Clinical trial NCT02928900: Patient Actor Training to Improve HIV Services for Adolescents in Kenya
Official title: Simulated Patient Encounters to Promote Early Detection and Engagement in HIV Care for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Adolescents
Clinical training
HIV care and treatment
Africa
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Nairobi
First posted: 2016-10-10
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge cluster RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Retention in HIV Care
timeFrame: Up to four years after baseline
Secondary outcomes:
measure: Proportion of HCWs With Pass/Fail Scores
timeFrame: Up to one month after last day of training
measure: Numeric Scores From SP Actors
timeFrame: Up to one week after last day of training
measure: Health Care Worker Competency
timeFrame: Baseline and every nine months for up to four years
measure: Health Care Workers' Satisfaction With Skills
timeFrame: Baseline and every nine months for up to four years
measure: Adolescent Patients' Satisfaction With Care
timeFrame: Baseline and every nine months for up to four years
measure: Retention in HIV Care (Secondary)
timeFrame: Baseline and every nine months for up to four years
Other outcomes:
measure: Antiretroviral (ART) Adherence in HIV-positive Adolescents
timeFrame: Baseline and every nine months for up to four years
measure: Viral Load in HIV-positive Adolescents
timeFrame: Baseline and every nine months for up to four years
measure: Linkage to Adolescent Friendly Services in HIV-positive Adolescents
timeFrame: Baseline and every nine months for up to four years
measure: AIDS Defining Illness in HIV-positive Adolescents
timeFrame: Baseline and every nine months for up to four years
measure: Mortality in HIV-positive Adolescents
timeFrame: Baseline and every nine months for up to four years
Locations:
city: Homa Bay
country: Kenya
facility: HIV care facility 6
city: Kiambu
country: Kenya
facility: HIV care facility 3
city: Kiambu
country: Kenya
facility: HIV care facility 4
city: Kisumu
country: Kenya
facility: HIV care facility 5
city: Nairobi
country: Kenya
facility: HIV care facility 1
city: Nairobi
country: Kenya
facility: HIV care facility 2
Study officials:
affiliation: University of Washington
name: Pamela Kohler, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nairobi
name: Dalton Wamalwa, MMed, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.