Suubi+Adherence4Youth
1 other identifier
interventional
576
1 country
1
Brief Summary
The study will test four economic empowerment intervention components to identify the combination that best enhance viral suppression. The study design is a 2-to-the 4 factorial experiment. The 2 represents the level of each component:0 (receive) or (don't receive) four components: 1) Financial Literacy Training (FLT); 2) Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs); 3) A manualized intervention for ART adherence and stigma reduction (Suubi Cartoon); and 4) Engagement with HIV treatment-experienced role models who share their lived experiences of HIV. Guided by the MOST framework, the study will test each of the four components' performance and their combinations on the primary outcome, viral suppression. Resulting in 16 unique conditions representing all possible combinations of the 4 components. The study will randomize at the level of health clinics (N=48). Clinics will be randomized to provide one of the 16 conditions, with 12 ALHIV (aged 11-17 years) enrolled per clinic, yielding main effects and interaction effects for the 4 components on sustained viral suppression. Sustained viral suppression is defined as an undetectable viral load on all 12-, 24- and 36-month follow-up assessments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Jun 2023
Longer than P75 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
January 13, 2026
January 1, 2026
4.1 years
October 5, 2022
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Achievement of Viral Suppression
Change in viral suppression will be assessed using viral load (VL) data collected from health clinic records. VL will be dichotomized between undetectable /suppression (VL\< 40 copies/ml) and detectable/failed viral suppression (VL \> =40 copies/ml) levels at each assessment time.
Baseline 12, 24 and 36 month follow-up
Cost-Effectiveness Analyses
Cost-effectiveness analyses measuring the cost of achieving an agreed upon benefit, such as cost of staff time, supplies, overhead of IDA's, as measured by admin review and project records.
Baseline 12, 24 and 36 month follow-up
Secondary Outcomes (6)
Financial Literacy
Baseline 12, 24 and 36 month follow-up
Financial management skills
Baseline 12, 24 and 36 month follow-up
Engagement with financial institutions
Baseline 12, 24 and 36 month follow-up
Change in confidence to save
Baseline 12, 24 and 36 month follow-up
Change in motivation to save
Baseline 12, 24 and 36 month follow-up
- +1 more secondary outcomes
Other Outcomes (11)
Change in ART knowledge and ART adherence
Baseline 12, 24 and 36 month follow-up
Reductions in internalized stigma
Baseline 12, 24 and 36 month follow-up
Sexual negotiation and communication skills
Baseline 12, 24 and 36 month follow-up
- +8 more other outcomes
Study Arms (16)
Condition 1: Components 1, 2,3 and 4
EXPERIMENTALParticipants will be assigned to receive all of the four intervention programs: 1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) 4. Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 2: Components 1, 2 and 3
EXPERIMENTAL1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 3. A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
Condition 3: Components 1, 2 and 4
EXPERIMENTAL1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 4: Components 1 and 2
EXPERIMENTAL1. Financial Literacy Training (FLT) Workshops 2. Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
Condition 5: Components 1,3 and 4
EXPERIMENTAL1.Financial Literacy Training (FLT) Workshops 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 6: Components 1 and 3
EXPERIMENTAL1.Financial Literacy Training (FLT) Workshops 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
Condition 7: Components 1 and 4
EXPERIMENTAL1.Financial Literacy Training (FLT) Workshops 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 8: Components 1
EXPERIMENTAL1.Financial Literacy Training (FLT) Workshops
Condition 9: Components 2,3 and 4
EXPERIMENTAL2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 10: Components 2 and 3
EXPERIMENTAL2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
Condition 11: Components 2 and 4
EXPERIMENTAL2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 12: Components 2
EXPERIMENTAL2.Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)
Condition 13: Components 3 and 4
EXPERIMENTAL3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon) 4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 14: Components 3
EXPERIMENTAL3.A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon)
Condition 15: Components 4
EXPERIMENTAL4.Engagement with HIV treatment-experienced role models who share lived experiences of HIV.
Condition 16: No Components
EXPERIMENTALParticipants not assigned to any of the 4 components
Interventions
SOC consisting of pediatric ART initiation and monitoring outlined by Uganda's Ministry of Health.
Participants will be assigned to receive FLT workshops which are implemented by community-level agencies in collaboration with the financial institutions. FLT comprises six workshops delivered over 6 weeks. Topics include: a) an introduction to the notion of asset-building; b) coverage of asset-building strategies in detail, e.g., saving; c) coverage of specific topics related to saving, e.g., the importance of saving and how to save, d) an introduction of banking services to participants and e) coverage of basics of borrowing and debt management. Participants from the same location, in this case, clinics are assigned to the same group. Workshops occur on weekends to accommodate participants week-day schedules, including school and/or gardening.
Participants assigned to this component will participate together with her/his caregiving family, in attending sixteen 60 minute sessions hosted within the community over 16 weeks. Each session involves 6-10 families. Participants will learn from the Suubi Cartoon curriculum about their HIV diagnosis and treatment needs, while coping with family loss, stigma, peer relationships, identity, and family functioning.
ALHIV will receive a YSA with a 1:1 matched savings program at a financial institution accredited by the Bank of Uganda. Each YDA will be opened in the name of the adolescent, with their primary caregiver as a co-signer, until the adolescent turns 18 years. The account will then be matched with money from the program on 1:1 rate. As part of YSA, ALHIV are also trained on investing in income-generating activities (IGA) and are normally allowed to use up to 30% of their matched savings to invest in an IGA to benefit their family. The IGA portion helps promote economic stability for families and enable the ALHIV to afford medical expenses.
Participants will be assigned to small groups with an average of 3-4 peers from the same health clinic, and each ALHIV stays in the same group -- for 9 sessions - with the same role model. This is intended to build trust and rapport not only between the role model and mentee, but also between all group members. The 9 sessions, to be conducted over a 6-month period, include activities, videos, scenarios, and role-playing to facilitate discussion and learning. This is intended to promote their self-esteem, improve their HIV care engagement, reduce stigma and stress, encourage hopefulness, build stronger communication skills with their caregivers and/or family members, enhance safe sexual decision-making, and decrease sexual risk-taking behavior.
Eligibility Criteria
You may qualify if:
- Adolescent:
- living with HIV (confirmed by medical report and aware of status)
- living within a family
- being 11-17 years of age (at enrollment)
- prescribed ART
- enrolled in ART care at one of the 48 health clinics in the study districts.
- Health clinics would be eligible if they:
- have existing procedures tailored to adolescent adherence (including adolescent-specific clinic days and peer counselling)
- Accredited by the Uganda Ministry of Health as a provider of ART within the study districts.
You may not qualify if:
- Includes an inability to understand study procedures and participant rights as assessed during informed consent/assent process with the adolescent or parent.
- If the adolescent or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
International Center for Child Health and Development
Masaka, Uganda
Related Publications (1)
Ssewamala FM, Sauceda JA, Brathwaite R, Neilands TB, Nabunya P, Brown D, Sensoy Bahar O, Namuwonge F, Nakasujja N, Mugarura A, Mwebembezi A, Nartey P, Mukasa B, Gwadz M. Suubi + Adherence4Youth: a study protocol to optimize the Suubi Intervention for Adherence to HIV treatment for youth living with HIV in Uganda. BMC Public Health. 2023 Apr 20;23(1):717. doi: 10.1186/s12889-023-15564-4.
PMID: 37081534DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be blinded to the experimental condition that the participant was assigned to.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 5, 2022
First Posted
October 31, 2022
Study Start
June 26, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of Sponsored Projects' data sharing agreement.