Person-centered approaches to reduce HIV viremia through connection, rapport, and engagement
PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY
This project will try a person-centered package to help people with HIV who are more than 30 days late for appointments — including pregnant and breastfeeding women, children, adolescents, and adults — get and keep their viral load under control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Sex | All |
| Sponsor | Centre for Infectious Disease Research in Zambia Academic / other |
| Locations | 2 sites (Lusaka, Lusaka Province and 1 other locations) |
| Trial ID | NCT07021092 on ClinicalTrials.gov |
What this trial studies
The project uses a three-aim design over 36 months at 24 facilities in Lusaka and Central provinces to reduce uncontrolled HIV viremia among high-priority groups. First, the team will identify common pathways and barriers that lead to sustained viremia and missed viral load monitoring. Second, stakeholders will use human-centered design methods to co-create tailored, scalable person-centered care pathways that address those barriers, with special attention to vulnerable groups. Third, the resulting P-CoRE package will be piloted with populations contributing most to remaining viremia to see if it improves retention and viral suppression.
Who should consider this trial
Good fit: Ideal candidates are people living with HIV at least 30 days late for scheduled clinic appointments, those returning to care without a recent viral load measure, patients six months late for a scheduled viral load, or those with a last documented viral load >1000 copies/mL, including pregnant and breastfeeding women, children, adolescents, and adults at participating clinics who can give informed consent.
Not a fit: People who are not living with HIV, those already virally suppressed with a recent documented viral load, or individuals unable or unwilling to provide informed consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could increase retention in care and viral suppression for groups most affected by viremia, reducing individual health risk and community transmission.
How similar studies have performed: Related person-centered, differentiated care and human-centered design interventions in sub-Saharan Africa have shown promising improvements in retention and viral suppression, though the exact P-CoRE package is a novel, context-specific application.
Eligibility criteria
Show full inclusion / exclusion 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);
Where this trial is running
Lusaka, Lusaka Province and 1 other locations
- Ministry of Health — Lusaka, Lusaka Province, Zambia (Not_yet_recruiting)
- 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, Zambia (Recruiting)
Study contacts
- Principal investigator: Dr Aaloke Mody — Washington University School of Medicine
- Study coordinator: Kombatende Sikombe
- Email: Kombatende.Sikombe@cidrz.org
- Phone: +260973824000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.