Clinical trial NCT06804382: Academic Detailing to Optimize PrEP Implementation in Pediatric Primary Care Settings: ADOPT-PrEP
Official title: Academic Detailing to Optimize PrEP Implementation in Pediatric Primary Care Settings: ADOPT-PrEP
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PrEP
HIV Prevention Program
Keywords: PrEP
STI
AYA
adolescent
hiv prevention
academic detailing
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, 50 pediatricians will participate in academic detailing, an evidence-based, 1-on-1 outreach education technique intended to promote clinician behavior change through brief, highly interactive, and individualized dialogues with trained educators, or "detailers". The goals of this study are to learn about whether this is a practical and acceptable technique, and whether it changes how pediatricians prescribe pre-exposure prophylaxis (PrEP) to adolescents and young adults (AYA) and how patients take it.

Detailed description: Adolescents and young adults (AYA) account for nearly 20% of new HIV diagnoses in the US. Only 10% of sexually active adolescents have ever been tested for HIV2 and very few have used pre-exposure prophylaxis (PrEP), despite it being safe, highly effective at preventing HIV transmission, and FDA-approved for youth. Pediatric health care providers (physicians and associate clinicians) could have a major impact on PrEP use for youth, as they are trusted sources of health information for AYA. However, pediatricians infrequently discuss or recommend PrEP due to limited training in sexual health and PrEP and a lack of tools and protocols to help them integrate PrEP into busy clinical workflows. Academic detailing, an evidence-based, 1-on-1 educational outreach technique for clinicians proven to change prescribing behaviors, could improve PrEP prescribing and persistence for AYA. Academic detailing has been associated with substantial increases in PrEP prescribing in adult settings but has not been tested in pediatric settings. The objective of this study is to develop an implementation strategy to improve PrEP provision to AYA at a large children's hospital and affiliated community health center in an HIV priority jurisdiction. Our hypothesis is that academic detailing for PrEP that has been adapted for a pediatric and young adult population will be feasible, acceptable, and result in rapid, sustained, and clinically significant improvements in PrEP provision in pediatric settings.

After conducting qualitative interviews with AYA and pediatric providers to explore barriers and facilitators and to them develop materials specific to this study, we will conduct a pilot study of academic detailing amongst 50 pediatric providers in the Boston area. Providers will be recruited from Boston-area practices and invited to participated in the pilot project. Providers will complete 2 academic detailing visits and a post-visit qualitative interview and survey to assess feasibility and acceptability. Secondary outcomes include preliminary impact of academic detailing on their knowledge, intentions and readiness to prescribe PrEP, and changes in PrEP prescriptions, persistence, and HIV testing after the intervention through electronic medical record review.

Eligibility criteria: Inclusion Criteria:

* Primary care provider at one of our 3 study sites (Boston Children's Hospital Adolescent/Young Adult Medicine, Martha Eliot Health Center, Children's Hospital Primary Care Center)

Exclusion Criteria:

* None

Primary outcomes:
measure: Feasibility
timeFrame: From enrollment to end of study interview at 4 months
measure: Feasibility
timeFrame: From enrollment to end of second academic detailing session at 1 month
measure: Acceptability
timeFrame: From enrollment to end of second academic detailing visit at 1 month.
measure: Acceptability
timeFrame: From enrollment to end of second academic detailing session at 1 month
Secondary outcomes:
measure: Impact of academic detailing on PrEP knowledge and prescribing
timeFrame: From enrollment to end of study interview at 4 months
measure: Change in PrEP Prescriptions
timeFrame: From 6 months prior to enrollment to 6 months after intervention
measure: HIV Testing
timeFrame: From 6 months prior to enrollment to 6 months after academic detailing intervention
measure: Fidelity to intervention
timeFrame: From enrollment to end of second academic detailing visit at 1 month.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: Krakower DS, Naja-Riese GM, Edelstein ZR, Gandhi AD, Wahnich A, Fischer MA. Academic Detailing to Increase Prescribing of HIV Pre-exposure Prophylaxis. Am J Prev Med. 2021 Nov;61(5 Suppl 1):S87-S97. doi: 10.1016/j.amepre.2021.05.030.