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OpenTrials
Completed

NCT Number: NCT06212544

An HIV Status-neutral Microeconomic Intervention

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ruth Ellis Center

Highland Park, Michigan, 48203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Immediate intervention

Behavioral

Enhanced microeconomic intervention

Delayed Intervention

Behavioral

Usual care and then access to enhanced microeconomic intervention

Primary outcomes

  1. Acceptability Quantitative

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Strengthening Community Responses to Economic Vulnerability and HIV Inequities

Acronym: Secure

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2024
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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