Long-acting Biomedical HIV Prevention in Transgender Women
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).
Conditions:
🦠 HIV Prevention
🦠 Transgender Women
🗓️ Study Start (Actual)
23 October 2020
🗓️ Primary Completion (Estimated)
31 January 2024
✅ Study Completion (Estimated)
31 January 2024
👥 Enrollment (Estimated)
45
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
New York, New York, United States
Description
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:
18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Yes
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
22 February 2019
- First Submitted that Met QC Criteria
25 February 2019
- First Posted
27 February 2019
Study Record Updates
- Last Update Submitted that Met QC Criteria
2 November 2022
- Last Update Posted
4 November 2022
- Last Verified
November 2022