MI-based PrEP Intervention

PrEP Uptake Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313765
• Other study ID #: R34DA042648
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2019
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PrEP Uptake

Intervention

Behavioral:
• Motivational interviewing (MI)
Brief MI intervention

Other:
• Standard-of-care
Standard-of-care education and counseling

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP uptake		Three months