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

NCT07021092 | Recruiting

• 2 other identifiers: CIDRZINV-050580
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Viremia; HIV -1 Infection

Keywords

Uncontrolled Viremia; Person Centred Care; Unmonitored Viral Load

Outcome Measures

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.

  2 years

Study Arms (1)

Tracing to Ascertain Outcome

OTHER

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

Interventions

Interventions will be developed in aim 2 of the study. OTHER

Person-centred package that connects patients to service delivery, builds rapports and improves engagement in care leading to sustained viral load suppressions

Also known as: Possible interventions to be developed will include 1) community- based outreach and in-person tracing to identify and establish contact with viremic patients and establish barriers to care, Improved counselling using PCC and being non-judgemental as a way of establishing rapport and relationship with individuals using PCC approach tailored to barriers, Facility based Viral load champions, couple counselling and access to DSD models as a way of providing structural interventions to bring individuals back to care, keep them in care and maintain VL sup

Tracing to Ascertain Outcome

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Participant that are willing to provide written informed consent in English, or any of the local languages that include Nyanja or Bemba.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead

Study Sites (2)

Ministry of Health

Lusaka, Lusaka Province, 10101, 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, 10101, Zambia

RECRUITING

Related Publications (1)

• 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.

  PMID: 34029346 BACKGROUND

Related Links

• The study will use similar procedures for a sampling based approach for outcome ascertainment as that used in the Better Information for Health in Zambia Study.
• Related Info

MeSH Terms

Interventions

Association

Intervention Hierarchy (Ancestors)

Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dr Aaloke Mody

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Kombatende Sikombe

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kombatende Sikombe

CONTACT

+260973824000; Kombatende.Sikombe@cidrz.org

Dr Sikazwe

CONTACT

+260977233829; Izukanji.Sikazwe@cidrz.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: June 13, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)