NCT05804461

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Sep 2023May 2026

First Submitted

Initial submission to the registry

March 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

March 27, 2023

Last Update Submit

May 29, 2025

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (1)

  • Primary

    PrEP uptake

    150 days

Study Arms (3)

Face-to-face intervention

EXPERIMENTAL

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

Online intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

No intervention. Pre-post evaluations will be administered.

Interventions

Motivational InterviewingBEHAVIORAL

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.

Face-to-face interventionOnline intervention

Eligibility Criteria

Age21 Years - 99 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Puerto Rico Medical Sciences Campus

San Juan, 00936, Puerto Rico

RECRUITING

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 7, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Locations

PR(1)