Bridges2Scale: Testing Implementation Strategies

NCT06347146 | Active Not Recruiting

• 1 other identifier: R01HD112323
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two multifaceted strategies (standard vs enhanced) for scaling Bridges in a two-arm Hybrid III effectiveness-implementation cluster randomized controlled trial (RCT) in adolescent and youths affected by AIDS \[AYaAIDS\] (ages 11-17 years) from 48 schools in the Greater Masaka region of Uganda. The main aims of the clinical trial are: Aim 1. Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. The investigators will assess fidelity to Bridges (primary implementation outcome) and sustainment of Bridges (exploratory implementation outcome). Aim 2. Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4. Compare the cost and cost-effectiveness of the two implementation strategies. Using an activity-based ingredients approach, the investigators will examine how much each strategy costs to achieve a unit of effect.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

• Intervention Fidelity

  The proportion of research assistants/facilitators that achieve 85% agreement on at least 3 of the fidelity assessment checklists. Field research assistants will be trained on using fidelity tools to track: (a) content of the intervention (e.g., saving), (b) process (e.g., mentoring skills), (c) activities (e.g., workshops). The team will practice fidelity assessment in pairs until they reach at least 85% agreement on at least 3 fidelity assessment checklists. In the field, independent fidelity observations will be conducted by research staff for 25% of Bridges sessions. Fidelity data will be used to assess the relationship between planned and actual implementation, and will be catalogued using FRAME-IS as a guide.

  Throughout intervention delivery (2 years (Baseline, 12 months, 24 months))

• HIV prevalence

  Prevalence of adolescents positive for HIV among the sample determined from biomarker data

  4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)

Secondary Outcomes (9)

• Sexual risk-taking behavior

  4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)

• Economic stability

  4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)

• School attainment

  4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)

• Depressive Symptoms

  4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)

• Proportion of adolescents living with HIV who are virally suppressed

  4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)

Study Arms (2)

Standard implementation strategy condition

EXPERIMENTAL

The Standard Implementation strategy condition is one that has been applied in our prior randomized controlled trials (RCTs). In applying this strategy, the investigators will meet with both non-governmental organizations (NGO) and school staff to gauge NGOs interest in partnering on study implementation and describe roles and responsibilities.

Behavioral: Financial Literacy Training (FLT) workshops; Behavioral: Mentorship; Behavioral: Income Generation Activity (IGA); Behavioral: Youth Development Accounts (YDA)

Enhanced Implementation strategy condition

EXPERIMENTAL

The Enhanced Implementation strategy condition will be developed using Implementation Mapping, a systematic protocol for developing implementation strategies using theory, evidence, and stakeholder input. This will ensure that known determinants of implementation, scale-up, and sustainment are addressed by strategies designed collaboratively with the community partners from a public-private partnership of government-funded public schools and non-government organizations (NGOs).

Behavioral: Financial Literacy Training (FLT) workshops; Behavioral: Mentorship; Behavioral: Income Generation Activity (IGA); Behavioral: Youth Development Accounts (YDA)

Interventions

Financial Literacy Training (FLT) workshops BEHAVIORAL

Adolescents and youths and their caregivers will receive six 1-2 hour workshop sessions that cover components on saving, and financial management. The sessions will: introduce participants to saving, saving strategies, career planning, and the utilization of financial institutions, including saving in banks.

Also known as: FLT workshops

Enhanced Implementation strategy condition; Standard implementation strategy condition

Mentorship BEHAVIORAL

Each adolescent and youth will have a mentor who will visit with them monthly for the duration of the intervention. The one-to-one mentorship program is intended to help AYaAIDS overcome a variety of challenges they face in daily life by fostering meaningful and lasting relationships with near peer or adult role models. Resilience theory posits that having a supportive adult outside the family reduces the impact of stress on AY's mental health. Mentors will be high school students who will be trained by the schools or NGO staff depending on study condition. All mentors will be reimbursed for their transport expenses to the field, plus an equivalent of a $5 gift card for airtime per visit.

Enhanced Implementation strategy condition; Standard implementation strategy condition

Income Generation Activity (IGA) BEHAVIORAL

Participants will be trained on investing in income-generating activities (IGA) during the FLT workshops and will be allowed to use up to 30% of their matched savings to invest in an IGA intended to benefit the adolescent and youth (AY) and their caregiving families. The IGA portion is intended to promote economic stability.

Enhanced Implementation strategy condition; Standard implementation strategy condition

Youth Development Accounts (YDA) BEHAVIORAL

Each adolescent and youth (AY) will receive a youth development account, which is a matched savings account held in the AY's name in a financial institution under the Central Bank (Bank of Uganda). Any of the AY's family members, relatives, or friends is encouraged to contribute towards the YDA. The account is then matched with money from the program. The match cap (maximum family contribution to be matched by the program) will be an equivalent of US$10 a month per family or US$200 for the 20-months intervention period. AY who save the maximum amount will have $600 ($200 plus $400 in match-a 2:1 match rate).

Enhanced Implementation strategy condition; Standard implementation strategy condition

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ages 11-17
• a student at one of the 48 public primary schools included in the study-schools located in high HIV/AIDS prevalence areas in the greater Masaka region
• living within a family and not an institution/orphanage
• self-identified and confirmed by the adolescent and youth as primary caregiver of the adolescent and youth
• capable of providing informed consent
• registered with the government of Uganda
• willing to work with the study team
• have a history of implementing micro-finance economic empowerment interventions.

You may not qualify if:

• \. anyone with a significant cognitive impairment that interferes with their understanding of the informed consent process, or is unable/unwilling to consent.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

International Center for Child Health and Development

Masaka, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 4, 2024
• Study Start: June 4, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

UG (1)