NCT05165745

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Oct 2021Oct 2026

Study Start

First participant enrolled

October 25, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2026

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

December 8, 2021

Last Update Submit

August 25, 2025

Conditions

HIV PreventionPre-exposure Prophylaxis

Outcome Measures

Primary Outcomes (3)

  • Correlation Between PrEP modality preference and PrEP initiation/persistence in care

    Description of CWTI's preferences for different PrEP modalities and the relationship between preference and PrEP initiation/persistence in care. Preferences are evaluated using questionnaires developed by the study team; questions include ranked choice and Likert score responses. Persistence in care is measured by using the electronic medical record to track sexual health care visits over study period.

    12 months

  • PrEP Measurement Preferences Scale Score

    CWTI's experience with and preferences regarding laboratory measurement techniques for PrEP. Preferences are evaluated based on a questionnaire developed by the study team; acceptability, feasibility, and perceived usefulness of varying PrEP measurement techniques are evaluated using a 5-point Likert scale. Scores range from 0 to 5, with a higher score indicating greater acceptability, feasibility, and usefulness.

    12 months

  • Percentage of participants on PrEP who remain engaged in sexual health care

    Effect of individualized feedback on retention in care at 12 months. Retention in care is measured by using the electronic medical record to track sexual health care visits over the study period. Outcome will be measured by percentage of participants on PrEP who remain engaged in sexual health care (attending visits) at study center through 12 months after enrollment.

    12 months

Secondary Outcomes (2)

  • Correlation of risk factors for low PrEP adherence and retention

    12 months

  • Web-Based App User Satisfaction Score

    12 months

Study Arms (1)

Cisgender Women and Trans Individuals (CWTI)

OTHER

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

Behavioral: Individualized Feedback

Interventions

Individualized FeedbackBEHAVIORAL

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.

Cisgender Women and Trans Individuals (CWTI)

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsCisgender women and transgender individuals
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cannot provide informed consent
  • Living with HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Study Officials

  • Magdalena Sobieszczyk, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Theodore, MD

CONTACT

2123052201dat2132@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Harold C. Neu Professor of Infectious Diseases (in Medicine) at the Columbia University Medical Center

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 21, 2021

Study Start

October 25, 2021

Primary Completion (Estimated)

October 25, 2026

Study Completion (Estimated)

October 25, 2026

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)