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Linkage of Transgender Individuals to PrEP

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ClinicalTrials.gov Identifier: NCT03191474
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
University of Southern California
LA Biomed at Harbor-UCLA
The Los Angeles Lesbian, Gay, Bisexual, and Transgender Center
The Family Health Centers of San Diego
Information provided by (Responsible Party):
California Collaborative Treatment Group

Brief Summary:
CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus standard of care (SOC).

Condition or disease Intervention/treatment Phase
HIV Seronegativity Linkage Behavioral: T-POWr Intervention Not Applicable

Detailed Description:

Up to 500 self-identified transgender / gender non-conforming persons seeking daily Pre-Exposure Prophylaxis (PrEP) for the prevention of HIV will be enrolled into this study. Each participant will be followed up to 28 weeks after enrollment. The primary endpoint, successful linkage to a PrEP evaluation visit, will be measured after 30 days of enrollment.

Participants expressing interest in PrEP will be referred to the regional transgender PrEP outreach work (T-POWr) via phone call. Enrolled participants will be randomized (1:1) to either SOC PrEP linkage vs T-POWr facilitated PrEP linkage. Participants randomized into the SOC Arm will receive an HIV risk assessment, PrEP education, and an appointment for a linkage visit. Participants randomized into the T-POWr arm will receive SOC and a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services.

Participants will be contacted at Week 4 to verify linkage, and at Weeks 16 and 28 to assess PrEP and HIV status, and access to referred services.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: CCTG 602: Linkage of Transgender Individuals to PrEP, A Multicenter Trial of the California Collaborative Treatment Group (CCTG)
Actual Study Start Date : July 28, 2017
Estimated Primary Completion Date : April 6, 2020
Estimated Study Completion Date : April 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care Arm
Participants will receive standard of care HIV risk assessment, PrEP education, and an appointment for a PrEP evaluation visit at an affiliated clinic.
Experimental: T-POWr Intervention Arm
Participants will receive the same HIV risk assessment, PrEP education, and appointment for a PrEP evaluation visit as the Control Arm. Participants in the Intervention Arm will also receive a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services.
Behavioral: T-POWr Intervention

All participants will be asked to complete a secure confidential online survey focusing on needs assessment.

Participants in the T-POWr Intervention Arm will receive a client-centered case management consultation based on how the participant responds to the online survey. The T-POWr will refer participants to assistance services based on the needs assessment, including accessing general health care, health insurance, hormone replacement therapy, housing, mental health care, domestic violence care, substance use treatment, etc. Each resource is extensively vetted to assure a trans-friendly experience and will be tailored to each geographic area across the project enrollment sites. The study facilitates referrals for services but will not provide extensive and ongoing case management.





Primary Outcome Measures :
  1. Facilitated Linkage [ Time Frame: Baseline up to Week 28 ]
    To evaluate the effectiveness of a T-POWr intervention to effectively link transgender / gender non-conforming persons to a PrEP evaluation visit.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Transgender or Gender Non-conforming, defined as identifying with a gender different from sex assigned at birth.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Self-identifies as a transgender or gender non-conforming person
  • Self-identifies as HIV-negative or unknown status
  • Ability to provide informed consent
  • English or Spanish speaking

Exclusion Criteria:

  • Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191474


Contacts
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Contact: Sheldon Morris, MD MPH 619.543.8080 shmorris@ucsd.edu
Contact: Eric E Ellorin, MAS 619.543.5011 eellorin@ucsd.edu

Locations
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United States, California
Los Angeles Lesbian, Gay, Bisexual, and Transgender Center Recruiting
Los Angeles, California, United States, 90027
Contact: Chloe Opalo       copalo@lalgbtcenter.org   
Contact: Madin Sadat       msadat@lalgbtcenter.org   
Principal Investigator: Robert Bolan, MD         
University of California, San Diego Recruiting
San Diego, California, United States, 92103
Contact: Brooke Sullivan       b5sullivan@ucsd.edu   
Contact: Elizabeth Lampley       elampley@ucsd.edu   
Principal Investigator: Sheldon Morris, MD MPH         
Sponsors and Collaborators
California Collaborative Treatment Group
University of Southern California
LA Biomed at Harbor-UCLA
The Los Angeles Lesbian, Gay, Bisexual, and Transgender Center
The Family Health Centers of San Diego
Investigators
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Study Chair: Sheldon Morris, MD MPH CCTG, UCSD AVRC

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Responsible Party: California Collaborative Treatment Group
ClinicalTrials.gov Identifier: NCT03191474     History of Changes
Other Study ID Numbers: CCTG 602
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by California Collaborative Treatment Group:
PrEP
Pre-exposure Prophylaxis
Truvada
Client-centered case management
Transgender
Gender non-conforming