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Not yet recruiting NCT06804382

Academic Detailing to Optimize PrEP Implementation in Pediatric Primary Care Settings: ADOPT-PrEP

No phase Interventional PrEP HIV Prevention Program

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Academic detailing.
Who it may be relevant to
Registry conditions: PrEP, HIV Prevention Program. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Academic detailing
    Academic detailing is an evidence-based, 1-on-1 outreach education technique intended to promote clinician behavior change. Information gained during earlier focus groups will be used to develop study-specific materials.

Primary outcome measures

  • Feasibility [Time frame: From enrollment to end of study interview at 4 months]
  • Feasibility [Time frame: From enrollment to end of second academic detailing session at 1 month]
  • Acceptability [Time frame: From enrollment to end of second academic detailing visit at 1 month.]
  • Acceptability [Time frame: From enrollment to end of second academic detailing session at 1 month]
Secondary outcome measures (4)
  • Impact of academic detailing on PrEP knowledge and prescribing [Time frame: From enrollment to end of study interview at 4 months]
  • Change in PrEP Prescriptions [Time frame: From 6 months prior to enrollment to 6 months after intervention]
  • HIV Testing [Time frame: From 6 months prior to enrollment to 6 months after academic detailing intervention]
  • Fidelity to intervention [Time frame: From enrollment to end of second academic detailing visit at 1 month.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Boston Children's Hospital — Boston

Publications

  • 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. PMID 34686295

Identifiers

NCT: NCT06804382 · IRB-P00050424

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