Peer Intervention Latino Immigrant MSM
Primary Purpose
HIV Infections, Sexually Transmitted Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer counseling
HIV/STI self-testing kits
Sponsored by
About this trial
This is an interventional screening trial for HIV Infections
Eligibility 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
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Listos peer intervention
Peer only group
Arm Description
Listos intervention (peer counseling, PrEP information, and HIV/STI testing kits)
Peer only group (peer counseling, PrEP information)
Outcomes
Primary Outcome Measures
Number of participants who test for HIV/STIs
Report of having tested for HIV or STIs
Number of participants who test for HIV/STIs
Report of having tested for HIV or STIs
Number of participants who test for HIV/STIs
Report of having tested for HIV or STIs
Number of participants who initiate PrEP
Report of use of PrEP
Number of participants who initiate PrEP
Report of use of PrEP
Number of participants who initiate PrEP
Report of use of PrEP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03922126
Brief Title
Peer Intervention Latino Immigrant MSM
Official Title
Development of a Peer Intervention to Increase HIV/STI Testing and PrEP Uptake Among Latino Immigrant Men Who Have Sex With Men
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Listos peer intervention
Arm Type
Experimental
Arm Description
Listos intervention (peer counseling, PrEP information, and HIV/STI testing kits)
Arm Title
Peer only group
Arm Type
Active Comparator
Arm Description
Peer only group (peer counseling, PrEP information)
Intervention Type
Other
Intervention Name(s)
Peer counseling
Intervention Description
Information, motivation, and behavioral skills for HIV/STI testing and pre-exposure prophylaxis uptake
Intervention Type
Diagnostic Test
Intervention Name(s)
HIV/STI self-testing kits
Intervention Description
Kits to self-test for HIV/STIs
Primary Outcome Measure Information:
Title
Number of participants who test for HIV/STIs
Description
Report of having tested for HIV or STIs
Time Frame
1 week
Title
Number of participants who test for HIV/STIs
Description
Report of having tested for HIV or STIs
Time Frame
6 weeks
Title
Number of participants who test for HIV/STIs
Description
Report of having tested for HIV or STIs
Time Frame
12 weeks
Title
Number of participants who initiate PrEP
Description
Report of use of PrEP
Time Frame
1 week
Title
Number of participants who initiate PrEP
Description
Report of use of PrEP
Time Frame
6 weeks
Title
Number of participants who initiate PrEP
Description
Report of use of PrEP
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane J Lee, PhD, LMSW
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Peer Intervention Latino Immigrant MSM
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