TerminatedNot Applicable

A Pharmacist-run PrEP Program for Women

Stopped: This protocol was early terminated on 10/15/2024 due to low enrollment

United States2 participantsStarted 2023-06-21

Plain-language summary

The primary objective of this study is to evaluate uptake and retention of long acting cabotegravir (LA-CAB) also known as Apretude versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) also known as Truvada for PrEP among high-risk women in metro-Orlando through week 48 (to also include reasons for lack of retention in PrEP care)

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Partner living with HIV with unknown viral load
. ≥1 sex partner of unknown HIV status
. Bacterial STI in the past 6 months (GC/Chlamydia or syphilis)

Exclusion criteria

Evidence of Hepatitis C virus (HCV) infection based on the results of testing at Screening for Hepatitis C antibody (HCV Ab) and HCV RNA as follows:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Uptake of LA-CAB vs. TDF/FTC for PrEP

Timeframe: 48 weeks

Persistence on LA-CAB vs. TDF/FTC for PrEP

Timeframe: 48 weeks

Trial details

NCT IDNCT05755204

SponsorOrlando Immunology Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-15

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