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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03922126
Other study ID # STUDY00007054
Secondary ID KL2TR002317
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date February 28, 2022

Study information

Verified date May 2022
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 28, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants who test for HIV/STIs Report of having tested for HIV or STIs 1 week
Primary Number of participants who test for HIV/STIs Report of having tested for HIV or STIs 6 weeks
Primary Number of participants who test for HIV/STIs Report of having tested for HIV or STIs 12 weeks
Primary Number of participants who initiate PrEP Report of use of PrEP 1 week
Primary Number of participants who initiate PrEP Report of use of PrEP 6 weeks
Primary Number of participants who initiate PrEP Report of use of PrEP 12 weeks
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