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Home Link: Post Hospital Care to Reduce HIV Mortality in South Africa (HomeLink)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436289
Recruitment Status : Active, not recruiting
First Posted : June 18, 2020
Last Update Posted : June 13, 2022
Sponsor:
Collaborator:
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

Background: This is a pilot randomized clinical trial (RCT) to demonstrate the feasibility and acceptability of a structural and behavioral intervention to reduce mortality following hospital discharge for people with HIV (PWH) in South Africa. Investigators' prior study showed that among 121 PWH discharged, 54% were readmitted and 26% had died by six months following discharge. In the prior study, investigators identified that missing clinic visits after discharge was associated with death. Here investigators are seeking to overcome key barriers in piloting a home-based post-hospital care intervention. Investigators' approach is informed by a conceptual model of key barriers to the care transition along with a behavioral explanatory model, the Behavioral Model for Vulnerable Populations.

The overarching goal of this study is to tailor and pilot the intervention that shifts initial post-discharge care from the out-patient clinic to the home and provides patient-centered counseling (Home Link intervention). For the intervention to prove effective it will need to substantially reduce post-discharge mortality. Specifically, in the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.

Aims: The aims of the study are to pilot a randomized clinical trial of home delivery of health services during the post-hospital period for PWH.

Methods: This project is a pilot randomized clinical trial (RCT) to refine and test the feasibility, acceptability, and preliminary effectiveness of the HomeLink intervention. At the conclusion of the R34 grant period investigators will have a protocol and procedural manual ready for a full RCT powered for effectiveness.

Significance: The proposed study is consistent with NIH HIV/AIDS highest priority research and the South African National Strategic Plan on HIV, tuberculosis (TB), and sexually transmitted infections (STIs) 2017-2022. The research addresses the HIV/AIDS Research Priority of "retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses."


Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Home Link Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized 1:1 to care as usual or Home Link arm. We will perform individual randomization blocked by HIV-status to enroll 30 HIV-uninfected per arm and 90 PWH per arm.
Masking: Single (Investigator)
Masking Description: Participants and members of the research team recruiting and implementing the strategy will be unmasked to randomization assignment due to the behavioral nature of the strategy and need for team members to explain the study arm procedures to participants. Study assignments will be masked to the investigators until all outcome data have been collected.
Primary Purpose: Health Services Research
Official Title: Home Link: Post Hospital Care to Reduce HIV Mortality in South Africa
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : May 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Care-as-usual (CAU) study arm
Participants will receive standard discharge care as provided at Tshepong Hospital during the study. This currently includes discharge counseling from a trained discharge counselor and will be provided with a follow-up return date (usually two weeks post-hospital). Discharge counseling will include a review of discharge medications and instructions regarding follow-up care visits.
Experimental: Home Link study arm
The Home Link intervention will be delivered by a home visit team including a primary care nurse and counselor trained in patient-centered counseling. A rotating hospital-based doctor will be available for pre-home visit clinical file review and post-visit discussion, via cell phone, for decision making and input on patient care during a household visit. We have termed this individual a "discharge officer". The discharge officer will be a Tshepong clinician who is working in the hospital. Supporting Home Link is expected to take <30 minutes of the physician's time during the day. For study-specific concerns, the team will consult with a GCP-trained, PHRU research doctor based at Tshepong Hospital.
Behavioral: Home Link
In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.




Primary Outcome Measures :
  1. Mortality at 6 months [ Time Frame: 6 months after hospital discharge ]
    Number of deaths from any cause.


Secondary Outcome Measures :
  1. Mortality at 12 months [ Time Frame: 12 months after hospital discharge ]
    Number of deaths from any cause.

  2. Time to any non-acute follow-up [ Time Frame: Up to 52 weeks post-hospital discharge ]
    Time to first clinic visit post-hospital discharge.

  3. Number of outpatient follow-up care encounters [ Time Frame: Up to 52 weeks post-hospital discharge ]
    Number of outpatient follow-up care encounters

  4. Number of nights of hospital readmission [ Time Frame: Up to 52 weeks post-hospital discharge ]
    Number of nights spent in hospital post-initial discharge

  5. Cost of care [ Time Frame: Up to 52 weeks post-hospital discharge ]
    Participant-reported out-of-pocket costs for medical care

  6. Acceptability of intervention as assessed by acceptability questionnaire and in-depth interviews [ Time Frame: Up to 52 weeks post-hospital discharge ]
    Acceptability questionnaire with 7 acceptability domains for healthcare workers (HCWs) and participants and in-depth interviews for HCWs and participants. An a priori code book will be developed that reflects key analytic concepts of predisposing, enabling, and need characteristics from the Andersen Behavioral Model. During the process of reading and coding of transcripts using this initial coding scheme, additional codes may be added to document emerging themes of interest.

  7. Feasibility of clinical trial as assessed by enrollment proportion [ Time Frame: Up to 52 weeks ]
    Proportion of approached and eligible individuals who enroll.

  8. Feasibility of clinical trial as assessed by proportion of participants with complete follow-up [ Time Frame: Up to 52 weeks ]
    Feasibility of clinical trial will be determined by the proportion of participants with complete follow-up.

  9. Feasibility of intervention as assessed by overall percentage from individual and composite scores [ Time Frame: 3 months post-hospital discharge ]
    Individual and composite score based on proportion of planned home visits completed, proportion of home medical assessments completed, proportion of home medication reconciliation completed, proportion of participants receiving patient-centered counseling, and proportion of participants with identified food insecurity who receive food supplementation/parcels at the first home visits. The proportions will be considered individually and with a composite score to be interpreted in the context of the efficacy results with a general threshold that substantially more than half of components expected to be completed need to be completed for the intervention to be considered feasible. Success will be based on a priori target of ≥90% of planned home visits completed, successful follow-up of ≥75% of participants, and vital status ascertainment of >90% of participants.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tested for HIV (can be living with HIV or HIV-uninfected)
  • Residing within Matlosana sub-district
  • Agree to post-discharge follow-up including home visit
  • Able to provide informed consent or, if lacking capacity at the time of recruitment (if unable to answer basic orientation questions including name, month/year, and residence location), as determined by the study team, having a next of kin able to provide informed consent

Exclusion Criteria:

  • <18 years of age
  • Length of stay <1 night
  • Unknown HIV status at the point of study screening and enrollment
  • Failure by the patient or next of kin to provide informed consent to be followed up by study staff after discharge
  • Residing outside of Matlosana sub-district
  • Not speaking any of the languages spoken by the study team

Late exclusions occurring after enrollment:

  • Death prior to hospital discharge
  • Hospital stay >30 days
  • Transfer to another hospital
  • Relocation outside of Matlosana sub-district at the point of discharge or within 7 days of discharge

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436289


Locations
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South Africa
Tshepong Hospital
Klerksdorp, North West Province, South Africa, 2574
Sponsors and Collaborators
Johns Hopkins University
University of Witwatersrand, South Africa
Investigators
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Principal Investigator: Christopher Hoffmann, MD, MPH Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04436289    
Other Study ID Numbers: IRB00214009
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified trial data will be made available one year after completion of all study activities.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: One year after completion of study activities.
Access Criteria: Contact PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
home-based
post-hospital care
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases