PrEP Access and Adherence Interventions for HIV Prevention

Recruiting at 1 trial location

Overseen By Fred M Ssewamala, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: PrEP

Disqualifiers: HIV positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist young women and girls in Uganda who face a high risk of contracting HIV. It tests various methods to encourage the initiation and adherence to PrEP, a daily pill that helps prevent HIV. Participants will be divided into groups: some will receive guidance on reducing HIV risk, others will also have peer supporters who share their own PrEP experiences, and some will additionally receive financial support and education to overcome financial barriers. This study suits young women who have engaged in high-risk sexual behaviors, such as having multiple partners or not using condoms, in the past six months. As an unphased trial, it offers a unique opportunity to contribute to innovative strategies for HIV prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that PrEP (pre-exposure prophylaxis) is safe and effective in preventing HIV, especially with regular use. Studies have found that consistent use of PrEP can lower the risk of contracting HIV by up to 99%. Most people tolerate it well, with only a few side effects reported.

The study's focus on economic empowerment, which includes savings accounts and financial education, presents no safety concerns. This component involves learning and financial support, so it carries no medical risks.

Peer support for PrEP users has also proven helpful and safe. It provides encouragement and advice from experienced users, making adherence to the treatment easier.

Overall, these combined efforts aim to support adherence to PrEP, making it a safe choice for HIV prevention. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for HIV prevention because they offer a multi-faceted approach that goes beyond traditional methods like medications. The economic empowerment component, which includes matched savings accounts and financial literacy sessions, tackles financial barriers to healthcare access, empowering participants to prioritize their health. The use of PrEP peer supporters introduces a community-based strategy, leveraging the experiences of women already on PrEP to enhance adherence and overcome personal obstacles. These interventions create a supportive network and address financial challenges, making them uniquely comprehensive compared to standard prevention techniques.

What evidence suggests that this trial's treatments could be effective for HIV prevention among adolescent girls and young women in Uganda?

Research has shown that PrEP (pre-exposure prophylaxis) effectively lowers the risk of contracting HIV. When taken regularly, it can be up to 93% effective. In this trial, participants in different arms will receive various interventions to support PrEP adherence. One arm includes support from peers—individuals with experience taking PrEP—to help others remember to take their medication consistently. Another arm provides financial assistance, such as savings programs and money management education, to reduce financial obstacles. Together, these strategies can improve adherence to PrEP, which is crucial for its success. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adolescent girls and young women aged 15-24 living in HIV hotspots in Uganda. They should be interested in starting or adhering to PrEP (a medication regimen that helps prevent HIV). The study excludes individuals who do not meet the age requirement, live outside the specified areas, or cannot commit to the duration of the study.

Inclusion Criteria

I am between 15 and 24 years old.

I am at high risk for HIV based on my recent sexual or drug use behaviors.

Exclusion Criteria

HIV positive

Unable to understand the study procedures and/or participant rights during the informed consent process

I am willing and able to complete the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive HIV risk reduction sessions, peer support, and economic empowerment interventions

20 months

Monthly visits for financial literacy sessions and peer support meetings

Follow-up

Participants are monitored for PrEP initiation and adherence

16 months

Data collection at baseline, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• HIV Risk Reduction (HIVRR)
• Matched Savings Accounts + Financial Literacy (FL)
• PrEP Peer Supporters (PS)

Trial Overview The Suubi4PrEP study tests a multilevel intervention combining HIV risk reduction education, support from peers experienced with PrEP, and an economic empowerment component including savings accounts and financial literacy. Participants are randomly placed into three groups: one receiving only education, another adding peer support, and a third adding both peer support and economic empowerment.

How Is the Trial Designed?

Group I: Treatment arm II: HIVRR+PS+EE Experimental Treatment 3 Interventions

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.

Group II: Treatment arm I: HIVRR+PS Experimental Treatment 2 Interventions

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.

Group III: Control arm: Bolstered Treatment Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Makerere University

Collaborator

Trials

297

Recruited

1,862,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4925182/

PrEP adherence patterns strongly impact individual HIV ... Results. Expected PrEP efficacy was 60% with periodic, 50% with random and 34% with block adherence when PrEP had a long protection profile and pills ...

2. academic.oup.com academic.oup.com/ofid/article/11/10/ofae569/7804282

Trajectories of Adherence to Oral Pre-exposure Prophylaxis ... A meta-analysis of RCTs also showed a strong association between PrEP adherence and PrEP efficacy, reporting 86% HIV risk reduction with at ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468266722001062

Real-world effectiveness of pre-exposure prophylaxis in ... We found that PrEP use was associated with an overall 60% reduction in the risk of HIV infection, reaching 93% for a high amount of PrEP consumption, and 86% if ...

4. cdc.gov cdc.gov/hivpartners/php/riskandprevention/index.html

HIV Risk and Prevention Estimates | HIV Partners The effectiveness estimate of PrEP, when taken daily or consistently, is presented here. The effectiveness estimates of PrEP as assigned within ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2816036

HIV Preexposure Prophylaxis With Emtricitabine and ... These findings were consistent with modeling data that estimated an HIV risk reduction of 76% for 2 doses per week, 96% for 4 doses per week ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/12/5/e048478

Oral pre-exposure prophylaxis (PrEP) to prevent HIV The estimated absolute RD was −0.03 (95% CI −0.01 to −0.05), indicating PrEP users had a 3% lower rate of HIV acquisition per person-year of follow-up.