Clinical trial NCT04754386: Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Zambia
Official title: Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Estimation of Acceptability, Feasibility and Effectiveness Linked to Index Testing Services in Zambia
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: 2021-02-15
Enrollment: 2730
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 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.

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.

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. According to the ZAMPHIA study, only 50.6% of HIV-positive Zambian children aged 0-14 years knew their HIV status (UNAIDS 1st 90). Pediatric case finding is the first and, critical step to close the pediatric ART gap. In Zambia, there are an estimated 25,920 CLHIV in need of HIV treatment. 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 of 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. Saliva-based screening tests may present a safe and reliable way to identify children living with HIV that can expand access to this essential service in resource-limited settings where most CLHIV reside.

Methods: The study will have a cross-sectional cluster sampling design, in which large facilities in two provinces will be selected using probability-proportional-to-size (PPS) sampling. Within each of 15 selected facilities, adult index parent/caregivers who are the parent/caregivers of approximately 200 children will be recruited to accept oral fluid-based HIV test kits for their children. There will be 3000 participants in the sample. Index parent/caregivers will be consented to participate in the study, given a number of OTKs corresponding to the number of children eligible for testing, followed up to confirm saliva-based test (SBT) results, participate in a testing experience survey, and return the OTK. All children screening HIV-positive will receive active linkage to confirmatory diagnostic testing, and treatment services for newly diagnosed HIV-positive children. In addition to these data, a sample (n=445) of caregivers will be asked questions regarding their experiences with administering the screening kit on their children.

Eligibility criteria: Inclusion Criteria for adult index parent/caregivers:

* All HIV-positive adults
* 18 years old or older with eligible children

Inclusion Criteria for Eligible children:

• All biological children (of an adult index case) 18 months - 14 years of age with an unknown HIV status

Exclusion Criteria for adult index parent/caregivers:

* 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

Exclusion Criteria for Children:

* 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
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 existing standard costs of the existing referral to testing program.
timeFrame: 6 months
Other outcomes:
Locations:
city: Mutendere
country: Zambia
facility: Mutendere Clinic
state: Lusaka
city: Mwavi
country: Zambia
facility: Chitope Rural Health Centre
state: Lusaka
city: Chikankata
country: Zambia
facility: Nadezwe Rural Health Center
state: Southern
city: Livingstone
country: Zambia
facility: Chivuna Rural Health Centre
state: Southern
city: Mazabuka
country: Zambia
facility: Munenga Rural Health Centre
state: Southern
city: Monze
country: Zambia
facility: Keemba Rural Health Centre
state: Southern
city: Monze
country: Zambia
facility: Manungu Rural Health Centre
state: Southern
city: Lusaka
country: Zambia
facility: Chazanga Clinic
city: Lusaka
country: Zambia
facility: Chilanga Clinic
city: Lusaka
country: Zambia
facility: Chilenje Clinic
city: Lusaka
country: Zambia
facility: Kalingalinga Clinic
city: Lusaka
country: Zambia
facility: Kazimva Rural Health Clinic
city: Lusaka
country: Zambia
facility: Matero Clinic
city: Lusaka
country: Zambia
facility: Nan'gongwe Clinic
city: Lusaka
country: Zambia
facility: Shimabala Rural Health Centre
Study officials:
affiliation: Catholic Relief Services - USCCB
name: Carl C Stecker, MPH, EdD
role: PRINCIPAL_INVESTIGATOR
References: