Confidential Care and Adolescent HIV Testing

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hiv
• Intervention / Treatment: Behavioral: Clinic protocols; Behavioral: Provider training

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 (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.

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Aivadyan; Phone Number: 631-987-4339; Email: christina.aivadyan@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No provider training or clinic protocols; This clinic will not receive training on state-specific laws regulating minors' access to confidential HIV testing or implementation of new protocols to support confidential care provision.
Active Comparator: Clinic protocols; This clinic will receive training on navigating new protocols to support confidential care provision.	Behavioral: 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.
Active Comparator: Provider training; This clinic will receive training on state-specific laws regulating minors' access to confidential HIV testing.	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.
Active Comparator: Provider training and clinic protocols; This clinic will receive training on state-specific laws regulating minors' access to confidential HIV testing and navigating new protocols to support confidential care provision.	Behavioral: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Christina Aivadyan, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pediatrics; HIV testing; Confidential care
• Other Study ID Numbers: 2000036999; 1K01MH136929-01 (Other Identifier: NIMH *ID not yet added)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No