HIV Care Cascade and Linkage to Antiretroviral Therapy Among Hospitalized Adults in Lusaka, Zambia

NCT03158844 | Completed

• 1 other identifier: F160812007
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The population of inpatients is large in Zambia; however, because of poor linkages between hospitals and community HIV care, there are few data to analyze their engagement in HIV care before and after hospitalization. The goal of the study is to learn more about Zambian adults who are HIV-infected and get hospitalized. The purpose of this study is to gather formative, preliminary data, to be used in future grant applications to improve linkage and engagement in HIV care in Zambia.

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• Undetectable HIV viral load at 90 days post-discharge

  Numerator is number with HIV RNA \<1000 c/mL tested at 90 days after hospital discharge; denominator is the # enrolled

  90 days after hospital discharge

Secondary Outcomes (3)

• Proportion of HIV-infected inpatients who are on ART upon admission

  Baseline

• Mortality rate

  90 days after hospital discharge

• ART initiation

  Baseline and 90 days after hospital discharge

Study Arms (2)

HIV+ patients (Standard of care)

300 HIV-infected and hospitalized adult patients at the University Teaching Hospital (UTH) will be recruited.

Other: Standard of care

Health systems informants

15 key Zambian health systems informants and leaders who can discuss inpatient care and the process of linking hospitalized patients to HIV care.

Other: Standard of care

Interventions

Standard of care OTHER

Routine standard of care per Ministry of Health protocol, including blood draws and examinations.

HIV+ patients (Standard of care); Health systems informants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In part 1, people will be recruited in a random fashion from HIV-infected patients hospitalized at the University Teaching Hospital (UTH) as documented in their UTH medical file regardless of their HIV treatment status. The bed spaces in the wards will be enumerated and using a random number generator the team will select patients for screening for study inclusion.

You may qualify if:

• years or older
• HIV-infected as documented in the UTH file
• Admitted to Internal Medicine Ward at UTH

You may not qualify if:

• Unable to provide informed consent
• Not planning to remain in Lusaka province for 3 months after discharge

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University Teaching Hospital: collaborator
• Centre for Infectious Disease Research in Zambia: collaborator

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

Biospecimen

Retention: NONE RETAINED

Blood will be drawn via phlebotomy for patients for whom CD4 and HIV viral load results are not available at baseline. For participants that have initiated ART treatment, we will collect a dried blood spot card using 5 drops of blood from finger prick to measure viral load 90 days after discharge.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael J Vinikoor, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 18, 2017
• Study Start: May 16, 2017
• Primary Completion: February 28, 2018
• Study Completion: May 31, 2018
• Last Updated: September 19, 2024

Record last verified: 2018-08

Locations

ZA (1)