Clinical trial NCT03856580: Long-acting Biomedical HIV Prevention in Transgender Women
Official title: Developing Tailored Delivery and Adherence Interventions for Use of Long-acting Biomedical HIV Prevention Strategies by Transgender Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV Prevention
Transgender Women
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: New York State Psychiatric Institute
First posted: 2019-02-27
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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

Primary outcomes:
measure: Number of completed injections at month 6
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute/Columbia University Medical Center
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Christine Rael, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: