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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06212544
Other study ID # F00423
Secondary ID R34MH130207
Status Recruiting
Phase N/A
First received
Last updated
Start date June 7, 2024
Est. completion date April 30, 2025

Study information

Verified date June 2024
Source University of Michigan
Contact Kristi E Gamarel, PhD
Phone 734-647-3178
Email kgamarel@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim is the current study is to establish feasibility and acceptability of the SeCuRE intervention to improve HIV prevention and care continua outcomes. To meet this aim, the study has the following objectives: 1. To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color. 2. The determine acceptability of the intervention with transgender women of color.


Description:

This is a two-arm randomized waitlist controlled trial in which transgender women of color will be randomly allocated to either the enhanced microeconomic intervention that builds on the Trans Sistas of Color Project's existing microeconomic interventions, which includes: (1) $250 in emergency assistance; and (2) peer support to obtain legal gender affirmation (i.e., legal name and gender markers on identification documents). The existing intervention will be enhanced to include (1) 12 weekly educational group sessions on economic empowerment (i.e., job acquisition, income generation through micro-business, and financial literacy) and HIV prevention and care; (2) employment-focused mentoring; and (3) an unconditional grant ($1,200) for use towards acquiring self-led or formal employment. Each condition will complete a baseline survey prior to randomization, a follow-up survey immediately following intervention completion, and 3-month survey after intervention completion. Participants will also complete qualitative exit interviews within one month of completion of intervention completion for both conditions.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. at least 18 years old; 2. assigned male at birth; 3. self identifies as female, transgender woman, or another feminine gender identity; 4. self identifies as a person of color (i.e., any racial/ethnic identity except non-Hispanic white); 5. reports earning less than $32,800 gross annual income (current living wage in Michigan); 6. reports condomless sex in the past 6 months; 7. lives in Detroit, MI greater metropolitan area (~50 mile radius); 8. speaks English.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Immediate Intervention
Enhanced microeconomic intervention
Delayed Intervention
Usual care and then access to enhanced microeconomic intervention

Locations

Country Name City State
United States Ruth Ellis Center Highland Park Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability Quantitative The Client Satisfaction Questionnaire (CSQ-8) will be used to assess intervention satisfaction. This is an 8-item scale where each individual item is scored separately with a range of 1 to 4 and a score of 3 or 4 on each item will be considered indicative of acceptable. 3 months
Primary Acceptability Qualitative Qualitative Exit Interviews where more than 80% of participants deem intervention acceptable 3 months
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