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

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804461
• Other study ID #: 2290030276
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: October 2023
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention

Intervention

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.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico Medical Sciences Campus	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary	PrEP uptake	150 days