Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04754386
Other study ID # CDC IRB 7272
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 8, 2021
Est. completion date December 8, 2021

Study information

Verified date February 2022
Source Catholic Relief Services
Contact n/a
Is FDA regulated No
Health authority
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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2730
Est. completion date December 8, 2021
Est. primary completion date December 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening Oral fluid-based HIV test
The project offers HIV oral test kits to index parents/caregivers with children eligible for index testing services at facility settings to expand access to HIV testing and treatment services for children, and to ensure that all children who screen positive with an oral fluid-based HIV screening kit are linked to confirmatory testing, and newly diagnosed children are initiated on ART.

Locations

Country Name City State
Zambia Nadezwe Rural Health Center Chikankata Southern
Zambia Chivuna Rural Health Centre Livingstone Southern
Zambia Chazanga Clinic Lusaka
Zambia Chilanga Clinic Lusaka
Zambia Chilenje Clinic Lusaka
Zambia Kalingalinga Clinic Lusaka
Zambia Kazimva Rural Health Clinic Lusaka
Zambia Matero Clinic Lusaka
Zambia Nan'gongwe Clinic Lusaka
Zambia Shimabala Rural Health Centre Lusaka
Zambia Munenga Rural Health Centre Mazabuka Southern
Zambia Keemba Rural Health Centre Monze Southern
Zambia Manungu Rural Health Centre Monze Southern
Zambia Mutendere Clinic Mutendere Lusaka
Zambia Chitope Rural Health Centre Mwavi Lusaka

Sponsors (2)

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

Country where clinical trial is conducted

Zambia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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.
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 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 existing standard costs of the existing referral to testing program. • 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
See also
  Status Clinical Trial Phase
Recruiting NCT04033718 - Inpatient Package to Reduce HIV and AIDS-related Death in Zambia N/A
Withdrawn NCT03938077 - A Community-University Approach to Preventing HIV N/A
Recruiting NCT05615935 - Experiential HIV Testing Increasing Testing Related Knowledge and Practice, and Reduce Stigma Toward HIV of Nurses. N/A
Active, not recruiting NCT06150937 - HST for Female Sex Workers/Drug Users in Kazakhstan N/A
Completed NCT01637324 - Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM N/A
Completed NCT05388084 - Peer Led Outreach to Engage Male Partners of Pregnant Women in Uganda (Okutuuka Study) N/A
Active, not recruiting NCT05306938 - Adolescent Wellness Visits in Tanzania N/A
Recruiting NCT05384145 - Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama N/A
Recruiting NCT05020353 - OraQuick® HIV Self-Test Study in Canada N/A
Active, not recruiting NCT02834572 - Using Technology to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options N/A
Completed NCT04210271 - Testing an Intervention to Increase HIV Self-Testing Among Young, Black MSM N/A
Active, not recruiting NCT04810559 - Near Patient Study of the OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in Oral Fluid and Fingerstick Whole Blood N/A
Completed NCT03939455 - Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care N/A
Not yet recruiting NCT02154802 - Increasing HIV Testing in Urban Emergency Departments Via Mobile Technology N/A
Completed NCT05685498 - Peer-led HIV Self-testing Among Men in Two Ugandan Fishing Communities N/A
Recruiting NCT04030689 - Free HIV Testing in Private Biological Laboratories: A New Offer to Encourage HIV Testing
Completed NCT02714140 - Does Preference-based HIV Testing Increase Uptake in High Risk Populations? N/A
Completed NCT05107401 - Crowdsourcing to Reduce HIV Stigma Among Adolescents and Young Adults in Kazakhstan N/A
Completed NCT01760057 - Evaluating the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men N/A
Recruiting NCT03757104 - Home-based Intervention to Test and Start N/A