HIV/AIDSNCT06347146
Bridges2Scale: Testing Implementation Strategies
A study testing Financial Literacy Training (FLT) workshops, Mentorship and Income Generation Activity (IGA) in people with HIV/AIDS, run by Washington University School of Medicine at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Financial Literacy Training (FLT) workshops, Mentorship and Income Generation Activity (IGA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 1 siteUganda
- Study dates
- 4 Jun 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescent inclusion criteria:
- 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
- Caregiver inclusion criteria:
- self-identified and confirmed by the adolescent and youth as primary caregiver of the adolescent and youth
Show all 11Show fewer
- capable of providing informed consent
- Youth-serving NGOs inclusion criteria:
- registered with the government of Uganda
- willing to work with the study team
- have a history of implementing micro-finance economic empowerment interventions.
Who cannot join
- 1. anyone with a significant cognitive impairment that interferes with their understanding of the informed consent process, or is unable/unwilling to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bridges2Scale: Testing Implementation Strategies for an Economic Empowerment Intervention Among Young People Orphaned by AIDS
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.
Read the detailed description
Economic empowerment (EE) interventions have demonstrated substantial promise in reducing HIV-related risk-taking behaviors, and improving ART treatment adherence and mental health outcomes. Our group has demonstrated the effectiveness of a multi-component EE intervention, Bridges, in four NIH-funded randomized control trials (RCT) in Uganda. Bridges involves: 1) financial literacy training (FLT) and mentorship; 2) family income-generating activities (IGA); and 3) incentivized savings via a matched Youth Development Account (YDA) for education, family small business investment, and/or health-related expenses. Bridges has demonstrated robust effects on HIV-related risk-taking behaviors, antiretroviral therapy (ART) adherence, mental health, psychosocial outcomes, educational achievement, family economics, and family cohesion. Yet, scaling EE interventions has been a challenge, signaling the need to identify and test implementation strategies and examine determinants of implementation and sustainment. In Bridges2Scale, 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 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. The investigators will assess HIV prevalence (primary outcome measured via participants' HIV status). In exploratory analyses, the investigators will assess economic stability, school attendance and attainment, sexual risk-taking behavior, mental health functioning, viral suppression (for AYLHIV), and pre-exposure prophylaxis (PrEP) use (for HIV-negative adolescents). Participants from each of the 48 schools will be randomly assigned to one of the two study conditions (n=720 participants; n=24 schools per study condition) such that all selected children from a particular school will receive the same intervention to reduce contamination. After the baseline assessment, data will be collected at 4 follow-up time points (12 months, 24 months, 36 months, and 48 months). The investigators will compare the implementation effectiveness (mean levels of fidelity) of the standard implementation strategy to the enhanced strategy and compare whether adolescents in the enhanced implementation strategy will have a lower odds of HIV prevalence at the final measurement point (48 months). The investigators will also compare the superiority of the enhanced implementation strategy to the standard implementation strategy group in lowering sexual risk-taking behavior, improving economic stability, education related outcomes (school attendance and attainment), and mental health functioning (for all adolescents), viral suppression (for AYLHIV), and PrEP use (for HIV negative adolescents).
Aim 3: Explore implementation processes, mechanisms, and determinants. Using mixed methods, the investigators will apply standardized measures and semi-structured interviews with implementing teams to explore any modifications to the two implementation strategies, perceptions of the implementation strategies (acceptability, appropriateness, feasibility), the mechanisms through which they may operate, and determinants (barriers and facilitators) of implementation that will inform future efforts to scale Bridges and other EE interventions.
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
- Being tested
- Financial Literacy Training (FLT) workshops, Mentorship, Income Generation Activity (IGA), Youth Development Accounts (YDA)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Literacy Training (FLT) workshopsBehavioural
Also called FLT workshops
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.
MentorshipBehavioural
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.
Income Generation Activity (IGA)Behavioural
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.
Youth Development Accounts (YDA)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Financial Literacy Training (FLT) workshops; Behavioral: Mentorship; Behavioral: Income Generation Activity (IGA); Behavioral: Youth Development Accounts (YDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Secondary outcomes (9)
Sexual risk-taking behavior
Sexual risk-taking behavior will be measured using the Risk Behavior Survey. scores range from 0-20, with higher total scores indicating higher risk to engage in sexual risk behaviors.
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Economic stability
Economic stability will be assessed via Bank statements
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
School attainment
School attainment will be assessed using the Adapted Monitoring the Future scale and the Primary Leaving Examinations (PLE) Results
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Depressive Symptoms
Depressive symptoms was assessed using the Adapted Child Depression Inventory. The total score range between 0 and 28 with a high score indicating higher levels of depressive symptoms.
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Proportion of adolescents living with HIV who are virally suppressed
Viral suppression will be assessed using biological assay
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Proportion of HIV negative adolescents who use PrEP
PrEP use will be assessed using biological assay
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Hopelessness
Hopelessness was assessed using the Beck Hopelessness Scale The total score range between 0 and 20 with a high score indicating higher levels of Hopelessness.
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Self-Esteem
Self-esteem was assessed using the Rosenberg Self-Esteems Scale. Scale scores range from 0 to 30 with higher scores indicative of higher self-esteem.
