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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Carolina Price, MPA contact

2034998075

carolina.price@yale.edu

Jaimie P Meyer, MD contact

2037376233

jaimie.meyer@yale.edu

United States1 site, 1 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

    Recruiting

Other trials in United States

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 groups in NCT06684613
Study groupRoleWhat they receive
PrEP Decision AidExperimentalParticipants 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 InformationOtherParticipants 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.

  1. PrEP initiation (prescribing)

    Whether PrEP was prescribed (yes/no) in the EHR within the 6-month time frame

    Measured: 6 months

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  1. PrEP initiation (dispensing)

    Whether PrEP was dispensed (yes/no) in the EHR within the 6-month time frame

    Measured: 6 months

  2. PrEP initiation (first use)

    Whether PrEP was started by the patient within the 6 months' time frame (yes/no)

    Measured: 6 months

  3. PrEP adherence

    Non-pharmacokinetic: (subjective) 3-item self-report with 30-day look-back

    Measured: 6 months

  4. PrEP adherence

    Non-pharmacokinetic: (objective) pharmacy refill data or injection dates for LAI.

    Measured: 6 months

  5. PrEP adherence

    Pharmacokinetic: (objective) urine tenofovir levels (units detected/ not detected)

    Measured: 6 months

  6. 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.

  1. First posted12 Nov 2024
  2. Study start11 Mar 2026
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion5 Sep 2027 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT06684613.

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.

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