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Stick2PrEP Cisgender Women and Trans Individuals

ConditionsHIV PreventionPre-exposure Prophylaxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Cannot provide informed consent

Living with HIV

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

175 Participants
are divided into 1 treatment group
Group A: Cisgender Women and Trans Individuals (CWTI)Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months

Secondary outcomes

1

Correlation of risk factors for low PrEP adherence and retention

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.

Time frame
12 months
2

Web-Based App User Satisfaction Score

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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