Confidential Care and Adolescent HIV Testing

NCT06279949 | Not Yet Recruiting DMC

• 2 other identifiers: 2000036999K01MH136929
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hiv

Keywords

Confidential care; Pediatrics; HIV testing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

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

  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

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

  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

  12 months

Study Arms (4)

No provider training or clinic protocols

NO INTERVENTION

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

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

Behavioral: Clinic protocols

Provider training

ACTIVE COMPARATOR

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

Behavioral: Provider training

Provider training and clinic protocols

ACTIVE COMPARATOR

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: Provider training; Behavioral: Clinic protocols

Interventions

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.

Provider training; Provider training and clinic protocols

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.

Clinic protocols; Provider training and clinic protocols

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 13-17 years old

You may not qualify if:

• \<13 years old
• \>17 years old

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Yale University: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Christina Aivadyan

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Aivadyan

CONTACT

631-987-4339; christina.aivadyan@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share