Clinical trial NCT07021092: PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY
Official title: PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Viremia
HIV -1 Infection
Keywords: Uncontrolled Viremia
Person Centred Care
Unmonitored Viral Load
Lead sponsor: Centre for Infectious Disease Research in Zambia
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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);

Primary outcomes:
measure: Updated Estimates of Viremia and Care Status
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Ministry of Health
state: Lusaka Province
city: Lusaka
country: Zambia
facility: 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
Study officials:
affiliation: Washington University School of Medicine
name: Dr Aaloke Mody
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Infectious Disease Research in Zambia
name: Kombatende Sikombe
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.