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

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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Other: Standard of care

Detailed Description

The main objective of this study is to generate preliminary data on the outcomes of Zambian HIV-infected individuals after discharge from University Teaching Hospital (UTH) Internal Medicine wards which can inform development of a linkage intervention. Our central hypothesis is that in Sub-Saharan African settings like Zambia hospitalizations among HIV-infected individuals are driven by suboptimal linkage and initiation of ART following HIV diagnosis. Specific Aims: (a) Characterize the distribution of hospitalized 300 HIV-infected adults across the HIV care continuum. (b) Identify structural, psychosocial, clinic, and medical factors that predict suboptimal linkage to care and ART initiation after 90 days of hospital discharge among HIV-infected Zambians.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Routine standard of care per Ministry of Health protocol, including blood draws and examinations.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of HIV-infected inpatients who are on ART upon admission	Numerator is number who report taking ART up to the time of admission; denominator is the # enrolled	Baseline
Mortality rate	Mortality from time of enrollment to 90 days after discharge	90 days after hospital discharge
ART initiation	Proportion not on ART upon admission to hospital who are on ART at 90 days after hospital discharge	Baseline and 90 days after hospital discharge

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Centre for Infectious Disease Research in Zambia; University Teaching Hospital
• Investigators: Principal Investigator: Michael J Vinikoor, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: F160812007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No