TB - TuberculosisNCT06511180
Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation
An observational study of TB - Tuberculosis and Household Contact, run by The Aurum Institute NPC.
Trial summary
The WHO has recommended TB preventive therapy (TPT) for children living with HIV (CLHIV) and household contacts of people living with TB, however, the scale-up and implementation of TPT has been sub-optimal globally particularly in children. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- TB - Tuberculosis, Household Contact, HIV
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Jun 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Clinic record review: Routine program data for CLHIV <12 years or children <12 years who are household contacts of people living with TB, who are initiated on TPT. [A household contact is defined as a person who shared the same enclosed living space with the index patient (someone with infectious TB as defined by country guidelines) for one or more nights or for frequent or extended periods during the day during the 3 months before commencement of the current treatment episode.] Qualitative study: Policy makers, healthcare workers and parents/caregivers will be interviewed - (>18 years) Clinic-level assessment: Pharmacy managers/pharmacists, procurement and supply management staff - (>18 years)
Who may be able to join
- Medical records of children <12 years who are either CLHIV or who are household contacts of people with pulmonary TB and who are initiated on TPT
- Adult caregiver (>18 years) of a child <12 years of age who is eligible for TPT
- Healthcare worker from one of the clinics in which the study will be conducted who sees outpatient pediatric consultations including TB-exposed children
- Policy maker or program manager who manages or is involved in PMTCT, TB and/or pediatric programming
Who cannot join
- Records will be excluded for children who are contacts of a drug-resistant, have presumptive TB disease or are currently on TB treatment
- Qualitative study
- Any adult caregivers, healthcare workers, policy makers or program managers who are unable or unwilling to provide informed consent for both the interview and audio-recording.
Trial locations and contacts
No sites are listed yet.
About this study
The WHO has recommended TB preventive therapy (TPT) for children living with HIV (CLHIV) and household contacts of people living with TB, however, the scale-up and implementation of TPT has been sub-optimal globally particularly in children. A safe and effective short-course TPT regimen, 3HP (rifapentine and isoniazid given once weekly for three months), is available but there is a lack of child-friendly formulations resulting in increased pill burden and there is a need to improve acceptability and adherence among children. The introduction of a dispersible rifapentine formulation has potential to improve uptake, treatment adherence and completion.
Overall goal is to generate critical knowledge to improve delivery of TPT and, more specifically, of dispersible 3HP, in children in routine programs.
This evaluation will create an important understanding of TPT uptake and completion among children and assess the impact of the introduction of a dispersible 3HP formulation. These results will provide actionable information for improving service delivery and the scale-up of TPT in the respective countries.
- Conditions
- TB - Tuberculosis, Household Contact, HIV, Children, Only
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children <12 years who are eligible for TPT - HHC | No intervention. Clinic record review: Data will be retrospectively abstracted from routine medical files using a standardised data collection tool that will document TPT uptake and outcomes | |
| Policy makers/Program managers | No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations. | |
| Healthcare Workers | No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations. | |
| Caregivers | No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations. | |
| Pharmacy managers/pharmacists | No intervention. Clinic assessment: We will assess provider barriers and facilitators to prescribing the new dispersible 3HP (single dispersible formulations of isoniazid and rifapentine) through a survey tool which will collect information on the flow of TPT from national supply to the clinic and dispensing to the child. | |
| Procurement managers/Supply managers | No intervention. Clinic assessment: We will assess provider barriers and facilitators to prescribing the new dispersible 3HP (single dispersible formulations of isoniazid and rifapentine) through a survey tool which will collect information on the flow of TPT from national supply to the clinic and dispensing to the child. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overarching Objective
The overarching goal of the evaluation is to generate critical knowledge to improve delivery of TPT and, more specifically, of dispersible 3HP, in children in routine programs.
Measured: 18 months
Primary Objective 1
To quantify the TPT care cascade from identification, screening, eligibility, treatment initiation to completion among children <12 years of age, stratified by regimen.
Measured: 18 months
Secondary outcomes (4)
Secondary Objective 1
To quantify the prescription of the new dispersible 3HP vs other regimens among children <12 years.
Measured: 18 months
Secondary Objective 2
To explore policy makers, healthcare workers and caregivers' insights on different regimens and formulations.
Measured: 18 months
Secondary Objective 3
To assess provider-level barriers and facilitators to delivery of the new dispersible 3HP regimen.
Measured: 18 months
Secondary Objective 4
To determine the impact of the new dispersible 3HP on supply chain and changes needed to accommodate them.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TB - TuberculosisStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Aurum Institute NPC
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, KNCV Tuberculosis Foundation, Clinton Health Access Initiative Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511180
- Sponsor's protocol ID
- AUR2-7-428
- Other IDs
- ERC.0004119
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The evaluation findings will be presented at stakeholder meetings at national level and disseminated to stakeholders and participating sites in each country by means of local meetings. Results will also be written up as conference abstracts and/or journal articles and submitted for publication to an appropriate journal to maximise their dissemination, particularly to clinicians involved in TB programmes.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation
- ClinicalTrials.gov ID
- NCT06511180
- Acronym / sponsor ID
- AUR2-7-428
- Conditions
- TB - Tuberculosis, Household Contact, HIV, Children, Only
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- The Aurum Institute NPCUniversity, hospital or other
- Collaborators
- Johns Hopkins University, KNCV Tuberculosis Foundation, Clinton Health Access Initiative Inc.
