HIV InfectionsNCT03922126
Peer Intervention Latino Immigrant MSM
A study testing Peer counseling and HIV/STI self-testing kits in people with HIV Infections and Sexually Transmitted Diseases, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Peer counseling and HIV/STI self-testing kits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Peer Intervention to Increase HIV/STI Testing and PrEP Uptake Among Latino Immigrant Men Who Have Sex With Men
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).
Read the 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.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Peer counseling, HIV/STI self-testing kits
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer counselingOther
Information, motivation, and behavioral skills for HIV/STI testing and pre-exposure prophylaxis uptake
HIV/STI self-testing kitsDiagnostic test
Kits to self-test for HIV/STIs
| Study group | Role | What they receive |
|---|---|---|
| Listos peer intervention | Experimental | Listos intervention (peer counseling, PrEP information, and HIV/STI testing kits) Receives: Other: Peer counseling; Diagnostic Test: HIV/STI self-testing kits |
| Peer only group | Active comparator | Peer only group (peer counseling, PrEP information) Receives: Other: Peer counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who test for HIV/STIs
Report of having tested for HIV or STIs
Measured: 1 week
Number of participants who test for HIV/STIs
Report of having tested for HIV or STIs
Measured: 6 weeks
Number of participants who test for HIV/STIs
Report of having tested for HIV or STIs
Measured: 12 weeks
Number of participants who initiate PrEP
Report of use of PrEP
Measured: 1 week
Number of participants who initiate PrEP
Report of use of PrEP
Measured: 6 weeks
Number of participants who initiate PrEP
Report of use of PrEP
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 May 2019
- Primary completion1 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane J. Lee, University of Washington
- Investigators
- Jane J Lee, PhD, LMSW, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922126
- Sponsor's protocol ID
- STUDY00007054
- Other IDs
- KL2TR002317
- Status last verified
- May 2022
- First submitted
- 15 Apr 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JJ, Robles G, Leyva Vera CA, Orellana ER, Graham SM, Nguyen AM, Wei Y, Sanchez AH, Dombrowski JC, Simoni JM. A Peer-Based Intervention to Increase HIV and Sexually Transmitted Infection Testing Among Latinx Immigrant Sexual Minority Men in the US Pacific Northwest: Pilot Randomized Controlled Trial Conducted During the COVID-19 Pandemic. JMIR Form Res. 2023 Jul 12;7:e45871. doi: 10.2196/45871.
PubMed 37436792
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Peer Intervention to Increase HIV/STI Testing and PrEP Uptake Among Latino Immigrant Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT03922126
- Acronym / sponsor ID
- STUDY00007054
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Listos peer intervention | Experimental | Other: Peer counseling, Diagnostic Test: HIV/STI self-testing kitsListos intervention (peer counseling, PrEP information, and HIV/STI testing kits) |
| Peer only group | Active comparator | Other: Peer counselingPeer only group (peer counseling, PrEP information) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer counselingInformation, motivation, and behavioral skills for HIV/STI testing and pre-exposure prophylaxis uptake | Other | Listos peer intervention, Peer only group |
| HIV/STI self-testing kitsKits to self-test for HIV/STIs | Diagnostic test | Listos peer intervention |
Primary outcome
Number of participants who test for HIV/STIs
Time frame: 1 week
Report of having tested for HIV or STIs
Number of participants who test for HIV/STIs
Time frame: 6 weeks
Report of having tested for HIV or STIs
Number of participants who test for HIV/STIs
Time frame: 12 weeks
Report of having tested for HIV or STIs
Number of participants who initiate PrEP
Time frame: 1 week
Report of use of PrEP
Number of participants who initiate PrEP
Time frame: 6 weeks
Report of use of PrEP
Number of participants who initiate PrEP
Time frame: 12 weeks
Report of use of PrEP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 37436792Lee JJ, Robles G, Leyva Vera CA, Orellana ER, Graham SM, Nguyen AM, Wei Y, Sanchez AH, Dombrowski JC, Simoni JM. A Peer-Based Intervention to Increase HIV and Sexually Transmitted Infection Testing Among Latinx Immigrant Sexual Minority Men in the US Pacific Northwest: Pilot Randomized Controlled Trial Conducted During the COVID-19 Pandemic. JMIR Form Res. 2023 Jul 12;7:e45871. doi: 10.2196/45871.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane J Lee, PhD, LMSW principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer counseling and HIV/STI self-testing kits in people with HIV Infections and Sexually Transmitted Diseases, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who test for HIV/STIs (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03922126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.