An HIV Status-neutral Microeconomic Intervention

Feasibility Studies Clinical Trial

— Secure  

Official title:

Strengthening Community Responses to Economic Vulnerability and HIV Inequities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212544
• Other study ID #: F00423
• Secondary ID: R34MH130207
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Feasibility Studies

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