PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY (P-CoRE)

Centre for Infectious Disease Research in Zambia

Status: Enrolling

Conditions: HIV -1 Infection; HIV Viremia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07021092

INV-050580 (Other Grant/Funding Number)

CIDRZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

3,000 participants in 1 patient group

Tracing to Ascertain Outcome

Other group

Treatment:

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