Long-acting Biomedical HIV Prevention in Transgender Women

HIV Prevention Clinical Trial

Official title:

Developing Tailored Delivery and Adherence Interventions for Use of Long-acting Biomedical HIV Prevention Strategies by Transgender Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03856580
• Other study ID #: 21-3620tx
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2022
• Source: University of Colorado, Denver
• Contact: Christine T Rael, Ph.D.
• Phone: 646-774-6967
• Email: cr2857[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention
• Transgender Women

Intervention

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
• 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)

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute/Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of completed injections at month 6	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.	6 months