Simulated Patient Encounters to Promote Early Detection and Engagement in HIV Care for Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Retention in HIV Care
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Retention in HIV Care
时间窗: 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).
次要结局
- Proportion of HCWs With Pass/Fail Scores(Up to one month after last day of training)
- Numeric Scores From SP Actors(Up to one week after last day of training)
- Health Care Worker Competency(Baseline and every nine months for up to four years)
- Health Care Workers' Satisfaction With Skills(Baseline and every nine months for up to four years)
- Adolescent Patients' Satisfaction With Care(Baseline and every nine months for up to four years)
- Retention in HIV Care (Secondary)(Baseline and every nine months for up to four years)
研究者
Pamela Kohler
Assistant Professor, Global Health and Nursing
University of Washington