Sexual Risk Behavior for HIV-infectionPhase 2NCT06684613
Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
A Phase 2 study testing PrEP Decision Aid and Generic Information in people with Sexual Risk Behavior for HIV-infection and Reproductive Health, run by Yale University at 1 site in United States.
Trial summary
This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Risk Behavior for HIV-infection, Reproductive Health
- What is being tested?
- PrEP Decision Aid and Generic Information
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to 5 Sep 2027
- Phase
- Phase 2
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Patients (inclusion):
- Woman
- Aged 18 years or older
- Have a uterus
- Do not have HIV (by self-report)
- Not currently on PrEP
- Comfortable conversing in English or Spanish
- Able to participate in informed consent procedures
Patients (exclusion):
- People who cannot become pregnant (i.e., have had a hysterectomy or tubal ligation)
- People who wish to become pregnant (will not qualify for pregnancy prevention counseling)
- Have a scheduled visit with a member of the investigative team (to minimize risk of potential ascertainment bias)
- Participants of Aim 1 cannot participate in Aim 2.
Sexual and Reproductive Health clinicians will be included if they provide sexual and reproductive health patient care at any of the participating sites. Clinic staff will be included if they work at any of the participating sites and have patient-facing or non-patient-facing roles .
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
Yale Clinical and Community Research
New Haven, Connecticut, 06519
Carolina Price, MPA, 203-499-8075, carolina.price@yale.edu
Jaimie P Meyer, MD, 2037376233, jaimie.meyer@yale.edu
About this study
Official title: Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.
Read the detailed description
The purpose of this study is to expand and enhance a PrEP decision aid to include the full array of available formulation options and then integrate its delivery into sexual and reproductive health settings during counseling visits, where PrEP can be provided to all women who are interested. Rooted in health implementation frameworks, this study evaluates health and implementation determinants simultaneously along: 1) innovation characteristics; 2) clinical encounter; 3) recipients; and 4) context.
In Aim 1, patients (n=15-20), clinicians (n=10), and staff (n=10) at sexual and reproductive health clinics across Greater New Haven, CT will be engaged for semi-structured interviews to expand and enhance an existing PrEP decision aid to include all available formulations and optimize its integration into sexual and reproductive health clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in sexual and reproductive health clinics.
In Aim 2 (a hybrid Type 2 effectiveness-implementation study), patients will be randomized (n=50) to receive either the PrEP decision aid or generic PrEP information prior to a clinician visit. In follow-up interviews immediately post-visit, and at Months 3 and 6, primary outcomes are clinical efficacy (PrEP initiation) and implementation (using Proctor definitions for feasibility, acceptability, penetration, and adoption) that are important for future planned scale-up.
- Being tested
- PrEP Decision Aid, Generic Information
- Keywords
- HIV Prevention, PrEP, sexual reproductive health, woman
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP Decision AidDevice
Patient-facing decision-aid on PrEP that will be enhanced to include various formulations of available PrEP. Can be integrated into sexual and reproductive health clinics as part of counseling.
Generic InformationOther
Participants will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis" (available online free of charge through the CDC web site). The video will serve as a time- and attention- based control to the decision aid.
| Study group | Role | What they receive |
|---|---|---|
| PrEP Decision Aid | Experimental | Participants randomized to the decision aid (active intervention arm), will interact with the enhanced PrEP decision aid in REDCap. This is an individualized, patient-facing decision aid that supports informed patient choice and is interactive. In contrast to shared decision aids that guide a clinical encounter, the participants uses the individualized decision aid prior to the clinical encounter to discretely assess HIV risk and build awareness before discussing with their clinician Receives: Device: PrEP Decision Aid |
| Generic Information | Other | Participants randomized to this arm will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis)" (available online free of charge through CDC website) that will serve as a time- and attention-based control. Receives: Other: Generic Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP initiation (prescribing)
Whether PrEP was prescribed (yes/no) in the EHR within the 6-month time frame
Measured: 6 months
Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy
Feasibility is defined as the extent to which the enhanced PrEP decision aid can be successfully used in SRH clinic settings (qualitative).
Measured: 6 months
Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)
Acceptability is defined as the user perception that the enhanced PrEP decision aid is acceptable in SRH settings.
Measured: 6 months
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
Penetration (reach) of the intervention, measured by recruitment rate (number of participants enrolled per month)
Measured: 6 months
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
Penetration (reach) of the intervention, measured by completion rate (percentage of participants completing 6-month interviews out of those enrolled)
Measured: 6 months
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
Penetration (reach) of the intervention, measured by reasons for not meeting inclusion criteria
Measured: 6 months
Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)
Adoption of the enhanced decision aid into SRH clinics, assessed by whether PrEP was discussed during the visit (yes/no)
Measured: 6 months
Secondary outcomes (6)
PrEP initiation (dispensing)
Whether PrEP was dispensed (yes/no) in the EHR within the 6-month time frame
Measured: 6 months
PrEP initiation (first use)
Whether PrEP was started by the patient within the 6 months' time frame (yes/no)
Measured: 6 months
PrEP adherence
Non-pharmacokinetic: (subjective) 3-item self-report with 30-day look-back
Measured: 6 months
PrEP adherence
Non-pharmacokinetic: (objective) pharmacy refill data or injection dates for LAI.
Measured: 6 months
PrEP adherence
Pharmacokinetic: (objective) urine tenofovir levels (units detected/ not detected)
Measured: 6 months
PrEP persistence
Dates of completed PrEP encounters in EHR (i.e., clinic dates)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start11 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion5 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Risk Behavior for HIV-infectionStudies of the same condition, open and under way.
- More trials run by Yale 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will use health-focused implementation frameworks to develop a semi-structured interview guide for the formative work in Aim 1. Domains will be measured in Aim 2 to examine implementation determinants. In Aim 2, we will randomize participants 1:1 to receive either a) the enhanced decision aid developed in Aim 1, or b) generic information on PrEP provided by a CDC-produced video, PrEP (Pre-Exposure Prophylaxis).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jaimie P Meyer, MD, Principal investigator, Yale Clinical and Community Research, Yale School of MedicineSangini S Sheth, MD, Principal investigator, Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684613
- Sponsor's protocol ID
- 2000038555
- Other IDs
- 1R34MH137756-01
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
- ClinicalTrials.gov ID
- NCT06684613
- Acronym / sponsor ID
- 2000038555
- Keywords
- HIV Prevention, PrEP, sexual reproductive health, woman
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 5 Sep 2027 (estimated)
- First posted
- 12 Nov 2024 (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.
This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.
Detailed description
The purpose of this study is to expand and enhance a PrEP decision aid to include the full array of available formulation options and then integrate its delivery into sexual and reproductive health settings during counseling visits, where PrEP can be provided to all women who are interested. Rooted in health implementation frameworks, this study evaluates health and implementation determinants simultaneously along: 1) innovation characteristics; 2) clinical encounter; 3) recipients; and 4) context.
In Aim 1, patients (n=15-20), clinicians (n=10), and staff (n=10) at sexual and reproductive health clinics across Greater New Haven, CT will be engaged for semi-structured interviews to expand and enhance an existing PrEP decision aid to include all available formulations and optimize its integration into sexual and reproductive health clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in sexual and reproductive health clinics.
In Aim 2 (a hybrid Type 2 effectiveness-implementation study), patients will be randomized (n=50) to receive either the PrEP decision aid or generic PrEP information prior to a clinician visit. In follow-up interviews immediately post-visit, and at Months 3 and 6, primary outcomes are clinical efficacy (PrEP initiation) and implementation (using Proctor definitions for feasibility, acceptability, penetration, and adoption) that are important for future planned scale-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will use health-focused implementation frameworks to develop a semi-structured interview guide for the formative work in Aim 1. Domains will be measured in Aim 2 to examine implementation determinants. In Aim 2, we will randomize participants 1:1 to receive either a) the enhanced decision aid developed in Aim 1, or b) generic information on PrEP provided by a CDC-produced video, PrEP (Pre-Exposure Prophylaxis).
| Arm | Type | Receives |
|---|---|---|
| PrEP Decision Aid | Experimental | Device: PrEP Decision AidParticipants randomized to the decision aid (active intervention arm), will interact with the enhanced PrEP decision aid in REDCap. This is an individualized, patient-facing decision aid that supports informed patient choice and is interactive. In contrast to shared decision aids that guide a clinical encounter, the participants uses the individualized decision aid prior to the clinical encounter to discretely assess HIV risk and build awareness before discussing with their clinician |
| Generic Information | Other | Other: Generic InformationParticipants randomized to this arm will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis)" (available online free of charge through CDC website) that will serve as a time- and attention-based control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PrEP Decision AidPatient-facing decision-aid on PrEP that will be enhanced to include various formulations of available PrEP. Can be integrated into sexual and reproductive health clinics as part of counseling. | Device | PrEP Decision Aid |
| Generic InformationParticipants will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis" (available online free of charge through the CDC web site). The video will serve as a time- and attention- based control to the decision aid. | Other | Generic Information |
Primary outcome
PrEP initiation (prescribing)
Time frame: 6 months
Whether PrEP was prescribed (yes/no) in the EHR within the 6-month time frame
Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy
Time frame: 6 months
Feasibility is defined as the extent to which the enhanced PrEP decision aid can be successfully used in SRH clinic settings (qualitative).
Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)
Time frame: 6 months
Acceptability is defined as the user perception that the enhanced PrEP decision aid is acceptable in SRH settings.
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
Time frame: 6 months
Penetration (reach) of the intervention, measured by recruitment rate (number of participants enrolled per month)
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
Time frame: 6 months
Penetration (reach) of the intervention, measured by completion rate (percentage of participants completing 6-month interviews out of those enrolled)
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
Time frame: 6 months
Penetration (reach) of the intervention, measured by reasons for not meeting inclusion criteria
Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)
Time frame: 6 months
Adoption of the enhanced decision aid into SRH clinics, assessed by whether PrEP was discussed during the visit (yes/no)
6 secondary outcomes
PrEP initiation (dispensing)
Time frame: 6 months
PrEP initiation (first use)
Time frame: 6 months
PrEP adherence
Time frame: 6 months
PrEP adherence
Time frame: 6 months
PrEP adherence
Time frame: 6 months
PrEP persistence
Time frame: 6 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 4 Sep 2026.
- PrEP (Pre-Exposure Prophylaxis)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Jaimie P Meyer, MD principal investigator
Yale Clinical and Community Research, Yale School of Medicine
Sangini S Sheth, MD principal investigator
Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PrEP Decision Aid and Generic Information in people with Sexual Risk Behavior for HIV-infection and Reproductive Health, run by Yale 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?
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 4 Sep 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Carolina Price, MPA (2034998075, carolina.price@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP initiation (prescribing) (time frame: 6 months). The study lists 7 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 4 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.