Clinical trial NCT04779736: Mitigating Sexual Stigma Within Healthcare Interactions Improve Engagement of MSM in HIV Prevention
Official title: Mitigating Sexual Stigma Within Healthcare Interactions to Improve Engagement of MSM in HIV Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Stigma, Social
Patient Engagement
Keywords: Implementation science
Health stigma and discrimination framework
Theoretical domains framework
Theory and techniques tool
Anal sex stigma
Men who have sex with men
Sexual and gender minority
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Columbia University
name: New York State Psychiatric Institute
name: GMR Transcription
First posted: 2021-03-03
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group study. Sequential explanatory mixed methods pre/post design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: MSM Participants

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
5. have had anal intercourse with a man in the past year or intend to in the next year Exclusion Criteria: Not applicable

Healthcare Worker Participants

Inclusion Criteria:

1. be aged 18 or older
2. read and communicate in English
3. bear a role responsibility for HIV-related screening and referral (e.g., as a peer/outreach worker, test counselor, case manager, social worker, medical assistant, nurse, physician assistant, physician) Exclusion Criteria: Not applicable

Primary outcomes:
measure: Acceptability, appropriateness, and feasibility of the website component as assessed by the AFAS
timeFrame: Post-intervention, 1 week after completion of all implementation strategies
measure: Acceptability, appropriateness, and feasibility of the in-person skills development workshop as assessed by the AFAS
timeFrame: Post-intervention, 1 week after completion of the in-person workshop
measure: Acceptability of the in-person skills development workshop as assessed by the AARP
timeFrame: Post-intervention, 1 week after completion of the in-person workshop
measure: Determinants of implementation of the in-person skills development workshop as assessed by the DIBQ
timeFrame: Post-intervention 1 week after completion of the in-person workshop
measure: Acceptability, appropriateness, and feasibility of the coaching calls as assessed by the AFAS
timeFrame: Post-intervention, 1 week after completion of all implementation strategies
measure: Acceptability, appropriateness, and feasibility of the quality improvement meetings as assessed by the AFAS
timeFrame: Post-intervention, 1 week after completion of all implementation strategies
measure: Acceptability, appropriateness, and feasibility of the set of implementation strategies as assessed by qualitative interviews
timeFrame: Post-workshop (1 week after delivery of the in-person workshop) and post-intervention ( 1 week after completion of all implementation strategies
measure: Changes to determinants of implementation behavior as assessed by the DIBQ
timeFrame: (1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of the in-person workshop, (3) Post-intervention 1 week after completion of all implementation strategies
measure: Changes to knowledge about anal health and sexuality as assessed by the iASK
timeFrame: (1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of the in-person workshop, (3) Post-intervention 1 week after completion of all implementation strategies
measure: Changes to self-efficacy offering social support as assessed by the MOS-SSS Informational and Emotional Social Support Subscale
timeFrame: (1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of the in-person workshop, (3) Post-intervention 1 week after completion of all implementation strategies
measure: Changes to comfort discussing anal health and sexuality as assessed by 10 study-specific items
timeFrame: (1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of the in-person workshop, (3) Post-intervention 1 week after completion of all implementation strategies
measure: Changes to the quality of care as assessed by 10 study-specific items
timeFrame: (1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of all implementation strategies
measure: Changes to the engagement in HIV-related services as measured by electronic health record (EHR) in two HIV service delivery sites
timeFrame: (1) the 3-month period pre-intervention, (2) the 3-month period during intervention, and then (3) the 3-month post-intervention, up to 9 months total.
measure: Impact of implementation strategies on the quality of care and engagement of clients as assessed by qualitative interviews
timeFrame: Post-intervention 1 month after completion of all implementation strategies
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Bryan Kutner, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: