HIV TestingNCT04754386
Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Zambia
An observational study of HIV Testing, run by Catholic Relief Services at 15 sites in Zambia.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Testing
- What is being tested?
- Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening Oral fluid-based HIV test
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 2,730 participants
- Where
- 15 sitesZambia
- Study dates
- 8 Feb 2021to 8 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- All HIV-positive adults
- 18 years old or older with eligible children
- All biological children (of an adult index case) 18 months - 14 years of age with an unknown HIV status
Who cannot join
- 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
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Zambia15 sites
Nadezwe Rural Health Center
Chikankata, Southern Province
Chivuna Rural Health Centre
Livingstone, Southern Province
Chazanga Clinic
Lusaka
Chilanga Clinic
Lusaka
Chilenje Clinic
Lusaka
Kalingalinga Clinic
Lusaka
Kazimva Rural Health Clinic
Lusaka
Matero Clinic
Lusaka
Nan'gongwe Clinic
Lusaka
Shimabala Rural Health Centre
Lusaka
Munenga Rural Health Centre
Mazabuka, Southern Province
Keemba Rural Health Centre
Monze, Southern Province
Manungu Rural Health Centre
Monze, Southern Province
Mutendere Clinic
Mutendere, Lusaka Province
Chitope Rural Health Centre
Mwavi, Lusaka Province
About this study
Official title: Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Estimation of Acceptability, Feasibility and Effectiveness Linked to Index Testing Services in Zambia
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.
Read the 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.
- Conditions
- HIV Testing
- Being tested
- Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening Oral fluid-based HIV test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening Oral fluid-based HIV testBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 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.
- 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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start8 Feb 2021
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic Relief Services
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Carl C Stecker, MPH, EdD, Principal investigator, Catholic Relief Services - USCCB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754386
- Sponsor's protocol ID
- CDC IRB 7272
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2021
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40316402
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Estimation of Acceptability, Feasibility and Effectiveness Linked to Index Testing Services in Zambia
- ClinicalTrials.gov ID
- NCT04754386
- Acronym / sponsor ID
- CDC IRB 7272
- Conditions
- HIV Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,730 participants (actual)
- Lead sponsor
- Catholic Relief ServicesUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- All HIV-positive adults
- 18 years old or older with eligible children
- All biological children (of an adult index case) 18 months - 14 years of age with an unknown HIV status
Key exclusion criteria (9 listed)
- 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
- Children <18 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening Oral fluid-based HIV testThe 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. | Behavioural | – |
Primary outcome
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.
Time frame: 6 months
* 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.
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.
Time frame: 6 months
* 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.
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.
Time frame: 6 months
* 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.
1 secondary outcome
Estimate the cost of caregiver-assisted oral fluid-based HIV screening compared to the existing standard costs of the existing referral to testing program.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Derived from this study: PubMed 40316402Gross 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl C Stecker, MPH, EdD principal investigator
Catholic Relief Services - USCCB
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Testing, run by Catholic Relief Services at 15 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.