CClinicalTrials.gg
Active, not recruitingNCT07021092P-CoREUpdated Aug 10, 2026

PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY

An interventional study of Interventions will be developed in aim 2 of the study. in HIV Viremia and HIV -1 Infection, sponsored by Centre for Infectious Disease Research in Zambia. Active, not recruiting at 2 sites in Zambia. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Centre for Infectious Disease Research in Zambia · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
3,000
Allocation
Not applicable
Sex
All
01

Study 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. 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.

02

Conditions studied

  • HIV Viremia
  • HIV -1 Infection

Keywords

  • Uncontrolled Viremia
  • Person Centred Care
  • Unmonitored Viral Load
03

In context

Lead sponsor

Centre for Infectious Disease Research in Zambia is the lead sponsor of 37 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.)
  2. Individuals returning to care after being out of care and not taking ART with no VL measure (i.e., unmeasured viremia)
  3. 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)
  4. 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)
  5. Participant that are willing to provide written informed consent in English, or any of the local languages that include Nyanja or Bemba.

Exclusion criteria

Exclusion Criteria:

  1. Patients that are unable to provide consent or unwilling to participate in the study
  2. Participant who is NOT living with HIV/AIDS;
  3. Participant is too sick i.e., failing to talk, general discomfort and emergency cases);
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,000 participants (estimated)

Study arms

  • Other
    Tracing to Ascertain Outcome

    Other: Interventions will be developed in aim 2 of the study.

Interventions

  • OtherInterventions will be developed in aim 2 of the study.

    Person-centred package that connects patients to service delivery, builds rapports and improves engagement in care leading to sustained viral load suppressions

    Also known as: 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

07

Study locations

2 sites
  • Ministry of Health
    Lusaka, Lusaka Province 10101, Zambia
  • 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, Zambia
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07021092
Lead sponsor
Centre for Infectious Disease Research in Zambia
Responsible party
Sponsor
First posted
Jun 13, 2025
Start date
Apr 1, 2025
Primary completion
Feb 28, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Dr Aaloke Mody
principal investigator · Washington University School of Medicine
Kombatende Sikombe
principal investigator · Centre for Infectious Disease Research in Zambia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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