MI-based PrEP Intervention

NCT ID: NCT03313765

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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PrEP Uptake

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Group Type EXPERIMENTAL

Motivational interviewing (MI)

Intervention Type BEHAVIORAL

Brief MI intervention

Standard-of-care

Group Type ACTIVE_COMPARATOR

Standard-of-care

Intervention Type OTHER

Standard-of-care education and counseling

Interventions

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Motivational interviewing (MI)

Brief MI intervention

Intervention Type BEHAVIORAL

Standard-of-care

Standard-of-care education and counseling

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip A Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University/The Miriam Hospital

Locations

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The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R34DA042648

Identifier Type: NIH

Identifier Source: org_study_id

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