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NCT Number: NCT07102745

HomeLink2: Reducing Posthospitalization Mortality Through Structured Home Care and Nutritional Support

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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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. 12-Month All-Cause Mortality

    Time frame: 12 months post hospital discharge

    Comparison of all-cause mortality at 12 months post-discharge between intervention arms and standard care.

  2. Days of Rehospitalization

    Time frame: 12 months post hospital discharge

    Total number of days hospitalized during the 12-month follow-up period analyzed using negative binomial regression.

  3. Time to First Care Visit

    Time frame: 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.

  4. Viral Load Suppression at 12 Weeks

    Time frame: 12 weeks post hospital discharge

    Proportion of participants with suppressed viral load at 12 weeks post-discharge by study arm.

  5. Weight Change at 12 Weeks

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Neil Martinson

CONTACT

[email protected]

+27 11 989 9838

Tumelo Moloantoa

CONTACT

[email protected]

+27 084-302-6059

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Perinatal HIV Research Unit of the University of the Witswatersrand

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 5, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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