TuberculosisSOARNCT03074799
Nurse-Led, Symptom-Based Screening of Household Child Contacts of Tuberculosis Index Cases
A study testing Symptom -based Screening(Child Contacts) and Clinical based Decisions in people with Tuberculosis, run by Johns Hopkins University at 1 site in South Africa.
Trial summary
To assess implementation of a nurse-led, symptom-based screening program in local, decentralized clinics for tuberculosis (TB) screening of child contacts less than 5 years old who were exposed to tuberculosis in the home. Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Symptom -based Screening(Child Contacts) and Clinical based Decisions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,054 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Oct 2015to 15 Sep 2018
- Phase
- Interventional
- 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 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child less than five years old
- Household contact of a drug-sensitive pulmonary or extrapulmonary TB index case (drug sensitivity is define as culture-confirmed OR absence of rifampin resistance on gene Xpert) admitted to one of the public clinics in the Matlosana sub-district on or after October 1, 2015.
Who cannot join
- Household contact of a drug-resistant TB index case. (Drug resistance defined either by culture or by presence of rifampin resistance on gene Xpert).
Trial locations and contacts
1 site in 1 country.
About this study
To assess implementation of a nurse-led, symptom-based screening program in local, decentralized clinics for tuberculosis (TB) screening of child contacts less than 5 years old who were exposed to tuberculosis in the home. This will allow nurses in decentralized clinics to either start IPT for those asymptomatic patients and refer symptomatic patients for evaluation of TB disease and possible antituberculous therapy (ATT).
Read the detailed description
Retrospective review of routine program data for child contacts less than five years of adult TB index cases who are receiving TB care at local, decentralized clinics in the Matlosana district of Northwest Province will be assessed. 16 clinics will be stratified and randomized in 1:1 fashion to either TST-based screening, the current standard of care, or symptom-based screening, the newly recommended standard of care in South Africa. Those who are TST positive in the TST-based group and those who are symptomatic in the symptom-based group will be referred to Klerkdorp Hospital for further evaluation of tuberculosis. Nurses in the decentralized clinics will initiate those who are TST negative or asymptomatic on IPT. Their clinical course will be monitored throughout treatment and adherence to therapy measured. The investigators will compare clinic-level outcomes including percentage of patients initiated on, adherent to, and completing IPT.
- Conditions
- Tuberculosis
- Being tested
- Symptom -based Screening(Child Contacts), Clinical based Decisions
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom -based Screening(Child Contacts)Other
Aim 1: Determine the number of child contacts per adult index case of tuberculosis to assess quality of contact tracing.
Aim 2: Determine the percentage of child contacts initiated on IPT or antituberculous therapy (ATT) and compare between intervention (symptom-based, nurse-led initiation of IPT) vs control clinics (TST-based screening with referral to hospital, current standard of care).
Aim 3: Compare outcomes of children initiated on IPT between both groups including: completion of therapy, discontinuation due to side effects, lost to follow up, and adherence while on therapy.
Clinical based DecisionsOther
the child is symptomatic, they will be referred to the hospital for further evaluation of TB disease including both chest X-ray and testing of either sputum or swallowed sputum. If the child is asymptomatic, the TB nurse at the local clinic will initiate them on weight-appropriate dosing of IPT
| Study group | Role | What they receive |
|---|---|---|
| TST-based Screening (Child contacts) | Active comparator | In the control clinics, decision regarding IPT will be made based on TST results, as is now the standard of care in this South African health district. In this setting, all TST negative children are initiated on IPT by the nurse at the local clinic. TST positive children are all referred to the district hospital for further evaluation of TB disease regardless of clinical symptoms. Again, clinical outcome data will be obtained from patient records and the same longitudinal child contact register. Receives: Other: Symptom -based Screening(Child Contacts) |
| Symptom -based Screening(Child Contacts) | Experimental | In the intervention clinics, decisions regarding IPT will be made on a clinical basis. If the child is symptomatic, they will be referred to the hospital for further evaluation of TB disease including both chest X-ray and testing of either sputum or swallowed sputum. If the child is asymptomatic, the TB nurse at the local clinic will initiate them on weight-appropriate dosing of IPT. Children will be followed at least monthly for the duration of the six month course of isoniazid, as is standard of care in South Africa at this time. Clinical outcome data will be obtained from patient records and implementation of a contact register aimed at improving longitudinal care of children on isoniazid preventive therapy. Receives: Other: Clinical based Decisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of child contacts placed on IPT
The primary outcome is the mean percentage of identified contacts initiated on IPT or ATT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 Oct 2015
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We propose a cluster randomized trial to be conducted in 16 decentralized care clinics with existing TB services that will measure the implementation of symptom-based, nurse-led initiation of IPT compared to the current standard of care with TST-based referral to a pediatricians at the district hospital. A baseline assessment of clinic records and procedures will inform clinic stratification prior to randomization. Clinics will be stratified by size (number of patients seen per month) and TB case notifications. The clinics will then be randomized in a 1:1 ratio to receive either the intervention or the current standard of care. Given the intervention will be carried out by a clinic in its entirety, neither the provider nor the patient will be blinded to the study procedure. No additional staff will be provided to the clinics to assist in this process as we wish to evaluate the implementation of IPT for child contacts under 5 years old in a real world, resource-limited setting.
