ClinicalTrials.gg
RecruitingNCT05804461Updated Jul 15, 2026

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

An interventional study of Motivational Interviewing in HIV Prevention, sponsored by University of Puerto Rico. Recruiting at 1 site in Puerto Rico. Open to male participants aged 21 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by University of Puerto Rico · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
21 Years to 99 Years
Sex
Male
01

Study summary

To develop, assess and compare the effectiveness of a Motivational Interviewing Intervention for increasing Pre-Exposure Prophylaxis (PrEP) uptake among Latino eligible men in Puerto Rico.

02

Conditions studied

  • HIV Prevention
03

In context

Lead sponsor

University of Puerto Rico is the lead sponsor of 46 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

Latino MSM group - Inclusion Criteria:

  • Biological male
  • Age 21 or older
  • Self-reported 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
182 participants (estimated)

Study arms

  • 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

  • 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

  • No intervention
    Control

    No intervention. Pre-post evaluations will be administered.

Interventions

  • BehavioralMotivational 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.

06

What researchers measure

Primary outcomes

  1. Primary

    PrEP uptake

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for May 2027, 44 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2023
First posted
Apr 7, 2023
StartActual
Sep 1, 2023
Primary completionEst.
May 31, 2027
CompletionEst.
May 31, 2027
Last update
Jul 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05804461
Lead sponsor
University of Puerto Rico
Responsible party
Sponsor
First posted
Apr 7, 2023
Start date
Sep 1, 2023
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Jul 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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