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Behavioral Intervention for PrEP Adherence in HIV Prevention (P4W Trial)

N/A

Recruiting

Led By Katie Biello, PhD

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Report having engaged in condomless anal sex with another man in the past 3 months

Identifies as male at enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month post stage 2 randomization

Awards & highlights

P4W Trial Summary

This trial tests if a behavior intervention can help male sex workers take and stick with PrEP, a medication to prevent HIV. #PreventionIsCare

Who is the study for?

This trial is for male sex workers over 18 who have had unprotected anal sex with men in the past 3 months, are HIV negative or unsure, not on PrEP, and can communicate in English or Spanish. They must also have exchanged sex for value within the same timeframe. Those with severe mental/physical conditions, on PrEP from a pilot study, or with health issues like chronic Hepatitis B cannot join.Check my eligibility

What is being tested?

'PrEPare for Work' is an RCT aiming to see if a behavioral intervention helps improve uptake, adherence to, and persistence of PrEP among male sex workers. Participants will first receive Strength Based Case Management followed by the 'PrEPare for Work' intervention.See study design

What are the potential side effects?

While specific side effects aren't listed here as it's focused on behavior interventions rather than medical treatments directly; generally speaking, PrEP medications can cause stomach discomfort, headaches and weight loss.

P4W Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had unprotected anal sex with a man in the last 3 months.

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I identify as male.

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I can understand and speak English or Spanish.

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I am not currently taking medication to prevent HIV.

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I am 18 years old or older.

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I was assigned male at birth.

P4W Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month post stage 2 randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month post stage 2 randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month post stage 2 randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Stage one: PrEP initiation

Stage two: PrEP adherence

Secondary outcome measures

PrEP persistence

P4W Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Stage 2 PrEPare for Work Intervention ConditionExperimental Treatment1 Intervention

Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.

Group II: Stage 1 Strength Based Case Management (SBCM) ConditionExperimental Treatment1 Intervention

Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.

Group III: Stage 1 Standard of Care (SOC) Control ConditionActive Control1 Intervention

SOC participants will receive an informational pamphlet about the PrEP as a form of HIV prevention and referrals to local PrEP Prescribers.

Group IV: Stage 2 SOC Control ConditionActive Control1 Intervention

Research staff will show a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission. Participants will continue to see their PrEP prescriber for routine clinical care.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor

456 Previous Clinical Trials

557,854 Total Patients Enrolled

2 Trials studying Prevention

217 Patients Enrolled for Prevention

The Miriam HospitalOTHER

238 Previous Clinical Trials

36,975 Total Patients Enrolled

1 Trials studying Prevention

111 Patients Enrolled for Prevention

University of California, Los AngelesOTHER

1,530 Previous Clinical Trials

10,264,208 Total Patients Enrolled

2 Trials studying Prevention

126 Patients Enrolled for Prevention

Media Library

Stage 1 Strength Based Case Management (SBCM) Condition Clinical Trial Eligibility Overview. Trial Name: NCT05736614 — N/A

Prevention Research Study Groups: Stage 1 Standard of Care (SOC) Control Condition, Stage 1 Strength Based Case Management (SBCM) Condition, Stage 2 SOC Control Condition, Stage 2 PrEPare for Work Intervention Condition

Prevention Clinical Trial 2023: Stage 1 Strength Based Case Management (SBCM) Condition Highlights & Side Effects. Trial Name: NCT05736614 — N/A

Stage 1 Strength Based Case Management (SBCM) Condition 2023 Treatment Timeline for Medical Study. Trial Name: NCT05736614 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots available for this clinical trial?

"The information on clinicaltrials.gov shows that this trial is currently recruiting participants. It first appeared on November 21st 2022 and was last updated February 8th 2023."

Answered by AI

What is the limitation of participants for this research initiative?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently searching for participants; it was initially posted on November 21st 2022 and most recently edited on February 8th 2023. The study hopes to recruit 500 patients across 5 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

2022. "Optimizing PrEP Uptake and Adherence Among Male Sex Workers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05736614.