MI-based PrEP Intervention

NCT03313765 | Completed

• 1 other identifier: R34DA042648
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PrEP Uptake

Outcome Measures

Primary Outcomes (1)

• PrEP uptake

  Three months

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Motivational interviewing (MI)

Standard-of-care

ACTIVE COMPARATOR

Other: Standard-of-care

Interventions

Motivational interviewing (MI) BEHAVIORAL

Brief MI intervention

Intervention

Standard-of-care OTHER

Standard-of-care education and counseling

Standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Enrollment of men who have sex with men (MSM) only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Interventions

Motivational Interviewing; Standard of Care

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Philip A Chan, MD

  Brown University/The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: January 10, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: August 25, 2021

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)