Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07102745

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

Led by Johns Hopkins University · Updated on 2025-08-05

780

Participants Needed

1

Research Sites

188 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented HIV infection confirmed by clinical records or treatment documentation
  • Age 18 years or older as shown in hospital or government records
  • Residence within the Matlosana sub-district by self-report
  • Admission to an adult internal medicine ward at Tshepong Hospital
  • Hospital stay of at least 2 nights before joining the study
  • Willingness to participate in follow-up including home visits
  • Ability to provide informed consent or have a next of kin provide consent if unable
Not Eligible

You will not qualify if you...

  • Admission to non-medical wards such as surgical or psychiatric, elective admissions, or transfers to other hospitals
  • Participant or next of kin unable to provide written informed consent in study languages or languages spoken by the study team

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tshepong Hospital

Klerksdorp, North West, South Africa

Actively Recruiting

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Research Team

T

Tumelo Moloantoa

CONTACT

N

Neil Martinson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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