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Completed

NCT Number: NCT02928900

Patient Actor Training to Improve HIV Services for Adolescents in Kenya

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HIV care facility 6, Homa Bay, Kenya

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Retention in HIV Care

    Time frame: Up to four years after baseline

    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).

Secondary outcomes

  1. Proportion of HCWs With Pass/Fail Scores

    Time frame: Up to one month after last day of training

    The proportion of HCW participants who achieved competency upon completion of the training.

  2. Numeric Scores From SP Actors

    Time frame: Up to one week after last day of training

    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.

  3. Health Care Worker Competency

    Time frame: Baseline and every nine months for up to four years

    This outcome is measured as change in mean competency score between intervention and control periods using a structured survey.

  4. Health Care Workers' Satisfaction With Skills

    Time frame: Baseline and every nine months for up to four years

    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.

  5. Adolescent Patients' Satisfaction With Care

    Time frame: Baseline and every nine months for up to four years

    This outcome is defined as mean change in satisfaction score between intervention and control periods, using a structured survey.

  6. Retention in HIV Care (Secondary)

    Time frame: Baseline and every nine months for up to four years

    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

Other outcomes

  1. Antiretroviral (ART) Adherence in HIV-positive Adolescents

    Time frame: Baseline and every nine months for up to four years

    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.

  2. Viral Load in HIV-positive Adolescents

    Time frame: Baseline and every nine months for up to four years

    This measure is defined as change in viral load between intervention and control periods using available EMR data.

  3. Linkage to Adolescent Friendly Services in HIV-positive Adolescents

    Time frame: Baseline and every nine months for up to four years

    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.

  4. AIDS Defining Illness in HIV-positive Adolescents

    Time frame: Baseline and every nine months for up to four years

    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.

  5. Mortality in HIV-positive Adolescents

    Time frame: Baseline and every nine months for up to four years

    This measure is defined as change in the proportion of deaths between intervention and control periods using available EMR data.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • University of Nairobi

Registry information

Official study title

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

Acronym: SPEED

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Oct 10, 2016
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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