Clinical trial NCT06684613: Integrating PrEP Decision Making Into Contraceptive Counseling in Family Planning Clinics
Official title: Project Carmenta: Integrating PrEP Decision Making Into Contraceptive Counseling in Family Planning Clinics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexual Risk Behavior for HIV-infection
Reproductive Health
Keywords: HIV Prevention
Cis-Women
PrEP
sexual reproductive health
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-11-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will use the Health Equity Implementation Framework (HEIF) to develop a semi-structured interview guide for the formative work in Aim 1. The HEIF addresses disparities in access to care and implicit bias, and domains will be measured in Aim 2 to examine health equity and 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).
Primary purpose: PREVENTION

Brief summary: This study addresses the need for HIV prevention to be integrated into contraceptive counseling visits at family planning 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 (SRH) settings during contraceptive counseling visits, where PrEP can be provided to all women who are interested. Rooted in the Health Equity Implementation Framework, this study evaluates health equity 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 SRH 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 SRH clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in SRH 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.

Eligibility criteria: Patients (inclusion):

* Cis-women
* 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 contraceptive 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 (SRH) clinicians will be included if they provide SRH patient care at any of the participating sites. SRH clinic staff will be included if they work at any of the participating sites and have patient-facing or non-patient-facing roles

Primary outcomes:
measure: PrEP initiation (prescribing)
timeFrame: 6 months
measure: Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy
timeFrame: 6 months
measure: Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)
timeFrame: 6 months
measure: Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
timeFrame: 6 months
measure: Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
timeFrame: 6 months
measure: Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)
timeFrame: 6 months
measure: Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)
timeFrame: 6 months
Secondary outcomes:
measure: PrEP initiation (dispensing)
timeFrame: 6 months
measure: PrEP initiation (first use)
timeFrame: 6 months
measure: PrEP adherence
timeFrame: 6 months
measure: PrEP adherence
timeFrame: 6 months
measure: PrEP adherence
timeFrame: 6 months
measure: PrEP persistence
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Clinical and Community Research
state: Connecticut
Study officials:
affiliation: Yale Clinical and Community Research, Yale School of Medicine
name: Jaimie P Meyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine
name: Sangini S Sheth, MD
role: PRINCIPAL_INVESTIGATOR
References: