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

Hiv Clinical Trial

— COLAH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158844
• Other study ID #: F160812007
• Status: Completed
• Start date: May 16, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 31, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

Other:
• Standard of care
Routine standard of care per Ministry of Health protocol, including blood draws and examinations.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Centre for Infectious Disease Research in Zambia, University Teaching Hospital

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mortality rate	Mortality from time of enrollment to 90 days after discharge	90 days after hospital discharge
Secondary	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