HIV PreventionNCT07002866
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
A study testing HIV Risk Reduction (HIVRR), PrEP Peer Supporters (PS) and Matched Savings Accounts + Financial Literacy (FL) in people with HIV Prevention, run by Washington University School of Medicine at 2 sites in 2 countries.
Trial summary
The study will employ a multilevel combination intervention focused on PrEP initiation and adherence among adolescent girls and young women (AGYW) (aged 15-24) living in HIV hotpots in Uganda. Read more about this study
- Who is it for?
- Ages 15 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- HIV Risk Reduction (HIVRR), PrEP Peer Supporters (PS) and Matched Savings Accounts + Financial Literacy (FL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Oct 2025to 31 Dec 2029
- 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 15 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 15-24 years
- At a high risk of HIV. AGYW will be deemed to be at substantial risk, and eligible to participate in the study, if they report at least one of the seven high-risk sexual behaviors on the risk assessment tool: 1) vaginal/anal sexual intercourse with more than one partner of unknown HIV status in the past six months, 2) vaginal/anal sex without a condom in the past six months, 3) sex in exchange for money, goods or a service in the last six months, 4) injecting drugs in the past six months, 5) diagnosis with an STI more than once in the past twelve months, 6) post-exposure prophylaxis (PEP) for sexual exposure to HIV in the past six months, and 7) having an HIV-infected sexual partner who was not on ART.
Who cannot join
- HIV positive
- Unable to understand the study procedures and/or participant rights during the informed consent process
- Unwilling or unable to commit to completing the study
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site
- Active, not recruiting
Washington University in St. Louis
St Louis, Missouri, 63130
Uganda1 site, 1 recruiting
- Recruiting
International Center for Child Health and Development (ICHAD)
Masaka
Juliet Babirye, MD, +256700-785-574, jbabirye7@yahoo.com
About this study
The study will employ a multilevel combination intervention focused on PrEP initiation and adherence among adolescent girls and young women (AGYW) (aged 15-24) living in HIV hotpots in Uganda. Specifically, the study will combine: 1) HIV risk reduction (HIVRR) that incorporates sessions on PrEP, 2) Peer Supporters (PS) with lived experiences taking PrEP to facilitate linkage to and continued care, share strategies to address misconceptions, manage disclosure and stigma, and model positive lifestyles while engaging in care services, and 3) an economic empowerment (EE) component that includes a matched savings account and financial literacy targeting poverty and financial barriers associated with PrEP access. Working within 30 health care systems, we will randomly assign 600 AGYW (at the community level) to one of three study arms (n=200 AGYW, n=10 sites per arm): 1) HIVRR only, 2) HIVRR+ PS, or 3) HIVRR + PS + EE. The interventions will be implemented for 20 months, and data collected at baseline, 12, 24, 36 months.
Read the detailed description
Adolescent girls and young women (AGYW) aged 15-24 are twice as likely to be living with HIV than young men in Sub-Saharan Africa (SSA). HIV prevention strategies available to AGYW primarily depend on male partner cooperation, limiting the ability for these strategies to reduce HIV spread. Oral pre-exposure prophylaxis (PrEP) is a highly effective biomedical HIV prevention method. However, as effective as PrEP has been, it is underutilized. Lack of social support, disclosure concerns, stigma and discrimination, financial costs associated with transport to clinics and food to accompany medication are still major barriers. Peer support interventions and PrEP awareness via peers has been associated with increased PrEP uptake. However, these approaches may not be as effective when delivered alone -given that poverty-associated factors, too, greatly undermine PrEP access, uptake and adherence. Thus, combining multilevel interventions, in this case, combining peer support with economic empowerment (EE) targeting poverty and financial constraints, may offer additive effects to overcome these barriers. We propose a multilevel combination intervention focused on PrEP initiation and adherence among AGYW living in HIV hotpots in Uganda. Suubi(hope)4PrEP will combine: 1) HIVRR that incorporates sessions on PrEP, 2) peer supporters (PS) with lived experiences taking PrEP to facilitate linkage to and continued care, and 3) EE components targeting financial barriers associated with PrEP access. We will randomly assign 600 AGYW (at the community level) to one of the three study arms (n=200 AGYW, n=10 sites per arm): 1) HIVRR only, 2) HIVRR+ PS, or 3) HIVRR + PS + EE. Specific aims are:
Aim 1. Examine the impact of Suubi4PrEP on PrEP initiation and adherence.
Aim 2. Examine the effect of Suubi4PrEP on hypothesized mechanisms of change and intervention mediation.
Aim 3. Use mixed methods to explore multi-level factors that influence PrEP initiation and adherence.
Aim 4. Assess the cost and cost-effectiveness of the interventions.
- Conditions
- HIV Prevention
- Being tested
- HIV Risk Reduction (HIVRR), PrEP Peer Supporters (PS), Matched Savings Accounts + Financial Literacy (FL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Risk Reduction (HIVRR)Behavioural
This is an intervention comprised of 5 sessions of an evidence-based, HIV/STI risk reduction with PrEP to strengthen HIV prevention knowledge and behavioral skills intervention. Session content cover harm reduction, social support networks, HIV knowledge, transmission risks and testing procedures for HIV/STIs, build enthusiasm for condom use, alternatives to unsafe sex, importance of safer sex negotiations, strategies to negotiate safer sex, setting appropriate risk reduction goals, introduction to PrEP, PrEP screening and eligibility; monitoring and managing PrEP side effects and stigma, recognizing and understanding consequences of abusive behavior by any sexual partners or others; build safety plan skills; review and identify ways to increase social support; build skill in communication with health care professionals.
PrEP Peer Supporters (PS)Behavioural
PrEP peer supporter are women currently on PrEP willing to share their lived experiences. Women will meet with peer supporters in a group at least 8 times during the intervention period (every 2-3 months). Sessions with peers will involve unstructured, in-depth discussions that integrate peers' own lived experiences and emerging PrEP-related issues as raised by participants. These may include, how to mitigate PrEP stigma and disclosure, creating PrEP adherence strategies, navigating family and intimate relationship issues, and navigating provider attitudes. At each stage of the facility visit (waiting space, consultation, and pharmacy), peer supporters will explain facility protocols, and strategies women can use to overcome facility-level barriers to care.
Matched Savings Accounts + Financial Literacy (FL)Behavioural
A matched savings account (MSA) is a savings account held at a local bank whereby deposits made by the participants are matched by the intervention to encourage savings and investment in skills and asset development. The accounts introduce participants to financial management skills, introduce them to formal financial institutions, and by matching their deposits, incentivize women to save small amounts. Each participant will receive an account held in her own name, and will be allowed to save an equivalent of US$10 a month or US$200 for the 20-months intervention period. During the intervention period, participants will have direct access to both their personal savings deposited in the accounts and the match provided by the study. In addition, participants will also receive six 1-2-hour financial literacy (FL) workshop sessions that cover components on saving, and financial management.
| Study group | Role | What they receive |
|---|---|---|
| Control arm: Bolstered Treatment | Experimental | Participants in this arm will receive 5 sessions of HIV risk reduction (HIVRR) that incorporates sessions on PrEP, aimed at strengthening HIV prevention, knowledge and skills. Sessions will be delivered by trained community healthcare workers. Receives: Behavioral: HIV Risk Reduction (HIVRR) |
| Treatment arm I: HIVRR+PS | Experimental | Participants randomized to this arm will receive 5 sessions of HIVRR (described about) and will engage with PrEP peer supporters (PS). Peers will be women currently on PrEP willing to share their lived experiences. Women will meet with peer supporters at least 8 times during the intervention period. Meetings will last approximately 1-hour and will explore the cost-benefits of service utilization and to problem solve how to overcome individual barriers to PrEP access, utilization and adherence. Receives: Behavioral: HIV Risk Reduction (HIVRR); Behavioral: PrEP Peer Supporters (PS) |
| Treatment arm II: HIVRR+PS+EE | Experimental | The economic empowerment (EE) intervention will be in the form of a matched savings account (MSA) plus financial literacy (FL) sessions. Participants enrolled in the combination intervention arm will receive 5 sessions of HIVRR and PrEP peer supporters (as described above) and a MSA. Specifically, our partnering banks will open up matched savings accounts for the participants in their name. Participants will save money in their matched savings accounts over a 20-month period. The study team will monitor the accounts using the statements received directly from the banks holding the accounts. Participants will receive monthly bank statements indicating their own savings and the associated match (1:1 match rate). They will also receive eight financial literacy (FL) sessions. Receives: Behavioral: HIV Risk Reduction (HIVRR); Behavioral: PrEP Peer Supporters (PS); Behavioral: Matched Savings Accounts + Financial Literacy (FL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Initiation
Proportion of eligible participants who initiate PrEP
Measured: Baseline, 12, 24 and 36 months
Secondary outcomes (1)
PrEP Adherence
PrEP adherence will be assessed using biological data (Tenofovir drug levels in urine). High urine tenofovir levels indicate good adherence to PrEP medication, while low or undetectable urine tenofovir levels indicate non-adherence to PrEP.
Measured: Baseline, 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start20 Oct 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Columbia University
- Responsible party
- Principal investigator, Fred Ssewamala, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002866
- Sponsor's protocol ID
- R01MH139471
- Status last verified
- Nov 2025
- First submitted
- 17 May 2025
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PIs and indicates the data will be used for the purposes of research (per CFR Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Brown School of Social Work Office of Sponsored Projects' data sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
- ClinicalTrials.gov ID
- NCT07002866
- Acronym / sponsor ID
- R01MH139471
- Conditions
- HIV Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Makerere University, Columbia University
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Jun 2025 (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 study will employ a multilevel combination intervention focused on PrEP initiation and adherence among adolescent girls and young women (AGYW) (aged 15-24) living in HIV hotpots in Uganda. Specifically, the study will combine: 1) HIV risk reduction (HIVRR) that incorporates sessions on PrEP, 2) Peer Supporters (PS) with lived experiences taking PrEP to facilitate linkage to and continued care, share strategies to address misconceptions, manage disclosure and stigma, and model positive lifestyles while engaging in care services, and 3) an economic empowerment (EE) component that includes a matched savings account and financial literacy targeting poverty and financial barriers associated with PrEP access. Working within 30 health care systems, we will randomly assign 600 AGYW (at the community level) to one of three study arms (n=200 AGYW, n=10 sites per arm): 1) HIVRR only, 2) HIVRR+ PS, or 3) HIVRR + PS + EE. The interventions will be implemented for 20 months, and data collected at baseline, 12, 24, 36 months.
Detailed description
Adolescent girls and young women (AGYW) aged 15-24 are twice as likely to be living with HIV than young men in Sub-Saharan Africa (SSA). HIV prevention strategies available to AGYW primarily depend on male partner cooperation, limiting the ability for these strategies to reduce HIV spread. Oral pre-exposure prophylaxis (PrEP) is a highly effective biomedical HIV prevention method. However, as effective as PrEP has been, it is underutilized. Lack of social support, disclosure concerns, stigma and discrimination, financial costs associated with transport to clinics and food to accompany medication are still major barriers. Peer support interventions and PrEP awareness via peers has been associated with increased PrEP uptake. However, these approaches may not be as effective when delivered alone -given that poverty-associated factors, too, greatly undermine PrEP access, uptake and adherence. Thus, combining multilevel interventions, in this case, combining peer support with economic empowerment (EE) targeting poverty and financial constraints, may offer additive effects to overcome these barriers. We propose a multilevel combination intervention focused on PrEP initiation and adherence among AGYW living in HIV hotpots in Uganda. Suubi(hope)4PrEP will combine: 1) HIVRR that incorporates sessions on PrEP, 2) peer supporters (PS) with lived experiences taking PrEP to facilitate linkage to and continued care, and 3) EE components targeting financial barriers associated with PrEP access. We will randomly assign 600 AGYW (at the community level) to one of the three study arms (n=200 AGYW, n=10 sites per arm): 1) HIVRR only, 2) HIVRR+ PS, or 3) HIVRR + PS + EE. Specific aims are:
Aim 1. Examine the impact of Suubi4PrEP on PrEP initiation and adherence.
Aim 2. Examine the effect of Suubi4PrEP on hypothesized mechanisms of change and intervention mediation.
Aim 3. Use mixed methods to explore multi-level factors that influence PrEP initiation and adherence.
Aim 4. Assess the cost and cost-effectiveness of the interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control arm: Bolstered Treatment | Experimental | Behavioral: HIV Risk Reduction (HIVRR)Participants in this arm will receive 5 sessions of HIV risk reduction (HIVRR) that incorporates sessions on PrEP, aimed at strengthening HIV prevention, knowledge and skills. Sessions will be delivered by trained community healthcare workers. |
| Treatment arm I: HIVRR+PS | Experimental | Behavioral: HIV Risk Reduction (HIVRR), Behavioral: PrEP Peer Supporters (PS)Participants randomized to this arm will receive 5 sessions of HIVRR (described about) and will engage with PrEP peer supporters (PS). Peers will be women currently on PrEP willing to share their lived experiences. Women will meet with peer supporters at least 8 times during the intervention period. Meetings will last approximately 1-hour and will explore the cost-benefits of service utilization and to problem solve how to overcome individual barriers to PrEP access, utilization and adherence. |
| Treatment arm II: HIVRR+PS+EE | Experimental | Behavioral: HIV Risk Reduction (HIVRR), Behavioral: PrEP Peer Supporters (PS), Behavioral: Matched Savings Accounts + Financial Literacy (FL)The economic empowerment (EE) intervention will be in the form of a matched savings account (MSA) plus financial literacy (FL) sessions. Participants enrolled in the combination intervention arm will receive 5 sessions of HIVRR and PrEP peer supporters (as described above) and a MSA. Specifically, our partnering banks will open up matched savings accounts for the participants in their name. Participants will save money in their matched savings accounts over a 20-month period. The study team will monitor the accounts using the statements received directly from the banks holding the accounts. Participants will receive monthly bank statements indicating their own savings and the associated match (1:1 match rate). They will also receive eight financial literacy (FL) sessions. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 15-24 years
- At a high risk of HIV. AGYW will be deemed to be at substantial risk, and eligible to participate in the study, if they report at least one of the seven high-risk sexual behaviors on the risk assessment tool: 1) vaginal/anal sexual intercourse with more than one partner of unknown HIV status in the past six months, 2) vaginal/anal sex without a condom in the past six months, 3) sex in exchange for money, goods or a service in the last six months, 4) injecting drugs in the past six months, 5) diagnosis with an STI more than once in the past twelve months, 6) post-exposure prophylaxis (PEP) for sexual exposure to HIV in the past six months, and 7) having an HIV-infected sexual partner who was not on ART.
Key exclusion criteria (3 listed)
- HIV positive
- Unable to understand the study procedures and/or participant rights during the informed consent process
- Unwilling or unable to commit to completing the study
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 |
|---|---|---|
| HIV Risk Reduction (HIVRR)This is an intervention comprised of 5 sessions of an evidence-based, HIV/STI risk reduction with PrEP to strengthen HIV prevention knowledge and behavioral skills intervention. Session content cover harm reduction, social support networks, HIV knowledge, transmission risks and testing procedures for HIV/STIs, build enthusiasm for condom use, alternatives to unsafe sex, importance of safer sex negotiations, strategies to negotiate safer sex, setting appropriate risk reduction goals, introduction to PrEP, PrEP screening and eligibility; monitoring and managing PrEP side effects and stigma, recognizing and understanding consequences of abusive behavior by any sexual partners or others; build safety plan skills; review and identify ways to increase social support; build skill in communication with health care professionals. | Behavioural | Control arm: Bolstered Treatment, Treatment arm I: HIVRR+PS, Treatment arm II: HIVRR+PS+EE |
| PrEP Peer Supporters (PS)PrEP peer supporter are women currently on PrEP willing to share their lived experiences. Women will meet with peer supporters in a group at least 8 times during the intervention period (every 2-3 months). Sessions with peers will involve unstructured, in-depth discussions that integrate peers' own lived experiences and emerging PrEP-related issues as raised by participants. These may include, how to mitigate PrEP stigma and disclosure, creating PrEP adherence strategies, navigating family and intimate relationship issues, and navigating provider attitudes. At each stage of the facility visit (waiting space, consultation, and pharmacy), peer supporters will explain facility protocols, and strategies women can use to overcome facility-level barriers to care. | Behavioural | Treatment arm I: HIVRR+PS, Treatment arm II: HIVRR+PS+EE |
| Matched Savings Accounts + Financial Literacy (FL)A matched savings account (MSA) is a savings account held at a local bank whereby deposits made by the participants are matched by the intervention to encourage savings and investment in skills and asset development. The accounts introduce participants to financial management skills, introduce them to formal financial institutions, and by matching their deposits, incentivize women to save small amounts. Each participant will receive an account held in her own name, and will be allowed to save an equivalent of US$10 a month or US$200 for the 20-months intervention period. During the intervention period, participants will have direct access to both their personal savings deposited in the accounts and the match provided by the study. In addition, participants will also receive six 1-2-hour financial literacy (FL) workshop sessions that cover components on saving, and financial management. | Behavioural | Treatment arm II: HIVRR+PS+EE |
Primary outcome
PrEP Initiation
Time frame: Baseline, 12, 24 and 36 months
Proportion of eligible participants who initiate PrEP
1 secondary outcome
PrEP Adherence
Time frame: Baseline, 12, 24, 36 months
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 5 Nov 2025.
- Individual participant dataSharing planned: Yes. Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PIs and indicates the data will be used for the purposes of research (per CFR Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Brown School of Social Work Office of Sponsored Projects' data sharing agreements.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Risk Reduction (HIVRR), PrEP Peer Supporters (PS) and Matched Savings Accounts + Financial Literacy (FL) in people with HIV Prevention, run by Washington University School of Medicine at 2 sites in 2 countries.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Contact Fred M Ssewamala, PhD (3149358521, fms1@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Initiation (time frame: Baseline, 12, 24 and 36 months). 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 5 Nov 2025.