Mitigating Sexual Stigma Within Healthcare Interactions Improve Engagement of MSM in HIV Prevention

NCT ID: NCT04779736

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2025-01-31

Brief Summary

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The purpose of this study is to explore drivers and mitigators of anal sex stigma in healthcare, and then to develop and pilot an intervention for health workers that mitigates the deterrent effects of this stigma on the engagement of gay and bisexual men in HIV-related services.

Detailed Description

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This 5-year study aims to understand determinants that perpetuate and mitigate stigma toward anal sex during healthcare encounters, in order to develop and pilot a strategy that responds to these determinants and thereby improves the quality of care and HIV service engagement among men who have sex with men (MSM). The study team collected data during in-depth interviews with 20 adult MSM as well as 20 adult healthcare workers (HCWs) to identify strategies that could be readily used in health services to reduce stigma. Analysis of this data then informed consultation with an advisory board of HCWs and healthcare consumers (not limited to MSM), to develop the content of a set of implementation strategies to mitigate stigma and thereby improve health service delivery. Evaluation of a set of implementation strategies was performed in the Southern US, a high incidence region, by pilot testing with 65 adult HCWs who in clinical sites where MSM are under-engaged in HIV services.

Conditions

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Human Immunodeficiency Virus Stigma, Social Patient Engagement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single group study. Sequential explanatory mixed methods pre/post design.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pre-post design

The pilot intervention will be evaluated using a pre-post design.

Group Type OTHER

A set of implementation strategies to reduce sexual stigma

Intervention Type BEHAVIORAL

The set of implementation strategies was finalized based on formative interviews and consultation with an advisory board. This included an in-person workshop for skills development, environmental restructuring through a website of information resources for healthcare consumers and HCWs, and supportive coaching components (i.e., coaching calls, an optional email listserve) and quality improvement meetings with two clinics to encourage and respond to the implementation of recommended practices.

Interventions

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A set of implementation strategies to reduce sexual stigma

The set of implementation strategies was finalized based on formative interviews and consultation with an advisory board. This included an in-person workshop for skills development, environmental restructuring through a website of information resources for healthcare consumers and HCWs, and supportive coaching components (i.e., coaching calls, an optional email listserve) and quality improvement meetings with two clinics to encourage and respond to the implementation of recommended practices.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. be aged 18 or older
2. report being assigned male at birth and identifying currently as male
3. reside in the United States
4. read and communicate in English

1. be aged 18 or older
2. read and communicate in English

Exclusion Criteria

Healthcare Worker Participants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role collaborator

GMR Transcription

UNKNOWN

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bryan Kutner, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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K23MH124569

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-14892

Identifier Type: -

Identifier Source: org_study_id

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