HomeLink2: Reducing Posthospitalization Mortality Through Structured Home Care and Nutritional Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 780
- Locations
- 1
- Primary Endpoint
- 6-month all-cause mortality by intervention arm
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard of care
Participants 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
In 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.
Intervention: HomeLink (Behavioral)
Home Visit Plus Nutritional Support Arm
Home 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.
Intervention: HomeLink (Behavioral)
Home Visit Plus Nutritional Support Arm
Home 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.
Intervention: HomeLink Plus Nutritional Support (Behavioral)
Outcomes
Primary Outcomes
6-month all-cause mortality by intervention arm
Time Frame: 6 months post hospital discharge
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.
Secondary Outcomes
- 12-Month All-Cause Mortality(12 months post hospital discharge)
- Days of Rehospitalization(12 months post hospital discharge)
- Viral Load Suppression at 12 Weeks(12 weeks post hospital discharge)
- Time to First Care Visit(From discharge until first care visit within 12 months)
- Weight Change at 12 Weeks(From enrollment to 12 weeks post hospital discharge)