HIV - Human Immunodeficiency VirusNCT07747987
Improving Management of Recipients of Care With HIV Viremia to Optimize Viral Suppression in Zambia: A Process and Outcome Evaluation
A study testing additional support in people with HIV - Human Immunodeficiency Virus, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV - Human Immunodeficiency Virus
- What is being tested?
- additional support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 1 siteZambia
- Study dates
- 1 Apr 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- ROCs< 15 years,
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV - Human Immunodeficiency Virus
- Being tested
- additional support
- Keywords
- High Viral Load
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional supportOther
Assigned specific day for high viral load recipients of care with a team of Health care providers to provide additional support and manage patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: additional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression
Viral Load copies < 1000 after 3 months off successful enhance adherence counselling in viremic clinic
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV - Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluation of outcome for veridic clinic implemented in Lusaka
- Masking
- None (open label)
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Micheal Herce, Medical Doctor, MPH, Principal investigator, Centre for Infectious Disease Research in ZambiaIzukanji Sikazwe, Medical Doctor, Principal investigator, Centre for Infectious Disease Research in ZambiaJames Simpungwe, Medical Doctor, Principal investigator, CDC-Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747987
- Sponsor's protocol ID
- HVL Evaluation 3848-2023
- Other IDs
- GH002251-01-01
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it will require approval from the Ministry of Health.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Management of Recipients of Care With HIV Viremia to Optimize Viral Suppression in Zambia: A Process and Outcome Evaluation
- ClinicalTrials.gov ID
- NCT07747987
- Acronym / sponsor ID
- HVL Evaluation 3848-2023
- Conditions
- HIV - Human Immunodeficiency Virus
- Keywords
- High Viral Load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluation of outcome for veridic clinic implemented in Lusaka
| Arm | Type | Receives |
|---|---|---|
| Viremic clinic | Other | Other: additional supportRecipients 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- ROCs< 15 years,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional supportAssigned specific day for high viral load recipients of care with a team of Health care providers to provide additional support and manage patients. | Other | Viremic clinic |
Primary outcome
Viral suppression
Time frame: 3 to 6 months
Viral Load copies < 1000 after 3 months off successful enhance adherence counselling in viremic clinic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. it will require approval from the Ministry of Health.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micheal Herce, Medical Doctor, MPH principal investigator
Centre for Infectious Disease Research in Zambia
Izukanji Sikazwe, Medical Doctor principal investigator
Centre for Infectious Disease Research in Zambia
James Simpungwe, Medical Doctor principal investigator
CDC-Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional support in people with HIV - Human Immunodeficiency Virus, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression (time frame: 3 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.