessarily with biological parent(s))

HIV-positive adolescents confirmed by medical report

Exclusion Criteria

Not enrolled in care at one of 40 medical clinics within study region

I do not have HIV.

I am HIV-positive and not on antiretroviral therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adherence counseling, financial education, and mentorship as part of the Suubi+Adherence intervention

10 years

Four to six counseling sessions initially, followed by annual assessments

Follow-up

Participants are monitored for adherence to HIV treatment and other health outcomes

10 years

Annual follow-up assessments

Treatment Details

Interventions

• Bolstered Standard of Care
• Suubi+Adherence

Trial Overview The study tests Suubi+Adherence, an economic empowerment intervention aimed to improve HIV treatment adherence among youth. It includes savings-led income generation to promote stability and applies it to their HIV treatment regimen.

Participant Groups

Group I: Suubi+Adherence Experimental Treatment 1 Intervention

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

Group II: Bolstered Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

The economic empowerment intervention significantly improved adherence to HIV treatment among adolescents after 24 months, indicating that financial support and training can enhance health outcomes.

Participants in the intervention group also showed higher school enrollment and reported better savings, suggesting that economic empowerment can lead to broader improvements in educational and financial stability for adolescents living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Long-term (5-year) Impact of a Family Economic Empowerment Intervention on Adolescents Living with HIV in Uganda: Analysis of Longitudinal Data from a Cluster Randomized Controlled Trial from the Suubi+Adherence Study (2012-2018). Brathwaite, R., Ssewamala, FM., Mutumba, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Structural Equation Model of the Impact of a Family-Based Economic Intervention on Antiretroviral Therapy Adherence Among Adolescents Living With HIV in Uganda. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Suubi4Cancer: A protocol for an innovative combination intervention to improve access to pediatric cancer services and treatment adherence among children living with HIV/AIDS in Uganda. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Behavioral economic incentives to improve adherence to antiretroviral medication. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The efficacy and cost-effectiveness of a family-based economic empowerment intervention (Suubi + Adherence) on suppression of HIV viral loads among adolescents living with HIV: results from a Cluster Randomized Controlled Trial in southern Uganda. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Long-term (5-year) Impact of a Family Economic Empowerment Intervention on Adolescents Living with HIV in Uganda: Analysis of Longitudinal Data from a Cluster Randomized Controlled Trial from the Suubi+Adherence Study (2012-2018). [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Financial Incentives and Real-Time Adherence Monitoring to Promote Daily Adherence to HIV Treatment and Viral Suppression Among People Living With HIV: A Pilot Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Suubi + Adherence4Youth: a study protocol to optimize the Suubi Intervention for Adherence to HIV treatment for youth living with HIV in Uganda. [2023]