HIV/AIDS
Conditions
Keywords
Adolescents, Clinical training, HIV care and treatment, Africa
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.
Interventions
BEHAVIORALClinician 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.
Sponsors
University of Nairobi
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped wedge cluster RCT
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in HIV Care | 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
| Measure | Time frame | Description |
|---|---|---|
| Numeric Scores From SP Actors | 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. |
| Proportion of HCWs With Pass/Fail Scores | Up to one month after last day of training | The proportion of HCW participants who achieved competency upon completion of the training. |
| Health Care Worker Competency | 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. |
| Health Care Workers' Satisfaction With Skills | 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. |
| Adolescent Patients' Satisfaction With Care | 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. |
| Retention in HIV Care (Secondary) | 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
| Measure | Time frame | Description |
|---|---|---|
| Linkage to Adolescent Friendly Services in HIV-positive Adolescents | 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. |
| AIDS Defining Illness in HIV-positive Adolescents | 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. |
| Mortality in HIV-positive Adolescents | 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. |
| Viral Load in HIV-positive Adolescents | 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. |
| Antiretroviral (ART) Adherence in HIV-positive Adolescents | 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. |
Countries
Kenya
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 2,123 |
| No Training Intervention Clinics prior to receiving training | 0 |
| No Training Intervention Clinics prior to receiving training | 2,472 |
| Total | 4,595 |
Baseline characteristics
| Characteristic | SP Training Intervention | No Training Intervention | Total |
|---|---|---|---|
| Age, Customized 10-14 | 220 Medical records | 278 Medical records | 498 Medical records |
| Age, Customized 15-19 | 474 Medical records | 639 Medical records | 1113 Medical records |
| Age, Customized 20-24 | 1429 Medical records | 1555 Medical records | 2984 Medical records |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Medical records | 0 Medical records | 0 Medical records |
| Race (NIH/OMB) Asian | 0 Medical records | 0 Medical records | 0 Medical records |
| Race (NIH/OMB) Black or African American | 2123 Medical records | 2472 Medical records | 4595 Medical records |
| Race (NIH/OMB) More than one race | 0 Medical records | 0 Medical records | 0 Medical records |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Medical records | 0 Medical records | 0 Medical records |
| Race (NIH/OMB) Unknown or Not Reported | 0 Medical records | 0 Medical records | 0 Medical records |
| Race (NIH/OMB) White | 0 Medical records | 0 Medical records | 0 Medical records |
| Region of Enrollment Kenya | 2123 Medical records | 2472 Medical records | 4595 Medical records |
| Sex/Gender, Customized Female | 1761 Medical records | 2021 Medical records | 3782 Medical records |
| Sex/Gender, Customized Male | 362 Medical records | 450 Medical records | 812 Medical records |
| Sex/Gender, Customized Missing | 0 Medical records | 1 Medical records | 1 Medical records |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,123 | 0 / 2,472 |
| other Total, other adverse events | 0 / 2,123 | 0 / 2,472 |
| serious Total, serious adverse events | 0 / 2,123 | 0 / 2,472 |
Outcome results
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).
Time frame: Up to four years after baseline
Population: Medical record review. Final analysis accounts for clustering by facility, time (stepped wedge design), and newly enrolled in care status.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent Records - Intervention Exposed | Retention in HIV Care | 1570 Participants |
| Adolescent Records - Unexposed | Retention in HIV Care | 1855 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.
Time frame: Baseline and every nine months for up to four years
Secondary
Health Care Worker Competency
This outcome is measured as change in mean competency score between intervention and control periods using a structured survey.
Time frame: 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.
Time frame: Baseline and every nine months for up to four years
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.
Time frame: Up to one week after last day of training
Secondary
Proportion of HCWs With Pass/Fail Scores
The proportion of HCW participants who achieved competency upon completion of the training.
Time frame: Up to one month after last day of training
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
Time frame: Baseline and every nine months for up to four years
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.
Time frame: Baseline and every nine months for up to four years
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.
Time frame: Baseline and every nine months for up to four years
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.
Time frame: Baseline and every nine months for up to four years
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.
Time frame: Baseline and every nine months for up to four years
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.
Time frame: Baseline and every nine months for up to four years