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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Prevention

Intervention / Treatment
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* Behavioral: Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Face-to-face intervention<br>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<br>* 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.<br>|
| Experimental: Online intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>No intervention. Pre-post evaluations will be administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary | PrEP uptake | 150 days |