Confidential Care and Adolescent HIV Testing

Yale University

Status: Begins enrollment in 6 months

Conditions: Hiv

Treatments: Behavioral: Provider training; Behavioral: Clinic protocols

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06279949

K01MH136929 (U.S. NIH Grant/Contract)

2000036999

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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4 participants in 4 patient groups

No provider training or clinic protocols

No Intervention group

Description:

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

Active Comparator group

Description:

This clinic will receive training on navigating new protocols to support confidential care provision.

Treatment:

Behavioral: Clinic protocols

Provider training

Active Comparator group

Description:

This clinic will receive training on state-specific laws regulating minors' access to confidential HIV testing.

Treatment:

Behavioral: Provider training

Provider training and clinic protocols

Active Comparator group

Description:

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.

Treatment:

Behavioral: Clinic protocols

Behavioral: Provider training