HIV Prevention, Transgender Women
Conditions
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).
Interventions
BEHAVIORALAlternative 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
BEHAVIORALmHealth 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)
Sponsors
New York State Psychiatric Institute
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of completed injections at month 6 | 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. |
Countries
United States
Outcome results
None listed