NCT04563715

Brief Summary

This study is a randomized controlled trial that evaluates the efficacy of a network intervention to promote regular HIV testing and prevention (risk reduction and PrEP awareness and referrals) among friendship networks of Latino men who have sex with men and transwomen (LMSMT) in three mid sized Midwestern cities.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
456

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
7mo left

Started Nov 2020

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Nov 2020Dec 2026

First Submitted

Initial submission to the registry

September 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 3, 2021

Status Verified

November 1, 2021

Enrollment Period

5 years

First QC Date

September 21, 2020

Last Update Submit

November 1, 2021

Conditions

HIV Infections

Keywords

HIVLatinosNetworksMen who have sex with menTransgenderUSA Midwest

Outcome Measures

Primary Outcomes (4)

  • Mean percentage of participants who report having tested for HIV twice in the past 12 months.

    Participants will complete surveys assessing HIV testing behavior.

    Past 12 months

  • Mean percentage of PrEP-eligible participants who report having consulted with a provider about PrEP.

    Participants will complete surveys in which they will report whether they consulted with a provider about PrEP.

    Past 6 months

  • Mean percentage of participants who report having had unprotected sex with a casual partner.

    Participants will complete surveys in which they will report whether they had unprotected sex with a casual partner.

    Past 6 months

  • Mean percentage of participants who report having tested for HIV in the past 6 months.

    Participants will complete surveys assessing HIV testing behavior.

    Past 6 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

HIV counseling and testing

Diagnostic Test: HIV counseling and testing

Standard of Care plus Network Intervention

EXPERIMENTAL

Network intervention

Diagnostic Test: HIV counseling and testingBehavioral: Network intervention

Interventions

HIV counseling and testingDIAGNOSTIC_TEST

Receive HIV testing risk assessment and advice about risk reduction and future testing.

Standard of CareStandard of Care plus Network Intervention
Network interventionBEHAVIORAL

Key individuals are trained to provide advice about regular testing and risk reduction.

Standard of Care plus Network Intervention

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale gender at birth
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Latinx men who have sex with men or transgender women 18 or more years of age.
  • Lives in the Milwaukee, Cleveland or Indianapolis area.
  • Can provide informed consent.

You may not qualify if:

  • Cis-gender female.
  • Did not have sex with men or identify as homosexual or bisexual.
  • Cannot provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shalom Health Care Center

Indianapolis, Indiana, 46222, United States

Location

AIDS Taskforce of Greater Cleveland

Cleveland, Ohio, 44115, United States

Location

Sixteenth Street Community Health Centers

Milwaukee, Wisconsin, 54204, United States

Location

MeSH Terms

Conditions

HIV InfectionsHomosexuality

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexualitySexual BehaviorBehavior

Study Officials

  • Laura R Glasman

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 24, 2020

Study Start

November 16, 2020

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

November 3, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)