Advanced HIV Disease During the First Six Months on Antiretroviral Therapy in Zambia

Not yet recruiting

• Conditions: Advanced HIV Disease

• Registration Number: NCT06904456
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Study First Posted: 2025-04-01
• Last Update Submitted: 2025-04-27
• Last Update Posted: 2025-04-30
• Study Start: 2025-05
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 11800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHAI-Zambia; 🇿🇲 Lusaka, Zambia