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Long-acting Biomedical HIV Prevention in Transgender Women

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: NCT03856580
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : June 30, 2021
Sponsor:
Collaborator:
New York State Psychiatric Institute
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
Transgender women (TW) have unique challenges related to HIV prevention medication adherence. Left unaddressed, these challenges will prevent TW from accessing the promising long-acting HIV prevention tools in the development pipeline. This study will develop a replicable process to tailor the delivery of these tools and an adherence intervention (that will include an mHealth app) to the needs of TW, using the example of inert injectable cabotegravir. Work builds on a pilot study to identify tailored methods to deliver injectable cabotegravir in TW, such as self-injection and injection by a healthcare provider at at "drop-in" clinic. The investigators will use qualitative methods (e.g., interviews, group discussions called "Design Sessions") to design the adherence intervention and the mHealth app. Then, investigators will execute a partially randomized patient-preference trial to determine if TW are able to use tailored injection strategies (self-injection or injection by a healthcare provider at "drop-in clinics") to improve adherence, compared to a control group of TW who will engage a protocol based on HPTN-083/084. This will serve as a "proof of concept" for the future R01 that will test this on a larger scale. Research and training will take place at NYSPI/Columbia, in affiliation with, 1) Project AFFIRM, a study of transgender identity (R01HD079603; PI: Bockting), that will provide infrastructure for critical research activities (e.g., recruitment), and 2) SLAP-HIV, a clinical trial to produce a long-acting form of cabotegravir (e.g., injection; UM1 AI120184; PI: Hope). SLAP-HIV will provide clinical oversight (e.g., ensure tailored delivery strategies are feasible).

Condition or disease Intervention/treatment Phase
HIV Prevention Transgender Women Behavioral: Alternative long-acting PrEP injection strategies Behavioral: mHealth adherence app Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developing Tailored Delivery and Adherence Interventions for Use of Long-acting Biomedical HIV Prevention Strategies by Transgender Women
Actual Study Start Date : October 23, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Self-injection
Participants will be trained on how to self-inject (intramuscular, gluteal muscle) an inert version of injectable cabotegravir. The inert substance is intended to mimic injectable cabotegravir as closely as possible (e.g., injection equipment, location of injection, volume of injection is identical to injectable cabotegravir). Specifically, participants will self-inject their choice of 300mg vitamin B12 or saline (3ml fluid) every 2 months for a total of 6 months (for a total of 4 injections). Participants will complete interviews and brief surveys on their experience. Additionally, they will be given access to an mHealth app to improve adherence, which will contain informational content such as instructions on how to self-inject, FAQs about self-injection, study contact information, etc..
 Behavioral: Alternative long-acting PrEP injection strategies
Participants in the two intervention groups will complete injection procedures (e.g., self-injection, injection by healthcare providers at "drop-in" clinics) to determine if this could facilitate improved adherence to an inert version of long-acting cabotegravir injections

Behavioral: mHealth adherence app
Participants in the two experimental arms will be given a smartphone application, designed to facilitate adherence (this app will be developed during earlier phases of the study using in-depth interviews and "design session" groups)
Experimental: Injection by HCP at "drop-in" clinics
Participants will report to a "drop-in" clinic, where a healthcare provider will inject them with an inert version of injectable cabotegravir. "Visits will take <10 minutes, and participants will be able to come whenever they want (when their injection is due) during clinic "drop-in" hours, which will be staggered in 2-hour windows during each week day. The inert substance that will be injected is intended to mimic injectable cabotegravir as closely as possible (described above). Participants will complete interviews and brief surveys on their experience. Additionally, they will be given access to an mHealth app to improve adherence, which will contain informational content such as "drop-in" clinic hours, directions to the "drop-in" clinic site, study contact information, etc...
 Behavioral: Alternative long-acting PrEP injection strategies
Participants in the two intervention groups will complete injection procedures (e.g., self-injection, injection by healthcare providers at "drop-in" clinics) to determine if this could facilitate improved adherence to an inert version of long-acting cabotegravir injections

Behavioral: mHealth adherence app
Participants in the two experimental arms will be given a smartphone application, designed to facilitate adherence (this app will be developed during earlier phases of the study using in-depth interviews and "design session" groups)
No Intervention: Control group
Participants will make an appointment when their injection is due to report to our clinic to complete injections. Visits and the injection protocol will follow similar procedures to HPTN-083/084. Participants will not have access to the mHealth adherence app.


Outcome Measures
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Primary Outcome Measures :
  1. Number of completed injections at month 6 [ Time Frame: 6 months ]
    Number of completed injections by each of the possible intervention arms (self-injection, injection by HCP at "drop-in" clinics), compared to the controls group at month 6.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Assigned male at birth but identifies as a woman, Transgender woman, Woman of transgender experience
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV-negative
  • self-identified transgender woman (or woman assigned male at birth)
  • at least 18 years old
  • willing to complete injections
  • own a smartphone that uses apps
  • speak English or Spanish
  • willing to take an HIV test
  • live in the NYC/tri-state area
  • report receptive or penetrative genital-to-genital sex with another person in the last 3 months

Exclusion Criteria:

  • HIV-positive
  • does not identify as a transgender woman (or woman assigned male at birth)
  • younger than 18
  • unwilling to complete injections
  • does not own a smartphone that uses apps
  • does not speak English or Spanish
  • refuses HIV test
  • lives outside of the NYC/tri-state area
  • has not had receptive or penetrative genital-to-genital sex with another person in the last 3 months
Contacts and Locations
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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): NCT03856580


Contacts
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Contact: Christine T Rael, Ph.D. 646-774-6967 cr2857@cumc.columbia.edu
Contact: Alex Carballo-Diéguez, Ph.D. 646-774-6930 ac72@cumc.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute/Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Christine Rael, Ph.D.    646-774-6967    cr2857@cumc.columbia.edu   
Contact: Javier Lopez-Rios, M.P.H.    646-774-6974    javier.lopezrios@nyspi.columbia.edu   
Sponsors and Collaborators
University of Colorado, Denver
New York State Psychiatric Institute
Investigators
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Principal Investigator: Christine Rael, Ph.D. New York State Psychiatric Institute
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03856580    
Other Study ID Numbers: 21-3620tx
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021

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