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

NCT04774666 | Completed

• 1 other identifier: CDC IRB 7292
• Study Type: observational
• Target: 4,865
• Locations: 1 country
• Sites: 32

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.

Conditions

HIV Testing

Outcome Measures

Primary Outcomes (3)

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

  * 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 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 (i.e., yield). * 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 were 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 standard cost of the existing referral to testing program, from the perspective of the health care provider.

  6 months

Interventions

Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening BEHAVIORAL

Oral fluid-based HIV test

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 32 PEPFAR-supported government health facilities, eligible adult index parents and their eligible children will be recruited during post-test counseling sessions when they are newly-diagnosed as HIV-positive, and/or at the ART clinic and/or mother-baby care point (MBCP).

You may qualify if:

• HIV-positive diagnosis
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (32)

Bugiri Hospital

Bugiri, Bugiri District, Uganda

Location

Nankoma HC IV

Bugiri, Bugiri District, Uganda

Location

Kabuyanda HC IV

Kabuyanda, Isingiro District, Uganda

Location

Rwekubo HC IV

Kahirimbi, Isingiro District, Uganda

Location

Buremba HC III

Kazo, Kazo District, Uganda

Location

Kazo HC IV

Kazo, Kazo District, Uganda

Location

Butunduzi HC III

Kyenjojo, Kyenjojo District, Uganda

Location

Kigarale HC III

Kyenjojo, Kyenjojo District, Uganda

Location

Kasaali HC III

Kyotera, Kyotera District, Uganda

Location

Barr HC III

Lira, Lira District, Uganda

Location

Lira Regional Ref Hospital

Lira, Lira District, Uganda

Location

Luwero HC IV

Kampala, Luwero District, Uganda

Location

St. Luke Namaliga HC III

Kampala, Luwero District, Uganda

Location

Kinoni HC III

Bukoto, Lwengo District, Uganda

Location

Kiwangala HC III

Mbirizi, Lwengo District, Uganda

Location

Kiyumba HC IV

Bukoto, Masaka District, Uganda

Location

Buwunga HC III

Masaka, Masaka District, Uganda

Location

Mbarara Regional Ref Hospital

Mbarara, Mbarara District, Uganda

Location

Nyamityobora HC II

Mbarara, Mbarara District, Uganda

Location

Kyantungo HC IV

Mityana, Mityana District, Uganda

Location

Mityana Hospital

Mityana, Mityana District, Uganda

Location

Mubende Kasambya HC III

Mubende, Mubende District, Uganda

Location

Nabingoola HC III

Nabingora, Mubende District, Uganda

Location

Mukono Cou HC IV

Mukono, Mukono District, Uganda

Location

Seeta-Nazigo HC III

Nakisunga, Mukono District, Uganda

Location

Kitwe HC IV

Kitwe, Ntungamo District, Uganda

Location

Ntungamo HC IV

Ntungamo, Ntungamo District, Uganda

Location

Lwamaggwa HC III

Rakai, Rakai District, Uganda

Location

Rakai Hospital

Rakai, Rakai Distsrict, Uganda

Location

Kajjansi HC III

Busiro, Wakiso District, Uganda

Location

Kasangati HC IV

Kasangati, Wakiso District, Uganda

Location

Mitukula HC III

Kyotera, Uganda

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, 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 9, 2021
• First Posted: March 1, 2021
• Study Start: April 19, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-02

Locations

UG (32)