HomeLink2: Reducing Posthospitalization Mortality Through Structured Home Care and Nutritional Support

Обзор

People living with HIV (PLWH) are at high risk of poor health outcomes after being discharged from the hospital. This study is designed to test whether providing structured care at home-either with or without nutritional support-can help reduce the risk of death within six months of discharge and improve long-term health outcomes. The investigators are conducting a randomized clinical trial to evaluate the effectiveness of home-based care on post-hospital recovery. Participants are randomly assigned to one of three groups: (1) standard post-discharge care, (2) home-based care that includes medical assessments, support for taking HIV medications (adherence support), and psychosocial counseling, or (3) the same home-based care plus food parcels to support nutrition. This is a three-arm, individually randomized clinical trial and a type-1 hybrid implementation-effectiveness study, which means the investigators are not only testing whether the interventions improve health outcomes, but also examining how the interventions are delivered and whether the interventions are practical and acceptable in real-world settings. The trial begins with a pilot phase to test the investigators enrollment procedures and improve baseline data collection. In addition to measuring whether the interventions reduce the risk of death, the study will assess how many people receive the intervention, whether it is acceptable to patients and families, and how consistently it is delivered. The investigators are also evaluating the economic impact of illness, hospitalization, and death on households, and analyzing the cost and resource needs of delivering home-based care, with or without food support. The investigators goal is to provide evidence that can improve care for people living with HIV after hospital discharge. If effective, this approach may be applied more broadly to improve outcomes for other high-risk patients in similar settings. Findings from the study will be used to inform health policy and clinical practice, particularly in areas with limited resources and high HIV burden.

Вмешательства

• Поведенческое HomeLink
  HomeLink is a structured post-discharge home-based care program for people living with HIV, designed to improve health outcomes after hospital discharge. Starting one week after discharge, trained nurse-clinician and counselor teams conduct regular home visits every two weeks for up to six visits. During these visits, the team will provide clinical assessments, medication adherence support, psychosocial counseling, specimen collection, and home safety evaluations. The intervention aims to offer
• Поведенческое HomeLink Plus Nutritional Support
  This intervention combines the HomeLink home-based care program with the provision of nutritional support through food parcels. Participants receive food parcels designed to address nutritional needs and support overall health and recovery. The combined approach aims to improve post-discharge outcomes by addressing both medical and nutritional factors contributing to patient well-being.

Первичные конечные точки

• 6-month all-cause mortality by intervention arm [Срок оценки: 6 months post hospital discharge]

Вторичные конечные точки (5)

• 12-Month All-Cause Mortality [Срок оценки: 12 months post hospital discharge]
• Days of Rehospitalization [Срок оценки: 12 months post hospital discharge]
• Time to First Care Visit [Срок оценки: From discharge until first care visit within 12 months]
• Viral Load Suppression at 12 Weeks [Срок оценки: 12 weeks post hospital discharge]
• Weight Change at 12 Weeks [Срок оценки: From enrollment to 12 weeks post hospital discharge]

Критерии участия

Критерии включения

• Documented HIV infection (either diagnosed during or prior to hospital admission), consisting of any clinical documentation, including a chart note of HIV positivity, Ritonavir-boosted darunavir (RVD) positivity, or antiretroviral therapy (ART) regimen documentation/prescription
• ≥18 years old as per hospital file or government issued document
• Self-report that the participant resides within Matlosana sub-district
• Admitted to an adult internal medicine ward at Tshepong Hospital
• Have spent at least 2 nights in the hospital prior to recruitment to the trial.
• Agree to post-discharge follow-up, including home visits
• Are able to provide informed consent or if lacking capacity to provide consent at the time of recruitment, as determined by the study team, have a next of kin able to provide informed consent.

Критерии исключения

• Admitted to a non-medical (i.e., surgical, psychiatric, etc.) ward, admitted for elective reasons, or admitted to facilitate onward transfer to another hospital
• Participant or next of kin unable to provide written informed consent in any of the languages of the informed consents or spoken by the study team

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

ЮАР · 1 центр

• Tshepong Hospital — Klerksdorp

Идентификаторы

NCT: NCT07102745 · IRB00449828 · R01MH138270

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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