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

Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06132672
• Other study ID #: IRB00101348
• Secondary ID: 1U01PS005250
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: August 2028

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: Lisa L Lewis
• Phone: 336.713.5074
• Email: Lisa.Lynn.Lewis[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: August 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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