- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774666
Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Uganda
Caregiver-Assisted Oral Fluid-based HIV Screening in Children: Estimation of Acceptability, Feasibility and Effectiveness Linked to Index Testing Services in Uganda
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kyotera, Uganda
- Mitukula HC III
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Bugiri District
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Bugiri, Bugiri District, Uganda
- Bugiri Hospital
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Bugiri, Bugiri District, Uganda
- Nankoma HC IV
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Isingiro District
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Kabuyanda, Isingiro District, Uganda
- Kabuyanda HC IV
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Kahirimbi, Isingiro District, Uganda
- Rwekubo HC IV
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Kazo District
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Kazo, Kazo District, Uganda
- Buremba HC III
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Kazo, Kazo District, Uganda
- Kazo HC IV
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Kyenjojo District
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Kyenjojo, Kyenjojo District, Uganda
- Butunduzi HC III
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Kyenjojo, Kyenjojo District, Uganda
- Kigarale HC III
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Kyotera District
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Kyotera, Kyotera District, Uganda
- Kasaali HC III
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Lira District
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Lira, Lira District, Uganda
- Barr HC III
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Lira, Lira District, Uganda
- Lira Regional Ref Hospital
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Luwero District
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Kampala, Luwero District, Uganda
- Luwero HC IV
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Kampala, Luwero District, Uganda
- St. Luke Namaliga HC III
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Lwengo District
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Bukoto, Lwengo District, Uganda
- Kinoni HC III
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Mbirizi, Lwengo District, Uganda
- Kiwangala HC III
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Masaka District
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Bukoto, Masaka District, Uganda
- Kiyumba HC IV
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Masaka, Masaka District, Uganda
- Buwunga HC III
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Mbarara District
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Mbarara, Mbarara District, Uganda
- Mbarara Regional Ref Hospital
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Mbarara, Mbarara District, Uganda
- Nyamityobora HC II
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Mityana District
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Mityana, Mityana District, Uganda
- Kyantungo HC IV
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Mityana, Mityana District, Uganda
- Mityana Hospital
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Mubende District
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Mubende, Mubende District, Uganda
- Mubende Kasambya HC III
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Nabingora, Mubende District, Uganda
- Nabingoola HC III
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Mukono District
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Mukono, Mukono District, Uganda
- Mukono Cou HC IV
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Nakisunga, Mukono District, Uganda
- Seeta-Nazigo HC III
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Ntungamo District
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Kitwe, Ntungamo District, Uganda
- Kitwe HC IV
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Ntungamo, Ntungamo District, Uganda
- Ntungamo HC IV
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Rakai District
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Rakai, Rakai District, Uganda
- Lwamaggwa Hc Iii
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Rakai Distsrict
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Rakai, Rakai Distsrict, Uganda
- Rakai Hospital
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Wakiso District
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Busiro, Wakiso District, Uganda
- Kajjansi HC III
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Kasangati, Wakiso District, Uganda
- Kasangati HC IV
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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6 months
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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
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6 months
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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
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carl C Stecker, EdD, Catholic Relief Services - USCCB
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC IRB 7292
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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