Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)
NCT ID: NCT06202898
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2023-07-11
2027-06-30
Brief Summary
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Detailed Description
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Transgender women are among the most at risk group of sexually active populations, yet least likely to be aware of and/or use preexposure prophylaxis (PrEP) to prevent HIV transmission.5 PrEP and routine HIV/STI screening, are effective approaches to reduce HIV incidence in marginalized at-risk populations and are consistent with the US National HIV/AIDS strategy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ENTRUST
The proposed intervention 'ENTRUST' will address structural disparities transgender women encounter by providing skills to aid with economic navigation while simultaneously strengthening and improving social cohesion to increase the odds of them linking to care that is available to them.
Baseline
At the baseline visits, all study participants will be complete an interviewer-assisted questionnaire using REDCap, and will also receive the SBIRT-T MI-based intervention. Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for strength sessions, and they will be provided with a schedule of strength session visits
ENTRUST
Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for economic strength sessions, group-based economic training through photovoice activities and adapted screening brief intervention and treatment (SBIRT-T) adapted for transgender women delivered by a facilitator or digitally.
Control
Comparison control group.
Baseline
At the baseline visits, all study participants will be complete an interviewer-assisted questionnaire using REDCap, and will also receive the SBIRT-T MI-based intervention. Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for strength sessions, and they will be provided with a schedule of strength session visits
Control
participants assigned to the control arm will have the option of participating in the four additional strength sessions.
Interventions
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Baseline
At the baseline visits, all study participants will be complete an interviewer-assisted questionnaire using REDCap, and will also receive the SBIRT-T MI-based intervention. Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for strength sessions, and they will be provided with a schedule of strength session visits
ENTRUST
Participants randomized to the ENTRUST intervention group will also be assigned to a cohort for economic strength sessions, group-based economic training through photovoice activities and adapted screening brief intervention and treatment (SBIRT-T) adapted for transgender women delivered by a facilitator or digitally.
Control
participants assigned to the control arm will have the option of participating in the four additional strength sessions.
Eligibility Criteria
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Inclusion Criteria
* Male at birth
* Identify as a woman/transgender woman
* Should not be consistently using PrEP (less than four doses per week)
* Should not have any known allergy or adverse reaction to PrEP or the active drug tenofovir in ART. One of the goals of the study is to move more people into a PrEP program
* Be able to speak and understand spoken English and/or Spanish (including persons who cannot read or write)
* Have a smart phone that can take pictures
Exclusion Criteria
* Participation in an HIV vaccine trial
* Have a life-threatening SUD\*
* Any condition, that in the opinion of the study staff, would make participation in the study unsafe, or interfere with achieving the study objective such as medical conditions which prevents the use of PrEP
* Unable to provide consent
18 Years
MALE
No
Sponsors
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Sunserve
UNKNOWN
Survivor's Pathway
UNKNOWN
26Health
UNKNOWN
National Institute of Drug Abuse
FED
University of Central Florida
OTHER
Responsible Party
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Principal Investigators
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Elena Cyrus, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Central Florida
Locations
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University of Central Florida
Orlando, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Elena Cyrus, PhD
Role: primary
Eric Schrimshaw, PhD
Role: backup
Other Identifiers
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STUDY00005488
Identifier Type: -
Identifier Source: org_study_id