NCT04096053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

September 16, 2019

Last Update Submit

July 30, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Workshop Recruitment Rate

    Number of people who participate in the workshop / Number of people invited to participate in the workshop

    3 hours

  • Workshop Completion Rate

    Number of people who finish all 3 hours of the workshop / Number of people who start the workshop

    3 hours

  • Survey completion rate

    Number of people who complete the post-survey/Number of people who complete the pre-survey

    3 hours

  • Satisfaction with the workshop

    Measured in two ways - satisfaction scale and willingness to attend another workshop on trans women with HIV

    3 hours

Secondary Outcomes (1)

  • attitudes/biases, perceived competency, and behavioral intention to provide gender- affirming HIV care to trans women living with HIV

    3 hours

Study Arms (1)

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.

Other: TEACHH

Interventions

TEACHHOTHER

See arm/group description.

TEACHH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not fitting the above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Factor-Inwentash Faculty of Social Work, University of Toronto

Toronto, Ontario, M5S1V4, Canada

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Social StigmaAcquired Immunodeficiency SyndromePatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 19, 2019

Study Start

September 1, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations