Patient Actor Training to Improve HIV Services for Adolescents in Kenya

NCT02928900 | Completed Results DMC

• 1 other identifier: STUDY00002035
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

HIV/AIDS

Keywords

Adolescents; Clinical training; HIV care and treatment; Africa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of HCWs With Pass/Fail Scores

  Up to one month after last day of training

• Numeric Scores From SP Actors

  Up to one week after last day of training

• Health Care Worker Competency

  Baseline and every nine months for up to four years

• Health Care Workers' Satisfaction With Skills

  Baseline and every nine months for up to four years

• Adolescent Patients' Satisfaction With Care

  Baseline and every nine months for up to four years

Other Outcomes (5)

• Antiretroviral (ART) Adherence in HIV-positive Adolescents

  Baseline and every nine months for up to four years

• Viral Load in HIV-positive Adolescents

  Baseline and every nine months for up to four years

• Linkage to Adolescent Friendly Services in HIV-positive Adolescents

  Baseline and every nine months for up to four years

Study Arms (2)

Intervention period

EXPERIMENTAL

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

Control period

NO INTERVENTION

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.

Interventions

Clinician training intervention BEHAVIORAL

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.

Intervention period

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Facilities:
• 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

Sponsors & Collaborators

• University of Washington: lead
• University of Nairobi: collaborator

Study Sites (6)

HIV care facility 6

Homa Bay, Kenya

Location

HIV care facility 3

Kiambu, Kenya

Location

HIV care facility 4

Kiambu, Kenya

Location

HIV care facility 5

Kisumu, Kenya

Location

HIV care facility 1

Nairobi, Kenya

Location

HIV care facility 2

Nairobi, Kenya

Location

Related Publications (3)

• 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.

  PMID: 37074998 DERIVED

• 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.

  PMID: 34939987 DERIVED

• 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.

  PMID: 29282109 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Data collection was suspended after Wave 4 training in March 2020 due to the COVID-19 pandemic

Results Point of Contact

• Title: Pamela Kohler
• Organization: University of Washington

pkohler2@uw.edu

206.221.5746

Study Officials

• Pamela Kohler, PhD, MPH, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

• Dalton Wamalwa, MMed, MPH

  University of Nairobi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Global Health and Nursing

Model Details: Stepped wedge cluster RCT

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 10, 2016
• Study Start: September 26, 2016
• Primary Completion: November 2, 2020
• Study Completion: March 31, 2021
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

KE (6)