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Behavioral Intervention

ACT-Based PrEP Intervention for HIV Prevention

N/A
Recruiting
Led By Trisha Arnold, PhD
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male sex assigned at birth
Not taken PrEP in past 3 months
Must not have
Unable to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 week visit
Awards & highlights
No Placebo-Only Group

Summary

This trial will adapt and test a brief Acceptance and Commitment Therapy (ACT)-based culturally appropriate pre-exposure prophylaxis (PrEP) intervention for young Black men who have sex with men (YBMSM).

Who is the study for?
This trial is for young Black men, aged 18-34, who have sex with men and are interested in HIV prevention. They must not have taken PrEP in the past 3 months, be English-speaking, assigned male at birth, and meet CDC guidelines for PrEP use. Those already in another PrEP study or unable to consent are excluded.
What is being tested?
The trial is testing a new Acceptance and Commitment Therapy (ACT)-based intervention called ACTPrEP against an enhanced standard of care. It's designed specifically for young Black MSM to increase engagement with Pre-exposure Prophylaxis (PrEP) as an HIV preventive measure.
What are the potential side effects?
Since this trial focuses on behavioral intervention rather than medication, traditional side effects like those seen with drugs aren't expected. Participants may experience emotional discomfort discussing personal topics during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was assigned male at birth.
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I have not taken PrEP in the last 3 months.
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I am between 18 and 34 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give my consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 week visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 week visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ACTPrEP Acceptability
ACTPrEP Feasibility

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ACTPrEPExperimental Treatment1 Intervention
ACTPrEP will include a 60-minute initial session and 30-minute sessions at 2, 6, and 12 weeks.
Group II: Control GroupActive Control1 Intervention
Control group will include one 30-minute PrEP education session.

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
265 Previous Clinical Trials
68,762 Total Patients Enrolled
University of Mississippi Medical CenterOTHER
182 Previous Clinical Trials
197,038 Total Patients Enrolled
Trisha Arnold, PhDPrincipal InvestigatorRhode Island Hospital

Media Library

ACTPrEP (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05087680 — N/A
HIV Prevention Research Study Groups: Control Group, ACTPrEP
HIV Prevention Clinical Trial 2023: ACTPrEP Highlights & Side Effects. Trial Name: NCT05087680 — N/A
ACTPrEP (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05087680 — N/A
~28 spots leftby Dec 2025
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