Clinical trial NCT06904456: Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
Official title: Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced HIV Disease
Keywords: Antiretroviral therapy (ART)
Zambia
Service delivery
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Clinton Health Access Initiative Inc.
name: Bill and Melinda Gates Foundation
First posted: 2025-04-01
Enrollment: 11800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Initiation characteristics
timeFrame: 6 months
measure: Inpatient characteristics
timeFrame: 6 months
measure: Six-month retention
timeFrame: 6 months
measure: Six-month viral suppression
timeFrame: 6 months
Secondary outcomes:
measure: 12-month retention
timeFrame: 12 months
measure: 12-month viral suppression
timeFrame: 12 months
measure: Guideline fidelity
timeFrame: 12 months
measure: Costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: CHAI-Zambia
Study officials:
affiliation: CHAI-Zambia
name: Thandiwe Ngoma
role: PRINCIPAL_INVESTIGATOR
References: