Human Immunodeficiency VirusNCT04779736
Mitigating Sexual Stigma Within Healthcare Interactions Improve Engagement of MSM in HIV Prevention
A study testing A set of implementation strategies to reduce sexual stigma in people with Human Immunodeficiency Virus and Stigma, Social, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Stigma, Social, Patient Engagement
- What is being tested?
- A set of implementation strategies to reduce sexual stigma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: 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.
Read the 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.
- Being tested
- A set of implementation strategies to reduce sexual stigma
- 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
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Social Stigma, Patient Participation, Homosexuality, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A set of implementation strategies to reduce sexual stigmaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-post design | Other | The pilot intervention will be evaluated using a pre-post design. Receives: Behavioral: A set of implementation strategies to reduce sexual stigma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: Post-intervention 1 month after completion of all implementation strategies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start23 Aug 2021
- Primary completion30 Sep 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group study. Sequential explanatory mixed methods pre/post design.
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Columbia University, New York State Psychiatric Institute, GMR Transcription
- Responsible party
- Sponsor
- Investigators
- Bryan Kutner, PhD, MPH, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779736
- Sponsor's protocol ID
- 2023-14892
- Other IDs
- K23MH124569, 2023
- Status last verified
- May 2025
- First submitted
- 21 Jan 2021
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Sexual Stigma Within Healthcare Interactions to Improve Engagement of MSM in HIV Prevention
- ClinicalTrials.gov ID
- NCT04779736
- Acronym / sponsor ID
- 2023-14892
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Columbia University, New York State Psychiatric Institute, GMR Transcription
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group study. Sequential explanatory mixed methods pre/post design.
| Arm | Type | Receives |
|---|---|---|
| Pre-post design | Other | Behavioral: A set of implementation strategies to reduce sexual stigmaThe pilot intervention will be evaluated using a pre-post design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A set of implementation strategies to reduce sexual stigmaThe 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. | Behavioural | Pre-post design |
Primary outcome
Acceptability, appropriateness, and feasibility of the website component as assessed by the AFAS
Time frame: Post-intervention, 1 week after completion of all implementation strategies
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
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.
Acceptability of the in-person skills development workshop as assessed by the AARP
Time frame: Post-intervention, 1 week after completion of the in-person workshop
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.
Determinants of implementation of the in-person skills development workshop as assessed by the DIBQ
Time frame: Post-intervention 1 week after completion of the in-person workshop
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.
Acceptability, appropriateness, and feasibility of the coaching calls as assessed by the AFAS
Time frame: Post-intervention, 1 week after completion of all implementation strategies
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 quality improvement meetings as assessed by the AFAS
Time frame: Post-intervention, 1 week after completion of all implementation strategies
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 set of implementation strategies as assessed by qualitative interviews
Time frame: Post-workshop (1 week after delivery of the in-person workshop) and post-intervention ( 1 week 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.
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 the in-person workshop, (3) Post-intervention 1 week after completion of all implementation strategies
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.
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 the in-person workshop, (3) Post-intervention 1 week 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.
Changes to self-efficacy offering social support as assessed by the MOS-SSS Informational and Emotional Social Support Subscale
Time frame: (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
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.
Changes to comfort discussing anal health and sexuality as assessed by 10 study-specific items
Time frame: (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
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.
Changes to the quality of care as assessed by 10 study-specific items
Time frame: (1) Baseline, pre-intervention, (2) Post-intervention 1 week after completion of all implementation strategies
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.
Changes to the engagement in HIV-related services as measured by electronic health record (EHR) in two HIV service delivery sites
Time frame: (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.
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.
Impact of implementation strategies on the quality of care and engagement of clients as assessed by qualitative interviews
Time frame: Post-intervention 1 month after completion of all implementation strategies
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Kutner, PhD, MPH principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A set of implementation strategies to reduce sexual stigma in people with Human Immunodeficiency Virus and Stigma, Social, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability, appropriateness, and feasibility of the website component as assessed by the AFAS (time frame: Post-intervention, 1 week after completion of all implementation strategies). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.