- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04096053
Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)
July 30, 2020 updated by: Carmen Logie, MSW, PhD, University of Toronto
'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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
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
-
-
Ontario
-
Toronto, Ontario, Canada, M5S1V4
- Factor-Inwentash Faculty of Social Work, University of Toronto
-
-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Not fitting the above criteria.
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TEACHH
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.
|
See arm/group description.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Workshop Recruitment Rate
Time Frame: 3 hours
|
Number of people who participate in the workshop / Number of people invited to participate in the workshop
|
3 hours
|
|
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
|
3 hours
|
|
Survey completion rate
Time Frame: 3 hours
|
Number of people who complete the post-survey/Number of people who complete the pre-survey
|
3 hours
|
|
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
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
attitudes/biases, perceived competency, and behavioral intention to provide gender- affirming HIV care to trans women living with HIV
Time Frame: 3 hours
|
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
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Lacombe-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.
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)
September 1, 2018
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2020
Study Registration Dates
First Submitted
September 16, 2019
First Submitted That Met QC Criteria
September 17, 2019
First Posted (Actual)
September 19, 2019
Study Record Updates
Last Update Posted (Actual)
July 31, 2020
Last Update Submitted That Met QC Criteria
July 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
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
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 00036238
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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