Home Link: Post Hospital Care to Reduce HIV Mortality in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Mortality at 6 Months
研究概览
简要总结
Background: This is a pilot randomized clinical trial (RCT) to demonstrate the feasibility and acceptability of a structural and behavioral intervention to reduce mortality following hospital discharge for people with HIV (PWH) in South Africa. Investigators' prior study showed that among 121 PWH discharged, 54% were readmitted and 26% had died by six months following discharge. In the prior study, investigators identified that missing clinic visits after discharge was associated with death. Here investigators are seeking to overcome key barriers in piloting a home-based post-hospital care intervention. Investigators' approach is informed by a conceptual model of key barriers to the care transition along with a behavioral explanatory model, the Behavioral Model for Vulnerable Populations.
The overarching goal of this study is to tailor and pilot the intervention that shifts initial post-discharge care from the out-patient clinic to the home and provides patient-centered counseling (Home Link intervention). For the intervention to prove effective it will need to substantially reduce post-discharge mortality. Specifically, in the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
Aims: The aims of the study are to pilot a randomized clinical trial of home delivery of health services during the post-hospital period for PWH.
Methods: This project is a pilot randomized clinical trial (RCT) to refine and test the feasibility, acceptability, and preliminary effectiveness of the HomeLink intervention. At the conclusion of the R34 grant period investigators will have a protocol and procedural manual ready for a full RCT powered for effectiveness.
Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research and the South African National Strategic Plan on HIV, tuberculosis (TB), and sexually transmitted infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research Priority of "retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses."
详细描述
BACKGROUND
Sub-Saharan Africa HIV mortality:
In 2016 in South Africa approximately 154,000 PWH died. Of these deaths, 110,000 have been characterized as excess mortality due to HIV (HIV associated deaths). Overall, HIV-associated deaths are associated advanced disease defined by a low cluster of differentiation 4 (CD4) count.
In-Hospital and Post-Hospital Mortality in Africa:
Inpatient mortality among people with HIV (PWH) in Africa is uniformly high ranging from 17.2 to 29.6% across the continent, including in South Africa. Following discharge from an index hospitalization the mortality is also high. In investigators' preliminary work investigators have observed a 26% mortality in the 6 months after hospital discharge. This observation is consistent with mortality from other reports: 50% mortality at twelve months and 30% and 31% at six months reported from Tanzania, Kenya, and South Africa, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
Participants and members of the research team recruiting and implementing the strategy will be unmasked to randomization assignment due to the behavioral nature of the strategy and need for team members to explain the study arm procedures to participants. Study assignments will be masked to the investigators until all outcome data have been collected.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tested for HIV (can be living with HIV or HIV-uninfected)
- •Residing within Matlosana sub-district
- •Agree to post-discharge follow-up including home visit
- •Able to provide informed consent or, if lacking capacity at the time of recruitment (if unable to answer basic orientation questions including name, month/year, and residence location), as determined by the study team, having a next of kin able to provide informed consent
排除标准
- •<18 years of age
- •Length of stay <2 nights
- •Unknown HIV status at the point of study screening and enrollment
- •Failure by the patient or next of kin to provide informed consent to be followed up by study staff after discharge
- •Residing outside of Matlosana sub-district
- •Not speaking any of the languages spoken by the study team
- •Late exclusions occurring after enrollment:
- •Death prior to hospital discharge
- •Discharged too late for the study team to deliver the intervention
- •Transfer to another hospital
- •Relocation outside of Matlosana sub-district at the point of discharge or within 7 days of discharge
结局指标
主要结局
Mortality at 6 Months
时间窗: 6 months after hospital discharge
Number of deaths from any cause.
次要结局
- Cost of Care(Up to 52 weeks post-hospital discharge)
- Number of Outpatient Follow-up Care Encounters(Up to 52 weeks post-hospital discharge)
- Mortality at 12 Months(12 months after hospital discharge)
- Feasibility of Clinical Trial as Assessed by Enrollment Percentage(Up to 52 weeks)
- Time (Days) to Any Non-acute Follow-up(Up to 52 weeks post-hospital discharge)
- Number of Nights of Hospital Readmission(Up to 52 weeks post-hospital discharge)
- Feasibility of Clinical Trial as Assessed by Percentage of Participants With Complete Follow-up(Up to 52 weeks)
- Feasibility of Intervention as Assessed by Participant Program Completion(Up to 6 months)
- Number of Participants Completing In-depth Interviews to Assess Acceptability of the Intervention(Up to 52 weeks post-hospital discharge)