← Back to Search

Behavioral Intervention

Immediate Intervention for Feasibility Studies (Secure Trial)

N/A

Waitlist Available

Led By Kristi Gamarel, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years old

Assigned male at birth

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Secure Trial Summary

This trial aims to test a new intervention called SeCuRE to improve HIV prevention and care outcomes in transgender women of color. The study will involve 40 participants and will evaluate the acceptability of the

Who is the study for?

This trial is for transgender women of color. It's a small study to see if the SeCuRE intervention can help with HIV prevention and care. Participants will be split into two groups, one getting the intervention right away and the other later.Check my eligibility

What is being tested?

The SeCuRE intervention is being tested in this pilot randomized controlled trial (RCT). The goal is to check if it's feasible and acceptable for improving HIV-related outcomes among participants.See study design

What are the potential side effects?

Since this study focuses on a microeconomic intervention rather than a medical treatment, traditional side effects are not applicable. However, there may be social or psychological impacts from participating.

Secure Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I was assigned male at birth.

Select...

I have had unprotected sex in the last 6 months.

Secure Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability Qualitative

Acceptability Quantitative

Secure Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate InterventionExperimental Treatment1 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

Group II: Delayed ArmActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Immediate Intervention

2017

N/A

~1940

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,378,018 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,785 Previous Clinical Trials

2,689,716 Total Patients Enrolled

Kristi Gamarel, PhDPrincipal InvestigatorUniversity of Michigan

3 Previous Clinical Trials

356 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this clinical trial currently open?

"According to the available information on clinicaltrials.gov, this particular research study is not currently actively seeking patients. The trial was initially posted on February 1st, 2024 and recently updated on January 13th, 2024. However, it is worth noting that there are five other ongoing studies at present that are actively searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An HIV Status-neutral Microeconomic Intervention

Kristi Gamarel 2024. "An HIV Status-neutral Microeconomic Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06212544.