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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Clinician training intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Homa Bay, Kenya
    • HIV care facility 6
  • Kiambu, Kenya
    • HIV care facility 3
  • Kiambu, Kenya
    • HIV care facility 4
  • Kisumu, Kenya
    • HIV care facility 5
  • Nairobi, Kenya
    • HIV care facility 1
  • Nairobi, Kenya
    • HIV care facility 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiretroviral (ART) Adherence in HIV-positive Adolescents	This measure is defined as change in the proportion of visits with ART refills within 1 week of scheduled visit between intervention and control periods using available electronic medical record (EMR) data.	Baseline and every nine months for up to four years
Viral Load in HIV-positive Adolescents	This measure is defined as change in viral load between intervention and control periods using available EMR data.	Baseline and every nine months for up to four years
Linkage to Adolescent Friendly Services in HIV-positive Adolescents	This measure is defined as change in the proportion of visits with referrals to affiliated services (e.g. family planning) between intervention and control periods using available EMR data.	Baseline and every nine months for up to four years
AIDS Defining Illness in HIV-positive Adolescents	This measure is defined as change in the proportion of visits with any AIDS defining illness between intervention and control periods using available EMR data.	Baseline and every nine months for up to four years
Mortality in HIV-positive Adolescents	This measure is defined as change in the proportion of deaths between intervention and control periods using available EMR data.	Baseline and every nine months for up to four years

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: University of Nairobi
• Investigators: Principal Investigator: Pamela Kohler, PhD, MPH, RN, University of Washington; Study Director: Dalton Wamalwa, MMed, MPH, University of Nairobi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2016
• Primary Completion (Actual): November 2, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimated): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): December 9, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Africa; Clinical training; HIV care and treatment
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: STUDY00002035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study investigators are prepared to share data with other researchers in accordance with NIH policies and other local regulations.