Clinical trial NCT03158844: HIV Care Cascade and Linkage to Antiretroviral Therapy Among Hospitalized Adults in Lusaka, Zambia
Official title: HIV Care Cascade and Linkage to Antiretroviral Therapy Among Hospitalized Adults in Lusaka, Zambia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University Teaching Hospital
name: Centre for Infectious Disease Research in Zambia
First posted: 2017-05-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Undetectable HIV viral load at 90 days post-discharge
timeFrame: 90 days after hospital discharge
Secondary outcomes:
measure: Proportion of HIV-infected inpatients who are on ART upon admission
timeFrame: Baseline
measure: Mortality rate
timeFrame: 90 days after hospital discharge
measure: ART initiation
timeFrame: Baseline and 90 days after hospital discharge
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael J Vinikoor, MD
role: PRINCIPAL_INVESTIGATOR
References: