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

NCT ID: NCT01790373

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

702 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-07

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Suubi+Adherence

Intervention Type 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

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 Type ACTIVE_COMPARATOR

Bolstered Standard of Care

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Fred Ssewamala

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fred M Ssewamala, MSW, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

International Center for Child Health and Asset Development

Masaka, , Uganda

Site Status

Countries

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United States Uganda

References

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Tutlam NT, Kizito S, Nabunya P, Naseh M, Nabbosa I, Kwesiga I, Namatovu P, Bahar OS, Nakasujja N, Ssewamala FM. Social Determinants of Mental Health Outcomes Among Refugee Adolescents and Youth Living with HIV in Refugee Settlements in Uganda: A Cross-Sectional Analysis. AIDS Behav. 2025 Nov;29(11):3432-3443. doi: 10.1007/s10461-025-04789-6. Epub 2025 Jun 16.

Reference Type DERIVED
PMID: 40518494 (View on PubMed)

Najjuuko C, Brathwaite R, Xu Z, Kizito S, Lu C, Ssewamala FM. Using machine learning to predict poor adherence to antiretroviral therapy among adolescents with HIV in low resource settings. AIDS. 2025 Jul 15;39(9):1204-1213. doi: 10.1097/QAD.0000000000004163. Epub 2025 Feb 24.

Reference Type DERIVED
PMID: 39998619 (View on PubMed)

Girma AZ, Brathwaite R, Karamagi Y, Nakabuye F, Nakasujja N, Byansi W, Nabunya P, Sensoy Bahar O, Ssewamala FM. Impact of COVID-19-Related Disruptions on Antiretroviral Therapy Adherence Among Young Adults Living with HIV in Southern Uganda. AIDS Behav. 2025 May;29(5):1640-1649. doi: 10.1007/s10461-025-04634-w. Epub 2025 Feb 10.

Reference Type DERIVED
PMID: 39928068 (View on PubMed)

Kizito S, Namuwonge F, Nabayinda J, Nalwanga D, Najjuuko C, Nabunya P, Atwebembere R, Namuyaba OI, Mukasa M, Ssewamala FM. A Cluster-Randomized Controlled Trial of an Economic Strengthening Intervention to Enhance Antiretroviral Therapy Adherence among Adolescents Living with HIV. AIDS Behav. 2024 May;28(5):1570-1580. doi: 10.1007/s10461-024-04268-4. Epub 2024 Jan 17.

Reference Type DERIVED
PMID: 38231361 (View on PubMed)

Nabunya P, Samuel K, Ssewamala FM. The effect of family support on self-reported adherence to ART among adolescents perinatally infected with HIV in Uganda: A mediation analysis. J Adolesc. 2023 Jun;95(4):834-843. doi: 10.1002/jad.12157. Epub 2023 Feb 22.

Reference Type DERIVED
PMID: 36810778 (View on PubMed)

Kizito S, Namuwonge F, Brathwaite R, Neilands TB, Nabunya P, Bahar OS, Damulira C, Mwebembezi A, Mellins C, McKay MM, Ssewamala FM. Monitoring adherence to antiretroviral therapy among adolescents in Southern Uganda: comparing Wisepill to Self-report in predicting viral suppression in a cluster-randomized trial. J Int AIDS Soc. 2022 Sep;25(9):e25990. doi: 10.1002/jia2.25990.

Reference Type DERIVED
PMID: 36052462 (View on PubMed)

Tozan Y, Capasso A, Sun S, Neilands TB, Damulira C, Namuwonge F, Nakigozi G, Mwebembezi A, Mukasa B, Sensoy Bahar O, Nabunya P, Mellins CA, McKay MM, Ssewamala FM. 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. J Int AIDS Soc. 2021 Jun;24(6):e25752. doi: 10.1002/jia2.25752.

Reference Type DERIVED
PMID: 34176245 (View on PubMed)

Ssewamala FM, Sensoy Bahar O, Nabunya P, Thames AD, Neilands TB, Damulira C, Mukasa B, Brathwaite R, Mellins C, Santelli J, Brown D, Guo S, Namatovu P, Kiyingi J, Namuwonge F, McKay MM. Suubi+Adherence-Round 2: A study protocol to examine the longitudinal HIV treatment adherence among youth living with HIV transitioning into young adulthood in Southern Uganda. BMC Public Health. 2021 Jan 21;21(1):179. doi: 10.1186/s12889-021-10202-3.

Reference Type DERIVED
PMID: 33478469 (View on PubMed)

Nabunya P, Bahar OS, Chen B, Dvalishvili D, Damulira C, Ssewamala FM. The role of family factors in antiretroviral therapy (ART) adherence self-efficacy among HIV-infected adolescents in southern Uganda. BMC Public Health. 2020 Mar 17;20(1):340. doi: 10.1186/s12889-020-8361-1.

Reference Type DERIVED
PMID: 32183762 (View on PubMed)

Ssewamala FM, Dvalishvili D, Mellins CA, Geng EH, Makumbi F, Neilands TB, McKay M, Damulira C, Nabunya P, Sensoy Bahar O, Nakigozi G, Kigozi G, Byansi W, Mukasa M, Namuwonge F. The long-term effects of a family based economic empowerment intervention (Suubi+Adherence) on suppression of HIV viral loads among adolescents living with HIV in southern Uganda: Findings from 5-year cluster randomized trial. PLoS One. 2020 Feb 10;15(2):e0228370. doi: 10.1371/journal.pone.0228370. eCollection 2020.

Reference Type DERIVED
PMID: 32040523 (View on PubMed)

Ssewamala FM, Byansi W, Bahar OS, Nabunya P, Neilands TB, Mellins C, McKay M, Namuwonge F, Mukasa M, Makumbi FE, Nakigozi G. Suubi+Adherence study protocol: A family economic empowerment intervention addressing HIV treatment adherence for perinatally infected adolescents. Contemp Clin Trials Commun. 2019 Oct 20;16:100463. doi: 10.1016/j.conctc.2019.100463. eCollection 2019 Dec.

Reference Type DERIVED
PMID: 31872152 (View on PubMed)

Other Identifiers

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1R01HD074949-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAK3852

Identifier Type: -

Identifier Source: org_study_id

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