Human Immunodeficiency VirusNCT06132672
Medical Mistrust Among Hispanic/Latino Gay, Bisexual and Other Men Who Have Sex With Men (HLMSM)
A study testing Navigators (peer navigator) training and delayed-intervention in people with Human Immunodeficiency Virus, run by Wake Forest University Health Sciences at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Navigators (peer navigator) training and delayed-intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- less than 18 years of age
- female
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Lisa L Lewis, 336-713-5074, Lisa.Lynn.Lewis@wakehealth.edulth.edu
Scott D Rhodes, PhD
About this study
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
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).
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Navigators (peer navigator) training, delayed-intervention
- Keywords
- Hispanic/Latino gay, bisexual men, HIV prevention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigators (peer navigator) trainingBehavioural
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-interventionBehavioural
Those in the delayed-intervention group will be trained in year 5
| Study group | Role | What they receive |
|---|---|---|
| Navigators (peer navigator) training | Experimental | 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 Receives: Behavioral: Navigators (peer navigator) training |
| delayed-intervention group | Experimental | Training is designed to increase knowledge and skills. The delayed-intervention group will be trained in year 5 Receives: Behavioral: delayed-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline to post-intervention up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study startMar 2027 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 5
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott D Rhodes, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132672
- Sponsor's protocol ID
- IRB00101348
- Other IDs
- 1U01PS005250
- Status last verified
- Apr 2026
- First submitted
- 9 Nov 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing data generated from this study is an essential part of our proposed activities. This study will generate both quantitative and qualitative data
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06132672
- Acronym / sponsor ID
- IRB00101348
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Hispanic/Latino gay, bisexual men, HIV prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 5
| Arm | Type | Receives |
|---|---|---|
| Navigators (peer navigator) training | Experimental | Behavioral: Navigators (peer navigator) trainingTraining 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 |
| delayed-intervention group | Experimental | Behavioral: delayed-interventionTraining is designed to increase knowledge and skills. The delayed-intervention group will be trained in year 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- less than 18 years of age
- female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigators (peer navigator) trainingThe 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 | Behavioural | Navigators (peer navigator) training |
| delayed-interventionThose in the delayed-intervention group will be trained in year 5 | Behavioural | delayed-intervention group |
Primary outcome
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. Sharing data generated from this study is an essential part of our proposed activities. This study will generate both quantitative and qualitative data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott D Rhodes, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigators (peer navigator) training and delayed-intervention in people with Human Immunodeficiency Virus, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa L Norfleet (336.713.5074, Lisa.Lynn.Lewis@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rate of medical mistrust (time frame: baseline to post-intervention up to 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.