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Antiretroviral Agent

Long-acting PrEP Injections + Adherence App for HIV Prevention in Transgender Women

N/A
Recruiting
Led By Christine Rael, Ph.D.
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test if transgender women (TW) can use tailored injection strategies, such as self-injection or injection by a healthcare provider at "drop-in clinics", to improve adherence to HIV prevention medication, compared to a control group of TW.

Who is the study for?
This trial is for HIV-negative transgender women over 18 years old who live in the NYC/tri-state area. Participants must be willing to take an HIV test, complete injections, and have had genital-to-genital sex in the last 3 months. They should own a smartphone with app capabilities and speak English or Spanish.Check my eligibility
What is being tested?
The study tests long-acting PrEP injection strategies tailored for transgender women, including self-injection or healthcare provider-administered injections at drop-in clinics. It also evaluates an mHealth adherence app designed through interviews and group discussions.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will use injectable cabotegravir which may include common drug-related side effects such as pain at the injection site, potential allergic reactions, or systemic effects like fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of completed injections at month 6

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Self-injectionExperimental Treatment2 Interventions
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..
Group II: Injection by HCP at "drop-in" clinicsExperimental Treatment2 Interventions
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...
Group III: Control groupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mHealth adherence app
2021
N/A
~20

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteOTHER
474 Previous Clinical Trials
153,212 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,631 Total Patients Enrolled
Christine Rael, Ph.D.Principal InvestigatorNew York State Psychiatric Institute

Media Library

Cabotegravir (Antiretroviral Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03856580 — N/A
Transgender Women Research Study Groups: Injection by HCP at "drop-in" clinics, Self-injection, Control group
Transgender Women Clinical Trial 2023: Cabotegravir Highlights & Side Effects. Trial Name: NCT03856580 — N/A
Cabotegravir (Antiretroviral Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03856580 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include elderly participants?

"In order to qualify for this clinical trial, applicants must be between 18 and 100. Those who are younger than 18 or older than 65 may still consider one of the 6 trials that cater exclusively to those age brackets."

Answered by AI

To what extent has enrollment been successful for this experiment?

"Affirmative. According to clinicaltrials.gov, this scientific research was initially posted on October 23rd 2020 and is currently recruiting participants. The trial requires 45 patients from one site for completion."

Answered by AI

For which patient population is this study most suitable?

"To be considered for inclusion in this trial, applicants must have a HIV diagnosis and fall in the age range of 18 to 100. The study is looking for 45 participants."

Answered by AI

Are there any available spots for participants in this trial?

"This clinical trial, which was initially publicized on October 23rd 2020 is actively recruiting participants. The study has been recently updated as of November 2nd 2022 and can be found online."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~10 spots leftby Mar 2025