Confidential Care and Adolescent HIV Testing

Hiv Clinical Trial

Official title:

Implementation of Confidential Care to Increase Adolescent HIV Testing in Pediatric Primary Care Settings

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279949
• Other study ID #: 2000036999
• Secondary ID: 1K01MH136929-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2026
• Est. completion date: October 2027

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Christina Aivadyan
• Phone: 631-987-4339
• Email: christina.aivadyan[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (e.g., 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

The intervention occurs at the clinic-level and so the enrolled participant is a pediatric primary care clinic. The patient-level outcome (i.e., change in HIV testing uptake) will be collected based on the following eligibility criteria:

Inclusion Criteria:

• 13-17 years old

Exclusion Criteria:

• <13 years old

• >17 years old

Related Conditions & MeSH terms

• Hiv

Intervention

Behavioral:
• Provider training
Clinics randomized to a condition involving provider training will receive training on state-specific laws regulating minors' access to confidential HIV testing.
• Clinic protocols
Clinics randomized to a condition involving the implementation of new clinic protocols to support confidential care provision will receive training on navigating the new protocols.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, defined as the extent to which structural intervention components to improve confidential care implementation can be successfully carried out in pediatric primary care settings	Feasibility will be measured with the Feasibility of Intervention Measure, a self-reported four-item measure with established reliability and validity. Item responses range from 1="completely disagree" to 5="completely agree." Scores are created by averaging responses. Score values range from 1 to 5, with higher scores indicating greater feasibility.	6 months
Primary	Acceptability, defined as the perception among pediatric primary care clinic leadership and providers that structural intervention components to improve confidential care implementation are agreeable or satisfactory	Acceptability will be measured with the Acceptability of Intervention Measure, a self-reported four-item measure with established reliability and validity. Item responses range from 1="completely disagree" to 5="completely agree." Scores are created by averaging responses. Score values range from 1 to 5, with higher scores indicating greater acceptability.	6 months
Primary	Change in HIV testing uptake	Change in HIV testing uptake will be assessed as the difference in the number of adolescent patients who were screened for, accepted, and received results of HIV testing during the 6-month pre-intervention period compared to the 6-month post-intervention period.	Baseline, 12 months
Secondary	Reach, defined as the number of adolescent patients who receive confidential care	Reach will be assessed through a brief online survey to be self-administered by providers after each visit with an adolescent patient.	6 months
Secondary	Adoption, defined as the proportion of pediatric primary care providers who have time alone with and/or provide confidentiality assurances to adolescent patients	Adoption will be assessed through a brief online survey to be self-administered by providers after each visit with an adolescent patient.	6 months
Secondary	Implementation, defined as pediatric primary care provider fidelity to confidential care provision	Implementation will be assessed through a brief online survey to be self-administered by providers after each visit with an adolescent patient.	6 months
Secondary	Maintenance, defined as the extent to which confidential care is provided and adolescent patients are screened for, accept, and receive results of HIV testing 6-months post-intervention	Maintenance will be assessed through a brief online survey to be self-administered by providers after each visit with an adolescent patient and the number of adolescent patients who were screened for, accepted, and received results of HIV testing during the 6-month post-intervention period.	12 months