Actively Recruiting
Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
Led by Boston University · Updated on 2025-05-29
11800
Participants Needed
1
Research Sites
110 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
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 Health (MOH) and other key stakeholders lack information about the characteristics and behaviors of AHD clients, including how they are defined and diagnosed (e.g. low CD4 count v. clinical condition), their demographic and socioeconomic profiles, their HIV care histories, what services they receive, and their short-term outcomes (achieve viral suppression, remain AHD, disengage from care, die) and the timing of these outcomes. The Retain6 project aims to improve HIV treatment outcomes during clients' first six months on ART, when disengagement from care and mortality are highest. This protocol, called Advanced HIV disease during the first six months on antiretroviral therapy in Zambia (AHD Zambia), describes an observational study that will describe the experiences of clients who are diagnosed with AHD upon ART initiation (or re-initiation) in Zambia. Data collected will include clinical and socioeconomic characteristics, clinical and non-clinical needs, services delivered and received, and clients' and providers' concerns and preferences. The study's overall goal is to provide information to the Zambia MOH, treatment program partners, providers, and other stakeholders to better understand who is presenting with AHD in Zambia, how they are currently managed, and their treatment outcomes after starting ART. This information will be useful in determining interventions and guideline changes that might improve short- and long-term outcomes for AHD patients. The study, which will be conducted in collaboration with the Zambia MOH, will include retrospective file reviews, prospective quantitative surveys with outpatient and inpatient clients, qualitative focus group discussions (FGDs) and interviews with clients, and provider surveys and interviews.
CONDITIONS
Official Title
Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
Who Can Participate
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 before or within 1 month of ART start
- Living with HIV and screened for AHD at a study site within 12 months of study data collection start
- Initiated or re-initiated ART within the past 6 months
- Returning to the study site for a clinic visit during enrollment period
- Admitted for inpatient care related to advanced HIV disease
- Employed by or at the study site for at least 6 months and directly interacting with clients with AHD
- Provided written informed consent to participate
You will not qualify if you...
- Pregnant or presenting for antenatal care
- Too ill at time of AHD screening or enrollment visit to participate
- Unable to communicate in any of the study languages or languages known to research assistant
- Been on ART for more than 6 months
- Confined to tuberculosis isolation ward, intensive care unit, or other ward for acute infectious disease
- Not physically, mentally, or emotionally able to participate before discharge (for inpatients)
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHAI-Zambia
Lusaka, Zambia
Actively Recruiting
Research Team
S
Sydney Rosen, MPA
CONTACT
N
Nancy Scott, DrPH MPH
CONTACT
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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