HomeLink2: Reducing Posthospitalization Mortality Through Structured Home Care and Nutritional Support
2 other identifiers
interventional
780
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Jul 2025
Typical duration for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2025
CompletedFirst Submitted
Initial submission to the registry
July 30, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 6, 2029
August 5, 2025
July 1, 2025
3.1 years
July 30, 2025
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6-month all-cause mortality by intervention arm
All-cause mortality at 6 months post-hospital discharge, comparing each intervention arm (HomeLink home visit, HomeLink plus nutritional support) separately and combined against standard discharge care.
6 months post hospital discharge
Secondary Outcomes (5)
12-Month All-Cause Mortality
12 months post hospital discharge
Days of Rehospitalization
12 months post hospital discharge
Time to First Care Visit
From discharge until first care visit within 12 months
Viral Load Suppression at 12 Weeks
12 weeks post hospital discharge
Weight Change at 12 Weeks
From enrollment to 12 weeks post hospital discharge
Study Arms (3)
Standard of care
NO INTERVENTIONParticipants in the standard of care arm will receive discharge care as routinely provided at Tshepong Hospital. This includes scheduling follow-up, which is usually two weeks following discharge and usually at the appropriate specialty clinic located at Tshepong Hospital.
Home Visit Study Arm
EXPERIMENTALIn addition to receiving the routine discharge care provided at Tshepong Hospital (as in the standard of care arm), participants in the home visit intervention arm will receive regular home visits every two weeks, starting one week after hospital discharge, for a total of 4 to 6 visits. Each visit will be conducted by a trained nurse-clinician and counselor, with the aim of building trust through continuity of care. During each visit, the team will provide clinical assessments, monitor vital signs, review medications with a focus on HIV treatment adherence, collect lab specimens if needed, and assess the home environment for safety and support. Psychosocial support will also be provided, including counseling on mental health, alcohol use, social support, and HIV-related challenges, using motivational interviewing techniques. Referrals will be made as needed for medical, mental health, or social services.
Home Visit Plus Nutritional Support Arm
EXPERIMENTALHome visits will be conducted for the 'home visit study arm.' In addition, participants randomized to the home visit plus nutritional support study arm will receive food parcels. Food parcels will be provided by the Perinatal HIV Research Unit (PHRU) study team in 3 standardized and pre-packaged deliveries at weeks 1, 5, and 9.
Interventions
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 personalized, continuous care that addresses medical, psychological, and social needs in the participant's home environment, enhancing recovery and reducing post-hospital mortality.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tshepong Hospital
Klerksdorp, North West, South Africa
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil Martinson
Perinatal HIV Research Unit (PHRU)
- PRINCIPAL INVESTIGATOR
Christopher Hoffmann
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2025
First Posted
August 5, 2025
Study Start
July 24, 2025
Primary Completion (Estimated)
September 4, 2028
Study Completion (Estimated)
March 6, 2029
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be available 6 to 24 months after completion of data collection, following cleaning, de-identification, and locking of datasets. Data will be stored and accessible for at least 10 years.
- Access Criteria
- Access will be granted to qualified researchers who submit a data use request to the Principal Investigator and obtain Institutional Review Board (IRB) approval for secondary analyses. Data access will be controlled through a repository (Dryad) that applies an independent review panel. Researchers will access de-identified and date-offset data and associated supporting documents via the repository under controlled conditions designed to protect participant privacy. Qualitative data will be accessed only by request and with restrictions.
De-identified datasets including HIV status, viral load, clinical data, health service use, food security, social support, quality of life, participant health costs, HIV stigma, violence screening, health system trust, and weight measurements. Qualitative interview data will be stored securely and may be shared upon request under restricted access. Data will be date-offset to protect confidentiality.