An HIV Status-neutral Microeconomic Intervention

Not Applicable

Active, not recruiting

• Conditions: Feasibility Studies
• Interventions: Behavioral: Immediate Intervention; Behavioral: Delayed Intervention

• Registration Number: NCT06212544
• Lead Sponsor: University of Michigan

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2024-01-13
• Study First Posted: 2024-01-19
• Study Start: 2024-06-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Immediate Intervention	Immediate Intervention	The intervention condition builds on our community partners' existing microeconomic intervention of: (1) a one-time emergency cash grant and (2) peer and legal support to obtain legal gender affirmation - plus a 12-week microeconomic intervention that adds: (3) weekly educational sessions and HIV prevention; (4) community mentoring; and (5) weekly posts of job openings in Detroit; and (6) a micro-grant for use towards acquiring self-led or formal employment
Delayed Arm	Delayed Intervention	Participants randomized to the control condition will receive UC during the 12-week period following randomization. Usual care consists of emergency assistance and access to legal name/gender marker change. After the RCT follow-up period is complete, waitlist control participants will be offered delayed access to the same intervention that is provided immediately to intervention arm participants.

Primary Outcome Measures

Name	Time	Method
Acceptability Quantitative	3 months	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.
Acceptability Qualitative	3 months	Qualitative Exit Interviews where more than 80% of participants deem intervention acceptable

Trial Locations

Locations (1)

Ruth Ellis Center; 🇺🇸 Highland Park, Michigan, United States