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

Study Overview
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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 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.

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

Conditions
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Human Immunodeficiency Virus, Stigma, Social, Patient Engagement

Intervention / Treatment
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* Behavioral: A set of implementation strategies to reduce sexual stigma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pre-post design<br>The pilot intervention will be evaluated using a pre-post design. | Behavioral: A set of implementation strategies to reduce sexual stigma<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 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. | (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 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. | (1) Baseline, pre-intervention, (2) Post-intervention 3 months after completion of all implementation strategies | 
| 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. | (1) Baseline, pre-intervention, (2) Post-intervention 3 months after completion of all implementation strategies | 
| 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. | Post-intervention 3 months after completion of all implementation strategies | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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