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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

≥18 years old

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

11,800 Participants
are grouped into 4 trial groups
Group A: 1. Prospective cohort
Group B: 2. Hybrid cohort
Group C: 3. Inpatient cohort
Group D: 4. Provider cohort

Trial outcomes

Primary outcomes

1

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
2

Inpatient characteristics

Characteristics of clients admitted to hospital after an AHD diagnosis.

Time frame
6 months
3

Six-month retention

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

Time frame
6 months
4

Six-month viral suppression

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

Time frame
6 months

Secondary outcomes

1

12-month retention

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

Time frame
12 months
2

12-month viral suppression

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

Time frame
12 months
3

Guideline fidelity

Facility and provider fidelity to Zambia's AHD guidelines

Time frame
12 months
4

Costs

Costs of resources used to provide AHD care

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston University

Lead sponsor

Clinton Health Access Initiative Inc.

Collaborator

Bill and Melinda Gates Foundation

Collaborator