HIV
Conditions
Keywords
HIV care post-hospitalization, Home-based care for HIV, Nutritional support for HIV, People living with HIV
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.
Interventions
BEHAVIORALHomeLink
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.
BEHAVIORALHomeLink Plus Nutritional Support
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.
Sponsors
Johns Hopkins University
National Institute of Mental Health (NIMH)
Perinatal HIV Research Unit of the University of the Witswatersrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Individually randomized, three arm clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month all-cause mortality by intervention arm | 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
| Measure | Time frame | Description |
|---|---|---|
| 12-Month All-Cause Mortality | 12 months post hospital discharge | Comparison of all-cause mortality at 12 months post-discharge between intervention arms and standard care. |
| Days of Rehospitalization | 12 months post hospital discharge | Total number of days hospitalized during the 12-month follow-up period analyzed using negative binomial regression. |
| Time to First Care Visit | From discharge until first care visit within 12 months | Time (measured in # of days) from hospital discharge to first care visit (home visit, fixed clinic, or fixed clinic only), analyzed using survival analysis methods. |
| Viral Load Suppression at 12 Weeks | 12 weeks post hospital discharge | Proportion of participants with suppressed viral load at 12 weeks post-discharge by study arm. |
| Weight Change at 12 Weeks | From enrollment to 12 weeks post hospital discharge | Comparison of weight change from enrollment to 12 weeks post-discharge between intervention arms. Weight will be measured in kilograms (kg). |
Countries
South Africa
Contacts
CONTACTTumelo Moloantoa
CONTACTNeil Martinson
PRINCIPAL_INVESTIGATORNeil Martinson
Perinatal HIV Research Unit (PHRU)
PRINCIPAL_INVESTIGATORChristopher Hoffmann
Johns Hopkins University
Outcome results
None listed