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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05804461
Enrollment
182
Registered
2023-04-07
Start date
2023-09-01
Completion date
2027-05-31
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention

Brief 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.

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.

Sponsors

University of Puerto Rico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Primary90 daysPrEP uptake

Countries

Puerto Rico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026