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Not yet recruiting NCT06132672

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

No phase Interventional Human Immunodeficiency Virus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Navigators (peer navigator) training, delayed-intervention.
Who it may be relevant to
Registry conditions: Human Immunodeficiency Virus. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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).

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.

Interventions

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

Primary outcome measures

  • Change in Rate of medical mistrust [Time frame: baseline to post-intervention up to 18 months]
  • Change in Rate of Human Immunodeficiency Virus (HIV) testing [Time frame: baseline to post-intervention up to 18 months]
  • Change in Rate of pre-exposure prophylaxis (PrEP) uptake [Time frame: baseline to post-intervention up to 18 months]
  • Change in the amount of use of HIV care services [Time frame: baseline to post-intervention up to 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT06132672 · IRB00101348 · 1U01PS005250

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