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Self-concept
Self-concept was assessed using the Tennessee Self-Concept Scale. Scale scores range from 20 to 100 with higher scores indicative of higher self-concept.
Measured: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start4 Jun 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Fred Ssewamala, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347146
- Sponsor's protocol ID
- R01HD112323
- Other IDs
- R01HD112323
- Status last verified
- May 2026
- First submitted
- 17 Mar 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridges2Scale: Testing Implementation Strategies for an Economic Empowerment Intervention Among Young People Orphaned by AIDS
- ClinicalTrials.gov ID
- NCT06347146
- Acronym / sponsor ID
- R01HD112323
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Economic empowerment (EE) interventions have demonstrated substantial promise in reducing HIV-related risk-taking behaviors, and improving ART treatment adherence and mental health outcomes. Our group has demonstrated the effectiveness of a multi-component EE intervention, Bridges, in four NIH-funded randomized control trials (RCT) in Uganda. Bridges involves: 1) financial literacy training (FLT) and mentorship; 2) family income-generating activities (IGA); and 3) incentivized savings via a matched Youth Development Account (YDA) for education, family small business investment, and/or health-related expenses. Bridges has demonstrated robust effects on HIV-related risk-taking behaviors, antiretroviral therapy (ART) adherence, mental health, psychosocial outcomes, educational achievement, family economics, and family cohesion. Yet, scaling EE interventions has been a challenge, signaling the need to identify and test implementation strategies and examine determinants of implementation and sustainment. In Bridges2Scale, 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 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. The investigators will assess HIV prevalence (primary outcome measured via participants' HIV status). In exploratory analyses, the investigators will assess economic stability, school attendance and attainment, sexual risk-taking behavior, mental health functioning, viral suppression (for AYLHIV), and pre-exposure prophylaxis (PrEP) use (for HIV-negative adolescents). Participants from each of the 48 schools will be randomly assigned to one of the two study conditions (n=720 participants; n=24 schools per study condition) such that all selected children from a particular school will receive the same intervention to reduce contamination. After the baseline assessment, data will be collected at 4 follow-up time points (12 months, 24 months, 36 months, and 48 months). The investigators will compare the implementation effectiveness (mean levels of fidelity) of the standard implementation strategy to the enhanced strategy and compare whether adolescents in the enhanced implementation strategy will have a lower odds of HIV prevalence at the final measurement point (48 months). The investigators will also compare the superiority of the enhanced implementation strategy to the standard implementation strategy group in lowering sexual risk-taking behavior, improving economic stability, education related outcomes (school attendance and attainment), and mental health functioning (for all adolescents), viral suppression (for AYLHIV), and PrEP use (for HIV negative adolescents).
Aim 3: Explore implementation processes, mechanisms, and determinants. Using mixed methods, the investigators will apply standardized measures and semi-structured interviews with implementing teams to explore any modifications to the two implementation strategies, perceptions of the implementation strategies (acceptability, appropriateness, feasibility), the mechanisms through which they may operate, and determinants (barriers and facilitators) of implementation that will inform future efforts to scale Bridges and other EE interventions.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard implementation strategy condition | Experimental | Behavioral: Financial Literacy Training (FLT) workshops, Behavioral: Mentorship, Behavioral: Income Generation Activity (IGA), Behavioral: Youth Development Accounts (YDA)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. |
| Enhanced Implementation strategy condition | Experimental | Behavioral: Financial Literacy Training (FLT) workshops, Behavioral: Mentorship, Behavioral: Income Generation Activity (IGA), Behavioral: Youth Development Accounts (YDA)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). |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- 1. anyone with a significant cognitive impairment that interferes with their understanding of the informed consent process, or is unable/unwilling to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial Literacy Training (FLT) workshopsAlso: FLT workshopsAdolescents 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. | Behavioural | Enhanced Implementation strategy condition, Standard implementation strategy condition |
| MentorshipEach 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. | Behavioural | Enhanced Implementation strategy condition, Standard implementation strategy condition |
| Income Generation Activity (IGA)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. | Behavioural | Enhanced Implementation strategy condition, Standard implementation strategy condition |
| Youth Development Accounts (YDA)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). | Behavioural | Enhanced Implementation strategy condition, Standard implementation strategy condition |
Primary outcome
Intervention Fidelity
Time frame: Throughout intervention delivery (2 years (Baseline, 12 months, 24 months))
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.
HIV prevalence
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Prevalence of adolescents positive for HIV among the sample determined from biomarker data
9 secondary outcomes
Sexual risk-taking behavior
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Economic stability
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
School attainment
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Depressive Symptoms
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Proportion of adolescents living with HIV who are virally suppressed
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Proportion of HIV negative adolescents who use PrEP
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Hopelessness
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Self-Esteem
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Self-concept
Time frame: 4 years (Baseline, 12 months, 24 months, 36 months, 48 months post-baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Literacy Training (FLT) workshops, Mentorship and Income Generation Activity (IGA) in people with HIV/AIDS, run by Washington University School of Medicine at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Fidelity (time frame: Throughout intervention delivery (2 years (Baseline, 12 months, 24 months))). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.