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

HIV Testing Clinical Trial

Official title:

Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Estimation of Acceptability, Feasibility and Effectiveness Linked to Index Testing Services in Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774666
• Other study ID #: CDC IRB 7292
• Status: Completed
• Start date: April 19, 2021
• Est. completion date: October 8, 2021

Study information

• Verified date: February 2022
• Source: Catholic Relief Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4865
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Index parent/caregivers:

• HIV-positive diagnosis

• 18 years old or older

• Emancipated minors (15-17 years of age) with eligible children

Inclusion Criteria for 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

Inclusion criteria for participation in survey after completion of care giver-assisted oral fluid-based HIV screening:

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

Exclusion Criteria for Index parent/caregivers:

• 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)

Exclusion Criteria for eligible children:

• 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

Exclusion criteria for participation in survey after completion of oral-based HIV screening:

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

Related Conditions & MeSH terms

• HIV Testing

Intervention

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

Locations

Country	Name	City	State
Uganda	Bugiri Hospital	Bugiri	Bugiri District
Uganda	Nankoma HC IV	Bugiri	Bugiri District
Uganda	Kinoni HC III	Bukoto	Lwengo District
Uganda	Kiyumba HC IV	Bukoto	Masaka District
Uganda	Kajjansi HC III	Busiro	Wakiso District
Uganda	Kabuyanda HC IV	Kabuyanda	Isingiro District
Uganda	Rwekubo HC IV	Kahirimbi	Isingiro District
Uganda	Luwero HC IV	Kampala	Luwero District
Uganda	St. Luke Namaliga HC III	Kampala	Luwero District
Uganda	Kasangati HC IV	Kasangati	Wakiso District
Uganda	Buremba HC III	Kazo	Kazo District
Uganda	Kazo HC IV	Kazo	Kazo District
Uganda	Kitwe HC IV	Kitwe	Ntungamo District
Uganda	Butunduzi HC III	Kyenjojo	Kyenjojo District
Uganda	Kigarale HC III	Kyenjojo	Kyenjojo District
Uganda	Kasaali HC III	Kyotera	Kyotera District
Uganda	Mitukula HC III	Kyotera
Uganda	Barr HC III	Lira	Lira District
Uganda	Lira Regional Ref Hospital	Lira	Lira District
Uganda	Buwunga HC III	Masaka	Masaka District
Uganda	Mbarara Regional Ref Hospital	Mbarara	Mbarara District
Uganda	Nyamityobora HC II	Mbarara	Mbarara District
Uganda	Kiwangala HC III	Mbirizi	Lwengo District
Uganda	Kyantungo HC IV	Mityana	Mityana District
Uganda	Mityana Hospital	Mityana	Mityana District
Uganda	Mubende Kasambya HC III	Mubende	Mubende District
Uganda	Mukono Cou HC IV	Mukono	Mukono District
Uganda	Nabingoola HC III	Nabingora	Mubende District
Uganda	Seeta-Nazigo HC III	Nakisunga	Mukono District
Uganda	Ntungamo HC IV	Ntungamo	Ntungamo District
Uganda	Lwamaggwa HC III	Rakai	Rakai District
Uganda	Rakai Hospital	Rakai	Rakai Distsrict

Sponsors (2)

Lead Sponsor	Collaborator
Catholic Relief Services	Centers for Disease Control and Prevention

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Comparative costs between oral fluid-based screening and the costs of the existing referral to testing program, from the perspective of the health care provider.	6 months