PS-PrEP for Preventing HIV Transmission

(PS-PrEP Trial)

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: PrEP

Disqualifiers: Unable to consent, Moving, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to prevent HIV transmission using a preventive treatment known as PrEP (pre-exposure prophylaxis). Researchers aim to determine if a new support method called PS-PrEP is more effective than phone-based support in linking people to care. Participants will join one of two groups to compare these approaches. The trial seeks African American/Black men who have sex with men, are HIV-negative, have never taken PrEP, and live in the Chicago area. As an unphased trial, it offers participants the chance to contribute to innovative strategies in HIV prevention.

Do I need to stop my current medications for this trial?

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

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

Research has shown that pre-exposure prophylaxis (PrEP) is a well-tolerated method for preventing HIV. Studies have found PrEP to be effective and safe for many individuals. For instance, one study confirmed that PrEP is generally safe for HIV prevention. Side effects may occur but are usually mild, such as nausea or headaches, and often resolve over time.

For the PS-PrEP intervention, separate safety data is not available, but since it is based on PrEP, it likely shares the same safety profile. Overall, PrEP has significantly reduced the risk of HIV when used correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PS-PrEP because it represents a new approach to preventing HIV transmission. Unlike standard pre-exposure prophylaxis (PrEP) options that primarily involve daily oral pills, PS-PrEP is exploring innovative ways to enhance PrEP effectiveness and adherence. This could be a game-changer, as it may offer a more reliable and user-friendly prevention strategy. By potentially improving how PrEP is used, PS-PrEP could significantly reduce new HIV infections and make a lasting impact on public health.

What evidence suggests that this trial's treatments could be effective for preventing HIV transmission?

Research has shown that pre-exposure prophylaxis (PrEP) effectively prevents HIV. Studies have found that PrEP can reduce the risk of contracting HIV from sex by up to 99% when taken correctly. It also lowers the risk by over 74% for individuals who use injection drugs. In this trial, participants in the PS-PrEP Intervention Group will receive support to facilitate access to and consistent use of PrEP, which is crucial for its effectiveness. By raising awareness and connecting more people to PrEP care, this program aims to maximize its protective benefits. Meanwhile, the PrEPLine Control Group will receive standard PrEP care. Overall, PrEP is a powerful tool in reducing HIV transmission when used as recommended. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking, African American/Black identified MSM aged 18-35 who live in the Chicago area more than half the year. Participants must own a personal cell phone, be HIV negative with completed counseling, and eligible for PrEP treatments according to guidelines but haven't taken PrEP in the last year.

Inclusion Criteria

HIV seronegative and completed post-test counseling

Lives in the Chicago metropolitan area for more than 6 months annually

I am willing to participate in follow-up sessions via text or phone.

Exclusion Criteria

Plan to move out of the area

I am unable to give my consent.

I have been on PrEP in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline Assessment

Participants complete baseline assessments including surveys on demographics, substance use, mental health, and stigma

1 day

1 visit (in-person)

Randomization and Initial Intervention

Participants are randomized into intervention or control groups and begin initial intervention sessions

1 day

1 visit (in-person)

Intervention Follow-up

Intervention group receives follow-up sessions to promote PrEP linkage and retention

12 weeks

Multiple visits (in-person and virtual)

3 Month Assessment

Both intervention and control groups complete a survey to track changes over time

1 day

1 visit (in-person)

6 Month Follow-up

Intervention group receives a mini-booster session to assess and address barriers to PrEP adherence

1 day

1 visit (in-person or virtual)

12 Month Assessment

Final survey for both groups to evaluate long-term outcomes and linkage to care

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PrEPLine Control Group
• PS-PrEP Intervention Group

Trial Overview

The study compares two methods of linking high-risk individuals to Pre-exposure Prophylaxis (PrEP) care: a new PS-PrEP intervention group versus a control group using phone-based support (PrEPLine). The goal is to see which method is better at connecting people to care within three months after starting.

How Is the Trial Designed?

Group I: PS-PrEP Intervention Group Experimental Treatment 1 Intervention

Group II: CDPH Prevention Projects Active Control 1 Intervention

Group III: PrEPLine Control Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8126498/

Population-Level Effectiveness of HIV Pre-exposure ...

Conclusions: Self-reported PrEP use was associated with a 79% reduction in HIV incidence among men who have sex with men and transgender persons who have sex ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S277306542500121X

HIV Pre-Exposure Prophylaxis Care Continuum in ...

The 34 studies were comprised of 71,162 individuals eligible for PrEP. Among them, 66% had increased HIV risk awareness, 55% had enhanced PrEP ...

3.

cdc.gov

cdc.gov/mmwr/volumes/73/wr/mm7347a3.htm

Progress Toward UNAIDS Global HIV Pre-Exposure ...

Oral pre-exposure prophylaxis (PrEP) reduces HIV acquisition from sex by 99% and from injection drug use by ≥74% when taken as recommended (1).

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8103968/

Embedding a Linkage to Pre-Exposure Prophylaxis (PrEP ...

Pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) is over 90% effective in preventing HIV transmission, and, in 2012, ...

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2838761

Excess HIV Infections and Costs Associated With ...

Pre-exposure prophylaxis (PrEP) is a proven effective intervention to reduce the risk for HIV infection. Critically, changes in policies ...

6.

cdc.gov

cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm

Clinical Recommendation for the Use of Injectable ...

The two trials reported LEN efficacy at reducing HIV infection as 100% among females and 96% among a primarily male trial population, compared ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3269441/

Preexposure Prophylaxis for HIV Prevention - PMC

This article provides a review of the data on the potential strengths and limitations of PrEP as an HIV prevention strategy.

8.

researchprotocols.org

researchprotocols.org/2022/3/e33045

Technology-Based Interventions to Promote the HIV ...

The efficacy and safety of preexposure prophylaxis (PrEP) for HIV prevention has been demonstrated through clinical trials among a range of ...