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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07021092
Acronym
P-CoRE
Enrollment
3000
Registered
2025-06-13
Start date
2025-04-01
Completion date
2027-06-30
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV -1 Infection, HIV Viremia

Keywords

Uncontrolled Viremia, Person Centred Care, Unmonitored Viral Load

Brief 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.

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.

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

Sponsors

Centre for Infectious Disease Research in Zambia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
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

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);

Design outcomes

Primary

MeasureTime frameDescription
Updated Estimates of Viremia and Care Status2 yearsThe 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.

Countries

Zambia

Contacts

PRINCIPAL_INVESTIGATORDr Aaloke Mody

Washington University School of Medicine

PRINCIPAL_INVESTIGATORKombatende Sikombe

Centre for Infectious Disease Research in Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026