HIV ViremiaP-CoRENCT07021092
PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY
A study testing Interventions will be developed in aim 2 of the study. in people with HIV Viremia and HIV -1 Infection, run by Centre for Infectious Disease Research in Zambia at 2 sites in Zambia.
Trial summary
The study aims to increase the reach of the person-centred interpersonal practices by developing and accessing a tailored, scalable, and sustainable approach that meets the distinctive needs of populations identified as most disproportionately affected by viremia in Zambia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Viremia, HIV -1 Infection
- What is being tested?
- Interventions will be developed in aim 2 of the study.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 2 sitesZambia
- Study dates
- 1 Apr 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients that are lost to follow up ([LTFU] from HIV care i.e. confirmed >30 days late for a scheduled appointment) at the time of sampling. (i.e. not people who were previously LTFU but then returned and have a documented VL.)
- Individuals returning to care after being out of care and not taking ART with no VL measure (i.e., unmeasured viremia)
- Patients that are 6 months late for a scheduled Viral Load (VL) according to Ministry of Health guidelines at the time of sampling (regardless of care status)
- Patients that have a last documented VL that is elevated, > 1000 copies/ml at time of sampling in current clinic population (CCP) (regardless of care status)
- Participant that are willing to provide written informed consent in English, or any of the local languages that include Nyanja or Bemba.
Who cannot join
- Patients that are unable to provide consent or unwilling to participate in the study
- Participant who is NOT living with HIV/AIDS;
- Participant is too sick i.e., failing to talk, general discomfort and emergency cases);
Trial locations and contacts
2 sites in 1 country.
Zambia2 sites
Ministry of Health
Lusaka, Lusaka Province, 10101
Railway GRZ Urban Health Centre, Kafue District Health Hospital, Nangongwe OPD Urban Health Centre, Chawama 1st level hospital, Chipate 1st level hospital, Matero Reference Health Centre, Mtendere Health Centre, Lwiimba Rural Health Centre
Lusaka, Lusaka Province, 10101
About this study
The study aims to increase the reach of the person-centred interpersonal practices by developing and accessing a tailored, scalable, and sustainable approach that meets the distinctive needs of populations identified as most disproportionately affected by viremia in Zambia. The study population include pregnant and breastfeeding women, children, adolescents and adult that are more than thirty -30 days late for their next hospital appointments.The study will be implemented over a period of 36 months in 24 facilities in Lusaka and Central province, Zambia.
Read the detailed description
The study has three aims, that include (1) To assess barriers to sustained viral suppression through identifying prevailing pathways to viremia (2) Apply Human Centred Design methods with stakeholders to co-create person-centred pathways to strengthen viral suppression, with particular attention to vulnerable groups (3) To test P-CoRE package with a focus on high- priority populations contributing to remaining viremia.
- Conditions
- HIV Viremia, HIV -1 Infection
- Being tested
- Interventions will be developed in aim 2 of the study.
- Keywords
- Uncontrolled Viremia, Person Centred Care, Unmonitored Viral Load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions will be developed in aim 2 of the study.Other
Also called Possible interventions to be developed will include 1) community- based outreach and in-person tracing to identify and establish contact with viremic patients and establish barriers to care, Improved counselling using PCC and being non-judgemental as a way of establishing rapport and relationship with individuals using PCC approach tailored to barriers, Facility based Viral load champions, couple counselling and access to DSD models as a way of providing structural interventions to bring individuals back to care, keep them in care and maintain VL sup
Person-centred package that connects patients to service delivery, builds rapports and improves engagement in care leading to sustained viral load suppressions
| Study group | Role | What they receive |
|---|---|---|
| Tracing to Ascertain Outcome | Other | Not described Receives: Other: Interventions will be developed in aim 2 of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Updated Estimates of Viremia and Care Status
The study will use a sampling based approach for outcome ascertainment as used in the Better Information for Health in Zambia(BetterInfo) study https://www.cidrz.org/wp-content/toolkits/betterinfo/, but adapt procedures so they are focused on assessments of viremia (rather than mortality as in the initial BetterInfo study) (21). This approach leverages data collected during routine care and augments it with targeted data collection in a smaller sample of clients with incomplete data (i.e., missing VL measurements) to provide robust and epidemiologically rigorous estimates for the full clinic population.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Apr 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV ViremiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Aaloke Mody, Principal investigator, Washington University School of MedicineKombatende Sikombe, Principal investigator, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021092
- Sponsor's protocol ID
- CIDRZ P-CoRE
- Other IDs
- INV-050580
- Acronym
- P-CoRE
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ehrenkranz P, Rosen S, Boulle A, Eaton JW, Ford N, Fox MP, Grimsrud A, Rice BD, Sikazwe I, Holmes CB. The revolving door of HIV care: Revising the service delivery cascade to achieve the UNAIDS 95-95-95 goals. PLoS Med. 2021 May 24;18(5):e1003651. doi: 10.1371/journal.pmed.1003651. eCollection 2021 May.
