NCT01790373

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
702

participants targeted

Target at P75+ for not_applicable hiv

Timeline
2mo left

Started Sep 2013

Longer than P75 for not_applicable hiv

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Sep 2013Jul 2026

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

September 7, 2013

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

12.9 years

First QC Date

February 11, 2013

Last Update Submit

January 12, 2026

Conditions

HIV

Keywords

SuubiAdolescentsPovertyEconomic empowerment interventionsAdherence to HIV antiretroviral therapyWisepillHIV/AIDS infected ChildrenMedical event monitoring systemUganda

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Protective Health Behaviors

    Every year for 10 years

  • Cost-Effectiveness Analyses

    Every year for 10 years

  • Cognitive functioning

    Every year in years 6 to 10

  • Substance misuse

    Every year in years 6 to 10

  • Social transitions

    Every year in years 6 to 10

  • +1 more secondary outcomes

Study Arms (2)

Suubi+Adherence

EXPERIMENTAL

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

Bolstered Standard of Care

ACTIVE COMPARATOR

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

Interventions

Suubi+AdherenceBEHAVIORAL

* 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

Suubi+Adherence
Bolstered Standard of CareBEHAVIORAL

-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

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • HIV-positive adolescents confirmed by medical report
  • Prescribed antiretroviral therapy
  • Enrolled in care at one of 40 medical clinics within study region
  • years of age at the time of enrollment
  • Living within a family (not necessarily with biological parent(s))

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

International Center for Child Health and Asset Development

Masaka, Uganda

Location

Related Publications (11)

  • 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.

    PMID: 40518494DERIVED

  • 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.

    PMID: 39998619DERIVED

  • 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.

    PMID: 39928068DERIVED

  • 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.

    PMID: 38231361DERIVED

  • 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.

    PMID: 36810778DERIVED

  • 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.

    PMID: 36052462DERIVED

  • 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.

    PMID: 34176245DERIVED

  • 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.

    PMID: 33478469DERIVED

  • 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.

    PMID: 32183762DERIVED

  • 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.

    PMID: 32040523DERIVED

  • 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.

    PMID: 31872152DERIVED

Study Officials

  • Fred M Ssewamala, MSW, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

September 7, 2013

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations

US(1)UG(1)