Clinical trial NCT04774666: Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Uganda
Official title: Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Estimation of Acceptability, Feasibility and Effectiveness Linked to Index Testing Services in Uganda
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Testing
Lead sponsor: Catholic Relief Services
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-03-01
Enrollment: 4865
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimate the acceptability of implementing caregiver-assisted oral fluid-based HIV screening of children as part of index testing services for HIV-positive adults.
timeFrame: 6 months
measure: Estimate the feasibility of implementing caregiver-assisted oral fluid-based HIV screening for children as part of index testing services for HIV-positive adults.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Bugiri
country: Uganda
facility: Bugiri Hospital
state: Bugiri District
city: Bugiri
country: Uganda
facility: Nankoma HC IV
state: Bugiri District
city: Kabuyanda
country: Uganda
facility: Kabuyanda HC IV
state: Isingiro District
city: Kahirimbi
country: Uganda
facility: Rwekubo HC IV
state: Isingiro District
city: Kazo
country: Uganda
facility: Buremba HC III
state: Kazo District
city: Kazo
country: Uganda
facility: Kazo HC IV
state: Kazo District
city: Kyenjojo
country: Uganda
facility: Butunduzi HC III
state: Kyenjojo District
city: Kyenjojo
country: Uganda
facility: Kigarale HC III
state: Kyenjojo District
city: Kyotera
country: Uganda
facility: Kasaali HC III
state: Kyotera District
city: Lira
country: Uganda
facility: Barr HC III
state: Lira District
city: Lira
country: Uganda
facility: Lira Regional Ref Hospital
state: Lira District
city: Kampala
country: Uganda
facility: Luwero HC IV
state: Luwero District
city: Kampala
country: Uganda
facility: St. Luke Namaliga HC III
state: Luwero District
city: Bukoto
country: Uganda
facility: Kinoni HC III
state: Lwengo District
city: Mbirizi
country: Uganda
facility: Kiwangala HC III
state: Lwengo District
city: Bukoto
country: Uganda
facility: Kiyumba HC IV
state: Masaka District
city: Masaka
country: Uganda
facility: Buwunga HC III
state: Masaka District
city: Mbarara
country: Uganda
facility: Mbarara Regional Ref Hospital
state: Mbarara District
city: Mbarara
country: Uganda
facility: Nyamityobora HC II
state: Mbarara District
city: Mityana
country: Uganda
facility: Kyantungo HC IV
state: Mityana District
city: Mityana
country: Uganda
facility: Mityana Hospital
state: Mityana District
city: Mubende
country: Uganda
facility: Mubende Kasambya HC III
state: Mubende District
city: Nabingora
country: Uganda
facility: Nabingoola HC III
state: Mubende District
city: Mukono
country: Uganda
facility: Mukono Cou HC IV
state: Mukono District
city: Nakisunga
country: Uganda
facility: Seeta-Nazigo HC III
state: Mukono District
city: Kitwe
country: Uganda
facility: Kitwe HC IV
state: Ntungamo District
city: Ntungamo
country: Uganda
facility: Ntungamo HC IV
state: Ntungamo District
city: Rakai
country: Uganda
facility: Lwamaggwa HC III
state: Rakai District
city: Rakai
country: Uganda
facility: Rakai Hospital
state: Rakai Distsrict
city: Busiro
country: Uganda
facility: Kajjansi HC III
state: Wakiso District
city: Kasangati
country: Uganda
facility: Kasangati HC IV
state: Wakiso District
city: Kyotera
country: Uganda
facility: Mitukula HC III
Study officials:
affiliation: Catholic Relief Services - USCCB
name: Carl C Stecker, EdD
role: PRINCIPAL_INVESTIGATOR
References: