Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

MI-based PrEP Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03313765
Recruitment Status : Recruiting
First Posted : October 18, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital

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.

Condition or disease Intervention/treatment Phase
PrEP Uptake Behavioral: Motivational interviewing (MI) Other: Standard-of-care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Brief Motivational Interviewing-based Intervention to Improve HIV Pre-exposure Prophylaxis Uptake Among Men Who Have Sex With Men
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. PrEP uptake [ Time Frame: Three months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Enrollment of men who have sex with men (MSM) only
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313765


Contacts
Layout table for location contacts
Contact: Philip A Chan, MD 401-793-2899 Philip_Chan@brown.edu

Locations
Layout table for location information
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Philip A Chan, MD         
Sponsors and Collaborators
The Miriam Hospital
Investigators
Layout table for investigator information
Principal Investigator: Philip A Chan, MD Brown University/The Miriam Hospital

Layout table for additonal information
Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03313765     History of Changes
Other Study ID Numbers: R34DA042648 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No