Linkage of Transgender Individuals to PrEP
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03191474|
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Seronegativity Linkage||Behavioral: T-POWr Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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|
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.
- 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.
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
|Contact: Sheldon Morris, MD MPHfirstname.lastname@example.org|
|Contact: Eric E Ellorin, MASemail@example.com|
|United States, California|
|Los Angeles Lesbian, Gay, Bisexual, and Transgender Center||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Chloe Opalo firstname.lastname@example.org|
|Contact: Madin Sadat email@example.com|
|Principal Investigator: Robert Bolan, MD|
|University of California, San Diego||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Brooke Sullivan firstname.lastname@example.org|
|Contact: Elizabeth Lampley email@example.com|
|Principal Investigator: Sheldon Morris, MD MPH|
|Study Chair:||Sheldon Morris, MD MPH||CCTG, UCSD AVRC|