Status:
RECRUITING
Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
Lead Sponsor:
Boston University
Collaborating Sponsors:
Clinton Health Access Initiative Inc.
Bill and Melinda Gates Foundation
Conditions:
Advanced HIV Disease
Eligibility:
All Genders
18+ years
Brief Summary
In Zambia, an estimated 20% of HIV-positive clients continue to present for first-time antiretroviral therapy (ART) initiation or re-initiation with advanced HIV disease (AHD). The Zambia Ministry of ...
Eligibility Criteria
Inclusion
- Cohort 1
- Inclusion
- ≥18 years old
- Presenting at a study site clinic for HIV diagnosis or care
- Not currently on ART (or on ART for up to 1 month if enrolled at next visit after AHD screening)
- Screened for AHD by clinic, prior to or within 1 month of ART initiation
- Written informed consent to participate
- Exclusion
- Pregnant and/or presenting for antenatal care
- Too ill at the time of AHD screening and at the next clinic visit to participate in the study
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Cohort 2
- Inclusion
- ≥18 years old
- Living with HIV and screened for AHD at a study site within 12 months of the start of study prospective data collection at that site
- All inclusion criteria for the full cohort
- Initiated/re-initiated ART within the past 6 months
- Returns to the study site for a clinic visit during the study enrollment period
- Written informed consent to participate
- Exclusion
- Pregnant and/or presenting for antenatal care as reported in records
- All exclusion criteria for the full cohort
- Too ill at the time of study enrollment visit to participate in the study
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Been on ART \>6 months
- Cohort 3
- Inclusion
- ≥18 years old
- Living with HIV
- Admitted for inpatient care related to AHD
- Initiated or re-initiated ART within the last 6 months
- Written informed consent to participate
- Exclusion
- Pregnant and/or presenting for antenatal care
- Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff
- Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
- Confined to tuberculosis isolation ward; intensive care unit; or other ward specifically for clients with acute infectious disease.
- Cohort 4
- Inclusion
- Employed by or at the study site for at least 6 months
- Directly interact with clients presenting with AHD
- Written informed consent to participate
- Exclusion
- None
Exclusion
Key Trial Info
Start Date :
April 22 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
11800 Patients enrolled
Trial Details
Trial ID
NCT06904456
Start Date
April 22 2025
End Date
June 1 2027
Last Update
May 29 2025
Active Locations (1)
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1
CHAI-Zambia
Lusaka, Zambia