Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico

October 2, 2023 updated by: University of Puerto Rico

Optimizing PrEP Uptake Among Latino MSM in Puerto Rico: A Comparative Effectiveness Study

To develop, assess and compare the effectiveness of a Motivational Interviewing Intervention for increasing Pre-Exposure Prophylaxis (PrEP) uptake among Latino Men Who Have Sex With Men (MSM) in Puerto Rico.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • Recruiting
        • University of Puerto Rico Medical Sciences Campus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Latino MSM group - Inclusion Criteria:

  • Biological male
  • Age 21 or older
  • Self-reported HIV negative or unknown status
  • Not using PrEP (participants who have discontinued PrEP use can participate in the study), Spanish fluency (ability to write and read in Spanish)
  • Presenting at least one of the eligibility criteria for PrEP as established by the CDC (including men who have had an infection (STI) in the past 6 months, HIV positive sexual partner)
  • Access to a portable technology device (e.g., phone, tablet, laptop) or desktop computer access to internet connection

Exclusion Criteria:

  • HIV positive individual
  • Evidence of being under the effects of alcohol or drugs
  • Indication of unstable or serious psychiatric symptoms
  • Evidence of major cognitive impairment
  • Inability to speak and read in Spanish

Healthcare Providers group - Inclusion Criteria:

  • Age 21 or older
  • Providing PrEP related health services at time of enrollment (e.g., case management, clinical services)
  • Spanish fluency (ability to write and read in Spanish)

Exclusion Criteria:

  • Evidence of being under the effects of alcohol or drugs
  • Indication of unstable or serious psychiatric symptoms
  • Evidence of major cognitive impairment
  • Inability to speak and read in Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention. Pre-post evaluations will be administered.
Experimental: Face-to-face intervention
A three-session face-to-face intervention using Motivational Interviewing with a facilitator; to increase Pre-Exposure Prophylaxis (PrEP) uptake. Pre-post-post evaluations after each session will be administered. Participation will last 150 days from the start to the last follow-up.
Behavioral: Motivational Interviewing
Upon refinement from Formative Research (Aim 1), a three-session, individual-level intervention to increase Pre-Exposure Prophylaxis (PrEP) uptake among men who have sex with men (MSM) in Puerto Rico will be implemented. The facilitator will use Motivational Interviewing techniques to guide the sessions. The intervention's design and content will be the same for each study group; the only difference will be the modality of implementation; one group of participants will receive a face-to-face intervention, while another group will receive an online intervention.A total of 170 participants will be randomized in a 1:1 ratio into each of the two intervention modalities (n=85 face-to-face and n=85 online) while a control group will be recruited following a 3:1 ratio of intervention vs. control. In addition to baseline assessment, participants will be asked to complete a post test at the end of the third session (60 days) and a follow-up post-test at the 150-day mark, separately.
Experimental: Online intervention
A three-session online intervention using Motivational Interviewing with a facilitator; to increase Pre-Exposure Prophylaxis (PrEP) uptake. Pre-post-post evaluations after each session will be administered. Participation will last 150 days from the start to the last follow-up.
Behavioral: Motivational Interviewing
Upon refinement from Formative Research (Aim 1), a three-session, individual-level intervention to increase Pre-Exposure Prophylaxis (PrEP) uptake among men who have sex with men (MSM) in Puerto Rico will be implemented. The facilitator will use Motivational Interviewing techniques to guide the sessions. The intervention's design and content will be the same for each study group; the only difference will be the modality of implementation; one group of participants will receive a face-to-face intervention, while another group will receive an online intervention.A total of 170 participants will be randomized in a 1:1 ratio into each of the two intervention modalities (n=85 face-to-face and n=85 online) while a control group will be recruited following a 3:1 ratio of intervention vs. control. In addition to baseline assessment, participants will be asked to complete a post test at the end of the third session (60 days) and a follow-up post-test at the 150-day mark, separately.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary
Time Frame: 150 days
PrEP uptake
150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2290030276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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