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

164 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates the feasibility (reach, adoption, safety and implementation) and initial efficacy (higher linkage to care) of the Partner Services Pre-exposure Prophylaxis (PS-PrEP) intervention versus phone based Pre-exposure Prophylaxis (PrEP) treatment at 3 months post randomization among a sample of high risk individuals 18 - 35 years from clinic-based recruitment and internal referrals from social network based projects. The evaluation of the intervention will be used to strengthen routine department of public health services linkage to PrEP care.

Eligibility Criteria

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

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

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

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

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)

Treatment Details

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.

Participant Groups

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+