Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279949
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-19
Brief Title:
Confidential Care and Adolescent HIV Testing
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Implementation of Confidential Care to Increase Adolescent HIV Testing in Pediatric Primary Care Settings
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the feasibility and acceptability of structural intervention components to increase adolescent HIV testing uptake by improving the implementation of confidential care as standard practice in pediatric primary care
Detailed Description:
This pilot study will evaluate a multicomponent structural intervention to increase adolescent HIV testing uptake by improving the implementation of confidential care as standard practice in pediatric primary care settings The objectives of the study are to a evaluate feasibility acceptability and other implementation outcomes eg reach b assess change in HIV testing uptake and c determine the combination of structural intervention components to be further evaluated in a future full-scale optimization trial These objectives will be achieved through a pilot optimization trial the trial will follow a full factorial experimental design with data collection at three time points over a 12-month period
During the 6-month pre-intervention period baseline measures will be assessed extracting electronic health record EHR data on the number of adolescent patients who were screened for accepted and received results of HIV testing During the 6-month intervention period clinics will be randomized to one of four experimental conditions based on the following two factors 1 provider training 2 implementation of clinic protocols to support confidential care provision Clinics randomized to a condition involving provider training will receive training on state-specific laws regulating minors access to confidential HIV testing Clinics randomized to a condition involving the implementation of clinic protocols will receive training on navigating the new protocols Measurement of intervention and implementation processes and outcomes will be guided by the five dimensions of the RE-AIM Framework reach efficacy adoption implementation and maintenance During the 6-month post-intervention period EHR data will be used to assess the change in HIV testing uptake over the study period
During the 6-month pre-intervention period baseline measures will be assessed extracting electronic health record EHR data on the number of adolescent patients who were screened for accepted and received results of HIV testing During the 6-month intervention period clinics will be randomized to one of four experimental conditions based on the following two factors 1 provider training 2 implementation of clinic protocols to support confidential care provision Clinics randomized to a condition involving provider training will receive training on state-specific laws regulating minors access to confidential HIV testing Clinics randomized to a condition involving the implementation of clinic protocols will receive training on navigating the new protocols Measurement of intervention and implementation processes and outcomes will be guided by the five dimensions of the RE-AIM Framework reach efficacy adoption implementation and maintenance During the 6-month post-intervention period EHR data will be used to assess the change in HIV testing uptake over the study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K01MH136929-01 | NIH | NIMH ID not yet added | httpsreporternihgovquickSearch1K01MH136929-01 |