NCT06684613 · Yale University
Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics
What this study is about
This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.
View original scientific description
This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.
Interventions
DEVICE
PrEP Decision Aid
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.
OTHER
Generic Information
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.
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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 .
Where
- New Haven, Connecticut
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations