- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04779736
Mitigating Sexual Stigma Within Healthcare Interactions Improve Engagement of MSM in HIV Prevention
November 14, 2023 updated by: Bryan Kutner
Mitigating Sexual Stigma Within Healthcare Interactions to Improve Engagement of MSM in HIV Prevention
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.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
188
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Bronx, New York, United States, 10461
- Albert Einstein College Of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Pre-post design
The pilot intervention will be evaluated using a pre-post design.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability, appropriateness, and feasibility of the mHealth component as assessed by the AFAS
Time Frame: Post-intervention, 1 week after completion of the mHealth component
|
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 mHealth component
|
Acceptability, appropriateness, and feasibility of the in-person skills development workshop as assessed by the AFAS
Time Frame: Post-intervention, 1 week after completion of the in-person workshop
|
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, appropriateness, and feasibility of the coaching calls and optional email listserv as assessed by the AFAS
Time Frame: Post-intervention, 1 week after completion of coaching calls and optional email listserv
|
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 coaching calls and optional email listserv
|
Reach of the mHealth component as assessed by the RE-AIM Framework
Time Frame: Post-intervention, 1 week after completion of the mHealth component
|
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).
|
Post-intervention, 1 week after completion of the mHealth component
|
Reach of the in-person skills development workshop as assessed by the RE-AIM Framework
Time Frame: Post-intervention, 1 week after completion of the in-person workshop
|
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).
|
Post-intervention, 1 week after completion of the in-person workshop
|
Reach of the coaching calls and optional email listserv as assessed by the RE-AIM Framework
Time Frame: Post-intervention, 1 week after completion of coaching calls and optional email listserv
|
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).
|
Post-intervention, 1 week after completion of coaching calls and optional email listserv
|
Acceptability, appropriateness, and feasibility of the set of implementation strategies as assessed by qualitative interviews
Time Frame: Post-intervention 3 months after completion of all implementation strategies
|
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-intervention 3 months after completion of all implementation strategies
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes to determinants of implementation behavior as assessed by the DIBQ
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
|
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.
|
(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
|
Changes to knowledge about anal health and sexuality as assessed by the iASK
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
|
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.
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(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
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Changes to comfort discussing anal health and sexuality as assessed by 6 study-specific items
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
|
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.
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(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
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Changes to the quality of care as assessed by 6 study-specific items
Time Frame: (1) Baseline, pre-intervention, (2) Post-intervention 3 months after completion of all implementation strategies
|
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.
|
(1) Baseline, pre-intervention, (2) Post-intervention 3 months after completion of all implementation strategies
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Changes to the engagement MSM in HIV-related services as measured by electronic health record (EHR) in two HIV service delivery sites
Time Frame: (1) Baseline, pre-intervention, (2) Post-intervention 3 months after completion of all implementation strategies
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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.
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(1) Baseline, pre-intervention, (2) Post-intervention 3 months after completion of all implementation strategies
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Impact of implementation strategies on the quality of care and engagement of MSM clients as assessed by qualitative interviews
Time Frame: Post-intervention 3 months after completion of all implementation strategies
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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.
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Post-intervention 3 months after completion of all implementation strategies
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 23, 2021
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
August 31, 2024
Study Registration Dates
First Submitted
January 21, 2021
First Submitted That Met QC Criteria
February 27, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 14, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 2023-14892
- K23MH124569 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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