HIVNCT07102745
HomeLink2: Reducing Posthospitalization Mortality Through Structured Home Care and Nutritional Support
A study testing HomeLink and HomeLink Plus Nutritional Support in people with HIV, run by Johns Hopkins University at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- HomeLink and HomeLink Plus Nutritional Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteSouth Africa
- Study dates
- 24 Jul 2025to 6 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Tshepong Hospital
Klerksdorp, North West
Tumelo Moloantoa, +270843026059, moloantoat@phru.co.za
Bekiwe Ncwana, +27727773750, ncwanab@phru.co.za
About this study
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.
Read more
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.
- Conditions
- HIV
- Being tested
- HomeLink, HomeLink Plus Nutritional Support
- Keywords
- HIV care post-hospitalization, Home-based care for HIV, Nutritional support for HIV, People living with HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeLinkBehavioural
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 SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HomeLink |
| 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. Receives: Behavioral: HomeLink; Behavioral: HomeLink Plus Nutritional Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post hospital discharge
Secondary outcomes (5)
12-Month All-Cause Mortality
Comparison of all-cause mortality at 12 months post-discharge between intervention arms and standard care.
Measured: 12 months post hospital discharge
Days of Rehospitalization
Total number of days hospitalized during the 12-month follow-up period analyzed using negative binomial regression.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From enrollment to 12 weeks post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start24 Jul 2025
- Primary completion4 Sep 2028 (estimated)
- Study completion6 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individually randomized, three arm clinical trial
- Masking
- None (open label)
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Perinatal HIV Research Unit of the University of the Witswatersrand
- Responsible party
- Sponsor
- Investigators
- Neil Martinson, Principal investigator, Perinatal HIV Research Unit (PHRU)Christopher Hoffmann, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102745
- Sponsor's protocol ID
- IRB00449828
- Other IDs
- R01MH138270
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HomeLink2: Reducing Posthospitalization Mortality Through Structured Home Care and Nutritional Support
- ClinicalTrials.gov ID
- NCT07102745
- Acronym / sponsor ID
- IRB00449828
- Conditions
- HIV
- Keywords
- HIV care post-hospitalization, Home-based care for HIV, Nutritional support for HIV, People living with HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Perinatal HIV Research Unit of the University of the Witswatersrand
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 4 Sep 2028 (estimated)
- Study completion
- 6 Mar 2029 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Individually randomized, three arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: HomeLinkIn 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 | Experimental | Behavioral: HomeLink, Behavioral: HomeLink Plus Nutritional SupportHome 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HomeLinkHomeLink 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. | Behavioural | Home Visit Plus Nutritional Support Arm, Home Visit Study Arm |
| HomeLink Plus Nutritional SupportThis 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. | Behavioural | Home Visit Plus Nutritional Support Arm |
Primary outcome
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.
5 secondary outcomes
12-Month All-Cause Mortality
Time frame: 12 months post hospital discharge
Days of Rehospitalization
Time frame: 12 months post hospital discharge
Time to First Care Visit
Time frame: From discharge until first care visit within 12 months
Viral Load Suppression at 12 Weeks
Time frame: 12 weeks post hospital discharge
Weight Change at 12 Weeks
Time frame: From enrollment to 12 weeks post hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil Martinson principal investigator
Perinatal HIV Research Unit (PHRU)
Christopher Hoffmann principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HomeLink and HomeLink Plus Nutritional Support in people with HIV, run by Johns Hopkins University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tumelo Moloantoa (+27 084-302-6059, moloantoat@phru.co.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month all-cause mortality by intervention arm (time frame: 6 months post hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.