Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial

Abstract

Background: Adolescent-friendly policies aim to tailor HIV services for adolescents and young adults aged 10-24 years (AYA) to promote health outcomes and improve retention in HIV care and treatment. However, few interventions focus on improving healthcare worker (HCW) competencies and skills for provision of high-quality adolescent care. Standardized patients (SPs) are trained actors who work with HCWs in mock clinical encounters to improve clinical assessment, communication, and empathy skills. This stepped-wedge randomized controlled trial will evaluate a clinical training intervention utilizing SPs to improve HCW skills in caring for HIV-positive AYA, resulting in increased retention in care.

Methods/design: The trial will utilize a stepped-wedge design to evaluate a training intervention using SPs to train HCWs in assessment, communication, and empathy skills for AYA HIV care. We will recruit 24 clinics in Kenya with an active electronic medical record (EMR) system and at least 40 adolescents enrolled in HIV care per site. Stratified randomization by county will be used to assign clinics to one of four waves - time periods when they receive the intervention - with each wave including six clinics. From each clinic, up to 10 HCWs will participate in the training intervention. SP training includes didactic sessions in adolescent health, current guidelines, communication skills, and motivational interviewing techniques. HCW participants will rotate through seven standardized SP scenarios, followed by SP feedback, group debriefing, and remote expert evaluation. AYA outcomes will be assessed using routine clinic data. The primary outcome is AYA retention in HIV care, defined as returning for first follow-up visit within 6 months of presenting to care, or returning for a first follow-up visit after re-engagement in care in AYA with a previous history of being lost to follow-up. Secondary outcomes include HCW competency scores, AYA satisfaction with care, and AYA clinical outcomes including CD4 and viral load. Additional analyses will determine cost-effectiveness of the intervention.

Discussion: This trial will contribute valuable information to HIV programs in Kenya and other low-resource settings, providing a potentially scalable strategy to improve quality of care and retention in critical HIV services in this population.

Trial registration: ClinicalTrials.gov, ID: NCT02928900. Registered 26 August 2016.

Keywords: Adolescents and young adults; Clinical training intervention; Retention in HIV care; Standardized patients; Stepped-wedge trial.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by University of Nairobi/Kenyatta National Hospital Ethics Review Committee (KNH ERC) (P476/06/2016) and the University of Washington Human Subjects Research Committee (51926 E/J). All HCW participants provide standard written informed consent. AYA aged 18 years and older and those aged 14–17 years, who are emancipated minors, provide oral consent to participate in surveys. Otherwise, AYA ages 10–17 years who participate in the surveys provide assent and caregivers provide oral informed consent. All SPs signed a confidentiality agreement and completed protection of human subjects training before any contact with participants. Important protocol amendments will be communicated to both ethics committees, the EAP, and trial registries.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Adapted CONSORT Diagram for trial

Fig. 2

Adapted Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Diagram for trial