- Study start
- Aug 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Jul 2024 (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 WHO has recommended TB preventive therapy (TPT) for children living with HIV (CLHIV) and household contacts of people living with TB, however, the scale-up and implementation of TPT has been sub-optimal globally particularly in children. A safe and effective short-course TPT regimen, 3HP (rifapentine and isoniazid given once weekly for three months), is available but there is a lack of child-friendly formulations resulting in increased pill burden and there is a need to improve acceptability and adherence among children. The introduction of a dispersible rifapentine formulation has potential to improve uptake, treatment adherence and completion.
Overall goal is to generate critical knowledge to improve delivery of TPT and, more specifically, of dispersible 3HP, in children in routine programs.
This evaluation will create an important understanding of TPT uptake and completion among children and assess the impact of the introduction of a dispersible 3HP formulation. These results will provide actionable information for improving service delivery and the scale-up of TPT in the respective countries.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Children <12 years who are eligible for TPT - HHC | – | –No intervention. Clinic record review: Data will be retrospectively abstracted from routine medical files using a standardised data collection tool that will document TPT uptake and outcomes |
| Policy makers/Program managers | – | –No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations. |
| Healthcare Workers | – | –No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations. |
| Caregivers | – | –No intervention. Qualitative study: We will recruit a purposive sample of policy makers, healthcare workers and caregivers who will be interviewed to evaluate buy-in and explore their insights and experiences on the different TPT regimens and formulations. |
| Pharmacy managers/pharmacists | – | –No intervention. Clinic assessment: We will assess provider barriers and facilitators to prescribing the new dispersible 3HP (single dispersible formulations of isoniazid and rifapentine) through a survey tool which will collect information on the flow of TPT from national supply to the clinic and dispensing to the child. |
| Procurement managers/Supply managers | – | –No intervention. Clinic assessment: We will assess provider barriers and facilitators to prescribing the new dispersible 3HP (single dispersible formulations of isoniazid and rifapentine) through a survey tool which will collect information on the flow of TPT from national supply to the clinic and dispensing to the child. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinic record review: Routine program data for CLHIV <12 years or children <12 years who are household contacts of people living with TB, who are initiated on TPT. [A household contact is defined as a person who shared the same enclosed living space with the index patient (someone with infectious TB as defined by country guidelines) for one or more nights or for frequent or extended periods during the day during the 3 months before commencement of the current treatment episode.] Qualitative study: Policy makers, healthcare workers and parents/caregivers will be interviewed - (>18 years) Clinic-level assessment: Pharmacy managers/pharmacists, procurement and supply management staff - (>18 years)
Key inclusion criteria (4 listed)
- Medical records of children <12 years who are either CLHIV or who are household contacts of people with pulmonary TB and who are initiated on TPT
- Adult caregiver (>18 years) of a child <12 years of age who is eligible for TPT
- Healthcare worker from one of the clinics in which the study will be conducted who sees outpatient pediatric consultations including TB-exposed children
- Policy maker or program manager who manages or is involved in PMTCT, TB and/or pediatric programming
Key exclusion criteria (3 listed)
- Records will be excluded for children who are contacts of a drug-resistant, have presumptive TB disease or are currently on TB treatment
- Qualitative study
- Any adult caregivers, healthcare workers, policy makers or program managers who are unable or unwilling to provide informed consent for both the interview and audio-recording.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overarching Objective
Time frame: 18 months
The overarching goal of the evaluation is to generate critical knowledge to improve delivery of TPT and, more specifically, of dispersible 3HP, in children in routine programs.
Primary Objective 1
Time frame: 18 months
To quantify the TPT care cascade from identification, screening, eligibility, treatment initiation to completion among children <12 years of age, stratified by regimen.
4 secondary outcomes
Secondary Objective 1
Time frame: 18 months
Secondary Objective 2
Time frame: 18 months
Secondary Objective 3
Time frame: 18 months
Secondary Objective 4
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Undecided. The evaluation findings will be presented at stakeholder meetings at national level and disseminated to stakeholders and participating sites in each country by means of local meetings. Results will also be written up as conference abstracts and/or journal articles and submitted for publication to an appropriate journal to maximise their dissemination, particularly to clinicians involved in TB programmes.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of TB - Tuberculosis and Household Contact, run by The Aurum Institute NPC.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Violet Chihota (+27 (0) 82 319 1559, vchihota@auruminstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overarching Objective (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2024.