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NCT Number: NCT06904456

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

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.

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Key information

Conditions

Advanced HIV Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHAI-Zambia

Lusaka, Zambia

Location status: Recruiting

Location contact

Hilda Shakwelele

CONTACT

[email protected]

‪+260 97 9153318‬

Thandiwe Ngoma

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Inpatient characteristics

    Time frame: 6 months

    Characteristics of clients admitted to hospital after an AHD diagnosis.

  3. Six-month retention

    Time frame: 6 months

    Retention in care of clients presenting with AHD at 6 months after AHD diagnosis.

  4. Six-month viral suppression

    Time frame: 6 months

    Viral suppression of clients presenting with AHD at 6 months after AHD diagnosis.

Secondary outcomes

  1. 12-month retention

    Time frame: 12 months

    Retention in care of clients presenting with AHD at 12 months after AHD diagnosis.

  2. 12-month viral suppression

    Time frame: 12 months

    Viral suppression of clients presenting with AHD at 12 months after AHD diagnosis.

  3. Guideline fidelity

    Time frame: 12 months

    Facility and provider fidelity to Zambia's AHD guidelines

  4. Costs

    Time frame: 12 months

    Costs of resources used to provide AHD care

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy Scott, DrPH MPH

CONTACT

[email protected]

(720) 345-4386

Sydney Rosen, MPA

CONTACT

[email protected]

(857) 207-7909

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Clinton Health Access Initiative Inc.

Registry information

Acronym: AHD-Zambia

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 1, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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