An interventional study of Navigators (peer navigator) training and delayed-intervention in Human Immunodeficiency Virus, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research
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).
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's planned enrollment of 144 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Training is designed to increase knowledge and skills. The delayed-intervention group will be trained in year 5
Behavioral: delayed-intervention
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
Those in the delayed-intervention group will be trained in year 5
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to post-intervention up to 18 months
Plan to share: Yes — Sharing data generated from this study is an essential part of our proposed activities. This study will generate both quantitative and qualitative data
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome→
Wake Forest University Health Sciences