Advanced HIV disease during the first six months on antiretroviral therapy in Zambia: research protocol for a prospective, observational, multi-cohort study.
Thandiwe Ngoma, Aniset Kamanga, Nancy Scott...
https://pubmed.ncbi.nlm.nih.gov/40896557Actively Recruiting
Age: 18Years +
All Genders
ID06904456
Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
Led by Boston University · Updated on 2026-05-27
11800
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
B
Boston University
Lead Sponsor
C
Clinton Health Access Initiative Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying advanced HIV disease (AHD) among adults in Zambia who are starting or restarting antiretroviral therapy (ART). The study aims to understand the characteristics, care, and outcomes of clients diagnosed with AHD during their first six months on ART, a period when risks of disengagement from care and death are highest. This observational study collects data to help the Zambia Ministry of Health and partners improve treatment guidelines and interventions for AHD patients. The study involves several groups: a prospective cohort of adults newly screened for AHD, a hybrid cohort of adults screened in the previous year, an inpatient cohort of adults hospitalized for AHD management, and a provider cohort of health workers involved in AHD care. Participants will be enrolled based on ART initiation status and AHD screening, with data collected from medical records, surveys, interviews, and focus groups. Data collection includes retrospective and prospective periods, covering up to 12 months before and after enrollment. Participants will undergo clinical record reviews and complete surveys and interviews about their care experiences and socioeconomic status. Healthcare providers at study sites will also provide input through surveys and interviews. Researchers will measure outcomes such as retention in care and viral suppression at 6 and 12 months, inpatient characteristics, guideline adherence, and costs. The study will monitor participants during their first six months on ART, with some follow-up extending to 12 months, to better understand and support AHD clients in Zambia.
CONDITIONS
Brief Title
Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- 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 advanced HIV disease by clinic prior to or within 1 month of ART initiation
- Living with HIV and screened for advanced HIV disease within 12 months before study data collection
- Initiated or re-initiated ART within the past 6 months
- Returns to study site for clinic visit during enrollment period
- Admitted for inpatient care related to advanced HIV disease
- Employed by or working at the study site for at least 6 months (for providers)
- Written informed consent to participate
You will not qualify if you...
- Pregnant or presenting for antenatal care
- Too ill to participate at time of screening or enrollment visit
- Unable to communicate in the languages used for the questionnaire
- Confined to tuberculosis isolation ward, intensive care unit, or other acute infectious disease wards
- Been on ART for more than 6 months (for hybrid cohort)
- Not physically, mentally, or emotionally able to participate before discharge (for inpatient cohort)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 12 months
Participants living with HIV who have been screened for advanced HIV disease and have initiated or re-initiated ART within the past 6 months are observed through medical record reviews and surveys to assess treatment and health outcomes.
1 baseline visit and additional visits depending on clinic follow-up schedule
Trial Site Locations
Total: 1 location
1
CHAI-Zambia
Lusaka, Zambia
Actively Recruiting
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Research Team
S
Sydney Rosen, MPA
N
Nancy Scott, DrPH MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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