Implementation of Confidential Care to Increase Adolescent HIV Testing in Pediatric Primary Care Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Yale University
- Enrollment
- 4
- Primary Endpoint
- 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
Study Overview
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 (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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
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.
Clinic protocols
This clinic will receive training on navigating new protocols to support confidential care provision.
Intervention: Clinic protocols (Behavioral)
Provider training
This clinic will receive training on state-specific laws regulating minors' access to confidential HIV testing.
Intervention: Provider training (Behavioral)
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.
Intervention: Provider training (Behavioral)
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.
Intervention: Clinic protocols (Behavioral)
Outcomes
Primary Outcomes
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
Time Frame: 6 months
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.
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
Time Frame: 6 months
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.
Change in HIV testing uptake
Time Frame: Baseline, 12 months
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.
Secondary Outcomes
- 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(12 months)
- Reach, defined as the number of adolescent patients who receive confidential care(6 months)
- Implementation, defined as pediatric primary care provider fidelity to confidential care provision(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(6 months)