- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03922126
Peer Intervention Latino Immigrant MSM
Development of a Peer Intervention to Increase HIV/STI Testing and PrEP Uptake Among Latino Immigrant Men Who Have Sex With Men
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98105
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Jane J Lee, PhD, LMSW, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
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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