MI-based PrEP Intervention

A Brief Motivational Interviewing-based Intervention to Improve HIV Pre-exposure Prophylaxis Uptake Among Men Who Have Sex With Men

Gay, bisexual and other men who have sex with men (MSM) are the group at highest risk of HIV infection in the United States. Pre-exposure prophylaxis (PrEP) has demonstrated high efficacy in preventing HIV infection among MSM. However, uptake in clinical settings has been slow for several reasons, including low awareness and education, low perceived HIV risk, concern for side-effects, and stigma associated with taking the medication. The purpose of the proposed study is to develop and evaluate a brief motivational interviewing (MI) intervention to promote PrEP uptake among MSM during the course of routine HIV screening at a public sexually transmitted disease (STD) clinic.

Study Overview

• Status: Completed
• Conditions: PrEP Uptake
• Intervention / Treatment: Behavioral: Motivational interviewing (MI); Other: Standard-of-care

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. 18 years of age or older
2. Assigned male at birth and currently identify as male
3. Score at least 10 on the HIV Incident Risk Index for MSM
4. HIV-negative based on results of antibody test
5. English- or Spanish-speaking
6. Have access to a working phone
7. Have not taken PrEP

Exclusion Criteria:

1. Have previously taken PrEP
2. Symptoms of acute HIV infection at baseline
3. HIV positive
4. A clinical contraindication to PrEP (e.g., renal dysfunction)
5. Non-English or non-Spanish speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Motivational interviewing (MI); Brief MI intervention
Active Comparator: Standard-of-care	Other: Standard-of-care; Standard-of-care education and counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PrEP uptake	Three months

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Investigators: Principal Investigator: Philip A Chan, MD, Brown University/The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: R34DA042648 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No