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

NCT04779736 | Completed DMC

• 2 other identifiers: 2023-14892K23MH124569
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (14)

• Acceptability, appropriateness, and feasibility of the website component as assessed by the AFAS

  Quantitative assessment using the 13-item Acceptability, Feasibility, \& Appropriateness Scale (AFAS), with three subscales for each construct. Acceptability refers to satisfaction with the implementation strategies. Feasibility refers to compatibility of recommended practices with participants' current practices. Appropriateness refers to perceived fit with participants' work mission and goals. Mean scores for individual items and mean scores for subscales will reflect the response category range from 1 (Not at all) to 5 (Extremely), with higher scores indicating, respectively, greater acceptability, appropriateness and feasibility.

  Post-intervention, 1 week after completion of all implementation strategies

• Acceptability, appropriateness, and feasibility of the in-person skills development workshop as assessed by the AFAS

  Quantitative assessment using the 13-item Acceptability, Feasibility, \& Appropriateness Scale (AFAS), with three subscales for each construct. Acceptability refers to satisfaction with the implementation strategies. Feasibility refers to compatibility of recommended practices with participants' current practices. Appropriateness refers to perceived fit with participants' work mission and goals. Mean scores for individual items and mean scores for subscales will reflect the response category range from 1 (Not at all) to 5 (Extremely), with higher scores indicating, respectively, greater acceptability, appropriateness and feasibility.

  Post-intervention, 1 week after completion of the in-person workshop

• Acceptability of the in-person skills development workshop as assessed by the AARP

  Quantitative assessment using the 8-item Abbreviated Acceptability Rating Profile (AARP). Acceptability refers to satisfaction with the implementation strategies. Mean scores for individual items and mean scores for the overall scale will reflect the response category range from 0 (Strongly disagree) to 5 (Strongly agree), with higher scores indicating, respectively, greater acceptability.

  Post-intervention, 1 week after completion of the in-person workshop

• Determinants of implementation of the in-person skills development workshop as assessed by the DIBQ

  Quantitative assessment using a 25-item adaptation to the Determinants of Implementation Behavior Questionnaire (DIBQ). The DIBQ measures multiple domains from within the Theoretical Domains Framework (e.g., behavioral control, reinforcement) that are posited as determinants of implementation. Mean scores for individual items and mean scores for subscales will reflect the response category range, from 1 (Very difficult) to 7 (Very easy), with higher scores indicating greater positive valence related to that domain.

  Post-intervention 1 week after completion of the in-person workshop

• Acceptability, appropriateness, and feasibility of the coaching calls as assessed by the AFAS

  Quantitative assessment using the 13-item Acceptability, Feasibility, \& Appropriateness Scale (AFAS), with three subscales for each construct. Acceptability refers to satisfaction with the implementation strategies. Feasibility refers to compatibility of recommended practices with participants' current practices. Appropriateness refers to perceived fit with participants' work mission and goals. Mean scores for individual items and mean scores for subscales will reflect the response category range from 1 (Not at all) to 5 (Extremely), with higher scores indicating, respectively, greater acceptability, appropriateness and feasibility.

  Post-intervention, 1 week after completion of all implementation strategies

• Acceptability, appropriateness, and feasibility of the quality improvement meetings as assessed by the AFAS

  Quantitative assessment using the 13-item Acceptability, Feasibility, \& Appropriateness Scale (AFAS), with three subscales for each construct. Acceptability refers to satisfaction with the implementation strategies. Feasibility refers to compatibility of recommended practices with participants' current practices. Appropriateness refers to perceived fit with participants' work mission and goals. Mean scores for individual items and mean scores for subscales will reflect the response category range from 1 (Not at all) to 5 (Extremely), with higher scores indicating, respectively, greater acceptability, appropriateness and feasibility.

  Post-intervention, 1 week after completion of all implementation strategies

• Acceptability, appropriateness, and feasibility of the set of implementation strategies as assessed by qualitative interviews

  Acceptability, appropriateness, and feasibility will be assessed through in-depth interviews following completion of quantitative assessments, as part of an explanatory sequential mixed-methods design.

