Patient Actor Training to Improve HIV Services for Adolescents in Kenya

HIV/AIDS Clinical Trial

— SPEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928900
• Other study ID #: STUDY00002035
• Status: Completed
• Phase: N/A
• Start date: September 26, 2016
• Est. completion date: March 31, 2021

Study information

• Verified date: June 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7450
• Est. completion date: March 31, 2021
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
Kenya	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	University of Nairobi

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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