Health TrialsbyHealthPanel

Economic Navigation and Strengthening to Research Unrestricted Services for Transgender Women (ENTRUST)

ConditionsTransgender WomenAidsHiv
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Central Florida

About this trial

The overall hypothesis is that stabilizing transgender women financially while providing them tailored counselling will increase their odds of them linking to substance use services, PrEP services if they do not have HIV, and transgender women who are living with HIV will be more adherent to their ART treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years

Male at birth

Identify as a woman/transgender woman

Should not be consistently using PrEP (less than four doses per week)

Disqualifiers

Unwilling to adhere to study procedures

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baseline

    Other intervention

    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

    Other intervention

    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

    Other intervention

    participants assigned to the control arm will have the option of participating in the four additional strength sessions.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: ENTRUSTExperimental treatment 2 interventions
Group B: ControlActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with substance abuse

The rate of change of substance abuse incidence for both arms

Time frame
1 year

Secondary outcomes

1

Rate of substance use in transgender women

The rate of stabilizing transgender women financially while providing them tailored counselling to increase their odds of them linking to substance use services, pre-exposure prophylaxis (PrEP) services if they do not have HIV, and transgender women who are living with HIV to be more adherent to their antiretroviral therapy (ART) treatment.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Central Florida

Lead sponsor

Sunserve

Collaborator

Survivor's Pathway

Collaborator

26Health

Collaborator

National Institute of Drug Abuse

Collaborator

Source ClinicalTrials.gov
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