NCT07102745Recruiting
HomeLink2: Reducing Posthospitalization Mortality Through Structured Home Care and Nutritional Support
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 780 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 24 Jul 2025
- Primary completion date
- 4 Sept 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- HIV
- NCT number
- NCT07102745
What you commit to
- Study type: Interventional
- Planned participants: 780
- From 24 Jul 2025 to the primary completion date, 4 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Admitted to a non-medical (i.e., surgical, psychiatric, etc.) ward, admitted for elective reasons, or admitted to facilitate onward transfer to another hospital
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tshepong Hospital Coordinator of this site? Confirm its status | Klerksdorp | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.