Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia (AHD-Zambia)

May 26, 2026 updated by: Boston University

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

11800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sydney Rosen, MPA
  • Phone Number: (857) 207-7909
  • Email: sbrosen@bu.edu

Study Contact Backup

  • Name: Nancy Scott, DrPH MPH
  • Phone Number: (720) 345-4386
  • Email: nscott@bu.edu

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be adult HIV treatment patients and providers at the study sites who meet inclusion and exclusion criteria for each cohort.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1. Prospective cohort
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.
2. Hybrid cohort
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.
3. Inpatient cohort
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.
4. Provider cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initiation characteristics
Time Frame: 6 months
Characteristics of clients presenting with AHD at treatment initiation or re-initiation, compared to clients screened but found not to have AHD.
6 months
Inpatient characteristics
Time Frame: 6 months
Characteristics of clients admitted to hospital after an AHD diagnosis.
6 months
Six-month retention
Time Frame: 6 months
Retention in care of clients presenting with AHD at 6 months after AHD diagnosis.
6 months
Six-month viral suppression
Time Frame: 6 months
Viral suppression of clients presenting with AHD at 6 months after AHD diagnosis.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-month retention
Time Frame: 12 months
Retention in care of clients presenting with AHD at 12 months after AHD diagnosis.
12 months
12-month viral suppression
Time Frame: 12 months
Viral suppression of clients presenting with AHD at 12 months after AHD diagnosis.
12 months
Guideline fidelity
Time Frame: 12 months
Facility and provider fidelity to Zambia's AHD guidelines
12 months
Costs
Time Frame: 12 months
Costs of resources used to provide AHD care
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

Bill and Melinda Gates Foundation
Clinton Health Access Initiative Inc.

Investigators

  • Principal Investigator: Thandiwe Ngoma, CHAI-Zambia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-45653
  • INV-031690 (Other Grant/Funding Number: Bill and Melinda Gates Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

IPD and supporting information will be available after study protocol closure. Data will remain in the public repository in perpetuity.

IPD Sharing Access Criteria

Data will be public (fully dis-identified) using the public data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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