- Masking
- None (open label)
- Enrolment
- 4,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Richard Chaisson, MD, Principal investigator, Director, Center for Tuberculosis Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074799
- Sponsor's protocol ID
- IRB00055079
- Acronym
- SOAR
- Status last verified
- Mar 2020
- First submitted
- 1 Mar 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study is ongoing; plans for data sharing are in process
Publications
Salazar-Austin N, Milovanovic M, West NS, Tladi M, Barnes GL, Variava E, Martinson N, Chaisson RE, Kerrigan D. Post-trial perceptions of a symptom-based TB screening intervention in South Africa: implementation insights and future directions for TB preventive healthcare services. BMC Nurs. 2021 Feb 8;20(1):29. doi: 10.1186/s12912-021-00544-z.
PubMed 33557831Salazar-Austin N, Cohn S, Barnes GL, Tladi M, Motlhaoleng K, Swanepoel C, Motala Z, Variava E, Martinson N, Chaisson RE. Improving Tuberculosis Preventive Therapy Uptake: A Cluster-randomized Trial of Symptom-based Versus Tuberculin Skin Test-based Screening of Household Tuberculosis Contacts Less Than 5 Years of Age. Clin Infect Dis. 2020 Apr 10;70(8):1725-1732. doi: 10.1093/cid/ciz436.
PubMed 31127284
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led, Symptom-Based Screening of Household Child Contacts of Tuberculosis Index Cases
- ClinicalTrials.gov ID
- NCT03074799
- Acronym / sponsor ID
- SOAR / IRB00055079
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,054 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 9 Mar 2017 (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.
To assess implementation of a nurse-led, symptom-based screening program in local, decentralized clinics for tuberculosis (TB) screening of child contacts less than 5 years old who were exposed to tuberculosis in the home. This will allow nurses in decentralized clinics to either start IPT for those asymptomatic patients and refer symptomatic patients for evaluation of TB disease and possible antituberculous therapy (ATT).
Detailed description
Retrospective review of routine program data for child contacts less than five years of adult TB index cases who are receiving TB care at local, decentralized clinics in the Matlosana district of Northwest Province will be assessed. 16 clinics will be stratified and randomized in 1:1 fashion to either TST-based screening, the current standard of care, or symptom-based screening, the newly recommended standard of care in South Africa. Those who are TST positive in the TST-based group and those who are symptomatic in the symptom-based group will be referred to Klerkdorp Hospital for further evaluation of tuberculosis. Nurses in the decentralized clinics will initiate those who are TST negative or asymptomatic on IPT. Their clinical course will be monitored throughout treatment and adherence to therapy measured. The investigators will compare clinic-level outcomes including percentage of patients initiated on, adherent to, and completing IPT.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We propose a cluster randomized trial to be conducted in 16 decentralized care clinics with existing TB services that will measure the implementation of symptom-based, nurse-led initiation of IPT compared to the current standard of care with TST-based referral to a pediatricians at the district hospital. A baseline assessment of clinic records and procedures will inform clinic stratification prior to randomization. Clinics will be stratified by size (number of patients seen per month) and TB case notifications. The clinics will then be randomized in a 1:1 ratio to receive either the intervention or the current standard of care. Given the intervention will be carried out by a clinic in its entirety, neither the provider nor the patient will be blinded to the study procedure. No additional staff will be provided to the clinics to assist in this process as we wish to evaluate the implementation of IPT for child contacts under 5 years old in a real world, resource-limited setting.
| Arm | Type | Receives |
|---|---|---|
| TST-based Screening (Child contacts) | Active comparator | Other: Symptom -based Screening(Child Contacts)In the control clinics, decision regarding IPT will be made based on TST results, as is now the standard of care in this South African health district. In this setting, all TST negative children are initiated on IPT by the nurse at the local clinic. TST positive children are all referred to the district hospital for further evaluation of TB disease regardless of clinical symptoms. Again, clinical outcome data will be obtained from patient records and the same longitudinal child contact register. |
| Symptom -based Screening(Child Contacts) | Experimental | Other: Clinical based DecisionsIn the intervention clinics, decisions regarding IPT will be made on a clinical basis. If the child is symptomatic, they will be referred to the hospital for further evaluation of TB disease including both chest X-ray and testing of either sputum or swallowed sputum. If the child is asymptomatic, the TB nurse at the local clinic will initiate them on weight-appropriate dosing of IPT. Children will be followed at least monthly for the duration of the six month course of isoniazid, as is standard of care in South Africa at this time. Clinical outcome data will be obtained from patient records and implementation of a contact register aimed at improving longitudinal care of children on isoniazid preventive therapy. |
Who may qualify
- Ages
- 1 day to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child less than five years old
- Household contact of a drug-sensitive pulmonary or extrapulmonary TB index case (drug sensitivity is define as culture-confirmed OR absence of rifampin resistance on gene Xpert) admitted to one of the public clinics in the Matlosana sub-district on or after October 1, 2015.
Key exclusion criteria (1 listed)
- Household contact of a drug-resistant TB index case. (Drug resistance defined either by culture or by presence of rifampin resistance on gene Xpert).
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 |
|---|---|---|
| Symptom -based Screening(Child Contacts)Aim 1: Determine the number of child contacts per adult index case of tuberculosis to assess quality of contact tracing. Aim 2: Determine the percentage of child contacts initiated on IPT or antituberculous therapy (ATT) and compare between intervention (symptom-based, nurse-led initiation of IPT) vs control clinics (TST-based screening with referral to hospital, current standard of care). Aim 3: Compare outcomes of children initiated on IPT between both groups including: completion of therapy, discontinuation due to side effects, lost to follow up, and adherence while on therapy. | Other | TST-based Screening (Child contacts) |
| Clinical based Decisionsthe child is symptomatic, they will be referred to the hospital for further evaluation of TB disease including both chest X-ray and testing of either sputum or swallowed sputum. If the child is asymptomatic, the TB nurse at the local clinic will initiate them on weight-appropriate dosing of IPT | Other | Symptom -based Screening(Child Contacts) |
Primary outcome
Percent of child contacts placed on IPT
Time frame: 2 years
The primary outcome is the mean percentage of identified contacts initiated on IPT or ATT
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 4 Mar 2020.
- Derived from this study: PubMed 33557831Salazar-Austin N, Milovanovic M, West NS, Tladi M, Barnes GL, Variava E, Martinson N, Chaisson RE, Kerrigan D. Post-trial perceptions of a symptom-based TB screening intervention in South Africa: implementation insights and future directions for TB preventive healthcare services. BMC Nurs. 2021 Feb 8;20(1):29. doi: 10.1186/s12912-021-00544-z.
- Derived from this study: PubMed 31127284Salazar-Austin N, Cohn S, Barnes GL, Tladi M, Motlhaoleng K, Swanepoel C, Motala Z, Variava E, Martinson N, Chaisson RE. Improving Tuberculosis Preventive Therapy Uptake: A Cluster-randomized Trial of Symptom-based Versus Tuberculin Skin Test-based Screening of Household Tuberculosis Contacts Less Than 5 Years of Age. Clin Infect Dis. 2020 Apr 10;70(8):1725-1732. doi: 10.1093/cid/ciz436.
- Individual participant dataSharing planned: Yes. Study is ongoing; plans for data sharing are in process
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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.
Richard Chaisson, MD principal investigator
Director, Center for Tuberculosis Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom -based Screening(Child Contacts) and Clinical based Decisions in people with Tuberculosis, run by Johns Hopkins University at 1 site in South Africa.
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 2 inclusion and 1 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Percent of child contacts placed on IPT (time frame: 2 years). 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 NCT03074799, which also lists 2 linked publications.
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 4 Mar 2020.