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

NCT04436289 | Completed Results DMC

• 2 other identifiers: IRB002140095R34MH118998
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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."

Conditions

HIV/AIDS

Keywords

home-based; post-hospital care

Outcome Measures

Primary Outcomes (1)

• Mortality at 6 Months

  Number of deaths from any cause.

  6 months after hospital discharge

Secondary Outcomes (9)

• Mortality at 12 Months

  12 months after hospital discharge

• Time (Days) to Any Non-acute Follow-up

  Up to 52 weeks post-hospital discharge

• Number of Outpatient Follow-up Care Encounters

  Up to 52 weeks post-hospital discharge

• Number of Nights of Hospital Readmission

  Up to 52 weeks post-hospital discharge

• Cost of Care

  Up to 52 weeks post-hospital discharge

Study Arms (4)

PLWH care-as-usual (CAU) study arm

NO INTERVENTION

Participants living with HIV 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.

PLWH Home Link study arm

EXPERIMENTAL

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

PLWOH care-as-usual (CAU) study arm

NO INTERVENTION

Participants living without HIV 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.

PLWOH Home Link study arm

EXPERIMENTAL

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

Interventions

Home Link BEHAVIORAL

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.

PLWH Home Link study arm; PLWOH Home Link study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<18 years of age
• Length of stay \<2 nights
• 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
• Death prior to hospital discharge
• Discharged too late for the study team to deliver the intervention
• Transfer to another hospital
• Relocation outside of Matlosana sub-district at the point of discharge or within 7 days of discharge

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Witwatersrand, South Africa: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Tshepong Hospital

Klerksdorp, North West, 2574, South Africa

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Christopher Hoffmann
• Organization: Johns Hopkins University

choffmann@jhmi.edu

410-614-4257

Study Officials

• Christopher Hoffmann, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 18, 2020
• Study Start: July 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: February 28, 2023
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after completion of study activities.
• Access Criteria: Contact PI.

Locations

ZA (1)