Patient Actor Training to Improve HIV Services for Adolescents in Kenya (SPEED)

University of Washington

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: Clinician training intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02928900

STUDY00002035

Details and patient eligibility

About

The goal of this study is to develop and evaluate a clinical training intervention utilizing standardized patient actors to improve communication and interpersonal skills of health care workers who serve HIV-infected adolescents and youth in Kenya, resulting in increased engagement in HIV care. The effect of the intervention on retention in care will be evaluated in a stepped-wedge randomized controlled trial at 24 HIV care and treatment facilities.

Full description

Adolescents and youth have the highest HIV incidence rates compared to any other age strata. Inadequate provision of accessible and acceptable HIV testing, counseling, and treatment services has been cited as a barrier to uptake of and retention in HIV care in this population.

The "SPEED" study aims to develop and evaluate a clinical training intervention utilizing Standardized Patient (SP) actors to improve communication and interpersonal skills of health care workers (HCWs) who work with adolescents and youth (ages 10-24), resulting in increased engagement in HIV care in Kenya. This intervention includes a series of role plays between HCW participants and professional Kenyan actors, followed by feedback and debriefing sessions. The hypothesis is that SP encounters will increase HCW confidence and capacity to facilitate HIV status disclosure and provide supportive interactions with HIV-infected youth, which will in turn increase uptake and improve retention in HIV services among adolescents and youth.

The pilot phase (Aim 1) will consist of developing patient case scripts specific to adolescent HIV-related care and counseling needs and establishing HCW competency scores. To evaluate the intervention, a cluster randomized controlled stepped-wedge trial will be conducted in 24 HIV care and treatment facilities to assess the impact of SP encounters on the proportion of adolescents and youth patients retained in care at HIV treatment facilities in Kenya (Aim 2). Finally, the cost effectiveness and cost utility of the SP intervention will be determined (Aim 3). The estimated study duration is five years.

The primary outcomes from Aim 1 are final scripts and pass/fail scores for use in SP encounters. The primary outcome for the randomized controlled trial (RCT) (Aim 2) is retention in care among HIV-positive adolescents and youth, based on electronic medical records data. Secondary outcomes will include satisfaction (patients and HCWs), HCW competency in youth- friendly counseling, antiretroviral therapy adherence, and viral suppression. For the cost effectiveness and cost utility analyses (Aim 3), the cost per additional HIV-infected adolescent/youth retained in care and the cost per additional life year saved and disability-adjusted life averted will be estimated.

Enrollment: 24 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Listed by population

Facilities:

• HIV care and treatment facilities in Kenya with ≥40 adolescents currently in HIV care
• EMR data systems
• No concurrent adolescent interventions

Adolescent patient records:

• Records of adolescents and youth ages 10-24
• Enrollment in HIV care and treatment at one of the study facilities

Adolescent satisfaction surveys:

• Patients ages 10-24 seeking counseling or treatment services at trial site who are HIV-infected
• Willing and able to provide informed consent or assent based on age and presence of a caregiver.
• Reside in Kenya

Health care workers:

• >18 years of age
• Employed at trial site in clinical care for at least three months and/or have a 1 year contract (i.e. not temporary staff)
• Provide clinical services to adolescents
• Reside in Kenya

Exclusion Criteria:

Facilities:

• If inclusion criteria are not met
• If anything would prevent the complete conduct of the training intervention at that site and/or the collection of outcome measures

Adolescents and health care worker surveys:

• If an individual has conditions that would place them at increased risk or preclude the individual's full compliance with or completion of the study

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Intervention period

Experimental group

Description:

In this stepped-wedge trial design, the experimental arm refers to the time period when the study sites receive the clinician training intervention. The intervention is a clinician training using standardized patient actors to improve communication and empathy skills of health care providers who serve HIV-positive adolescents and youth.

Treatment:

Behavioral: Clinician training intervention

Control period

No Intervention group

Description:

In this stepped-wedge trial design, the no intervention arm refers to the time period before the study sites receive the clinician training intervention, during which standard of care is provided.