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NCT Number: NCT05165745

Stick2PrEP Cisgender Women and Trans Individuals

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.

Recruiting

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Key information

Conditions

HIV Prevention Pre-exposure Prophylaxis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Deborah Theodore, MD

CONTACT

[email protected]

212-305-2201

About this study

Participants will receive online questionnaires about demographic characteristics, social determinants of health, and preferences regarding PrEP modalities. Qualitative, in-depth surveys will be conducted with 12 CWTI who decide not to start PrEP and 12 CWTI who decide to discontinue PrEP to explore the drivers behind those decisions. Participants who are taking PrEP will be offered the option of providing dried blood spot samples at clinic visits to measure PrEP levels and will receive an online questionnaire addressing their preferences regarding different modalities of measuring PrEP levels. The purpose of the HemaSpot™ kit is to understand the subjects' perceptions of using this kit for self-testing PrEP levels; this will inform future strategies regarding PrEP monitoring. Participants taking PrEP will also receive questionnaires regarding self-reported weekly PrEP adherence; they will then receive individualized text-message or email feedback based on their self-reported adherence in addition to standard-of-care retention/adherence counseling. Participants on PrEP can also elect to receive or emails messages to remind them to take PrEP and attend follow up appointments.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized Feedback

Behavioral

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 outcomes

  1. Correlation Between PrEP modality preference and PrEP initiation/persistence in care

    Time frame: 12 months

    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.

  2. PrEP Measurement Preferences Scale Score

    Time frame: 12 months

    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.

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

    Time frame: 12 months

    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.

Secondary outcomes

  1. Correlation of risk factors for low PrEP adherence and retention

    Time frame: 12 months

    Risk factors that may be associated with poor retention in PrEP/sexual health care and low adherence to PrEP. Adherence to PrEP is measured by weekly self-report among participants taking PrEP. Retention in sexual healthcare is measured by review of the electronic medical record to track sexual health care visits over the study period.

  2. Web-Based App User Satisfaction Score

    Time frame: 12 months

    User comfort/satisfaction with the web-based app will be assessed using Likert scale responses. Scores range from 0 to 5 with a higher score indicating greater user comfort/satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Theodore, MD

CONTACT

[email protected]

2123052201

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Stick2PrEP Women/Trans Individuals: Increasing Pre-Exposure Prophylaxis (PrEP) Uptake, Adherence, and Retention in Care, and Understanding PrEP Preferences Among Predominantly Black and Latinx Cisgender Women and Transgender Individuals

Acronym: S2P:CWTI

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2021
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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