NCT07747987

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2025

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

March 24, 2025

Last Update Submit

August 4, 2026

Conditions

Keywords

High Viral Load

Outcome Measures

Primary Outcomes (1)

  • Viral suppression

    Viral Load copies \< 1000 after 3 months off successful enhance adherence counselling in viremic clinic

    3 to 6 months

Study Arms (1)

Viremic clinic

OTHER

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

Interventions

Assigned specific day for high viral load recipients of care with a team of Health care providers to provide additional support and manage patients.

Viremic clinic

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • RoCs in the qualitative evaluation clinics
  • Aged \>15 years old
  • having received EAC in the past 6 months.
  • \- Health care workers involved in the care of those who are not virally suppressed (treatment supporters, EAC counselors, professional healthcare workers)

You may not qualify if:

  • \- ROCs\< 15 years,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIDRZ

Lusaka, 10101, Zambia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Evaluation of outcome for veridic clinic implemented in Lusaka
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

August 5, 2026

Study Start

April 1, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

August 5, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

it will require approval from the Ministry of Health.

Locations