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HIVNCT01790373

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

A study testing Suubi+Adherence in people with HIV, run by Washington University School of Medicine at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 10 to 16 yearsHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Suubi+Adherence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
702 participants
Where
2 sitesin 2 countries
Study dates
7 Sep 2013to 31 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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))

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • Washington University in St. Louis

    St Louis, Missouri, 63130

Other trials in United States

Uganda1 site
  • International Center for Child Health and Asset Development

    Masaka

Other trials in Uganda

About this study

Official title: Suubi+Adherence: Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence

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.

Conditions
HIV
Being tested
Suubi+Adherence, Bolstered Standard of Care
Keywords
Suubi, Adolescents, Poverty, Economic empowerment interventions, Adherence to HIV antiretroviral therapy, Wisepill, HIV/AIDS infected Children, Medical event monitoring system, Uganda

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suubi+AdherenceBehavioural

    • 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 CareBehavioural

    -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

Study groups in NCT01790373
Study groupRoleWhat they receive
Suubi+AdherenceExperimentalSuubi+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
Receives: Behavioral: Suubi+Adherence
Bolstered Standard of CareActive comparatorBolstered 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
Receives: Behavioral: Bolstered Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Every year for 10 years

Secondary outcomes (6)
  1. Protective Health Behaviors

    Using a series of standardized and pre-tested instruments, potential mechanisms of protective health behaviors, knowledge, and beliefs, including: 1) financial/economic stability, 2) sexual risk-taking behavior, 3) personal beliefs about HIV medication, 4) hopelessness, 5) future plans and aspirations, and 6) adherence self-efficacy, will be measured during a structured interview at baseline and at every subsequent follow-up assessment.

    Measured: Every year for 10 years

  2. Cost-Effectiveness Analyses

    Cost-effectiveness analyses measure the cost of achieving an agreed upon benefit, such as an additional year of schooling, employment, or a reduction in a disease. Costs will be measured on a per person basis. The costs of the intervention will include all program costs. Research costs will not be included.

    Measured: Every year for 10 years

  3. Cognitive functioning

    Using a series of standardized and pre-tested instruments, cognitive functioning will be measured during a structured interview at wave 6 and at every subsequent follow-up assessment.

    Measured: Every year in years 6 to 10

  4. Substance misuse

    Using a series of standardized and pre-tested instruments, substance misuse will be measured during a structured interview at wave 6 and at every subsequent follow-up assessment.

    Measured: Every year in years 6 to 10

  5. Social transitions

    Using a series of standardized and pre-tested instruments, social transitions will be measured during a structured interview at wave 6 and at every subsequent follow-up assessment.

    Measured: Every year in years 6 to 10

  6. HIV stigma

    Using a series of standardized and pre-tested instruments, HIV stigma will be measured during a structured interview at wave 6 and at every subsequent follow-up assessment.

    Measured: Every year in years 6 to 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2013 (estimated)
  2. Study start7 Sep 2013
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
702 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01790373
Sponsor's protocol ID
AAAK3852
Other IDs
1R01HD074949-01
Status last verified
Jan 2026
First submitted
11 Feb 2013
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40518494
  • 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.

    PubMed 39998619
  • 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.

    PubMed 39928068
  • 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.

    PubMed 38231361
  • 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.

    PubMed 36810778
  • 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.

    PubMed 36052462
  • 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.

    PubMed 34176245
  • 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.

    PubMed 33478469
  • 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.

    PubMed 32183762
  • 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.

    PubMed 32040523
  • 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.

    PubMed 31872152

Questions about this trial

What is this clinical trial studying?

A study testing Suubi+Adherence in people with HIV, run by Washington University School of Medicine at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to follow-up assessments of adherence to HIV treatment (time frame: Every year for 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01790373, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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