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NCT Number: NCT05804461

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

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.

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Key information

Conditions

Age range

21 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Puerto Rico Medical Sciences Campus

San Juan, 00936, Puerto Rico

Location status: Recruiting

Location contact

Souhail M Malave Rivera, PhD

CONTACT

[email protected]

787 758 2525 ext. 4412

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing

Behavioral

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.

Primary outcomes

  1. Primary

    Time frame: 90 days

    PrEP uptake

Sponsors and collaborators

Lead sponsor

University of Puerto Rico

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2023
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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