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临床试验/NCT07428577
NCT07428577尚未招募不适用

Tracking and Continuity of Care in Advanced HIV Disease

Boston University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
Linkage to primary care ART

研究概览

简要总结

Despite the scale-up of HIV testing and the implementation of the universal test-and-treat policy, a substantial proportion of people living with HIV (PLHIV) continue to present with advanced HIV disease (AHD), defined by a CD4 count below 200 cells/µL and/or WHO clinical staging of stage 3 or 4. Global and regional analyses estimate that nearly half of hospitalized PLHIV meet criteria for AHD, with similar findings reported in South Africa. Patients with AHD face high risks of opportunistic infections, hospitalization, and mortality, and frequently disengage from care after discharge. This study aims to examine inpatient and post-discharge care pathways for individuals with AHD in South Africa, identify gaps in continuity of care between hospitals and primary healthcare (PHC) facilities, and generate evidence to inform strategies that strengthen linkage, retention, and long-term outcomes.

A prospective cohort study with a nested process evaluation will be conducted at Helen Joseph Hospital, a large public tertiary facility in Johannesburg. Adult patients (≥18 years) admitted with HIV-related conditions and meeting AHD criteria will be consecutively enrolled once deemed clinically stable. Data will be collected through structured inpatient interviews, medical-record reviews, and follow-up telephone interviews at four- and eight-weeks post-discharge to assess linkage to PHC services, ART continuation, and readmissions. Quantitative data will be analyzed descriptively using standard statistical methods.

This study will generate a detailed understanding of how patients with AHD transition from inpatient to outpatient HIV care, highlighting critical points where continuity of care fails. Findings will identify system- and patient-level barriers to effective linkage and retention and inform interventions to improve post-discharge outcomes. The study poses minimal risk to participants, involving only structured interviews and review of existing medical records, with no invasive procedures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Known HIV positive status
  • Admitted to inpatient care for an AHD-related illness
  • Aged 18 years and above
  • Able to provide written consent or consent using a thumbprint
  • Consent to be contacted after discharge and can provide contact information

排除标准

  • Confined to tuberculosis isolation ward or other wards for patients with acute infectious disease that requires isolation procedures
  • Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff
  • Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant

研究组 & 干预措施

Prospective cohort

Adults aged 18 or older admitted to a medical (not surgical, obstetric, or psychiatric) unit at the Helen Joseph hospital with an HIV-related condition.

结局指标

主要结局

Linkage to primary care ART

时间窗: 8 weeks after hospital discharge

Self-reported proportion of discharged patients who successfully return to PHC facilities and start, resume, or continue ART.

次要结局

  • Referral documentation(8 weeks after hospital discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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