Patient Actor Training to Improve HIV Services for Adolescents in Kenya

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Simulated Patient Encounters to Promote Early Detection and Engagement in HIV Care for Adolescents

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: Clinician training intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention period<br>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. | Behavioral: Clinician training intervention<br>* This intervention is a clinician training using SP actors to improve communication and empathy skills of HIV care providers who serve HIV-positive adolescents and youth in Kenya.<br>|
| No Intervention: Control period<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in HIV care | The primary outcome is change in retention in HIV care between the intervention and control periods, where retention is defined as return for first follow-up visit within 3 months among newly enrolled adolescent clients OR follow-up visit after 're-engagement visit' (after lost-to-follow-up for >90 days since last visit, with no record of death or transfer). | Up to four years after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of HCWs with pass/fail scores | The proportion of HCW participants who achieved competency upon completion of the training. | Up to one month after last day of training | 
| Numeric scores from SP actors | All SP actors will complete a check-list to provide non-technical feedback to each HCW participant. Scores will be used to compute the overall pass/fail score at completion of the training. | Up to one week after last day of training | 
| Health care worker competency | This outcome is measured as change in mean competency score between intervention and control periods using a structured survey. | Baseline and every nine months for up to four years | 
| Health care workers' satisfaction with skills | This outcome is measured as change in mean satisfaction scores between intervention (post-training) and control periods (pre-training), using a structured survey. These surveys will be conducted at baseline, and every nine months at the end of the training in each wave. Exit interviews among trained participants will be conducted about one year after each training wave for up to four waves to complement the quantitative results. | Baseline and every nine months for up to four years | 
| Adolescent patients' satisfaction with care | This outcome is defined as mean change in satisfaction score between intervention and control periods, using a structured survey. | Baseline and every nine months for up to four years | 
| Cost per additional HIV-infected adolescent retained in care | This outcome measure will be computed based on a mathematical model of total direct and indirect costs using a combination of primary data collection (surveys), program data, and published literature. The denominator will be the number of adolescents retained in care. | End of study, up to four years | 
| Cost-utility of the intervention | This outcome measure will be computed using a mathematical model of cost per life year saved and disability-adjusted life year (DALY), where cost data will come from primary data, program records, and literature, and denominator data will come from the most relevant models of DALYs for adolescents. | End of study, up to four years | 
| Retention in HIV care (secondary) | A secondary measure of retention in HIV care is return for any follow-up visit within 3 months (90 days) among currently enrolled HIV-positive adolescent patients | Baseline and every nine months for up to four years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Clinical training, HIV care and treatment, Africa