PERSON-CENTERED APPROACHES TO VIREMIA: CONNECTION, RAPPORT, AND ENGAGEMENT STUDY
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCentre for Infectious Disease Research in Zambia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.)
Individuals returning to care after being out of care and not taking ART with no VL measure (i.e., unmeasured viremia)
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)
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)
Disqualifiers
Patients that are unable to provide consent or unwilling to participate in the study
Participant who is NOT living with HIV/AIDS;
Participant is too sick i.e., failing to talk, general discomfort and emergency cases);
Trial design
Design model
Single group
Treatments tested in this trial
Interventions will be developed in aim 2 of the study.
Other interventionPerson-centred package that connects patients to service delivery, builds rapports and improves engagement in care leading to sustained viral load suppressions
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Tracing to Ascertain OutcomeOther 1 intervention
Trial outcomes
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 yearsSponsors and contacts
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Source ClinicalTrials.gov