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Emotion Management Counseling + App for HIV Prevention (PARTI Trial)

N/A
Recruiting
Led By Adam W Carrico, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Reports condomless anal sex (CAS) with men in the past 6 months
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

PARTI Trial Summary

This trial is testing a new way to help people taking PrEP (a medication to prevent HIV) to stick with their medication and stay safe. The new method includes a smartphone app and counseling to help manage emotions. The goal is to see if this new method reduces the risk of HIV infection.

Who is the study for?
This trial is for sexual minority men in California or Florida who use stimulants, are HIV negative, have had condomless anal sex recently, and are on PrEP but may not adhere to it strictly. They must be 18+, speak English, own a smartphone, and identify as male or gender minority. Those assigned female at birth or planning to move soon cannot join.Check my eligibility
What is being tested?
The study tests the PARTI program—a positive affect intervention—combined with Contingency Management (CM) for taking PrEP doses against an attention-control condition with CM. The goal is to see if PARTI+CM better prevents HIV by encouraging consistent use of PrEP.See study design
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medications directly administered during the study, there aren't typical medication side effects; however, participants will continue their usual PrEP regimen which can include side effects like nausea and headaches.

PARTI 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 men in the last 6 months.
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I am 18 years old or older.
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I was assigned male at birth.

PARTI Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Engaging HIV Acquisition Risk
Secondary outcome measures
Positive Affect
PrEP Persistence
Retention in PrEP Care
+1 more

PARTI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PARTI and CM (Contingency Management)Experimental Treatment2 Interventions
The PARTI intervention will be delivered in five individual sessions during a 12-week contingency management protocol for PrEP adherence
Group II: Attention-Control and CM (Contingency Management)Active Control2 Interventions
The attention-control condition will consist of five individual sessions where participants complete self-report measures and neutral writing exercises during a 12-week contingency management protocol for PrEP adherence

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
901 Previous Clinical Trials
409,746 Total Patients Enrolled
Florida International UniversityLead Sponsor
100 Previous Clinical Trials
17,315 Total Patients Enrolled
University of California, San FranciscoOTHER
2,505 Previous Clinical Trials
15,237,315 Total Patients Enrolled

Media Library

Attention-Control Clinical Trial Eligibility Overview. Trial Name: NCT04899024 — N/A
Medication Adherence Research Study Groups: PARTI and CM (Contingency Management), Attention-Control and CM (Contingency Management)
Medication Adherence Clinical Trial 2023: Attention-Control Highlights & Side Effects. Trial Name: NCT04899024 — N/A
Attention-Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT04899024 — N/A

Frequently Asked Questions

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

Is enrollment in this experiment accessible to participants at present?

"As indicated by clinicaltrials.gov, the trial is currently taking in participants since its first posting on January 31st 2022 and latest update on November 18th 2022."

Answered by AI

How many individuals are eligible to partake in this trial?

"Affirmative. The information hosted on clinicaltrials.gov affirms that the trial is actively searching for participants, with 350 required from 2 medical centres. This research project was first posted to the website on January 31st 2022 and recently updated on November 18th of this year."

Answered by AI

Who else is applying?

What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
PrEP Affect Regulation Treatment Innovation
Adam Carrico, PhD 2022. "PrEP Affect Regulation Treatment Innovation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04899024.
~82 spots leftby Jul 2025
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