HomeLink2: structured home care with optional nutrition to reduce deaths after hospital discharge
HomeLink2: Reducing Posthospitalization Mortality Through Structured Home Care and Nutritional Support
This trial will test whether structured home-based medical care and support—with or without food parcels—helps adults living with HIV recover better and reduce deaths in the six months after leaving the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 780 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Klerksdorp, North West) |
| Trial ID | NCT07102745 on ClinicalTrials.gov |
What this trial studies
This randomized, three-arm trial enrolls adults living with HIV who were admitted to the internal medicine ward at Tshepong Hospital and live in the Matlosana sub-district. Participants are randomly assigned to standard post-discharge care, home-based medical assessments with adherence support and psychosocial counseling, or the same home-based care plus food parcels to support nutrition. The primary outcome is death within six months of discharge, with secondary outcomes including medication adherence, retention in care, and longer-term health measures; the design is a type-1 hybrid implementation-effectiveness trial to collect both outcome and implementation data. Home visits and structured follow-up are used to deliver the interventions and gather outcome information.
Who should consider this trial
Good fit: Adults (≥18) with documented HIV who were admitted to an adult internal medicine ward at Tshepong Hospital, reside in the Matlosana sub-district, and can accept post-discharge home visits (or have a next of kin to consent) are the intended participants.
Not a fit: Patients admitted to surgical, psychiatric, or elective wards, those living outside the Matlosana catchment area, or individuals who cannot receive home visits or provide consent are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could lower post-discharge deaths and improve medication adherence, retention in care, and nutritional recovery for people living with HIV.
How similar studies have performed: Related home-based adherence and nutrition programs have shown improved retention and health outcomes in some low-resource settings, but randomized trials specifically targeting posthospital mortality among people living with HIV are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Klerksdorp, North West
- Tshepong Hospital — Klerksdorp, North West, South Africa (Recruiting)
Study contacts
- Principal investigator: Neil Martinson — Perinatal HIV Research Unit (PHRU)
- Study coordinator: Tumelo Moloantoa
- Email: moloantoat@phru.co.za
- Phone: +27 084-302-6059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.