Patient Actor Training to Improve HIV Services for Adolescents in Kenya
NCT ID: NCT02928900
Last Updated: 2024-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2016-09-26
2021-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention period
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.
Clinician training intervention
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.
Control period
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.
No interventions assigned to this group
Interventions
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Clinician training intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
10 Years
ALL
Yes
Sponsors
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University of Nairobi
OTHER
University of Washington
OTHER
Responsible Party
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Pamela Kohler
Assistant Professor, Global Health and Nursing
Principal Investigators
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Pamela Kohler, PhD, MPH, RN
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Dalton Wamalwa, MMed, MPH
Role: STUDY_DIRECTOR
University of Nairobi
Locations
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HIV care facility 6
Homa Bay, , Kenya
HIV care facility 3
Kiambu, , Kenya
HIV care facility 4
Kiambu, , Kenya
HIV care facility 5
Kisumu, , Kenya
HIV care facility 1
Nairobi, , Kenya
HIV care facility 2
Nairobi, , Kenya
Countries
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References
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Kohler PK, Mugo C, Wilson KS, Moraa H, Onyango A, Tapia K, Pike K, Mburu C, Nduati M, Guthrie B, Richardson BA, Owens T, Bukusi D, Inwani I, John-Stewart G, Wamalwa D. Simulated patient training to improve youth engagement in HIV care in Kenya: A stepped wedge cluster randomized controlled trial. PLOS Glob Public Health. 2023 Apr 19;3(4):e0001765. doi: 10.1371/journal.pgph.0001765. eCollection 2023.
Wilson K, Onyango A, Mugo C, Guthrie B, Slyker J, Richardson B, John-Stewart G, Inwani I, Bukusi D, Wamalwa D, Kohler P. Kenyan HIV Clinics With Youth-Friendly Services and Trained Providers Have a Higher Prevalence of Viral Suppression Among Adolescents and Young Adults: Results From an Observational Study. J Assoc Nurses AIDS Care. 2022 Jan-Feb 01;33(1):45-53. doi: 10.1097/JNC.0000000000000302.
Wilson KS, Mugo C, Bukusi D, Inwani I, Wagner AD, Moraa H, Owens T, Babigumira JB, Richardson BA, John-Stewart GC, Slyker JA, Wamalwa DC, Kohler PK. Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial. Trials. 2017 Dec 28;18(1):619. doi: 10.1186/s13063-017-2266-z.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY00002035
Identifier Type: -
Identifier Source: org_study_id