PubMed 34029346
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY
- ClinicalTrials.gov ID
- NCT07021092
- Acronym / sponsor ID
- P-CoRE / CIDRZ P-CoRE
- Conditions
- HIV Viremia, HIV -1 Infection
- Keywords
- Uncontrolled Viremia, Person Centred Care, Unmonitored Viral Load
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Jun 2025 (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 study aims to increase the reach of the person-centred interpersonal practices by developing and accessing a tailored, scalable, and sustainable approach that meets the distinctive needs of populations identified as most disproportionately affected by viremia in Zambia. The study population include pregnant and breastfeeding women, children, adolescents and adult that are more than thirty -30 days late for their next hospital appointments.The study will be implemented over a period of 36 months in 24 facilities in Lusaka and Central province, Zambia.
Detailed description
The study has three aims, that include (1) To assess barriers to sustained viral suppression through identifying prevailing pathways to viremia (2) Apply Human Centred Design methods with stakeholders to co-create person-centred pathways to strengthen viral suppression, with particular attention to vulnerable groups (3) To test P-CoRE package with a focus on high- priority populations contributing to remaining viremia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracing to Ascertain Outcome | Other | Other: Interventions will be developed in aim 2 of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients that are lost to follow up ([LTFU] from HIV care i.e. confirmed >30 days late for a scheduled appointment) at the time of sampling. (i.e. not people who were previously LTFU but then returned and have a documented VL.)
- Individuals returning to care after being out of care and not taking ART with no VL measure (i.e., unmeasured viremia)
- Patients that are 6 months late for a scheduled Viral Load (VL) according to Ministry of Health guidelines at the time of sampling (regardless of care status)
- Patients that have a last documented VL that is elevated, > 1000 copies/ml at time of sampling in current clinic population (CCP) (regardless of care status)
- Participant that are willing to provide written informed consent in English, or any of the local languages that include Nyanja or Bemba.
Key exclusion criteria (3 listed)
- Patients that are unable to provide consent or unwilling to participate in the study
- Participant who is NOT living with HIV/AIDS;
- Participant is too sick i.e., failing to talk, general discomfort and emergency cases);
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 |
|---|---|---|
| Interventions will be developed in aim 2 of the study.Also: Possible interventions to be developed will include 1) community- based outreach and in-person tracing to identify and establish contact with viremic patients and establish barriers to care, Improved counselling using PCC and being non-judgemental as a way of establishing rapport and relationship with individuals using PCC approach tailored to barriers, Facility based Viral load champions, couple counselling and access to DSD models as a way of providing structural interventions to bring individuals back to care, keep them in care and maintain VL supPerson-centred package that connects patients to service delivery, builds rapports and improves engagement in care leading to sustained viral load suppressions | Other | Tracing to Ascertain Outcome |
Primary outcome
Updated Estimates of Viremia and Care Status
Time frame: 2 years
The study will use a sampling based approach for outcome ascertainment as used in the Better Information for Health in Zambia(BetterInfo) study https://www.cidrz.org/wp-content/toolkits/betterinfo/, but adapt procedures so they are focused on assessments of viremia (rather than mortality as in the initial BetterInfo study) (21). This approach leverages data collected during routine care and augments it with targeted data collection in a smaller sample of clients with incomplete data (i.e., missing VL measurements) to provide robust and epidemiologically rigorous estimates for the full clinic population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 34029346Ehrenkranz P, Rosen S, Boulle A, Eaton JW, Ford N, Fox MP, Grimsrud A, Rice BD, Sikazwe I, Holmes CB. The revolving door of HIV care: Revising the service delivery cascade to achieve the UNAIDS 95-95-95 goals. PLoS Med. 2021 May 24;18(5):e1003651. doi: 10.1371/journal.pmed.1003651. eCollection 2021 May.
- The study will use similar procedures for a sampling based approach for outcome ascertainment as that used in the Better Information for Health in Zambia Study.Link provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dr Aaloke Mody principal investigator
Washington University School of Medicine
Kombatende Sikombe principal investigator
Centre for Infectious Disease Research in Zambia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions will be developed in aim 2 of the study. in people with HIV Viremia and HIV -1 Infection, run by Centre for Infectious Disease Research in Zambia at 2 sites 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 10 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Updated Estimates of Viremia and Care Status (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07021092, which also lists 1 linked publication.
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 10 Aug 2026.