HIV Clinical Trial - Confidential Care & Adolescent HIV Testing

Status Not yet recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06279949
Study type	Interventional
Source	Yale University
Contact	Christina Aivadyan
Phone	631-987-4339
Email	christina.aivadyan@yale.edu
Status	Not yet recruiting
Phase	N/A
Start date	April 2026
Completion date	October 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Confidential Care and Adolescent HIV Testing

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms