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Clinical Trials/NCT05434390
NCT05434390
Completed
Not Applicable

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

University of California, Los Angeles2 sites in 1 country105 target enrollmentOctober 3, 2022

Overview

Phase
Not Applicable
Intervention
Estoy PrEParado/ I am PrEPared intervention
Conditions
HIV
Sponsor
University of California, Los Angeles
Enrollment
105
Locations
2
Primary Endpoint
PrEP initiation
Status
Completed
Last Updated
12 days ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 3, 2022
End Date
August 31, 2024
Last Updated
12 days ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ronald Andrew Brooks

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

Arms & Interventions

Latino MSM PrEP intervention

The Latino MSM PrEP intervention consists of 4 small group sessions with concurrent peer navigation and counseling.

Intervention: Estoy PrEParado/ I am PrEPared intervention

Control condition

The control condition consists of usual care at the study site (i.e., referrals to PrEP services).

Intervention: Usual Care

Outcomes

Primary Outcomes

PrEP initiation

Time Frame: assessed at 3-month follow-up

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).

PrEP adherence urine sample

Time Frame: assessed at 3-month follow-up

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.

PrEP adherence single measure

Time Frame: assessed at 3-month follow-up

We will assess adherence to the PrEP medication using a single-item self-rating adherence measure.

PrEP initiation

Time Frame: assessed at 1-month follow-up

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).

PrEP adherence single measure

Time Frame: assessed at 1-month follow-up

We will assess adherence to the PrEP medication using a single-item self-rating adherence measure.

PrEP adherence urine sample

Time Frame: assessed at 1-month follow-up

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.

Secondary Outcomes

  • Changes in Readiness to Adopt PrEP(assessed at 3-month follow-up)
  • Changes in Readiness to Adopt PrEP(assessed at 1-month follow-up)

Study Sites (2)

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