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

NCT ID: NCT04774666

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4865 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2021-10-08

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. 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.1 Pediatric case finding is the first, critical step to close the pediatric ART gap. In Uganda, there are an estimated 36,873 CLHIV in need of HIV treatment.2 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 for 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. Oral fluid-based screening may present a safe, convenient and reliable way to identify CLHIV that can expand access to essential testing services in resource-limited settings where most CLHIV reside.

Methods: The study will use a cross-sectional cluster sampling design, in which 32 facilities in 16 districts will be selected using probability-proportional-to-size (PPS) sampling. In the 32 selected facilities, index parent/caregivers of approximately 4,687 children will be recruited to accept test kits for their children. Adult index parent/caregivers will be consented to participate in the study and asked for parental permission for their child(ren) to participate, given a number of oral screening kits corresponding to the number of children eligible for screening, and followed-up to confirm the oral fluid-based screening results and participate in a testing experience survey. Any children who screen HIV reactive will receive confirmatory testing and active linkage to care and treatment services. A cost analysis which includes savings associated with facility or home-based costs averted, using existing sources to estimate the costs of facility-based testing and home-based by a community health worker (CHW), preferably from antenatal settings will be undertaken.

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• HIV-positive diagnosis
• 18 years old or older
• Emancipated minors (15-17 years of age) with eligible children

• Biological children (of an index parent/caregiver) 18 months - 14 years of age with an unknown HIV status
• Non-biological children living in the same household as the index parent/caregivers where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased)
• Biological children (of an index parent/caregiver) 18 months - 14 years of age, as well as non-biological children living in the same household as the index parent/caregiver where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased), with a known previous HIV-negative status completed less than three months following the cessation of breastfeeding and whose parent/caregiver states that there is reason to suspect a new exposure

• Adult index parents who complete the oral-based HIV screening with at least one eligible child, regardless of screening result.

Exclusion Criteria

• Adults answering "yes" to any of the first three intimate partner violence (IPV) risk assessment questions
• Adults answering "yes", "maybe" or I don't know" to the fourth IPV question
• Those unable to provide independent informed consent due to mental disability or other limitations (as deemed by study staff)

• Children <18 months of age
• Children 18 months - 14 years of age with a known HIV-positive status
• Biological children (of an index parent/caregiver) 18 months - 14 years of age where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased), with previous known HIV-negative status completed less than three months following the cessation of breastfeeding and whose parent/caregiver states that they have no reason to suspect a new exposure
• Non-biological children living in the same household as the index parent/caregiver age where the child has a history of HIV exposure (where the mother is HIV-positive, of unknown status, unavailable for testing, or who is deceased), with previous known HIV-negative status completed less than three months following the cessation of breastfeeding and whose parent/caregiver states that they have no reason to suspect a new exposure
• Children still breastfeeding
• Children with cessation of breastfeeding < 3 months

• Adult index parent/caregivers who do not complete the oral-based HIV screening with at least one eligible child

• 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, EdD

Role: PRINCIPAL_INVESTIGATOR

Catholic Relief Services - USCCB

Locations

Bugiri Hospital

Bugiri, Bugiri District, Uganda

Nankoma HC IV

Bugiri, Bugiri District, Uganda

Kabuyanda HC IV

Kabuyanda, Isingiro District, Uganda

Rwekubo HC IV

Kahirimbi, Isingiro District, Uganda

Buremba HC III

Kazo, Kazo District, Uganda

Kazo HC IV

Kazo, Kazo District, Uganda

Butunduzi HC III

Kyenjojo, Kyenjojo District, Uganda

Kigarale HC III

Kyenjojo, Kyenjojo District, Uganda

Kasaali HC III

Kyotera, Kyotera District, Uganda

Barr HC III

Lira, Lira District, Uganda

Lira Regional Ref Hospital

Lira, Lira District, Uganda

Luwero HC IV

Kampala, Luwero District, Uganda

St. Luke Namaliga HC III

Kampala, Luwero District, Uganda

Kinoni HC III

Bukoto, Lwengo District, Uganda

Kiwangala HC III

Mbirizi, Lwengo District, Uganda

Kiyumba HC IV

Bukoto, Masaka District, Uganda

Buwunga HC III

Masaka, Masaka District, Uganda

Mbarara Regional Ref Hospital

Mbarara, Mbarara District, Uganda

Nyamityobora HC II

Mbarara, Mbarara District, Uganda

Kyantungo HC IV

Mityana, Mityana District, Uganda

Mityana Hospital

Mityana, Mityana District, Uganda

Mubende Kasambya HC III

Mubende, Mubende District, Uganda

Nabingoola HC III

Nabingora, Mubende District, Uganda

Mukono Cou HC IV

Mukono, Mukono District, Uganda

Seeta-Nazigo HC III

Nakisunga, Mukono District, Uganda

Kitwe HC IV

Kitwe, Ntungamo District, Uganda

Ntungamo HC IV

Ntungamo, Ntungamo District, Uganda

Lwamaggwa HC III

Rakai, Rakai District, Uganda

Rakai Hospital

Rakai, Rakai Distsrict, Uganda

Kajjansi HC III

Busiro, Wakiso District, Uganda

Kasangati HC IV

Kasangati, Wakiso District, Uganda

Mitukula HC III

Kyotera, , Uganda

Countries

Uganda

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 7292

Identifier Type: -

Identifier Source: org_study_id