PrEPADOPT-PrEPNCT06804382
Academic Detailing to Optimize PrEP Implementation in Pediatric Primary Care Settings: ADOPT-PrEP
A study testing Academic detailing in people with PrEP and HIV Prevention Program, run by Boston Children's Hospital at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PrEP, HIV Prevention Program
- What is being tested?
- Academic detailing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 30 Mar 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- PrEP, HIV Prevention Program
- Being tested
- Academic detailing
- Keywords
- PrEP, STI, AYA, adolescent, hiv prevention, academic detailing
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic detailingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| pediatricians | Experimental | Not described Receives: Behavioral: Academic detailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility will be assessed using survey question from other academic detailing campaigns and assessed on a 5-point Likert scale. Questions will be: "the key messages are feasible to implement in my practice" (1= not at all through 5= extremely)
Measured: From enrollment to end of study interview at 4 months
Feasibility
Feasibility of academic detailing based on number of enrolled providers who complete both academic detailing visits
Measured: From enrollment to end of second academic detailing session at 1 month
Acceptability
Acceptability of academic detailing as measured by provider satisfaction with the academic detailing visit. This will be assessed via the Prescriber Satisfaction with Academic Detailing questionnaire (PSAD). Answers are on a 5 point Likert scale (1=not at all through 5=extremely).
Measured: From enrollment to end of second academic detailing visit at 1 month.
Acceptability
Acceptability of academic detailing based on completion of academic detailing sessions
Measured: From enrollment to end of second academic detailing session at 1 month
Secondary outcomes (4)
Impact of academic detailing on PrEP knowledge and prescribing
Preliminary impact of academic detailing on their knowledge, intentions and readiness to prescribe PrEP. This will be assessed via adapted questionnaires from other academic detailing campaigns. Questions will be assessed on a 5 point Likert scale (1=strongly agree through 5= strongly disagree). Example questions include: "I am or would be comfortable prescribing and managing patients on PrEP;" "I am willing to talk to my patients about PrEP if it might be indicated."
Measured: From enrollment to end of study interview at 4 months
Change in PrEP Prescriptions
Changes in PrEP prescriptions provided by participants to their patients by review of electronic medical record following academic detailing intervention. This will include refills of oral PrEP medications and on-time injections of injectable PrEP.
Measured: From 6 months prior to enrollment to 6 months after intervention
HIV Testing
Participant rates of HIV testing of their patients by review of the medical record.
Measured: From 6 months prior to enrollment to 6 months after academic detailing intervention
Fidelity to intervention
Fidelity will be assessed by having academic detailers observe each other and then will provide feedback on adherence to academic detailing procedures by using a structured checklist (e.g., detailer delivers key messages, seeks commitment to behavior change from pediatrician).
Measured: From enrollment to end of second academic detailing visit at 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Apr 2027 (estimated)
- Primary completion30 Mar 2030 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrEPStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly Guss, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804382
- Sponsor's protocol ID
- IRB-P00050424
- Acronym
- ADOPT-PrEP
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to participant privacy and data de-identification needs.
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.
PubMed 34686295