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NCT03856580 · ClinicalTrials.gov registry record · NA
Long-acting Biomedical HIV Prevention in Transgender Women
A NA study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT03856580 is a NA study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 19 participants.
The verdict
NCT03856580, a NA study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study 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
- BEHAVIORAL mHealth adherence app
- BEHAVIORAL Alternative long-acting PrEP injection strategies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2023-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03856580
The ClinicalTrials.gov registry entry for NCT03856580 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which mHealth adherence app is the first listed.
NCT03856580 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03856580 about?
NCT03856580 is a clinical study titled "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 deliv...
What is the current status of trial NCT03856580?
This trial is currently terminated. It is a NA study. The enrollment target is 19 participants. The study started on 2020-10-23. Estimated completion is 2023-04-30.
What interventions are being tested in trial NCT03856580?
The interventions under investigation include: mHealth adherence app (BEHAVIORAL), Alternative long-acting PrEP injection strategies (BEHAVIORAL).
Who is sponsoring clinical trial NCT03856580?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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