Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
NCT ID: NCT01790373
Last Updated: 2026-01-13
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
702 participants
INTERVENTIONAL
2013-09-07
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
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
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
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
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
16 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Fred Ssewamala
Professor
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
International Center for Child Health and Asset Development
Masaka, , Uganda
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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AAAK3852
Identifier Type: -
Identifier Source: org_study_id
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