Improving Management of Recipients of Care With HIV Viremia to Optimize Viral Suppression in Zambia: A Process and Outcome Evaluation

August 4, 2026 updated by: Centre for Infectious Disease Research in Zambia
The Centre for Infectious Disease Research in Zambia (CIDRZ) as an implementing partner (IP) through its Centers for Disease Control and Prevention (CDC) and President's Emergency Plan for AIDS Relief (PEPFAR)-funded programs provides technical assistance to the Zambian Ministry of Health (MOH) to support the 95-95-95 HIV care cascade targets. Following the expansion of the DSD approach to cover non-established PLHIV, the MOH, with assistance from CIDRZ piloted the introduction of viremic clinics (VCs) as a DSD model in Lusaka to manage recipients of care (ROCs) with unsuppressed viral loads. In this paper, we describe and report on the programmatic performance and outcomes of VL testing at 6 and 12-months in PLHIV on first line ART in the VC model programme in Lusaka province as well as identify the patient and healthcare workers facilitators and barriers to improve viral suppression within the VCs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To review and understand the progress on management of viremic RoCs in PEPFAR supported HIV programs in three Districts in Lusaka province. This evaluation is essential to help facility staff to tailor client centered service delivery solutions to improve outcomes in HIV viremic clinics. Results from this evaluation will not only help the Ministry of health (MoH), CIDRZ and other implementing partners to make strategic decisions to maximize re-suppression in the high viral load cascade, but will help to improve the management of RoCs and inform national guidance and policy.

Study Type

Interventional

Enrollment (Actual)

548

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Zambia
      • Lusaka, Zambia, 10101
        • CIDRZ

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • RoCs will be included if they are aged 15 years and above ,
  • Started first line ART before March 2020
  • on ART at least 6 months of continuous ART treatment
  • With complete medical records in smart care, HVL registers and enrolled with HVL RoCs and active

Inclusion criteria for IDIs:

  • RoCs in the qualitative evaluation clinics
  • Aged >15 years old
  • having received EAC in the past 6 months.

Inclusion criteria for FGDs :

- Health care workers involved in the care of those who are not virally suppressed (treatment supporters, EAC counselors, professional healthcare workers)

Exclusion Criteria:

- ROCs< 15 years,

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Viremic clinic
Recipients of care managed in viremic clinics are assigned clinician and health care providers to provide patient entered care and manage them closely to achieve viral suppression.
Other: additional support
Assigned specific day for high viral load recipients of care with a team of Health care providers to provide additional support and manage patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral suppression
Time Frame: 3 to 6 months
Viral Load copies < 1000 after 3 months off successful enhance adherence counselling in viremic clinic
3 to 6 months

Collaborators and Investigators

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

Sponsor

Centre for Infectious Disease Research in Zambia

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Micheal Herce, Medical Doctor, MPH, Centre for Infectious Disease Research in Zambia
  • Principal Investigator: Izukanji Sikazwe, Medical Doctor, Centre for Infectious Disease Research in Zambia
  • Principal Investigator: James Simpungwe, Medical Doctor, CDC-Zambia

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 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVL Evaluation 3848-2023
  • GH002251-01-01 (Other Grant/Funding Number: CDC PROUD-Z)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

it will require approval from the Ministry of Health.

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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