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Stick2PrEP Cisgender Women and Trans Individuals (S2P:CWTI)

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Columbia University

Status

Enrolling

Conditions

Pre-exposure Prophylaxis
HIV Prevention

Treatments

Behavioral: Individualized Feedback

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05165745
AAAS6460

Details and patient eligibility

About

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.

Full 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.

Enrollment

175 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

175 participants in 1 patient group

Cisgender Women and Trans Individuals (CWTI)
Other group
Description:
Cisgender women and trans individuals (CWTI) who are taking PrEP, have considered and decided not to take PrEP, or who have discontinued PrEP.
Treatment:
Behavioral: Individualized Feedback

Trial contacts and locations

1

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Central trial contact

Deborah Theodore, MD

Data sourced from clinicaltrials.gov

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