  Post-workshop (1 week after delivery of the in-person workshop) and post-intervention ( 1 week after completion of all implementation strategies

• Changes to determinants of implementation behavior as assessed by the DIBQ

  Quantitative assessment using a 26-item adaptation to the Determinants of Implementation Behavior Questionnaire (DIBQ). The DIBQ measures multiple domains from within the Theoretical Domains Framework (e.g., role responsibility, confidence, positive and negative emotions) that are posited as mechanisms of action that mediate behavior change among health care workers. Mean scores for individual items and mean scores for subscales will reflect the response category range, from 1 (Very difficult) to 7 (Very easy), with higher scores indicating ease related to that domain.

  (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

• Changes to knowledge about anal health and sexuality as assessed by the iASK

  Quantitative assessment using the 10-item Inventory of Anal Sex Knowledge (iASK). The iASK measures knowledge as a potential mediator of behavior change. All items are scored as True/False for a total percentage of correct responses, ranging from 0-10, with higher scores indicating greater knowledge.

  (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

• Changes to self-efficacy offering social support as assessed by the MOS-SSS Informational and Emotional Social Support Subscale

  Quantitative assessment using 8 items adapted from the Medical Outcomes Study Social Support Survey to measure changes in self-efficacy offering social support (e.g., Be someone to give information to help a client understand a situation involving anal sex). Mean scores for individual items will reflect the response category range, from 1 (Very easy) to 5 (Very difficult), with lower scores indicating greater self-efficacy offering informational and emotional social support.

  (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

• Changes to comfort discussing anal health and sexuality as assessed by 10 study-specific items

  Quantitative assessment using 10 items developed for the current study to measure changes to comfort discussing anal health and sexuality with clients (e.g., Asking clients about their sexual orientation; Asking clients about their anal sex practices; Initiating a conversation about anal health; Asking clients about their specific questions or concerns related to anal health). Mean scores for individual items will reflect the response category range, from 0 (Not at all comfortable) to 6 (Very comfortable), with higher scores indicating greater comfort related to that activity.

  (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

• Changes to the quality of care as assessed by 10 study-specific items

  Quantitative assessment using 10 items developed for the current study to measure changes to frequency of discussing quality of care with clients (e.g., Asking clients about their sexual orientation; Asking clients about their anal sex practices; Initiating a conversation about anal health; Asking clients about their specific questions or concerns related to anal health). Mean scores for individual items will reflect the response category range, from 0 (Not at all comfortable) to 6 (Very comfortable), with higher scores indicating greater reported frequency of each activity.

  (1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of all implementation strategies

• Changes to the engagement in HIV-related services as measured by electronic health record (EHR) in two HIV service delivery sites

  In two HIV service delivery sites, among all sites involved in the study, engagement of clients will be assessed via EHR by measuring the number over the past 30 days of patients who have sought (a) HIV testing, (b) screening for PrEP eligibility, (c) received anogenital cytology for sexually transmitted infection. EHR will also be reviewed to assess documentation of (a) anal health conditions, (b) sexual history and (c) sexual behavior.

  (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.

• Impact of implementation strategies on the quality of care and engagement of clients as assessed by qualitative interviews

  Impact of the implementation strategies (i.e., website and environmental restructuring, in-person workshop, coaching calls, email listserv, and any additional implementation strategies developed over the course of the study) assessed through in-depth interviews following completion of quantitative assessments, as part of an explanatory sequential mixed-methods design.

  Post-intervention 1 month after completion of all implementation strategies

Study Arms (1)

Pre-post design

OTHER

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

Behavioral: A set of implementation strategies to reduce sexual stigma

Interventions

A set of implementation strategies to reduce sexual stigma 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.

Pre-post design

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: For the formative phase of in-depth interviews, we required MSM to identify as adult and male and to report being assigned male at birth. Formative in-depth interviews with healthcare workers, advisory board membership, and pilot evaluation required no specific gender eligibility requirements.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be aged 18 or older
• report being assigned male at birth and identifying currently as male
• reside in the United States
• read and communicate in English

You may not qualify if:

• Healthcare Worker Participants
• be aged 18 or older
• read and communicate in English

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator
• Columbia University: collaborator
• New York State Psychiatric Institute: collaborator
• GMR Transcription: collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Social Stigma; Patient Participation; Homosexuality; Coitus

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Sexuality; Sexual Behavior

Study Officials

• Bryan Kutner, PhD, MPH

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single group study. Sequential explanatory mixed methods pre/post design.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: March 3, 2021
• Study Start: August 23, 2021
• Primary Completion: September 30, 2024
• Study Completion: January 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)