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| Name | Class |
|---|---|
| University of Nairobi | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria: Listed by population
Facilities:
Adolescent patient records:
Adolescent satisfaction surveys:
Health care workers:
Exclusion Criteria:
Facilities:
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
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Kohler, PhD, MPH, RN | University of Washington | Principal Investigator |
| Dalton Wamalwa, MMed, MPH | University of Nairobi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIV care facility 6 | Homa Bay | Kenya | ||||
| HIV care facility 3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37074998 | Derived | 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. | |
| 34939987 |
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The study investigators are prepared to share data with other researchers in accordance with NIH policies and other local regulations.
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Stepped wedge design: 24 facilities randomized to when they received the training intervention. Once trained, all sites were considered intervention exposed for the duration of the study.
De-identified adolescent medical records were analyzed for the primary outcome
| ID | Title | Description |
|---|---|---|
| FG000 | Standardized Patient Training | Once assigned to the intervention, clinics received standardized patient actor training to improve quality of adolescent HIV care |
| FG001 | Control | Time period before exposure to training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Wave 1 |
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| Wave 2 |
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| Wave 3 |
| |||||||||||||
| Wave 4 |
|
Clinics were assigned to the training intervention. Medical records were evaluated to assess study outcomes
| ID | Title | Description |
|---|---|---|
| BG000 | SP Training Intervention | HIV clinics were randomized to when they received the training intervention. The intervention consisted of a 2-day training for health providers at participating clinics. Once trained, all sites were considered intervention exposed for the duration of the study. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Medical record review. Final analysis accounts for clustering by facility, time (stepped wedge design), and newly enrolled in care status. | Posted | Count of Participants | Participants | Up to four years after baseline |
|
4 years following the first intervention training.
De-identified medical records are reported as the study population as they provided outcome data, however mortality data are largely missing in electronic records and the study was determined to be minimal risk (a health worker training program), thus we monitored for social harms related to counseling procedures and not post-training mortality among clients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SP Training Intervention | In this stepped-wedge trial design, the experimental arm refers to the time period after study site clinicians receive the patient actor training intervention. All study sites eventually received the training intervention. Adolescents in the intervention arm presented for care after their site received training. |
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Data collection was suspended after Wave 4 training in March 2020 due to the COVID-19 pandemic
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Kohler | University of Washington | 206.221.5746 | pkohler2@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2020 | Jan 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Stepped wedge cluster RCT
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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 |
| 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 |
| 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 | Kenya |
| 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. |
| 29282109 | 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. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| No Training Intervention |
Clinics prior to receiving training |
| BG002 | Total | Total of all reporting groups |
| Medical records |
|
| Medical records |
| Medical records |
|
| Sex/Gender, Customized | Number | Medical records | Medical records |
|
| Race (NIH/OMB) | Count of Units | Medical records | Medical records |
|
| Region of Enrollment | Number | Medical records | Medical records |
|
| OG001 |
| Adolescent Records - Unexposed |
Records from adolescents whose first eligible visit occurred at a facility before the facility received the training intervention |
|
|
| Secondary | Proportion of HCWs With Pass/Fail Scores | The proportion of HCW participants who achieved competency upon completion of the training. | Not Posted | Up to one month after last day of training | Participants |
| 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. | Not Posted | Up to one week after last day of training | Participants |
| Secondary | Health Care Worker Competency | This outcome is measured as change in mean competency score between intervention and control periods using a structured survey. | Not Posted | Baseline and every nine months for up to four years | Participants |
| 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. | Not Posted | Baseline and every nine months for up to four years | Participants |
| 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. | Not Posted | Baseline and every nine months for up to four years | Participants |
| 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 | Not Posted | Baseline and every nine months for up to four years | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline and every nine months for up to four years | Participants |
| Other Pre-specified | Viral Load in HIV-positive Adolescents | This measure is defined as change in viral load between intervention and control periods using available EMR data. | Not Posted | Baseline and every nine months for up to four years | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline and every nine months for up to four years | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline and every nine months for up to four years | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline and every nine months for up to four years | Participants |
| 0 |
| 2,123 |
| 0 |
| 2,123 |
| 0 |
| 2,123 |
| EG001 | No Training Intervention | In this stepped-wedge design, adolescents in the control arm presented for care before their site received training. | 0 | 2,472 | 0 | 2,472 | 0 | 2,472 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |