Tuberculosis InfectionNCT04494516
Qualitative Understanding of Community TB Services Pre and Post the CHIP-TB Trial
An observational study of Tuberculosis Infection and Tuberculosis Prevention, run by Johns Hopkins University at 2 sites in 2 countries.
Trial summary
This qualitative study is designed to elicit the perspectives of relevant stakeholders to adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention treatment (TPT) initiation for child TB contacts, to design its implementation strategy and, post intervention, to assess lessons learned for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis Infection, Tuberculosis Prevention
- How many people
- 183 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Jun 2021to 30 Jun 2023
- 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: The study population will include key stakeholders from the target communities in South Africa (Ekurhuleni, Gauteng Province) and Ethiopia (East Shewa Zone of the Oromia regional state), including caregivers of TB-exposed children, community health teams including nurses and community health workers, clinic-based nurse and clinic/hospital-based physician providers, program managers and policy makers.
Who may be able to join
- Adult caregiver (18 years of age or older) of a child (<15 years of age) who was exposed to TB in the last two years where at least one child was evaluated for and offered either TB preventive therapy or TB treatment.
- or
- Community health team members from one of the Ethiopian or South African clinics in which the CHIP-TB trial will be conducted.
- or
- TB nurse from one of the 16 Ethiopian or South African clinics in which the study will be conducted
- or
Show all 11Show fewer
- Pediatrician or medical officer working in pediatrics at the relevant Ethiopian or South African District Hospital who sees outpatient pediatric consultations including TB-exposed children
- or
- Program manager or policy maker in the relevant Ethiopian or South African district or provincial office who manages TB, PMTCT, and/or other pediatric programming
- Any community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers who participated in the program for at least 3 months
- Any adult caregiver whose child participated in the community-based TB prevention program
Who cannot join
- Any adult caregivers, community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers who are unable or unwilling to provide informed consent for both the interview and audio-recording
- Any adult caregivers, community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers who are unable or unwilling to provide informed consent for both the interview and audio-recording
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Qualitative Study to Optimize a Community-Based Pediatric TB/HIV Prevention Intervention and Implementation Strategy
This qualitative study is designed to elicit the perspectives of relevant stakeholders to adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention treatment (TPT) initiation for child TB contacts, to design its implementation strategy and, post intervention, to assess lessons learned for future scale up. Participants will include policy makers and health system managers, nurse and physician providers, community health team members, and child caregivers of TB-exposed children. Stakeholders will be asked to participate in two interviews, one prior to the cluster randomized trial assessing this intervention and one after the cluster randomized trial. Trained interviewers will conduct 1-hour semi-structured in-depth interviews that will be audio-recorded, translated and transcribed for thematic analysis using a priori and emergent domains of interest. Free-listing, ranking exercises and cultural consensus will be used to identify context-specific intervention adaptations and implementation strategies.
Read the detailed description
Tuberculosis (TB) remains a top 10 cause of child mortality in sub-Saharan Africa. Short-course combination TB preventive therapy (TPT) regimens are highly effective with high completion rates and therefore hold promise to reduce the 1 million pediatric TB patients and 233,000 child TB deaths annually. TPT effectiveness requires improvement in access to pediatric TB preventive care. The World Health Organization (WHO) estimates only 23% of the 1.3 million TB-exposed children under 5 years old initiated TPT in 2017. The investigators' previous data suggest 50-75% of TB-exposed children under 5 years old fail to be either identified or linked to TB preventive care. Children under 5 years are at exceptionally high risk of TB disease due to not only immature immune systems, but also HIV infection and HIV exposure. Guidelines have long recommended TPT for children under 5 years, but have recently been expanded to children under 15 years. Developing and testing innovative health care delivery models to accompany new WHO-endorsed short-course combination TPT regimens is essential to reduce TB-associated global child morbidity and mortality.
Integrated community case management (iCCM) is a cost-effective intervention that increases child survival by bringing curative therapies to at risk children in the community. Recently, algorithms for screening pediatric patients with household exposure to TB have been simplified to include symptom screening only, eliminating costly laboratory and radiographic evaluations that are barriers to treatment and do not improve sensitivity and specificity of the assessment. The CHIP-TB Trial plans to assess whether integrated community-based pediatric TB/HIV prevention services is feasible, acceptable and effective in increasing TPT uptake among child TB contacts under 15 years in a cluster-randomized trial in South Africa and Ethiopia, two high-burden, resource-limited settings.
Nested within this larger trial, the investigators will use qualitative research to (1) describe the social context in which the community health teams perform the team's duties, (2) make context-specific adaptations to the intervention to maximize its effectiveness, (3) define a context-specific implementation strategy and evaluation plan, and (4) learn important lessons for the future scale up and dissemination of the community-based intervention.
The investigators will conduct 10-15 paired semi-structured individual in-depth interviews (IDI) for each of the four key stakeholder groups: (1) caregivers of TB-exposed children, (2) community health team members, (3) clinic-based nurse and clinic or hospital-based physician providers, and (4) health system managers and policy makers, for a total of ~120 IDIs (~60 in South Africa and ~60 in Ethiopia) both pre and post trial. Before the intervention the investigators will conduct a one-hour interview that will explore the inner setting of the community health team's environment from each stakeholder perspective and will develop and decide upon key intervention adaptations and implementation strategies for the community-based TB/HIV prevention program that will be assessed with a one-year cluster-randomized trial. Upon trial completion, the investigators will conduct another 10-15 semi-structured IDIs with each stakeholder group in each country (total ~120 IDIs) to identify key facilitators and barriers to the implementation. Thematic content analysis with an inductive approach will be used to analyze transcripts for both a priori and emergent domains of interest. A coding scheme will be adapted from Consolidated Framework for Implementation Research (CFIR) constructs. Free listing, ranking, and cultural consensus will be used to identify intervention adaptations and implementation strategies that are context specific. The investigators will use Smith's Saliency Index to analyze the free listed data, mean rank order to assess ranking exercises, and the Eigenvalue to evaluate consensus across groups all using the ANTHROPAC ® 4.0 software.
- Conditions
- Tuberculosis Infection, Tuberculosis Prevention
- 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 |
|---|---|---|
| Pre-trial | This cohort of participants will be recruited preceding evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with design of the intervention and implementation strategy. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites. | |
| Post-trial | This cohort of participants will be recruited after evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with future scale up and dissemination of the intervention. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of intervention adaptations as assessed by an in-depth interview
In-depth, semi-structured interviews will explore perceptions of context-specific adaptations to the community-based TB prevention intervention needed for success.
Measured: Within six months prior to CHIP-TB trial initiation
Perception of implementation strategies as assessed by an in-depth interview
In-depth, semi-structured interviews will explore perceptions of context-specific implementation strategies for the community-based TB prevention intervention needed for success.
Measured: Within six months prior to CHIP-TB trial initiation
Perception of the social context of the community-based health teams as assessed by an in-depth interview
In-depth, semi-structured interviews will explore the social context and inner setting of the community health teams.
Measured: Within six months prior to CHIP-TB trial initiation
Perception of the lessons learned as assessed by an in-depth interview
In-depth, semi-structured interviews will explore lessons learned for the future scale up and dissemination of the community-based TB prevention intervention.
Measured: Within four months after CHIP-TB Trial completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start4 Jun 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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 Tuberculosis InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- UNITAID, Aurum Institute, KNCV Tuberculosis Foundation
- Responsible party
- Sponsor
- Investigators
- Nicole Salazar-Austin, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494516
- Sponsor's protocol ID
- IRB00237243
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2020
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salazar-Austin N, Bergman AJ, Mulder C, Tudor C, Mulatu F, Conradie G, Chaisson RE, Golub JE, Churchyard G, Bedru A, Kerrigan D. Improving access to tuberculosis preventive treatment for children in Ethiopia: designing a home-based contact management intervention for the CHIP-TB trial through formative research. BMC Health Serv Res. 2024 Sep 10;24(1):1043. doi: 10.1186/s12913-024-11451-9.
PubMed 39252005
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study to Optimize a Community-Based Pediatric TB/HIV Prevention Intervention and Implementation Strategy
- ClinicalTrials.gov ID
- NCT04494516
- Acronym / sponsor ID
- IRB00237243
- Conditions
- Tuberculosis Infection, Tuberculosis Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- UNITAID, Aurum Institute, KNCV Tuberculosis Foundation
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 31 Jul 2020 (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.
This qualitative study is designed to elicit the perspectives of relevant stakeholders to adapt a community-based TB/HIV intervention aimed on providing home-based TB prevention treatment (TPT) initiation for child TB contacts, to design its implementation strategy and, post intervention, to assess lessons learned for future scale up. Participants will include policy makers and health system managers, nurse and physician providers, community health team members, and child caregivers of TB-exposed children. Stakeholders will be asked to participate in two interviews, one prior to the cluster randomized trial assessing this intervention and one after the cluster randomized trial. Trained interviewers will conduct 1-hour semi-structured in-depth interviews that will be audio-recorded, translated and transcribed for thematic analysis using a priori and emergent domains of interest. Free-listing, ranking exercises and cultural consensus will be used to identify context-specific intervention adaptations and implementation strategies.
Detailed description
Tuberculosis (TB) remains a top 10 cause of child mortality in sub-Saharan Africa. Short-course combination TB preventive therapy (TPT) regimens are highly effective with high completion rates and therefore hold promise to reduce the 1 million pediatric TB patients and 233,000 child TB deaths annually. TPT effectiveness requires improvement in access to pediatric TB preventive care. The World Health Organization (WHO) estimates only 23% of the 1.3 million TB-exposed children under 5 years old initiated TPT in 2017. The investigators' previous data suggest 50-75% of TB-exposed children under 5 years old fail to be either identified or linked to TB preventive care. Children under 5 years are at exceptionally high risk of TB disease due to not only immature immune systems, but also HIV infection and HIV exposure. Guidelines have long recommended TPT for children under 5 years, but have recently been expanded to children under 15 years. Developing and testing innovative health care delivery models to accompany new WHO-endorsed short-course combination TPT regimens is essential to reduce TB-associated global child morbidity and mortality.
Integrated community case management (iCCM) is a cost-effective intervention that increases child survival by bringing curative therapies to at risk children in the community. Recently, algorithms for screening pediatric patients with household exposure to TB have been simplified to include symptom screening only, eliminating costly laboratory and radiographic evaluations that are barriers to treatment and do not improve sensitivity and specificity of the assessment. The CHIP-TB Trial plans to assess whether integrated community-based pediatric TB/HIV prevention services is feasible, acceptable and effective in increasing TPT uptake among child TB contacts under 15 years in a cluster-randomized trial in South Africa and Ethiopia, two high-burden, resource-limited settings.
Nested within this larger trial, the investigators will use qualitative research to (1) describe the social context in which the community health teams perform the team's duties, (2) make context-specific adaptations to the intervention to maximize its effectiveness, (3) define a context-specific implementation strategy and evaluation plan, and (4) learn important lessons for the future scale up and dissemination of the community-based intervention.
The investigators will conduct 10-15 paired semi-structured individual in-depth interviews (IDI) for each of the four key stakeholder groups: (1) caregivers of TB-exposed children, (2) community health team members, (3) clinic-based nurse and clinic or hospital-based physician providers, and (4) health system managers and policy makers, for a total of ~120 IDIs (~60 in South Africa and ~60 in Ethiopia) both pre and post trial. Before the intervention the investigators will conduct a one-hour interview that will explore the inner setting of the community health team's environment from each stakeholder perspective and will develop and decide upon key intervention adaptations and implementation strategies for the community-based TB/HIV prevention program that will be assessed with a one-year cluster-randomized trial. Upon trial completion, the investigators will conduct another 10-15 semi-structured IDIs with each stakeholder group in each country (total ~120 IDIs) to identify key facilitators and barriers to the implementation. Thematic content analysis with an inductive approach will be used to analyze transcripts for both a priori and emergent domains of interest. A coding scheme will be adapted from Consolidated Framework for Implementation Research (CFIR) constructs. Free listing, ranking, and cultural consensus will be used to identify intervention adaptations and implementation strategies that are context specific. The investigators will use Smith's Saliency Index to analyze the free listed data, mean rank order to assess ranking exercises, and the Eigenvalue to evaluate consensus across groups all using the ANTHROPAC ® 4.0 software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-trial | – | –This cohort of participants will be recruited preceding evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with design of the intervention and implementation strategy. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites. |
| Post-trial | – | –This cohort of participants will be recruited after evaluation of the community-based pediatric TB prevention intervention (CHIP-TB; NCT04369326) to assist with future scale up and dissemination of the intervention. Participants will include four stakeholder groups including: (1) policy makers, program managers, (2) nurse and physician clinicians, (3) community health team members, and (4) caregivers of child contacts from both South African and Ethiopian sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include key stakeholders from the target communities in South Africa (Ekurhuleni, Gauteng Province) and Ethiopia (East Shewa Zone of the Oromia regional state), including caregivers of TB-exposed children, community health teams including nurses and community health workers, clinic-based nurse and clinic/hospital-based physician providers, program managers and policy makers.
Key inclusion criteria (11 listed)
- Adult caregiver (18 years of age or older) of a child (<15 years of age) who was exposed to TB in the last two years where at least one child was evaluated for and offered either TB preventive therapy or TB treatment.
- or
- Community health team members from one of the Ethiopian or South African clinics in which the CHIP-TB trial will be conducted.
- or
- TB nurse from one of the 16 Ethiopian or South African clinics in which the study will be conducted
Key exclusion criteria (2 listed)
- Any adult caregivers, community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers who are unable or unwilling to provide informed consent for both the interview and audio-recording
- Any adult caregivers, community health team members, TB nurses, medical officers or pediatricians, program managers or policy makers 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
Perception of intervention adaptations as assessed by an in-depth interview
Time frame: Within six months prior to CHIP-TB trial initiation
In-depth, semi-structured interviews will explore perceptions of context-specific adaptations to the community-based TB prevention intervention needed for success.
Perception of implementation strategies as assessed by an in-depth interview
Time frame: Within six months prior to CHIP-TB trial initiation
In-depth, semi-structured interviews will explore perceptions of context-specific implementation strategies for the community-based TB prevention intervention needed for success.
Perception of the social context of the community-based health teams as assessed by an in-depth interview
Time frame: Within six months prior to CHIP-TB trial initiation
In-depth, semi-structured interviews will explore the social context and inner setting of the community health teams.
Perception of the lessons learned as assessed by an in-depth interview
Time frame: Within four months after CHIP-TB Trial completion
In-depth, semi-structured interviews will explore lessons learned for the future scale up and dissemination of the community-based TB prevention intervention.
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 12 Jul 2023.
- Derived from this study: PubMed 39252005Salazar-Austin N, Bergman AJ, Mulder C, Tudor C, Mulatu F, Conradie G, Chaisson RE, Golub JE, Churchyard G, Bedru A, Kerrigan D. Improving access to tuberculosis preventive treatment for children in Ethiopia: designing a home-based contact management intervention for the CHIP-TB trial through formative research. BMC Health Serv Res. 2024 Sep 10;24(1):1043. doi: 10.1186/s12913-024-11451-9.
- Individual participant dataSharing planned: No
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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.
Nicole Salazar-Austin, MD principal investigator
Johns Hopkins School of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis Infection and Tuberculosis Prevention, run by Johns Hopkins University at 2 sites in 2 countries.
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 11 inclusion and 2 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia, South Africa. 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?
Perception of intervention adaptations as assessed by an in-depth interview (time frame: Within six months prior to CHIP-TB trial initiation). The study lists 4 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 NCT04494516, 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 12 Jul 2023.