Suubi+Adherence4Youth

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.

Conditions

• HIV

Interventions

BEHAVIORAL

Financial Literacy Training (FLT) Workshops

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.

BEHAVIORAL

Incentivized Matched Youth Savings Accounts (YSA) with income-generating activities (IGAs)

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.

BEHAVIORAL

A manualized visual-based intervention for ART adherence and stigma reduction using multiple family group approach (Suubi Cartoon).

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.

BEHAVIORAL

Engagement with HIV treatment-experienced role models who share lived experiences of HIV

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.

OTHER

Standard of Care (SOC)

SOC consisting of pediatric ART initiation and monitoring outlined by Uganda's Ministry of Health.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of California, San Francisco

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

11 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-26

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• Uganda

Study Locations