Economic Empowerment for HIV Treatment Adherence

Not currently recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether savings accounts and financial education can help HIV-positive adolescents adhere better to their treatment plans. It tests if economic empowerment, such as saving money and learning about finances, can improve how these young people manage their HIV treatment. Participants will receive either typical care with counseling sessions (Bolstered Standard of Care) or an additional program that includes financial tools and support (Suubi+Adherence). The trial seeks HIV-positive adolescents, ages 10 to 16, who are already receiving antiretroviral therapy at specific clinics in southern Uganda. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that could enhance treatment adherence and improve lives.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Suubi+Adherence program helps HIV-positive teenagers adhere to their treatment plans by offering financial education, mentorship, and family business training. The program has improved the finances and overall health of young people and their families.

No evidence suggests safety concerns with the Suubi+Adherence program itself. Instead, it supports existing medical and emotional care by addressing financial challenges, making it a supportive program rather than a medical treatment. This means there is little risk of negative effects from the program itself.

Since this study is not a typical clinical trial with new drugs, the main focus is on how well the program aids treatment adherence, rather than any direct safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Suubi+Adherence approach because it goes beyond traditional HIV treatment methods by integrating economic empowerment with health care. Unlike standard care, which focuses mainly on medical and psychosocial support, this treatment provides adolescents with matched savings accounts, financial education, and mentorship. This innovative combination aims to improve medication adherence by addressing economic barriers, empowering youth to manage their health more effectively, and fostering long-term planning skills. This holistic approach could significantly enhance treatment adherence and overall well-being for adolescents living with HIV.

What evidence suggests that this trial's treatments could be effective for improving HIV treatment adherence in adolescents?

Research shows that the Suubi+Adherence program, a treatment arm in this trial providing financial support, may enhance teenagers' adherence to HIV treatment. Studies have found that young people in financial support programs often experience better health, including more regular medication use. The program includes savings accounts with matching contributions, financial education, and mentorship. These components have been linked to improved medication adherence and mental health. Early results suggest this approach can help control the virus in the short term and lead to overall positive health effects in teenagers. This underscores the importance of financial support in managing HIV effectively. Meanwhile, the other trial arm, the Bolstered Standard of Care, focuses on adherence counseling practices and standard medical and psychosocial support. ^{2 3 6 7 8}

Who Is on the Research Team?

Fred M Ssewamala, MSW, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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

HIV-positive adolescents confirmed by medical report

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34176245/

The efficacy and cost-effectiveness of a family ... - PubMed This study aims to assess the efficacy and cost-effectiveness of a savings-led family-based EE intervention, Suubi + Adherence, aimed at improving ...

2. ichad.wustl.edu ichad.wustl.edu/suubiadherence/

Suubi+Adherence-R2 (2020-2025) It examines the impact and cost associated with an economic empowerment intervention to increase adherence to HIV treatment for HIV positive adolescents in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S245186541930225X

Suubi+Adherence study protocol: A family economic ... The study addresses two primary outcomes: 1) adherence to HIV treatment regimen and 2) HIV knowledge and attitudes. Secondary outcomes include family ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-15564-4

Suubi + Adherence4Youth: a study protocol to optimize the ... Suubi is an evidenced based multi-component intervention that targets psychosocial and economic hardships to improve ART adherence, viral suppression, mental ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7818782/

Suubi+Adherence-Round 2: A study protocol to examine the ... The study findings pointed to superior short-term viral suppression and positive adolescent health and mental health functioning among participants receiving ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6915750/

Suubi+Adherence study protocol: A family economic ... The study addresses two primary outcomes: 1) adherence to HIV treatment regimen and 2) HIV knowledge and attitudes. Secondary outcomes include family ...

7. clinicaltrial.be clinicaltrial.be/en/details/30455?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

M-Suubi: A Multi-Level Integrated Intervention to Reduce... ALHIV in schools are more disadvantaged and have lower levels of HIV treatment adherence due to high levels of HIV stigma within schools, rigid ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0277953624010001

A cluster-randomized controlled trial in Southern Uganda ALHIV have poor adherence to ART leading to low viral suppression. ... Only 60% of ALHIV in our sample achieved viral suppression at baseline. ... Economic ...