A Latino MSM Focused Pre-Exposure Prophylaxis Uptake Intervention

Study Overview
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Brief Summary
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The clinical study will evaluate the feasibility and acceptability of a culturally tailored behavioral intervention to improve uptake of pre-exposure prophylaxis for HIV prevention among at-risk Latino men who have sex with men.

Detailed Description
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The clinical study will evaluate the feasibility and acceptability of a brief small group and peer navigation behavioral intervention to improve uptake of pre-exposure prophylaxis (PrEP) for HIV prevention among at-risk Latino men who have sex with men. The brief intervention consists of 4 small group sessions with concurrent peer navigation and counseling. Study participants will be randomized to either an intervention or control condition. Participants in the control condition will receive usual care for PrEP promotion (i.e., referral to PrEP services). The study will determine the feasibility and acceptability of the intervention among Latino men who have sex with men and assess the preliminary impact of the intervention compared to control condition in facilitating PrEP uptake.

Official Title
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Evaluating the Feasibility and Acceptability of a Latino MSM Focused PrEP Uptake Intervention

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Estoy PrEParado/ I am PrEPared intervention
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older assigned male at birth Identifies as Latino/Hispanic origin HIV-negative or HIV status unknown Man who has had sex with other men in the past 24 months Not currently using PrEP for HIV prevention Exclusion Criteria: Male under 18 years of age Not identifying as being of Latino/Hispanic origin Man who has not had sex with other men in the past 24 months Identifies as cisgender or transgender Female/woman Assigned female at birth

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Parallel model. Participants will be randomly assigned to either an intervention or control arm of the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Latino MSM PrEP intervention<br>The Latino MSM PrEP intervention consists of 4 small group sessions with concurrent peer navigation and counseling. | Behavioral: Estoy PrEParado/ I am PrEPared intervention<br>* Participants will receive an Information, Motivation, and Behavioral skills model PrEP intervention tailored for mixed immigrant status Latino men who have sex with men<br>|
| Active Comparator: Control condition<br>The control condition consists of usual care at the study site (i.e., referrals to PrEP services). | Behavioral: Usual Care<br>* Participants will be offered PrEP navigation services as part of usual care at the study site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP initiation | We will assess PrEP uptake using evidence of a prescription for Truvada® or Descovy® (participant shows us their prescription bottle in person or via a text photo). | assessed at 1-month follow-up | 
| PrEP initiation | We will assess PrEP uptake using evidence of a prescription for Truvada® or Descovy® (participant shows us their prescription bottle in person or via a text photo). | assessed at 3-month follow-up | 
| PrEP adherence single measure | We will assess adherence to the PrEP medication using a single-item self-rating adherence measure. | assessed at 1-month follow-up | 
| PrEP adherence single measure | We will assess adherence to the PrEP medication using a single-item self-rating adherence measure. | assessed at 3-month follow-up | 
| PrEP adherence urine sample | We will assess adherence to the PrEP medication by analyzing participants' urine sample to determine the presence of the medication tenofovir, a key medication in the PrEP medication. | assessed at 1-month follow-up | 
| PrEP adherence urine sample | We will assess adherence to the PrEP medication by analyzing participants' urine sample to determine the presence of the medication tenofovir, a key medication in the PrEP medication. | assessed at 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Readiness to Adopt PrEP | We will assess changes in readiness to adopt PrEP using the PrEP Transtheoretical Stages of Change Model measure (pre-contemplation, contemplation, preparation, action & initiation, and maintenance). | assessed at 1-month follow-up | 
| Changes in Readiness to Adopt PrEP | We will assess changes in readiness to adopt PrEP using the PrEP Transtheoretical Stages of Change Model measure (pre-contemplation, contemplation, preparation, action & initiation, and maintenance). | assessed at 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, Pre-exposure prophylaxis, Latino men who have sex with men