Long-acting Biomedical HIV Prevention in Transgender Women

Study Overview
=================
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).

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

Conditions
-----------------
HIV Prevention, Transgender Women

Intervention / Treatment
-----------------
* Behavioral: Alternative long-acting PrEP injection strategies
* Behavioral: mHealth adherence app


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-injection<br>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<br>* 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<br>Behavioral: mHealth adherence app<br>* 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)<br>|
| Experimental: Injection by HCP at drop-in clinics<br>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<br>* 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<br>Behavioral: mHealth adherence app<br>* 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)<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |