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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05804461
Other study ID # 2290030276
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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