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NCT Number: NCT06132672

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location contact

Lisa L Lewis

CONTACT

[email protected]

336-713-5074

Scott D Rhodes, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

delayed-intervention

Behavioral

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

Primary outcomes

  1. Change in Rate of medical mistrust

    Time frame: 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

  2. Change in Rate of Human Immunodeficiency Virus (HIV) testing

    Time frame: 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

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

    Time frame: 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

  4. Change in the amount of use of HIV care services

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa L Norfleet

CONTACT

[email protected]

336.713.5074

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Nov 15, 2023
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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