An observational study in Advanced HIV Disease, sponsored by Boston University. Recruiting at 1 site in Zambia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Boston University · Observational
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.
Boston University is the lead sponsor of 270 studies on the registry; 36 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be adult HIV treatment patients and providers at the study sites who meet inclusion and exclusion criteria for each cohort.
Cohort 1
Inclusion
Exclusion
Cohort 2
Inclusion
Exclusion
Cohort 3
Inclusion
Exclusion
Cohort 4
Inclusion
Exclusion
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort 1 is a prospective cohort of adults screened for AHD during the approximately three-month data collection period of the AHD Zambia study. Clients will be enrolled into the study if they 1) are not on ART or have been on ART for up to one month, and 2) are screened for AHD on the day of study enrollment or, if missed on the day they are screened for AHD, will be enrolled at the next clinic visit within one month of AHD screening. Record review for up to 12 months before and 12 months after study enrollment. Baseline survey and qualitative follow up.
Cohort 2 is a hybrid cohort of all adult HIV clients recorded in study sites' AHD screening registers, improvised registers, and/or clinic records as having been screened for AHD at or before ART initiation in the 12 months preceding the start of Cohort 1 data collection. Electronic and paper medical record data will be collected for all of Cohort 2 for the 12 months before and 12 months after the AHD screening date. A subset of Cohort 2 respondents-those who return to the study sites for a clinic visit during the data collection period-will be invited to consent and participate in a quantitative survey and in follow-up qualitative interviews, similar to Cohort 1 enrollees.
Cohort 3 includes adult HIV clients admitted in a study health facility for AHD management. Under the Zambia Ministry of Health's "hub and spoke model" for AHD management, AHD patients requiring hospitalization are admitted to hub facilities. Of the 24 study facilities in AHD-Zambia, 8 are hubs that admit AHD patients. The remaining 16 study sites refer AHD clients requiring admission to the nearest hospital. We will enroll Cohort 3 only at the 8 sites that offer inpatient admission for AHD.
At each study site, we will ask the facility manager to refer us to up to 5 staff who provide care for AHD clients and represent different cadres. This may include doctors and clinical officers, nurses, counselors, and pharmacists, though we anticipate the majority of respondents to be doctors, nurses and clinical officers, who provide most HIV care in Zambia. Each cohort participant will be administered a one-time survey regarding AHD care at the facility.
Initiation characteristics
Characteristics of clients presenting with AHD at treatment initiation or re-initiation, compared to clients screened but found not to have AHD.
Time frame: 6 months
Inpatient characteristics
Characteristics of clients admitted to hospital after an AHD diagnosis.
Time frame: 6 months
Six-month retention
Retention in care of clients presenting with AHD at 6 months after AHD diagnosis.
Time frame: 6 months
Six-month viral suppression
Viral suppression of clients presenting with AHD at 6 months after AHD diagnosis.
Time frame: 6 months
12-month retention
Retention in care of clients presenting with AHD at 12 months after AHD diagnosis.
Time frame: 12 months
12-month viral suppression
Viral suppression of clients presenting with AHD at 12 months after AHD diagnosis.
Time frame: 12 months
Guideline fidelity
Facility and provider fidelity to Zambia's AHD guidelines
Time frame: 12 months
Costs
Costs of resources used to provide AHD care
Time frame: 12 months
Plan to share: Yes — Fully anonymized data generated by the study, such as survey responses and qualitative data (not routine medical record data, which will not be owned by the study team), will be posted to a public data repository after final closure of the study protocol.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD and supporting information will be available after study protocol closure. Data will remain in the public repository in perpetuity.
Access criteria: Data will be public (fully dis-identified) using the public data repository.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.
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