Reproductive Health, Sexual Risk Behavior for HIV-infection
Conditions
Keywords
HIV Prevention, PrEP, sexual reproductive health, woman
Brief summary
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.
Interventions
DEVICEPrEP 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.
OTHERGeneric 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.
Sponsors
Yale University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation (prescribing) | 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 | 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) | 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) | 6 months | Penetration (reach) of the intervention, measured by recruitment rate (number of participants enrolled per month) |
| Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy) | 6 months | Adoption of the enhanced decision aid into SRH clinics, assessed by whether PrEP was discussed during the visit (yes/no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP initiation (dispensing) | 6 months | Whether PrEP was dispensed (yes/no) in the EHR within the 6-month time frame |
| PrEP initiation (first use) | 6 months | Whether PrEP was started by the patient within the 6 months' time frame (yes/no) |
| PrEP adherence | 6 months | Non-pharmacokinetic: (subjective) 3-item self-report with 30-day look-back |
| PrEP persistence | 6 months | Dates of completed PrEP encounters in EHR (i.e., clinic dates) |
Countries
United States
Contacts
CONTACTCarolina Price, MPA
CONTACTJaimie P Meyer, MD
PRINCIPAL_INVESTIGATORJaimie P Meyer, MD
Yale Clinical and Community Research, Yale School of Medicine
PRINCIPAL_INVESTIGATORSangini S Sheth, MD
Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine
Outcome results
None listed