Re-engagement at Discharge 2

NCT05694546 | Completed Results DMC

• 1 other identifier: R34MH122265
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 2

Brief Summary

Early post-discharge mortality is high among Zambians living with HIV admitted to the hospital. This may be due to missed opportunities in post-discharge care, such as inadequate follow-up and treatment. In this study the investigators will develop and pilot a new approach to post-discharge HIV care to improve care coordination and treatment adherence.

Conditions

HIV/AIDS; Hospitalization; Transitions of Care; Opportunistic Infections

Outcome Measures

Primary Outcomes (3)

• Post-Discharge Visits

  Proportion of discharged patients who are successfully visited after discharge.

  Through three months post-discharge

• Comprehensive Post-Discharge Visits

  Number of participants that receive a comprehensive discharge follow-up visit from a community health worker

  Through three months post-discharge

• Post-Discharge Clinic Visits

  Proportion of initial post-discharge visits to the HIV clinic that are attended by the participant's community health worker

  Through three months post-discharge

Secondary Outcomes (4)

• HIV Viral Load Suppression

  6 months post-discharge

• Mortality

  6 months post-discharge

• Retention in HIV Care

  6 months post-discharge

• Antiretroviral Therapy Clinic Visit

  1 month post-discharge

Study Arms (1)

Community Health Worker Post-Discharge Intervention

EXPERIMENTAL

This group will be offered a community-based visit from a community health worker following hospital discharge.

Behavioral: Community Health Worker Post-Discharge Intervention

Interventions

Community Health Worker Post-Discharge Intervention BEHAVIORAL

Clients will be offered a community-based follow-up from a community health worker after hospital discharge.

Community Health Worker Post-Discharge Intervention

Eligibility Criteria

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

You may qualify if:

• Age 18+ years
• HIV-positive
• Hospitalized for at least 1 night at study site
• Clinically stable and expected to be discharged according to their clinician
• Objective evidence of suboptimal HIV outcome, defined as HIV viral load above the lower limit of the assay or T-cell cluster of differentiation 4 count \<=200.

You may not qualify if:

• Unable to provide informed consent
• No phone
• Planning to reside outside of Lusaka urban district after discharge

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University Teaching Hospital, Lusaka, Zambia: collaborator
• University of Alabama at Birmingham: collaborator
• University of Maryland, College Park: collaborator

Study Sites (2)

Levy Mwanawasa University Teaching Hospital

Lusaka, Zambia

Location

University Teaching Hospital

Lusaka, Zambia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Opportunistic Infections

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: Cassidy Claassen
• Organization: University of Maryland Baltimore

cclaassen@ihv.umaryland.edu

316-727-6185

Study Officials

• Cassidy Claassen, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Community health worker follow-up after discharge from hospital

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 23, 2023
• Study Start: August 18, 2023
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)