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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06132672

Collaborator

(none)

144

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus	Behavioral: Navigators (peer navigator) training Behavioral: delayed-intervention	N/A

Detailed Description

Medical mistrust is associated with HIV disparities among HLMSM because mistrust may result in delayed or reduced use of needed HIV prevention (e.g., HIV testing and Pre-exposure prophylaxis (PrEP) uptake) and care (e.g., AntiretroViral Therapy [ART]) services.

While advances have been made to increase the use of HIV prevention and care services, profound disparities persist, and a need remains for increased understanding of the multilevel drivers of medical mistrust and for effective interventions to address these drivers among HLMSM in the US.

This research proposes a mixed-method study that includes rigorous qualitative and quantitative methods to better understand the drivers of medical mistrust among Spanish-speaking, English-speaking, and bilingual (including Spanish and English, or an indigenous language and Spanish and/or English) HLMSM. This study also proposes to refine and test a multilevel intervention designed to address medical mistrust and increase the use of needed HIV prevention and care services among diverse HLMSM in Mecklenburg County, NC, a jurisdiction prioritized by the Ending the HIV Epidemic in the US (EHE) initiative.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 5Recruit, 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

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Identifying and Addressing Historical and Structural Drivers of Medical Mistrust Among Hispanic/Latino Gay, Bisexual and Other Men Who Have Sex With Men

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2028

Anticipated Study Completion Date :

Aug 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Navigators (peer navigator) training 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 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
Experimental: delayed-intervention group Training is designed to increase knowledge and skills. The delayed-intervention group will be trained in year 5	Behavioral: delayed-intervention Those in the delayed-intervention group will be trained in year 5

Arm

Intervention/Treatment

Experimental: Navigators (peer navigator) training

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

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

Experimental: delayed-intervention group

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

Behavioral: delayed-intervention

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

Outcome Measures

Primary Outcome Measures

Change in Rate of medical mistrust [baseline to post-intervention up to 18 months]
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
Change in Rate of Human Immunodeficiency Virus (HIV) testing [baseline to post-intervention up to 18 months]
Change in Rate of Human Immunodeficiency Virus (HIV) testing - Self-Report - did participant use testing in past 12 months
Change in Rate of pre-exposure prophylaxis (PrEP) uptake [baseline to post-intervention up to 18 months]
Change in Rate of pre-exposure prophylaxis (PrEP) uptake - did participant use PrEP in past 12 months
Change in the amount of use of HIV care services [baseline to post-intervention up to 18 months]
Change in the amount of use of HIV care services - did participant use HIV care in past 12 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

less than 18 years of age
female

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

Principal Investigator: Scott D Rhodes, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT06132672

Other Study ID Numbers:

IRB00101348
1U01PS005250

First Posted:

Nov 15, 2023

Last Update Posted:

Nov 15, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wake Forest University Health Sciences

Hispanic/Latino gay

bisexual men

HIV prevention

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome

HIV Infections

Study Results

No Results Posted as of Nov 15, 2023