Stigma, SocialTEACHHNCT04096053
Transgender Education for Affirmative and Competent HIV and Healthcare
A study testing TEACHH in people with Stigma, Social and HIV/AIDS, run by University of Toronto at 1 site in Canada.
Trial summary
Educational workshops are an efficacious strategy to increase healthcare providers' ability to provide gender-affirming care for transgender (trans) people. This strategy may also reduce healthcare providers' stigma towards trans people and people living with HIV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stigma, Social, HIV/AIDS, Health Care Acceptability
- What is being tested?
- TEACHH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 31 Mar 2020
- 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
- Workshop participants must be 18 years or older and identify as working at a location that provides health or social services to trans women or being in-training to work in health or social services (e.g., medical student, social work student). Workshop participants may include a mix of HIV- and non-HIV service providers.
Who cannot join
- Not fitting the above criteria.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Factor-Inwentash Faculty of Social Work, University of Toronto
Toronto, Ontario, M5S1V4
About this study
Official title: 'Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)': Protocol of Community-based Participatory Intervention Development and a Non-randomized Multi-site Pilot Study With Pre- Post-test Design
Educational workshops are an efficacious strategy to increase healthcare providers' ability to provide gender-affirming care for transgender (trans) people. This strategy may also reduce healthcare providers' stigma towards trans people and people living with HIV. There is less evidence, however, of educational workshops that address HIV prevention and care among trans women. This protocol details the development and pilot testing of the TEACHH: Transgender Education for Affirmative and Competent HIV and Healthcare intervention that aims to increase gender-affirming HIV care competency among healthcare providers.This community-based research (CBR) project involves intervention development and implementation of a non-randomized multi-site pilot study with pre- post-test design. First, the investigators will conduct a qualitative formative phase involving focus groups with 30 trans women and individual interviews with 12 providers to understand HIV care access barriers for trans women and elicit feedback on a proposed workshop. Second, the investigators will pilot test the intervention with 90-150 providers (n=30-50x3 in-person settings). Primary outcomes include feasibility (e.g., completion rate), workshop satisfaction, and willingness to attend another workshop. Secondary pre- and post-intervention outcomes, assessed directly preceding and following the workshop, include perceived competency, intention to provide gender-affirming HIV care, and attitudes/biases towards trans women with HIV. Primary outcomes will be summarized as frequencies and proportions (categorical variables) and means and standard deviations (continuous variables). The investigators will conduct paired-sample t tests to assess pre- and post-intervention differences for secondary outcomes.
- Conditions
- Stigma, Social, HIV/AIDS, Health Care Acceptability
- Being tested
- TEACHH
- Medical subject headings
- Social Stigma, Acquired Immunodeficiency Syndrome, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEACHHOther
See arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| TEACHH | Experimental | The training workshop is designed as a 3-hour session for care providers. The training will be delivered by trans women. During this training, we plan to have providers: 1) discuss human rights for trans women; 2) teach providers about common words with which to discuss gender identity and expression, and develop a basic understanding of trans healthcare, HIV prevention, and HIV treatment, and how these types of healthcare affect trans women living with and affected by HIV; 3) discuss what it means to be trans-affirming in their work and how they can make their organizations more trans- affirming; and 4) have participants complete a case study to apply what they have learned to practice. These case studies will address issues affecting trans women who are immigrants/newcomers, trans women who are living with HIV, and trans women who experience other vulnerabilities. Receives: Other: TEACHH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Workshop Recruitment Rate
Number of people who participate in the workshop / Number of people invited to participate in the workshop
Measured: 3 hours
Workshop Completion Rate
Number of people who finish all 3 hours of the workshop / Number of people who start the workshop
Measured: 3 hours
Survey completion rate
Number of people who complete the post-survey/Number of people who complete the pre-survey
Measured: 3 hours
Satisfaction with the workshop
Measured in two ways - satisfaction scale and willingness to attend another workshop on trans women with HIV
Measured: 3 hours
Secondary outcomes (1)
attitudes/biases, perceived competency, and behavioral intention to provide gender- affirming HIV care to trans women living with HIV
a scale adapted from (1) Nyblade et al.'s brief, standardized tool for measuring HIV- related stigma among health facility staff and (2) trans-specific questions from Bidell's Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS), an interdisciplinary self-assessment for health providers
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Sep 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stigma, SocialStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Logie, MSW, PhD, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096053
- Sponsor's protocol ID
- 00036238
- Acronym
- TEACHH
- Status last verified
- Jul 2020
- First submitted
- 16 Sep 2019
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lacombe-Duncan A, Logie CH, Persad Y, Leblanc G, Nation K, Kia H, Scheim AI, Lyons T, Horemans C, Olawale R, Loutfy M. Implementation and evaluation of the 'Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)' provider education pilot. BMC Med Educ. 2021 Nov 4;21(1):561. doi: 10.1186/s12909-021-02991-3.
