Recruiting

HIV Prevention

Sponsor:

Columbia University

Code:

NCT05165745

Conditions

HIV Prevention

Pre-exposure Prophylaxis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Individualized Feedback

Study Details

Brief summary:

Taking a daily anti-HIV pill can protect people from HIV infection. This is called preexposure prophylaxis \[PrEP\]. Many cisgender women and trans individuals do not know this medication is available; others struggle to take the pill every day. It is important to understand attitudes and preferences about HIV prevention options, especially as new options become available. This study plans to evaluate preferences over time among cisgender women and trans individuals who are taking medication to prevent HIV, and among cisgender women and trans individuals who are not taking medication but are at risk of HIV. The investigators enroll up to 175 participants who visit the HIV prevention clinic, and the investigators will ask participants to complete questionnaires at regular follow up visits and between visits. This study may help the investigators understand how best to prevent HIV among people at risk.

Conditions

HIV Prevention

Pre-exposure Prophylaxis

Study ID

NCT05165745

Start date

Oct 25, 2021

Status verified date

Aug, 2025

Completion date

Oct 25, 2026

Anticipated

Primary completion date

Oct 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Cisgender women and trans individuals who have an indication for PrEP and have 1) decided to take PrEP, 2) decided not to take PrEP, or 3) decided to discontinue PrEP

Exclusion Criteria:

  • Cannot provide informed consent
  • Living with HIV

Study Design

Enrollment

175 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Cisgender Women and Trans Individuals (CWTI)

Cisgender women and trans individuals (CWTI) who are taking PrEP, have considered and decided not to take PrEP, or who have discontinued PrEP.

Interventions

Individualized Feedback

Participants taking PrEP will receive questionnaires regarding self-reported weekly PrEP adherence; they will then receive individualized text-message or email feedback based on their self-reported adherence.

Primary outcome measure

  • Correlation Between PrEP modality preference and PrEP initiation/persistence in care [ Time Frame: 12 months ]
  • PrEP Measurement Preferences Scale Score [ Time Frame: 12 months ]
  • Percentage of participants on PrEP who remain engaged in sexual health care [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Deborah Theodore, MD

2123052201dat2132@cumc.columbia.edu

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Deborah Theodore, MD

212-305-2201dat2132@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-09-02.