Optimizing PrEP Among Latino MSM in Puerto Rico

Sponsor

University of Puerto Rico (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05804461

Collaborator

(none)

182

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To develop, assess and compare the effectiveness of a Motivational Interviewing Intervention for increasing PrEP uptake among Latino MSM in Puerto Rico.

Condition or Disease	Intervention/Treatment	Phase
HIV Prevention	Behavioral: Motivational Interviewing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

182 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 31, 2026

Anticipated Study Completion Date :

May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Face-to-face intervention A three-session face-to-face intervention using Motivational Interviewing with a facilitator; to increase 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 Upon refinement from Formative Research (Aim 1), a three-session, individual-level intervention to increase PrEP uptake among 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.
Experimental: Online intervention A three-session online intervention using Motivational Interviewing with a facilitator; to increase 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 Upon refinement from Formative Research (Aim 1), a three-session, individual-level intervention to increase PrEP uptake among 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.
No Intervention: Control No intervention. Pre-post evaluations will be administered.

Arm

Intervention/Treatment

Experimental: Face-to-face intervention

A three-session face-to-face intervention using Motivational Interviewing with a facilitator; to increase 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

Upon refinement from Formative Research (Aim 1), a three-session, individual-level intervention to increase PrEP uptake among 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.

Experimental: Online intervention

A three-session online intervention using Motivational Interviewing with a facilitator; to increase 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

No Intervention: Control

No intervention. Pre-post evaluations will be administered.

Outcome Measures

Primary Outcome Measures

Primary [150 days]
PrEP uptake

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 99 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Latino MSM: 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 two of the eligibility criteria for PrEP as established by the CDC74 (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.

Healthcare Providers: 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: Evidence of being under the effects of alcohol or drugsIndication of unstable or serious psychiatric symptomsEvidence of major cognitive impairmentInability to speak and read in Spanish

Exclusion Criteria:

HIV positive individual Evidence of being under the effects of alcohol or drugsIndication of unstable or serious psychiatric symptomsEvidence of major cognitive impairmentInability to speak and read in Spanish

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Puerto Rico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Puerto Rico

ClinicalTrials.gov Identifier:

NCT05804461

Other Study ID Numbers:

2290030276

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 7, 2023