NCT03922126

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started May 2019

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

April 15, 2019

Last Update Submit

May 16, 2022

Conditions

HIV InfectionsSexually Transmitted Diseases

Outcome Measures

Primary Outcomes (6)

  • Number of participants who test for HIV/STIs

    Report of having tested for HIV or STIs

    1 week

  • Number of participants who test for HIV/STIs

    Report of having tested for HIV or STIs

    6 weeks

  • Number of participants who test for HIV/STIs

    Report of having tested for HIV or STIs

    12 weeks

  • Number of participants who initiate PrEP

    Report of use of PrEP

    1 week

  • Number of participants who initiate PrEP

    Report of use of PrEP

    6 weeks

  • Number of participants who initiate PrEP

    Report of use of PrEP

    12 weeks

Study Arms (2)

Listos peer intervention

EXPERIMENTAL

Listos intervention (peer counseling, PrEP information, and HIV/STI testing kits)

Other: Peer counselingDiagnostic Test: HIV/STI self-testing kits

Peer only group

ACTIVE COMPARATOR

Peer only group (peer counseling, PrEP information)

Other: Peer counseling

Interventions

Peer counselingOTHER

Information, motivation, and behavioral skills for HIV/STI testing and pre-exposure prophylaxis uptake

Listos peer interventionPeer only group
HIV/STI self-testing kitsDIAGNOSTIC_TEST

Kits to self-test for HIV/STIs

Listos peer intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • 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.

    PMID: 37436792DERIVED

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jane J Lee, PhD, LMSW

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, School of Social Work

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 19, 2019

Study Start

May 1, 2019

Primary Completion

February 1, 2022

Study Completion

February 28, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

US(1)