N/A
N=195
Home Link: Post Hospital Care to Reduce HIV Mortality in South Africa
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT04436289 ↗Enrolled (actual)
195
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Mortality at 6 Months — 4; 10; 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home Link (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality at 6 Months |
4; 10; 3; 4 | — |
| SECONDARY Mortality at 12 Months |
7; 12; 8; 7 | — |
| SECONDARY Time (Days) to Any Non-acute Follow-up |
13; 28; 13; 31 | — |
| SECONDARY Number of Outpatient Follow-up Care Encounters |
11; 3.5; 7; 4 | — |
| SECONDARY Number of Nights of Hospital Readmission |
9; 11.5; 10; 11.5 | — |
| SECONDARY Cost of Care |
— | — |
| SECONDARY Number of Participants Completing In-depth Interviews to Assess Acceptability of the Intervention |
33; 8 | — |
| SECONDARY Feasibility of Clinical Trial as Assessed by Enrollment Percentage |
195 | — |
| SECONDARY Feasibility of Clinical Trial as Assessed by Percentage of Participants With Complete Follow-up |
55; 51; 30; 31 | — |
| SECONDARY Feasibility of Intervention as Assessed by Participant Program Completion |
50; 27 | — |
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."
Eligibility 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 <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
Late exclusions occurring after enrollment:
- 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
Data sourced from ClinicalTrials.gov (NCT04436289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.