HIV TestingNCT04774666
Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Uganda
An observational study of HIV Testing, run by Catholic Relief Services at 32 sites in Uganda.
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… 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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 4,865 participants
- Where
- 32 sitesUganda
- Study dates
- 19 Apr 2021to 8 Oct 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 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).
Who may be able to join
- HIV-positive diagnosis
- 18 years old or older
- Emancipated minors (15-17 years of age) with 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.
Who cannot join
- 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)
- 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
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- 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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Uganda32 sites
Bugiri Hospital
Bugiri, Bugiri District
Nankoma HC IV
Bugiri, Bugiri District
Kinoni HC III
Bukoto, Lwengo District
Kiyumba HC IV
Bukoto, Masaka District
Kajjansi HC III
Busiro, Wakiso District
Kabuyanda HC IV
Kabuyanda, Isingiro District
Rwekubo HC IV
Kahirimbi, Isingiro District
Luwero HC IV
Kampala, Luwero District
St. Luke Namaliga HC III
Kampala, Luwero District
Kasangati HC IV
Kasangati, Wakiso District
Buremba HC III
Kazo, Kazo District
Kazo HC IV
Kazo, Kazo District
Kitwe HC IV
Kitwe, Ntungamo District
Butunduzi HC III
Kyenjojo, Kyenjojo District
Kigarale HC III
Kyenjojo, Kyenjojo District
Kasaali HC III
Kyotera, Kyotera District
Mitukula HC III
Kyotera
Barr HC III
Lira, Lira District
Lira Regional Ref Hospital
Lira, Lira District
Buwunga HC III
Masaka, Masaka District
Mbarara Regional Ref Hospital
Mbarara, Mbarara District
Nyamityobora HC II
Mbarara, Mbarara District
Kiwangala HC III
Mbirizi, Lwengo District
Kyantungo HC IV
Mityana, Mityana District
Mityana Hospital
Mityana, Mityana District
Mubende Kasambya HC III
Mubende, Mubende District
Mukono Cou HC IV
Mukono, Mukono District
Nabingoola HC III
Nabingora, Mubende District
Seeta-Nazigo HC III
Nakisunga, Mukono District
Ntungamo HC IV
Ntungamo, Ntungamo District
Lwamaggwa HC III
Rakai, Rakai District
Rakai Hospital
Rakai, Rakai Distsrict
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 Uganda
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.
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.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.
- Conditions
- HIV Testing
- Being tested
- Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening
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 screeningBehavioural
Oral fluid-based HIV test
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 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.
Measured: 6 months
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.
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 (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.
Measured: 6 months
Secondary outcomes (1)
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.
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 posted1 Mar 2021
- Study start19 Apr 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 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
- 4,865 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, EdD, Principal investigator, Catholic Relief Services - USCCB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774666
- Sponsor's protocol ID
- CDC IRB 7292
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2021
- Last updated
- 11 Mar 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 11 Mar 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 Uganda
- ClinicalTrials.gov ID
- NCT04774666
- Acronym / sponsor ID
- CDC IRB 7292
- Conditions
- HIV Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,865 participants (actual)
- Lead sponsor
- Catholic Relief ServicesUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 1 Mar 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. 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.
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 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).
Key inclusion criteria (8 listed)
- HIV-positive diagnosis
- 18 years old or older
- Emancipated minors (15-17 years of age) with 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)
Key exclusion criteria (11 listed)
- 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)
- Children <18 months of age
- Children 18 months - 14 years of age with a known HIV-positive status
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 screeningOral fluid-based HIV test | Behavioural | – |
Primary outcome
Estimate the acceptability of implementing caregiver-assisted oral fluid-based HIV screening of children as part of index testing services for HIV-positive adults.
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 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 (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.
1 secondary outcome
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.
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 11 Mar 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, EdD principal investigator
Catholic Relief Services - USCCB
32 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 32 sites in Uganda.
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 8 inclusion and 11 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Uganda. 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 of children as part of index testing services for HIV-positive adults. (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 NCT04774666, 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 11 Mar 2022.