HIV PreventionS2P:CWTINCT05165745
Stick2PrEP Cisgender Women and Trans Individuals
A study testing Individualized Feedback in people with HIV Prevention and Pre-exposure Prophylaxis, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Pre-exposure Prophylaxis
- What is being tested?
- Individualized Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 25 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cannot provide informed consent
- Living with HIV
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Deborah Theodore, MD, 212-305-2201, dat2132@cumc.columbia.edu
About this study
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
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.
Read the 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
- Being tested
- Individualized Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized FeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cisgender Women and Trans Individuals (CWTI) | Other | Cisgender women and trans individuals (CWTI) who are taking PrEP, have considered and decided not to take PrEP, or who have discontinued PrEP. Receives: Behavioral: Individualized Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start25 Oct 2021
- Primary completion25 Oct 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Magdalena Sobieszczyk, Columbia University
- Investigators
- Magdalena Sobieszczyk, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165745
- Sponsor's protocol ID
- AAAS6460
- Acronym
- S2P:CWTI
- Status last verified
- Aug 2025
- First submitted
- 8 Dec 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05165745
- Acronym / sponsor ID
- S2P:CWTI / AAAS6460
- Conditions
- HIV Prevention, Pre-exposure Prophylaxis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisgender Women and Trans Individuals (CWTI) | Other | Behavioral: Individualized FeedbackCisgender women and trans individuals (CWTI) who are taking PrEP, have considered and decided not to take PrEP, or who have discontinued PrEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Cannot provide informed consent
- Living with HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized FeedbackParticipants 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. | Behavioural | Cisgender Women and Trans Individuals (CWTI) |
Primary outcome
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.
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.
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.
2 secondary outcomes
Correlation of risk factors for low PrEP adherence and retention
Time frame: 12 months
Web-Based App User Satisfaction Score
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magdalena Sobieszczyk, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Feedback in people with HIV Prevention and Pre-exposure Prophylaxis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Theodore, MD (2123052201, dat2132@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between PrEP modality preference and PrEP initiation/persistence in care (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.