Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Zambia

NCT ID: NCT04754386

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2730 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2021-12-08

Brief Summary

The purpose of this study is to evaluate the acceptability, feasibility and effectiveness of a caregiver-assisted oral fluid-based HIV test to screen children for HIV in Zambia. The results of this study are intended to support expanded access to HIV testing and treatment services for children, and to ensure that all newly diagnosed children are linked to clinical care.

Detailed Description

Rationale: Globally, there are 1.8 million children living with HIV (CLHIV); however, despite great progress over the past 15 years, only 52% are receiving antiretroviral therapy (ART), leaving approximately 864,000 children in need of treatment. According to the ZAMPHIA study, only 50.6% of HIV-positive Zambian children aged 0-14 years knew their HIV status (UNAIDS 1st 90). Pediatric case finding is the first and, critical step to close the pediatric ART gap. In Zambia, there are an estimated 25,920 CLHIV in need of HIV treatment. Reaching this population is challenging, because children are dependent on parents and caregivers to access HIV testing services. Parents and caregivers often face logistical, societal and other barriers that limit the uptake of testing services for children. In order to achieve the second and third UNAIDS 95 targets of pediatric HIV treatment coverage and viral load suppression to reach epidemic control, country programs need to utilize increasingly targeted and innovative testing modalities to optimize the identification CLHIV. Saliva-based screening tests may present a safe and reliable way to identify children living with HIV that can expand access to this essential service in resource-limited settings where most CLHIV reside.

Methods: The study will have a cross-sectional cluster sampling design, in which large facilities in two provinces will be selected using probability-proportional-to-size (PPS) sampling. Within each of 15 selected facilities, adult index parent/caregivers who are the parent/caregivers of approximately 200 children will be recruited to accept oral fluid-based HIV test kits for their children. There will be 3000 participants in the sample. Index parent/caregivers will be consented to participate in the study, given a number of OTKs corresponding to the number of children eligible for testing, followed up to confirm saliva-based test (SBT) results, participate in a testing experience survey, and return the OTK. All children screening HIV-positive will receive active linkage to confirmatory diagnostic testing, and treatment services for newly diagnosed HIV-positive children. In addition to these data, a sample (n=445) of caregivers will be asked questions regarding their experiences with administering the screening kit on their children.

Conditions

HIV Testing

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening Oral fluid-based HIV test

The project offers HIV oral test kits to index parents/caregivers with children eligible for index testing services at facility settings to expand access to HIV testing and treatment services for children, and to ensure that all children who screen positive with an oral fluid-based HIV screening kit are linked to confirmatory testing, and newly diagnosed children are initiated on ART.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• All HIV-positive adults
• 18 years old or older with eligible children

• All biological children (of an adult index case) 18 months - 14 years of age with an unknown HIV status

Exclusion Criteria

• Adults answering "yes" to any of the four intimate partner violence risk assessment questions
• Adults previously diagnosed as mentally disabled
• Adults currently in prison are excluded from this study.
• Adult partners of index parent/caregivers

• Children <18 months of age
• All biological children (of an index case) 18 months - 14 years of age with a documented HIV-negative status after cessation of breastfeeding
• All biological children (of an index case) 18 months - 14 years of age with a documented HIV-positive status
• Children still breastfeeding or with cessation of breastfeeding < 3 months
• Non-biological children of the index parent/caregiver

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Catholic Relief Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl C Stecker, MPH, EdD

Role: PRINCIPAL_INVESTIGATOR

Catholic Relief Services - USCCB

Locations

Mutendere Clinic

Mutendere, Lusaka Province, Zambia

Chitope Rural Health Centre

Mwavi, Lusaka Province, Zambia

Nadezwe Rural Health Center

Chikankata, Southern Province, Zambia

Chivuna Rural Health Centre

Livingstone, Southern Province, Zambia

Munenga Rural Health Centre

Mazabuka, Southern Province, Zambia

Keemba Rural Health Centre

Monze, Southern Province, Zambia

Manungu Rural Health Centre

Monze, Southern Province, Zambia

Chazanga Clinic

Lusaka, , Zambia

Chilanga Clinic

Lusaka, , Zambia

Chilenje Clinic

Lusaka, , Zambia

Kalingalinga Clinic

Lusaka, , Zambia

Kazimva Rural Health Clinic

Lusaka, , Zambia

Matero Clinic

Lusaka, , Zambia

Nan'gongwe Clinic

Lusaka, , Zambia

Shimabala Rural Health Centre

Lusaka, , Zambia

Countries

Zambia

References

Gross J, Tumwesigye NM, Mutembo S, Moyo N, Mukose A, Chilyabanyama O, Matoba J, Parris K, Lee B, Churchill T, Williamson D, Pals S, Biribawa C, Kagaayi J, Ndubani P, Okello F, Zyambo Z, Taasi G, Magongo EN, Munthali G, Mwiya M, Nazziwa E, Awor AC, Itoh M, Boyd AM, Macleod D, Rivadeneira E, Oliver D, Ferrand RA, Stecker C; FASTER Study Team. Acceptability, feasibility, and effectiveness of caregiver-assisted HIV self-testing among children using an oral mucosal test in Uganda and Zambia: a prospective interventional study. Lancet HIV. 2025 May;12(5):e325-e337. doi: 10.1016/S2352-3018(25)00005-0.

Reference Type: DERIVED

PMID: 40316402 (View on PubMed)

Other Identifiers

CDC IRB 7272

Identifier Type: -

Identifier Source: org_study_id