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Peer Intervention Latino Immigrant MSM

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ClinicalTrials.gov Identifier: NCT03922126
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jane J. Lee, University of Washington

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
HIV Infections Sexually Transmitted Diseases Other: Peer counseling Diagnostic Test: HIV/STI self-testing kits Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Development of a Peer Intervention to Increase HIV/STI Testing and PrEP Uptake Among Latino Immigrant Men Who Have Sex With Men
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Listos peer intervention
Listos intervention (peer counseling, PrEP information, and HIV/STI testing kits)
Other: Peer counseling
Information, motivation, and behavioral skills for HIV/STI testing and pre-exposure prophylaxis uptake

Diagnostic Test: HIV/STI self-testing kits
Kits to self-test for HIV/STIs

Active Comparator: Peer only group
Peer only group (peer counseling, PrEP information)
Other: Peer counseling
Information, motivation, and behavioral skills for HIV/STI testing and pre-exposure prophylaxis uptake




Primary Outcome Measures :
  1. Number of participants who test for HIV/STIs [ Time Frame: 1 week ]
    Report of having tested for HIV or STIs

  2. Number of participants who test for HIV/STIs [ Time Frame: 6 weeks ]
    Report of having tested for HIV or STIs

  3. Number of participants who test for HIV/STIs [ Time Frame: 12 weeks ]
    Report of having tested for HIV or STIs

  4. Number of participants who initiate PrEP [ Time Frame: 1 week ]
    Report of use of PrEP

  5. Number of participants who initiate PrEP [ Time Frame: 6 weeks ]
    Report of use of PrEP

  6. Number of participants who initiate PrEP [ Time Frame: 12 weeks ]
    Report of use of PrEP



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922126


Contacts
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Contact: Jane J Lee, PhD, LMSW 206-616-8984 janejlee@uw.edu

Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Jane J Lee, PhD, LMSW University of Washington

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Responsible Party: Jane J. Lee, Assistant Professor, School of Social Work, University of Washington
ClinicalTrials.gov Identifier: NCT03922126     History of Changes
Other Study ID Numbers: STUDY00007054
KL2TR002317 ( U.S. NIH Grant/Contract )
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female