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

Primary Purpose

Human Immunodeficiency Virus, Stigma, Social, Patient Engagement

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A set of implementation strategies to reduce sexual stigma
Sponsored by
Bryan Kutner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Immunodeficiency Virus focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pre-post design

Arm Description

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

Outcomes

Primary Outcome Measures

Acceptability, appropriateness, and feasibility of the mHealth 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.
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.
Acceptability, appropriateness, and feasibility of the coaching calls and optional email listserv 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.
Reach of the mHealth component as assessed by the RE-AIM Framework
Quantitative assessment of how many health workers are exposed to implementation strategies and how representative they are of the health worker population within the health delivery setting. This will be calculated as a percentage of health workers reached: (# health workers actually exposed)/(# health workers ideally exposed).
Reach of the in-person skills development workshop as assessed by the RE-AIM Framework
Quantitative assessment of how many health workers are exposed to implementation strategies and how representative they are of the health worker population within the health delivery setting. This will be calculated as a percentage of health workers reached: (# health workers actually exposed)/(# health workers ideally exposed).
Reach of the coaching calls and optional email listserv as assessed by the RE-AIM Framework
Quantitative assessment of how many health workers are exposed to implementation strategies and how representative they are of the health worker population within the health delivery setting. This will be calculated as a percentage of health workers reached: (# health workers actually exposed)/(# health workers ideally exposed).
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.

Secondary Outcome Measures

Changes to determinants of implementation behavior 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., perceived behavioral control, optimism, attitude, outcome expectancy, intentions) 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.
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.
Changes to comfort discussing anal health and sexuality as assessed by 6 study-specific items
Quantitative assessment using 6 items developed for the current study to measure changes to comfort discussing anal health and sexuality with clients (e.g., Asking male clients about their sexual orientation; Asking male clients about their anal sex practices; Initiating a conversation about anal health; Asking MSM 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.
Changes to the quality of care as assessed by 6 study-specific items
Quantitative assessment using 6 items developed for the current study to measure changes to frequency of discussing anal health and sexuality with clients (e.g., Asking male clients about their sexual orientation; Asking male clients about their anal sex practices; Initiating a conversation about anal health; Asking MSM 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.
Changes to the engagement MSM 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 MSM will be assessed via EHR by measuring the number over the past 30 days of self-identified gay and bisexual men who have sought (a) HIV testing, (b) screening for PrEP eligibility, (c) received anogenital cytology for sexually transmitted infection, and (d) been retained in HIV care (as defined by returning for their most recent 3-month visit, if living with HIV). EHR will also be reviewed to assess documentation for self-identified gay and bisexual men over the past 30 days of (a) anal health conditions, (b) sexual history and (c) sexual behavior.
Impact of implementation strategies on the quality of care and engagement of MSM clients as assessed by qualitative interviews
Impact of the implementation strategies (i.e., mHealth education, in-person workshop, coaching calls, email listserv, and any additional implementation strategies developed over the course of the study) will be assessed through in-depth interviews following completion of quantitative assessments, as part of an explanatory sequential mixed-methods design.

