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Transgender Education for Affirmative and Competent HIV and Healthcare (TEACHH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096053
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Carmen Logie, MSW, PhD, University of Toronto

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stigma, Social HIV/AIDS Health Care Acceptability Other: TEACHH Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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.
Other: TEACHH
See arm/group description.




Primary Outcome Measures :
  1. Workshop Recruitment Rate [ Time Frame: 3 hours ]
    Number of people who participate in the workshop / Number of people invited to participate in the workshop

  2. 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. Survey completion rate [ Time Frame: 3 hours ]
    Number of people who complete the post-survey/Number of people who complete the pre-survey

  4. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096053


Contacts
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Contact: Carmen H Logie (416) 946-3365 carmen.logie@utoronto.ca

Locations
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Canada, Ontario
Factor-Inwentash Faculty of Social Work, University of Toronto Recruiting
Toronto, Ontario, Canada, M5S1V4
Contact: Carmen H Logie, PhD         
Sponsors and Collaborators
University of Toronto
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Responsible Party: Carmen Logie, MSW, PhD, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT04096053    
Other Study ID Numbers: 00036238
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases