Peer Intervention Latino Immigrant MSM

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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HIV Infections, Sexually Transmitted Diseases

Intervention / Treatment
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* Other: Peer counseling
* Diagnostic Test: HIV/STI self-testing kits


Participation Criteria
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Eligibility Criteria
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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

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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