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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH138270 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Perinatal HIV Research Unit of the University of the Witswatersrand | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | 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 | Experimental | 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. |
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| Home Visit Plus Nutritional Support Arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HomeLink | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 12-Month All-Cause Mortality | Comparison of all-cause mortality at 12 months post-discharge between intervention arms and standard care. | 12 months post hospital discharge |
| Days of Rehospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tumelo Moloantoa | Contact | +27 084-302-6059 | moloantoat@phru.co.za | |
| Neil Martinson | Contact | +27 11 989 9838 | martinson@phru.co.za |
| Name | Affiliation | Role |
|---|---|---|
| Neil Martinson | Perinatal HIV Research Unit (PHRU) | Principal Investigator |
| Christopher Hoffmann | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tshepong Hospital | Recruiting | Klerksdorp | North West | South Africa |
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.
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 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.
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| ID | Term |
|---|---|
| D018529 | Nutritional Support |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Individually randomized, three arm clinical trial
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| HomeLink Plus Nutritional Support | Behavioral | 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. |
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Total number of days hospitalized during the 12-month follow-up period analyzed using negative binomial regression.
| 12 months post hospital discharge |
| Time to First Care Visit | 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. | From discharge until first care visit within 12 months |
| Viral Load Suppression at 12 Weeks | Proportion of participants with suppressed viral load at 12 weeks post-discharge by study arm. | 12 weeks post hospital discharge |
| Weight Change at 12 Weeks | Comparison of weight change from enrollment to 12 weeks post-discharge between intervention arms. Weight will be measured in kilograms (kg). | From enrollment to 12 weeks post hospital discharge |