Suubi+Adherence4Youth

HIV Clinical Trial

Official title:

Suubi+Adherence4Youth: Optimizing the Suubi Intervention for Adherence to HIV Treatment for Youth Living With HIV in Uganda

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05600621
• Other study ID #: R01MH131507
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: June 2024
• Source: Washington University School of Medicine
• Contact: Fred M Ssewamala, PhD
• Phone: 3149358521
• Email: fms1[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 576
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Uganda	International Center for Child Health and Development	Masaka

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH), University of California, San Francisco

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in ART knowledge and ART adherence	Change in adolescent Self reported medication adherence. This will be measured using the Adherence and retention in care questionnaire focusing on the pharmacy refills, pill counts and missed appointments at each assessment time.	Baseline 12, 24 and 36 month follow-up
Other	Reductions in internalized stigma	Reductions in internalized stigma will be measured using the Social Impact Scale on a range of 24 - 96, with higher scores indicating higher levels of internalized stigma.	Baseline 12, 24 and 36 month follow-up
Other	Sexual negotiation and communication skills	Ability to negotiate safe sex practices measured using the Sexual Communication Scale. Responses are summed and scored on a range of 20 - 100, with higher scores representing greater levels of communication.	Baseline 12, 24 and 36 month follow-up
Other	Change in mental health-hopelessness symptoms	Hopelessness will be measured using the Beck Hopelessness Scale. The study will assess the mean scores over time. The total score range is between 0 - 20, with a higher score indicating higher levels of child hopelessness.	Baseline 12, 24 and 36 month follow-up
Other	Change in depressive symptoms	Depression will be measured using the Center for Epidemiological Studies-Depression Scale (CES-D). The total score range is between 0 - 60, with higher scores indicating the presence of more symptomatology.	Baseline 12, 24 and 36 month follow-up
Other	Change in HIV Stigma	Change in HIV stigma will be measured using the Negative Self-image sub-scale of HIV Stigma Scale. The total score range is between 40 - 160 with higher scores indicating higher levels of perceived HIV-associated stigma.	Baseline 12, 24 and 36 month follow-up
Other	Positive HIV Identity	HIV Positive Identity Scale	Baseline 12, 24 and 36 month follow-up
Other	Problem solving of HIV care logistics	Self-reported questionnaires	Baseline 12, 24 and 36 month follow-up
Other	Self-esteem	Self esteem will be measured using Rosenberg Self-Esteem Scale. The study will assess the mean scores over time. The total score range between10 - 40, with a higher score indicating high levels of child self esteem.	Baseline 12, 24 and 36 month follow-up
Other	Social support	Change in social support will be measured by Social Support Behavior Scale.	Baseline 12, 24 and 36 month follow-up
Other	Engagement and retention of HIV care metrics	The degree to which a patient feels engaged/disengaged from HIV care will be measured using the HIV Index of Engagement on a range of 10 - 50, with higher scores indicating better engagement.	Baseline 12, 24 and 36 month follow-up
Primary	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
Primary	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	Financial Literacy	Change in Financial Literacy knowledge will be measured using the Financial Literacy Knowledge item, with higher scores indicating higher financial literacy.	Baseline 12, 24 and 36 month follow-up
Secondary	Financial management skills	Change in financial management skills will be measured using the Attitudes about Saving Scale, with higher scores indicating greater financial management skills.	Baseline 12, 24 and 36 month follow-up
Secondary	Engagement with financial institutions	Change in engagement with financial institutions will be measured using the frequency of deposits and withdrawals by data from bank statements.	Baseline 12, 24 and 36 month follow-up
Secondary	Change in confidence to save	Change in confidence to save will be measured using the Financial Literacy Knowledge item, with higher scores indicating higher confidence to save.	Baseline 12, 24 and 36 month follow-up
Secondary	Change in motivation to save	Motivation to save will be measured using the Financial Literacy Knowledge item, with higher scores indicating higher motivation to save.	Baseline 12, 24 and 36 month follow-up
Secondary	Change in savings amount and Investment in IGA	Change in savings amount and investment measured by data from bank statements	Baseline 12, 24 and 36 month follow-up