Suubi+Adherence4Youth

NCT ID: NCT05600621

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 576 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2027-07-31

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.

Detailed Description

The number of adolescents living with HIV (ALHIV) in Uganda is over 170,000 and growing. Ugandan ALHIV are a priority due to social and structural inequities that make them highly vulnerable to HIV infection and sub-optimal access and adherence to antiretroviral therapy (ART). Less than 50% of ALHIV in Uganda are ART-adherent leading to low rates of viral suppression and high rates of attrition from HIV care. In response to the call for expanding differentiated care approaches for ALHIV and new forms of combination HIV interventions, we seek to intervene on social and structural inequities as economic and psychosocial hardships exacerbate the risk for viral load non-suppression. Addressing these hardships can improve the livelihoods of ALHIV and give them the knowledge and resources to sustainably manage HIV.

With 15+ years of intervention research combining 1) economic empowerment (EE) and 2) psychosocial components for HIV prevention, care and support for adolescents in SSA, we have demonstrated the effectiveness of Suubi (Hope), our multi-component combination intervention tested in four RCTs in Uganda (R01HD070727, R01HD074949, R34MH081763, R01MH113486) and one foundation-funded study in Kenya. With EE components to address economic hardships and psychosocial components to address ART non-adherence and HIV stigma, we have improved viral suppression and psychosocial and mental health functioning. Suubi is evidence-based and theory-informed and has 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. Suubi has shown robust effects on viral suppression and ART adherence, mental health, psychosocial outcomes, and family financial stability and cohesion. However, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Given our successes and infrastructure, we are well-positioned to unpack and optimize Suubi to identify the most impactful and sustainable components for scale up across Uganda.

The study will use a factorial experiment to unpack, test, and optimize the Suubi intervention to enhance scale up in health systems using the multi-phase optimization strategy (MOST), an engineering-inspired intervention framework. Guided by the MOST framework, the study will test each of the four components' performance and their combinations in a fully powered efficient factorial experiment on the primary outcome, viral suppression. Then a pre-specified optimization objective will be set to create the new "optimized" intervention. We define our "optimization objective" as the most cost-effective components that addresses three real-world constraints (i.e., challenges to implementation): 1) efficiency (do the components work within our existing health systems?), 2) affordability (do observed effect sizes justify costs and labor?), and 3) scalability (do components perform exactly as they would at scale?). The study will evaluate various component combination effect sizes and balance them against real-world constraints and costing data to empirically arrive at optimization. Our goal is to build Suubi 2.0 (hereafter, Suubi+Adherence4Youth), a combination of components for viral suppression that meets standards for being efficient, affordable, and working at scale.

The study will be guided by the following specific aims:

Aim 1. Conduct a factorial experiment (optimization trial) to test the main effects of each of the four Suubi intervention components and combinations of components (interactions) on viral suppression (primary outcome);

Aim 2. Test mediators and explore moderators that explain and modify the relationship between each of the four Suubi intervention components and viral suppression;

Aim 3. Compare the cost and cost-effectiveness of each of the four Suubi intervention components and every combination of components.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Condition 1: Components 1, 2,3 and 4

Participants 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.

Group Type: EXPERIMENTAL

Financial Literacy Training (FLT) Workshops

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 2: Components 1, 2 and 3

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)

Group Type: EXPERIMENTAL

Financial Literacy Training (FLT) Workshops

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 3: Components 1, 2 and 4

1. 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.

Group Type: EXPERIMENTAL

Financial Literacy Training (FLT) Workshops

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 4: Components 1 and 2

1. Financial Literacy Training (FLT) Workshops

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

Group Type: EXPERIMENTAL

Financial Literacy Training (FLT) Workshops

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 5: Components 1,3 and 4

1.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.

Group Type: EXPERIMENTAL

Financial Literacy Training (FLT) Workshops

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 6: Components 1 and 3

1.Financial Literacy Training (FLT) Workshops

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

Group Type: EXPERIMENTAL

Financial Literacy Training (FLT) Workshops

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 7: Components 1 and 4

1.Financial Literacy Training (FLT) Workshops

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

Group Type: EXPERIMENTAL

Financial Literacy Training (FLT) Workshops

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 8: Components 1

1.Financial Literacy Training (FLT) Workshops

Group Type: EXPERIMENTAL

Financial Literacy Training (FLT) Workshops

Intervention Type: BEHAVIORAL

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.

Condition 9: Components 2,3 and 4

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 10: Components 2 and 3

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)

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 11: Components 2 and 4

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 12: Components 2

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Condition 13: Components 3 and 4

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: BEHAVIORAL

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.

Condition 14: Components 3

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Condition 15: Components 4

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Condition 16: No Components

Participants not assigned to any of the 4 components

Group Type: EXPERIMENTAL

Standard of Care (SOC)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Standard of Care (SOC)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Fred Ssewamala

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

International Center for Child Health and Development

Masaka, , Uganda

Countries

Uganda

References

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.

Reference Type: DERIVED

PMID: 37081534 (View on PubMed)

Other Identifiers

R01MH131507

Identifier Type: NIH

Identifier Source: org_study_id

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