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NCT Number: NCT06279949

Confidential Care and Adolescent HIV Testing

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Provider training

Behavioral

Clinics randomized to a condition involving provider training will receive training on state-specific laws regulating minors' access to confidential HIV testing.

Clinic protocols

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Reach, defined as the number of adolescent patients who receive confidential care

    Time frame: 6 months

    Reach will be assessed through a brief online survey to be self-administered by providers after each visit with an adolescent patient.

  2. Adoption, defined as the proportion of pediatric primary care providers who have time alone with and/or provide confidentiality assurances to adolescent patients

    Time frame: 6 months

    Adoption will be assessed through a brief online survey to be self-administered by providers after each visit with an adolescent patient.

  3. Implementation, defined as pediatric primary care provider fidelity to confidential care provision

    Time frame: 6 months

    Implementation will be assessed through a brief online survey to be self-administered by providers after each visit with an adolescent patient.

  4. 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

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Aivadyan

CONTACT

[email protected]

631-987-4339

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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