Clinical trial NCT05165745: Stick2PrEP Cisgender Women and Trans Individuals
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Pre-exposure Prophylaxis
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-12-21
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation Between PrEP modality preference and PrEP initiation/persistence in care
timeFrame: 12 months
measure: PrEP Measurement Preferences Scale Score
timeFrame: 12 months
measure: Percentage of participants on PrEP who remain engaged in sexual health care
timeFrame: 12 months
Secondary outcomes:
measure: Correlation of risk factors for low PrEP adherence and retention
timeFrame: 12 months
measure: Web-Based App User Satisfaction Score
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Magdalena Sobieszczyk, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: