NCT04436289: HomeLink

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

Completed NA Results posted Last updated 9 January 2024

What this trial tests

NA trial testing Home Link in HIV/AIDS in 195 participants. Completed in 28 February 2023.

Timeline

1 July 2020

Primary endpoint
31 May 2022

28 February 2023

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	195
Start date	1 July 2020
Primary completion	31 May 2022
Estimated completion	28 February 2023
Sites	1 location across South Africa

Drugs / interventions tested

• Home Link

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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."

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Reducing HIV-Associated Post-Hospital Mortality Through Home-Based Care in South Africa: A Randomized Controlled Trial.
   Hoffmann CJ, Shearer K, Kekana B, Kerrigan D, et al · · 2024 · cited 2× · PMID 38051643 · DOI 10.1093/cid/ciad727
2. TB diagnoses and mortality in hospitalized people living with HIV in South Africa.
   Shearer K, Variava E, Kekana B, Abraham P, et al · · 2024 · cited 1× · PMID 38822479 · DOI 10.5588/ijtld.23.0431