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

NCT04754386 | Completed

• 1 other identifier: CDC IRB 7272
• Study Type: observational
• Target: 2,730
• Locations: 1 country
• Sites: 15

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.

Conditions

HIV Testing

Outcome Measures

Primary Outcomes (3)

• Estimate the acceptability of implementing caregiver-assisted oral fluid-based HIV screening fluid-based HIV screening for children as a part of index testing services for index parent/caregivers.

  * Proportion of eligible index parent/caregivers (disaggregated by sex) that accepted an oral fluid-based HIV screening kit as part of innovative index testing services for their eligible children when first offered. * Proportion of eligible index parent/caregivers (disaggregated by sex) that accepted an oral fluid-based HIV screening kit as part of innovative index testing services for their eligible children when they returned for a subsequent visit. * Proportion of eligible children (i.e. unknown HIV status) screened with an oral fluid-based HIV screening kit.

  6 months

• Estimate the feasibility of implementing caregiver-assisted oral fluid-based HIV screening fluid-based HIV screening for children as part of index testing services for HIV-positive adults.

  * Proportion of index parent/caregivers who reported that the caregiver-assisted oral fluid-based HIV screening kit to screen children for HIV was easy to use. * Proportion of index parent/caregivers who reported needing additional assistance with administering the oral fluid-based HIV screening kit. * Proportion of index parent/caregivers who reported adverse events related to the use of caregiver-assisted oral fluid-based HIV screening kits to screen their children for HIV.

  6 months

• Estimate the effectiveness of caregiver-assisted oral fluid-based HIV screening on testing yield, return to clinic, and linkage to ART for newly identified CLHIV.

  * Proportion of eligible children screened reactive through a caregiver-assisted oral fluid-based HIV screening kit. * Proportion of eligible children who screened reactive through a caregiver-assisted oral fluid-based HIV screening kit who received confirmatory testing, within 1 day, 1 week, 1 month of their reactive screen. * Proportion of eligible children who screened reactive through a caregiver-assisted oral fluid-based HIV screening kit who started on ART within 1 day, 1 week, 1 month of their confirmatory test. * Proportion of index parent/caregivers who were offered an oral fluid-based test kit to screen their eligible children for HIV used it.

  6 months

Secondary Outcomes (1)

• Estimate the cost of caregiver-assisted oral fluid-based HIV screening compared to the existing standard costs of the existing referral to testing program.

  6 months

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At the 15 PEPFAR-supported health facilities, all eligible adult HIV-positive clients will be offered oral fluid-based HIV screening kits for their children as a part of index testing services. Study participants will be recruited during post-test counseling sessions for adults who are newly identified as HIV-positive, and/or ART clinic visits for HIV-positive adults already on treatment.

You may qualify if:

• All HIV-positive adults
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic Relief Services: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (15)

Mutendere Clinic

Mutendere, Lusaka Province, Zambia

Location

Chitope Rural Health Centre

Mwavi, Lusaka Province, Zambia

Location

Nadezwe Rural Health Center

Chikankata, Southern Province, Zambia

Location

Chivuna Rural Health Centre

Livingstone, Southern Province, Zambia

Location

Munenga Rural Health Centre

Mazabuka, Southern Province, Zambia

Location

Keemba Rural Health Centre

Monze, Southern Province, Zambia

Location

Manungu Rural Health Centre

Monze, Southern Province, Zambia

Location

Chazanga Clinic

Lusaka, Zambia

Location

Chilanga Clinic

Lusaka, Zambia

Location

Chilenje Clinic

Lusaka, Zambia

Location

Kalingalinga Clinic

Lusaka, Zambia

Location

Kazimva Rural Health Clinic

Lusaka, Zambia

Location

Matero Clinic

Lusaka, Zambia

Location

Nan'gongwe Clinic

Lusaka, Zambia

Location

Shimabala Rural Health Centre

Lusaka, Zambia

Location

Related Publications (1)

• 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.

  PMID: 40316402 DERIVED

Study Officials

• Carl C Stecker, MPH, EdD

  Catholic Relief Services - USCCB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 15, 2021
• Study Start: February 8, 2021
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

ZA (15)