An HIV Status-neutral Microeconomic Intervention

NCT06212544 | Completed Results

• 2 other identifiers: F00423R34MH130207
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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. 1.To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color.
2. 2.The determine acceptability of the intervention with transgender women of color.

Conditions

Feasibility Studies

Keywords

Transgender; HIV; microeconomic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

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

Behavioral: Immediate Intervention

Delayed Arm

ACTIVE COMPARATOR

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.

Behavioral: Delayed Intervention

Interventions

Immediate Intervention BEHAVIORAL

Enhanced microeconomic intervention

Immediate Intervention

Delayed Intervention BEHAVIORAL

Usual care and then access to enhanced microeconomic intervention

Delayed Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years old;
• assigned male at birth;
• self identifies as female, transgender woman, or another feminine gender identity;
• self identifies as a person of color (i.e., any racial/ethnic identity except non-Hispanic white);
• reports earning less than $32,800 gross annual income (current living wage in Michigan);
• reports condomless sex in the past 6 months;
• lives in Detroit, MI greater metropolitan area (\~50 mile radius);
• speaks English.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ruth Ellis Center

Highland Park, Michigan, 48203, United States

Location

Related Publications (1)

• Gamarel K, Mayo-Wilson LJ, Jadwin-Cakmak L, Reyes L, Monro D, Ubong IA, Sullivan S, Abad J, Poindexter J, Harris H, Riser C, Stephenson J, Ortiz G, Peitzmeier SM, Neilands TB, Poteat T. Strengthening Community Responses to Economic vulnerability (SeCuRE): a protocol of an HIV status-neutral pilot randomized clinical trial with transgender women of color in Detroit, Michigan. Pilot Feasibility Stud. 2024 Nov 8;10(1):135. doi: 10.1186/s40814-024-01558-5.

  PMID: 39511631 DERIVED

Results Point of Contact

• Title: Kristi Gamarel
• Organization: University of Michigan

kgamarel@umich.edu

7346473178

Study Officials

• Kristi Gamarel, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Health Behavior and Health Education

Model Details: Pilot waitlist randomized controlled trial

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 19, 2024
• Study Start: June 7, 2024
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)