PubMed 34732178Lacombe-Duncan A, Logie CH, Persad Y, Leblanc G, Nation K, Kia H, Scheim AI, Lyons T, Loutfy M. 'Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)': protocol of community-based intervention development and a non-randomised multisite pilot study with pre-post test design in Canada. BMJ Open. 2020 Jul 31;10(7):e034144. doi: 10.1136/bmjopen-2019-034144.
PubMed 32737085
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)': Protocol of Community-based Participatory Intervention Development and a Non-randomized Multi-site Pilot Study With Pre- Post-test Design
- ClinicalTrials.gov ID
- NCT04096053
- Acronym / sponsor ID
- TEACHH / 00036238
- Conditions
- Stigma, Social, HIV/AIDS, Health Care Acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 19 Sep 2019 (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.
Educational workshops are an efficacious strategy to increase healthcare providers' ability to provide gender-affirming care for transgender (trans) people. This strategy may also reduce healthcare providers' stigma towards trans people and people living with HIV. There is less evidence, however, of educational workshops that address HIV prevention and care among trans women. This protocol details the development and pilot testing of the TEACHH: Transgender Education for Affirmative and Competent HIV and Healthcare intervention that aims to increase gender-affirming HIV care competency among healthcare providers.This community-based research (CBR) project involves intervention development and implementation of a non-randomized multi-site pilot study with pre- post-test design. First, the investigators will conduct a qualitative formative phase involving focus groups with 30 trans women and individual interviews with 12 providers to understand HIV care access barriers for trans women and elicit feedback on a proposed workshop. Second, the investigators will pilot test the intervention with 90-150 providers (n=30-50x3 in-person settings). Primary outcomes include feasibility (e.g., completion rate), workshop satisfaction, and willingness to attend another workshop. Secondary pre- and post-intervention outcomes, assessed directly preceding and following the workshop, include perceived competency, intention to provide gender-affirming HIV care, and attitudes/biases towards trans women with HIV. Primary outcomes will be summarized as frequencies and proportions (categorical variables) and means and standard deviations (continuous variables). The investigators will conduct paired-sample t tests to assess pre- and post-intervention differences for secondary outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEACHH | Experimental | Other: TEACHHThe training workshop is designed as a 3-hour session for care providers. The training will be delivered by trans women. During this training, we plan to have providers: 1) discuss human rights for trans women; 2) teach providers about common words with which to discuss gender identity and expression, and develop a basic understanding of trans healthcare, HIV prevention, and HIV treatment, and how these types of healthcare affect trans women living with and affected by HIV; 3) discuss what it means to be trans-affirming in their work and how they can make their organizations more trans- affirming; and 4) have participants complete a case study to apply what they have learned to practice. These case studies will address issues affecting trans women who are immigrants/newcomers, trans women who are living with HIV, and trans women who experience other vulnerabilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Workshop participants must be 18 years or older and identify as working at a location that provides health or social services to trans women or being in-training to work in health or social services (e.g., medical student, social work student). Workshop participants may include a mix of HIV- and non-HIV service providers.
Key exclusion criteria (1 listed)
- Not fitting the above criteria.
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 |
|---|---|---|
| TEACHHSee arm/group description. | Other | TEACHH |
Primary outcome
Workshop Recruitment Rate
Time frame: 3 hours
Number of people who participate in the workshop / Number of people invited to participate in the workshop
Workshop Completion Rate
Time frame: 3 hours
Number of people who finish all 3 hours of the workshop / Number of people who start the workshop
Survey completion rate
Time frame: 3 hours
Number of people who complete the post-survey/Number of people who complete the pre-survey
Satisfaction with the workshop
Time frame: 3 hours
Measured in two ways - satisfaction scale and willingness to attend another workshop on trans women with HIV
1 secondary outcome
attitudes/biases, perceived competency, and behavioral intention to provide gender- affirming HIV care to trans women living with HIV
Time frame: 3 hours
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 31 Jul 2020.
- Derived from this study: PubMed 34732178Lacombe-Duncan A, Logie CH, Persad Y, Leblanc G, Nation K, Kia H, Scheim AI, Lyons T, Horemans C, Olawale R, Loutfy M. Implementation and evaluation of the 'Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)' provider education pilot. BMC Med Educ. 2021 Nov 4;21(1):561. doi: 10.1186/s12909-021-02991-3.
- Derived from this study: PubMed 32737085Lacombe-Duncan A, Logie CH, Persad Y, Leblanc G, Nation K, Kia H, Scheim AI, Lyons T, Loutfy M. 'Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)': protocol of community-based intervention development and a non-randomised multisite pilot study with pre-post test design in Canada. BMJ Open. 2020 Jul 31;10(7):e034144. doi: 10.1136/bmjopen-2019-034144.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEACHH in people with Stigma, Social and HIV/AIDS, run by University of Toronto at 1 site in Canada.
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 1 inclusion and 1 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 31 Jul 2020. 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 Canada. 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?
Workshop Recruitment Rate (time frame: 3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04096053, which also lists 2 linked publications.
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 31 Jul 2020.