Peer Intervention Latino Immigrant MSM

May 16, 2022 updated by: Jane J. Lee, University of Washington

Development of a Peer Intervention to Increase HIV/STI Testing and PrEP Uptake Among Latino Immigrant Men Who Have Sex With Men

This study evaluates a peer intervention with HIV/STI self-testing kits to increase HIV/STI testing and PrEP uptake among Latino immigrant men who have sex with men. Half of participants will receive the "Listos" intervention (peer counseling, PrEP information, and HIV/STI testing kits) and half will receive the active control intervention (peer only group with no HIV/STI testing kits).

Study Overview

Detailed Description

HIV testing is crucial for early detection of HIV infection; yet, Latino immigrants are at high risk for late HIV diagnosis. Increased screening for HIV and STIs is particularly important for Latino immigrant men who have sex with men (MSM), a group disproportionately at risk for HIV that also encounters barriers to health access due to factors associated with immigrant status. Latino MSM recently experienced a significant increase (25%) in new HIV diagnoses (2008-2015), while diagnoses among MSM overall remained stable. Based on these trends, 1 in 4 Latino MSM will be diagnosed with HIV in their lifetimes, highlighting their urgent need for HIV prevention. Notably, pre-exposure prophylaxis (PrEP) can reduce risk of HIV among high-risk groups; yet, only 3% of Latinos who could benefit from PrEP have received it. As undiagnosed HIV contributes to 40% of new HIV infections, and STIs increase HIV risk, targeted interventions that address Latino immigrant MSM's barriers to HIV/STI testing and PrEP uptake are critical for curbing the HIV epidemic.

Studies have shown that peers can influence HIV-related behaviors by enhancing information, motivation, and behavior skills (IMB Model). Peers share characteristics with the target population, which facilitates role modeling and can empower individuals to engage in behaviors. While peer interventions have demonstrated success in shaping behaviors among Latino MSM, their utility for addressing immigrant-specific barriers to HIV/STI testing and PrEP use is less understood.

While the IMB Model and empowerment theory highlight relevant psychological determinants of behavior, competent attention to structural factors (i.e. access) is key for HIV prevention. The availability of HIV/STI self-testing kits presents opportunities to overcome structural barriers to testing. HIV/STI self-testing kits are convenient testing methods as they allow for at-home testing, reducing the need for health care visits. The research combines these approaches (peers and HIV/STI self-testing kits) to address individual and structural barriers to HIV prevention among Latino immigrant MSM.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male sex (at birth)
  • adult aged 18 and older
  • immigrant (not born in continental U.S.)
  • Latino (identifies as either Latinx or Hispanic
  • reports sex with men in past 12 months
  • reports not knowing their HIV status or being HIV negative

Exclusion Criteria:

  • Does not identify as Latino/Hispanic
  • Born in the continental U.S.
  • Female sex (at birth)
  • Does not report sex with men in the last 12 months
  • Reports being HIV positive
  • Younger than 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Listos peer intervention
Listos intervention (peer counseling, PrEP information, and HIV/STI testing kits)
Information, motivation, and behavioral skills for HIV/STI testing and pre-exposure prophylaxis uptake
Kits to self-test for HIV/STIs
Active Comparator: Peer only group
Peer only group (peer counseling, PrEP information)
Information, motivation, and behavioral skills for HIV/STI testing and pre-exposure prophylaxis uptake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who test for HIV/STIs
Time Frame: 1 week
Report of having tested for HIV or STIs
1 week
Number of participants who test for HIV/STIs
Time Frame: 6 weeks
Report of having tested for HIV or STIs
6 weeks
Number of participants who test for HIV/STIs
Time Frame: 12 weeks
Report of having tested for HIV or STIs
12 weeks
Number of participants who initiate PrEP
Time Frame: 1 week
Report of use of PrEP
1 week
Number of participants who initiate PrEP
Time Frame: 6 weeks
Report of use of PrEP
6 weeks
Number of participants who initiate PrEP
Time Frame: 12 weeks
Report of use of PrEP
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jane J Lee, PhD, LMSW, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00007054
  • KL2TR002317 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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