Medical Mistrust Among Hispanic/Latino Gay, Bisexual and Other Men Who Have Sex With Men (HLMSM)

NCT06132672 | Not Yet Recruiting

• 2 other identifiers: IRB001013481U01PS005250
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

There is an urgent need to address HIV inequities and disparities in the US, particularly within vulnerable communities such as Hispanic/Latino gay, bisexual, and other men who have sex with men (HLMSM).

Conditions

Human Immunodeficiency Virus

Keywords

Hispanic/Latino gay; bisexual men; HIV prevention

Outcome Measures

Primary Outcomes (4)

• Change in Rate of medical mistrust

  The Group-Based Medical Mistrust Scale (GBMMS) - The response key was a Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree) and the score range was 12 to 60 - higher scores indicate greater levels of medical mistrust

  baseline to post-intervention up to 18 months

• Change in Rate of Human Immunodeficiency Virus (HIV) testing

  Change in Rate of Human Immunodeficiency Virus (HIV) testing - Self-Report - did participant use testing in past 12 months

  baseline to post-intervention up to 18 months

• Change in Rate of pre-exposure prophylaxis (PrEP) uptake

  Change in Rate of pre-exposure prophylaxis (PrEP) uptake - did participant use PrEP in past 12 months

  baseline to post-intervention up to 18 months

• Change in the amount of use of HIV care services

  Change in the amount of use of HIV care services - did participant use HIV care in past 12 months

  baseline to post-intervention up to 18 months

Study Arms (2)

Navigators (peer navigator) training

EXPERIMENTAL

Training is designed to increase knowledge and skills. Navigators in the intervention group will be trained and supported for 12 months of implementation across years 3 and 4

Behavioral: Navigators (peer navigator) training

delayed-intervention group

EXPERIMENTAL

Training is designed to increase knowledge and skills. The delayed-intervention group will be trained in year 5

Behavioral: delayed-intervention

Interventions

Navigators (peer navigator) training BEHAVIORAL

The Navigators training will be designed to increase knowledge and skills to help others (i.e., social network members). Navigators in the intervention group will be trained and supported for 12 months of implementation across years 3 and 4

Navigators (peer navigator) training

delayed-intervention BEHAVIORAL

Those in the delayed-intervention group will be trained in year 5

delayed-intervention group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• reside in Mecklenburg County, NC
• identify as Hispanic/Latino
• be ≥18 years of age
• speak English and Spanish
• report identifying as male and having had sex with at least 1 man in the past 6 months
• provide informed consent

You may not qualify if:

• less than 18 years of age
• female

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Scott D Rhodes, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa L Norfleet

CONTACT

336.713.5074; Lisa.Lynn.Lewis@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Recruit, enroll, and collect baseline data from 144 Hispanic/Latino Gay, Bisexual and Other Men Who Have Sex With Men (HLMSM), including 16 Community-Based Peer Navigators (known as Navigators) and their social network members (n=8 unique social network members per leader). Navigators (coupled with their social networks) will be randomly assigned to intervention (n=8 Navigators; n=64 social network members) or delayed-intervention (n=8 Navigators; n=64 social network members) groups. Navigators in the intervention group will be trained and supported for 12 months of implementation across years 3 and 4; those in the delayed-intervention group will be trained in year 5

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 15, 2023
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Last 6 months of Year 5
• Access Criteria: De-identified data and associated documentation (including codebooks) will be available from the Principal Investigators under a data-sharing agreement with users that provides for a commitment to: (1) using the data for research purposes; (2) securing the data using appropriate computer technology; and (3) to destroying or returning the data after analyses are completed

Locations

US (1)