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

NCT ID: NCT07021092

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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HIV Viremia HIV -1 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tracing to Ascertain Outcome

Group Type OTHER

Interventions will be developed in aim 2 of the study.

Intervention Type OTHER

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

Interventions

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Interventions will be developed in aim 2 of the study.

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

Intervention Type OTHER

Other Intervention Names

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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

Eligibility Criteria

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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);
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Aaloke Mody

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Kombatende Sikombe

Role: PRINCIPAL_INVESTIGATOR

Centre for Infectious Disease Research in Zambia

Locations

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Ministry of Health

Lusaka, Lusaka Province, Zambia

Site Status 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

Site Status RECRUITING

Countries

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Zambia

Central Contacts

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Kombatende Sikombe

Role: CONTACT

+260973824000

Dr Sikazwe

Role: CONTACT

+260977233829

Facility Contacts

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Kombatende Sikombe Sikombe

Role: primary

+26097 3824000

References

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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.

Reference Type BACKGROUND
PMID: 34029346 (View on PubMed)

Related Links

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https://www.cidrz.org/wp-content/toolkits/betterinfo/

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.

Other Identifiers

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INV-050580

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CIDRZ

Identifier Type: -

Identifier Source: org_study_id

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