NCT05165745

Stick2PrEP Cisgender Women and Trans Individuals

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• HIV Prevention
• Pre-exposure Prophylaxis

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2021-10-25
• Primary completion: 2026-10-25
• Completion: 2026-10-25
• First posted: 2021-12-21
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States