Full Information

First Posted
January 21, 2021
Last Updated
October 10, 2023
Sponsor
Bryan Kutner
Collaborators
National Institute of Mental Health (NIMH), Albert Einstein College of Medicine, Columbia University, New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04779736
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bryan Kutner
Collaborators
National Institute of Mental Health (NIMH), Albert Einstein College of Medicine, Columbia University, New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 will collect 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 will then inform consultation with an advisory board of 4 adult MSM and 4 adult HCWs 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 will be performed in two high incidence regions in the United States, by pilot testing with 120 adult HCWs who do not specialize in MSM health and who work in clinical sites where MSM are under-engaged in HIV services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-post design
Arm Type
Other
Arm Description
The pilot intervention will be evaluated using a pre-post design.
Intervention Type
Behavioral
Intervention Name(s)
A set of implementation strategies to reduce sexual stigma
Intervention Description
The intervention will be finalized based on formative interviews and consultation with an advisory board. It is likely to include an educational mHealth component followed by an in-person workshop for skills development, then supportive coaching components (i.e., coaching calls and an optional email listserve) to encourage and respond to the implementation of recommended practices.
Primary Outcome Measure Information:
Title
Acceptability, appropriateness, and feasibility of the mHealth component as assessed by the AFAS
Description
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.
Time Frame
Post-intervention, 1 week after completion of the mHealth component
Title
Acceptability, appropriateness, and feasibility of the in-person skills development workshop as assessed by the AFAS
Description
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.
Time Frame
Post-intervention, 1 week after completion of the in-person workshop
Title
Acceptability, appropriateness, and feasibility of the coaching calls and optional email listserv as assessed by the AFAS
Description
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.
Time Frame
Post-intervention, 1 week after completion of coaching calls and optional email listserv
Title
Reach of the mHealth component as assessed by the RE-AIM Framework
Description
Quantitative assessment of how many health workers are exposed to implementation strategies and how representative they are of the health worker population within the health delivery setting. This will be calculated as a percentage of health workers reached: (# health workers actually exposed)/(# health workers ideally exposed).
Time Frame
Post-intervention, 1 week after completion of the mHealth component
Title
Reach of the in-person skills development workshop as assessed by the RE-AIM Framework
Description
Quantitative assessment of how many health workers are exposed to implementation strategies and how representative they are of the health worker population within the health delivery setting. This will be calculated as a percentage of health workers reached: (# health workers actually exposed)/(# health workers ideally exposed).
Time Frame
Post-intervention, 1 week after completion of the in-person workshop
Title
Reach of the coaching calls and optional email listserv as assessed by the RE-AIM Framework
Description
Quantitative assessment of how many health workers are exposed to implementation strategies and how representative they are of the health worker population within the health delivery setting. This will be calculated as a percentage of health workers reached: (# health workers actually exposed)/(# health workers ideally exposed).
Time Frame
Post-intervention, 1 week after completion of coaching calls and optional email listserv
Title
Acceptability, appropriateness, and feasibility of the set of implementation strategies as assessed by qualitative interviews
Description
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.
Time Frame
Post-intervention 3 months after completion of all implementation strategies
Secondary Outcome Measure Information:
Title
Changes to determinants of implementation behavior as assessed by the DIBQ
Description
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., perceived behavioral control, optimism, attitude, outcome expectancy, intentions) 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.
Time Frame
(1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of mHealth component, (3) Post-intervention 1 week after completion of the in-person workshop, (4) Post-intervention 3 months after completion of all implementation strategies
Title
Changes to knowledge about anal health and sexuality as assessed by the iASK
Description
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.
Time Frame
(1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of mHealth component, (3) Post-intervention 1 week after completion of the in-person workshop, (4) Post-intervention 3 months after completion of all implementation strategies
Title
Changes to comfort discussing anal health and sexuality as assessed by 6 study-specific items
Description
Quantitative assessment using 6 items developed for the current study to measure changes to comfort discussing anal health and sexuality with clients (e.g., Asking male clients about their sexual orientation; Asking male clients about their anal sex practices; Initiating a conversation about anal health; Asking MSM 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.
Time Frame
(1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of mHealth component, (3) Post-intervention 1 week after completion of the in-person workshop, (4) Post-intervention 3 months after completion of all implementation strategies
Title
Changes to the quality of care as assessed by 6 study-specific items
Description
Quantitative assessment using 6 items developed for the current study to measure changes to frequency of discussing anal health and sexuality with clients (e.g., Asking male clients about their sexual orientation; Asking male clients about their anal sex practices; Initiating a conversation about anal health; Asking MSM 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.
Time Frame
(1) Baseline, pre-intervention, (2) Post-intervention 3 months after completion of all implementation strategies
Title
Changes to the engagement MSM in HIV-related services as measured by electronic health record (EHR) in two HIV service delivery sites
Description
In two HIV service delivery sites, among all sites involved in the study, engagement of MSM will be assessed via EHR by measuring the number over the past 30 days of self-identified gay and bisexual men who have sought (a) HIV testing, (b) screening for PrEP eligibility, (c) received anogenital cytology for sexually transmitted infection, and (d) been retained in HIV care (as defined by returning for their most recent 3-month visit, if living with HIV). EHR will also be reviewed to assess documentation for self-identified gay and bisexual men over the past 30 days of (a) anal health conditions, (b) sexual history and (c) sexual behavior.
Time Frame
(1) Baseline, pre-intervention, (2) Post-intervention 3 months after completion of all implementation strategies
Title
Impact of implementation strategies on the quality of care and engagement of MSM clients as assessed by qualitative interviews
Description
Impact of the implementation strategies (i.e., mHealth education, in-person workshop, coaching calls, email listserv, and any additional implementation strategies developed over the course of the study) will be assessed through in-depth interviews following completion of quantitative assessments, as part of an explanatory sequential mixed-methods design.
Time Frame
Post-intervention 3 months after completion of all implementation strategies

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
For the formative phase of in-depth interviews, we will require MSM to identify as male and to report being assigned male at birth. Formative in-depth interviews with healthcare workers and pilot evaluation will not be limited by gender identity.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
MSM Participants Inclusion Criteria: 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 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: be aged 18 or older read and communicate in English 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
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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