TuberculosisCHIP-TBNCT04369326
Community Initiated Preventive Therapy for TB
A study testing Community-Based TPT Initiation in people with Tuberculosis, run by Johns Hopkins University at 1 site in Ethiopia.
Trial summary
Background: The World Health Organization (WHO) currently recommends household contact investigation for new tuberculosis (TB) patients in low- and middle-income countries, with an emphasis on pediatric contacts. Read more about this study
- Who is it for?
- Ages 0 days to 14 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Community-Based TPT Initiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,168 participants
- Where
- 1 siteEthiopia
- Study dates
- 7 Sep 2021to 30 Jun 2023
- 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 0 days to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adult pulmonary TB patient being treated for pulmonary TB disease (with bacteriologic confirmation including smear, GeneXpert® MTB/RIF and/or liquid mycobacterial culture) in one of the participating clinics
- Willing to have a home visit and disclose their diagnosis to household members
- Lives in the catchment areas of a study clinic
- Age 18 years or older
- Provides informed consent
- Adult or child being treated for pulmonary TB disease (clinical with or without microbiologic diagnosis) in one of the participating clinics
Show all 16Show fewer
- Willing to have a home visit and disclose their diagnosis to household members
- Lives in the catchment areas of a study clinic
- Age 18 years or older
- Provides informed consent
- Child less than 15 years old living in the household of the TB index patient
- Caregiver willing to provide informed consent
- Children 7 years and older must also provide assent
- Child less than 15 years old living in the household of the TB index patient
- Caregiver willing to provide informed consent
- Children 12 years and older must also provide assent
Who cannot join
- Exclusion Criteria for Index Patient in South Africa and Ethiopia:
- Extrapulmonary TB with no evidence of concurrent pulmonary TB
- Evidence of rifampin and/or isoniazid resistance on GeneXpert® MTB/RIF or drug sensitivity testing performed on M. tuberculosis isolates identified on culture
- Household has already participated in study (more than one index patient in the household) and child contacts under 15 years have already been evaluated and remain on TPT and/or TB treatment
- Household child contact of a drug-resistant TB index patient. (Drug resistance defined either by the presence of rifampin resistance on GeneXpert® MTB/RIF OR drug sensitivity testing on isolates identified by culture).
- Household child contact of a drug-resistant TB index patient. (Drug resistance defined either by the presence of rifampin resistance on GeneXpert® MTB/RIF OR drug sensitivity testing on isolates identified by culture).
- Household contact 15 years and older
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Initiated Preventive Therapy for TB (CHIP-TB Trial)
Background: The World Health Organization (WHO) currently recommends household contact investigation for new tuberculosis (TB) patients in low- and middle-income countries, with an emphasis on pediatric contacts. Although the aim of this policy is to find previously undetected TB patients and reduce transmission, such investigations represent a missed opportunity to start contacts without TB on preventive therapy (TPT). The WHO guidelines do not address the optimal implementation of contact investigation. The standard of care (SOC) in most settings, passive referral of pediatric contacts to the clinic by the index TB patient, has largely remained unsuccessful in practice. In 2017, the WHO estimated only 23% of eligible child contacts were started on TB preventive therapy. Household contact investigation has been shown to have a higher yield in active TB case finding, but is labor intensive, and may be challenging to implement in densely populated urban settings or informal settlements/slums. The WHO recently endorsed the use of a new TPT regimen (rifapentine and isoniazid weekly (3HP)) for both children and adults in high burden settings, and the programmatic roll out of this regimen offers the opportunity to simultaneously examine new strategies to improve the identification and treatment of pediatric TB household contacts.
Objective: To compare the effectiveness of community-based versus facility-based child contact investigation and delivery of TB preventive care to inform the optimal implementation strategy for investigating pediatric household TB contacts.
Read more
Study Design: Cluster-randomized trial in 32 clinics (16 clinics per arm) divided equally among South Africa and Ethiopia (8 clinics per arm per country).
Methods: Newly diagnosed qualifying TB index patients (determined by South African or Ethiopian National TB guidelines) and participants' household child contacts will be recruited to participate. Local staff, including the relevant nurses and community health workers in the intervention and control clinics, will be trained to conduct contact investigation with a symptom-based approach for all child contacts under 15 years old in home and at the clinic. Data will be collected using routine medical files and then retrospectively abstracted by the research team. Thirty-two primary health clinics will be stratified (by TB case notification and by country) and randomized in 1:1 fashion to either community-based or facility-based delivery of care. Household child contacts under 15 years of age who screen negative for TB disease will be initiated on TPT by a healthcare worker (nurse, community health worker, etc.) either in the home or clinic setting. Children in the intervention arm who screen positive will first be sent to the nurse at the clinic for repeat screening. Children who have a persistently positive screen in the intervention arm and those with a positive screen in the control arm using South Africa's or Ethiopia's pediatric symptom screening tool will be referred to a physician at the district hospital for further investigation of TB disease, as is the standard of care in both settings. Investigators will compare clinic-level outcomes including proportion of household TB contacts under 15 years of age that were screened, initiated on TPT, and who completed TPT, and reasons for not completing TPT including loss to follow up and incident TB disease while on TPT.
- Conditions
- Tuberculosis
- Being tested
- Community-Based TPT Initiation
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-Based TPT InitiationOther
Community-based care delivery model for pediatric tuberculosis evaluation and initiation of preventive therapy
| Study group | Role | What they receive |
|---|---|---|
| Community-Based TPT Initiation | Experimental | All TB index patients who agree to participate will have a home visit by clinic staff who will perform: (1) contact enumeration (2) TB symptom screening of all children <15 years (3) Initiation of TPT for all asymptomatic children and (4) Referral of all symptomatic children less than 15 years, including those living with HIV. HIV testing will be offered to all child contacts 12 months of age and older. Those children less than 12 months will be referred to the clinic for HIV testing, if indicated by local guidelines. In South Africa, these home visits will occur by a combination of community health workers and professional nurses. In Ethiopia, home visits will occur by health extension workers supported by nurses. Receives: Other: Community-Based TPT Initiation |
| Facility-Based TPT Initiation | No intervention | Children less than 15 years living in the home of TB index patients who agree to participate in the study will be referred to clinic for TB symptom screening and initiation of TPT for all asymptomatic child contacts. Symptomatic child contacts will be referred to a physician for evaluation, as is currently the standard of care. Additionally, child contacts identified in any maternal and child health program will be referred to the TB clinic for TB symptom screening. HIV testing will be offered at the clinic for all child contacts and will be performed according to local guideline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cluster-level ratio of the number of household child contacts less than 15 years of age initiated on TB preventive therapy (TPT) per index patient, comparing the intervention to the control arm
TPT includes 3 months of weekly rifapentine and isoniazid, 3 months of daily rifampin and isoniazid or 6 months of isoniazid
Measured: 4 months
Secondary outcomes (26)
The cluster-level ratio of the number of household child contacts less than 15 years of age identified per index patient, comparing the intervention to the control arm
Measured: 4 months
The cluster-level proportions of estimated child contacts under 15 years who are identified
We will calculate the estimated child contacts per household using Demographic and Health Survey data and prior community-based contact tracing studies in both South Africa and Ethiopia. We will measure identified child TB contacts using the index patient's clinic-based contact tracing report, the child contact management file and the community-level file maintained by community health teams.
Measured: 6 months
The cluster-level proportions of estimated child contacts under 15 years who are screened
We will calculate the estimated child contacts per household using Demographic and Health Survey data and prior community-based contact tracing studies in both South Africa and Ethiopia. We will define screening as the child's documented visit to the TB clinic or a documented visit to the home by the community health team (where the child was present) within four months of the index patient's TB clinic admission.
Measured: 6 months
The cluster-level proportions of estimated child contacts under 15 years who are initiated on TB preventive therapy
We will calculate the estimated child contacts per household using Demographic and Health Survey data and prior community-based contact tracing studies in both South Africa and Ethiopia. Clinic staff or community health workers will document TPT initiation on the child contact management file.
Measured: 6 months
The cluster-level proportions of estimated child contacts under 15 years who complete TB preventive therapy
We will calculate the estimated child contacts per household using Demographic and Health Survey data and prior community-based contact tracing studies in both South Africa and Ethiopia. Clinic staff or community health workers will document TPT completion on the child contact management file.
Measured: 6 months
The cluster-level ratio of the number of household child contacts less than 15 years of age initiated on TB preventive therapy per index patient, comparing the intervention to the control arm in South Africa
Measured: 4 months
The cluster-level ratio of the number of household child contacts less than 15 years of age initiated on TB preventive therapy per index patient, comparing the intervention to the control arm in Ethiopia
Measured: 4 months
The cluster-level ratio of the number of household child contacts less than 15 years of age initiated on TB preventive therapy per index patient, comparing the intervention to the control arm among those less than 5 years of age
Measured: 4 months
The proportion of child contacts, by study arm, who discontinued TPT due to incident TB
Measured: 6 months
The proportion of child contacts, by study arm, who discontinued TPT due to pregnancy
Measured: 6 months
The proportion of child contacts, by study arm, who discontinued TPT due to severe malaria
Measured: 6 months
The proportion of child contacts, by study arm, who discontinued TPT due to a side effect
Measured: 6 months
The proportion of child contacts, by study arm, who were lost to follow up
Measured: 6 months
The proportion of children, by study arm, who were HIV-tested
Measured: 3 months
The proportion of newly diagnosed HIV-positive children, by study arm, who are referred for initiation of antiretroviral therapy by the community health team
Measured: 3 months
The proportion of newly diagnosed HIV-positive children, by study arm, who are initiated on antiretroviral therapy
Measured: 3 months
The proportion of identified child contacts in the intervention arm whose caregiver agrees for them to be screened by community-based healthcare workers in their home
Measured: 4 months
Mean number of attempted household visits per household
Measured: 6 months
Mean duration of time per household visit
Measured: 6 months
The proportion of TB contacts initiated on the correct TPT regimen by age and HIV status
Measured: 6 months
The proportion of TPT initiations with the correct dose for weight
Measured: 6 months
Proportion of TB index patient households in the intervention arm who refused a household visit due to stigma
Measured: 6 months
Proportion of TB index patient households in the intervention arm who refused a household visit due to lack of time
Measured: 6 months
Proportion of TB index patient households in the intervention arm who refused a household visit due to well status of the child
Measured: 6 months
Proportion of TB index patient households in the intervention arm who do not receive a home visit because the family and/or child was not home on three separate attempts
Measured: 6 months
Proportion of TB index patient households in the intervention arm who refused a household visit due to fear of disclosure
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 posted30 Apr 2020
- Study start7 Sep 2021
- Primary completion31 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,168 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369326
- Sponsor's protocol ID
- IRB00249787
- Acronym
- CHIP-TB
- Status last verified
- Aug 2023
- First submitted
- 24 Apr 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salazar-Austin N, Cohn S, Nonyane BAS, Mulder C, Mulatu F, Bayu S, Bizuayehu M, Conradie G, Malhotra A, Phan P, Morfin NH, Borsboom S, Mitiku P, Fulas D, Tulema M, Golub JE, Chaisson RE, Churchyard G, Bedru A. Effectiveness of a Home-based Approach to Child Contact Investigation and Tuberculosis Preventive Treatment Management by Community Health Workers in Ethiopia: A Pragmatic Cluster-randomized Trial. Clin Infect Dis. 2025 Dec 24;81(5):e385-e392. doi: 10.1093/cid/ciaf203.
PubMed 40376825Malhotra A, Bedru A, Mulatu F, Nonyane BAS, Cohn S, Mulder C, Bayu S, Borsboom S, Conradie G, Golub JE, Chaisson RE, Churchyard G, Dowdy DW, Sohn H, Salazar-Austin N. Cost and cost-effectiveness of pediatric home-based versus facility-based TB Preventive Treatment in Ethiopia (CHIP-TB). PLOS Glob Public Health. 2025 Apr 30;5(4):e0004466. doi: 10.1371/journal.pgph.0004466. eCollection 2025.
PubMed 40305495Salazar-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 39252005Malhotra A, Nonyane BAS, Shirey E, Mulder C, Hippner P, Mulatu F, Ratshinanga A, Mitiku P, Cohn S, Conradie G, Chihota V, Chaisson RE, Churchyard GJ, Golub J, Dowdy D, Sohn H, Charalambous S, Bedru A, Salazar-Austin N. Pragmatic cluster-randomized trial of home-based preventive treatment for TB in Ethiopia and South Africa (CHIP-TB). Trials. 2023 Jul 25;24(1):475. doi: 10.1186/s13063-023-07514-7.
PubMed 37491264
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Initiated Preventive Therapy for TB (CHIP-TB Trial)
- ClinicalTrials.gov ID
- NCT04369326
- Acronym / sponsor ID
- CHIP-TB / IRB00249787
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,168 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- UNITAID, Aurum Institute, KNCV Tuberculosis Foundation
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Apr 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.
Background: The World Health Organization (WHO) currently recommends household contact investigation for new tuberculosis (TB) patients in low- and middle-income countries, with an emphasis on pediatric contacts. Although the aim of this policy is to find previously undetected TB patients and reduce transmission, such investigations represent a missed opportunity to start contacts without TB on preventive therapy (TPT). The WHO guidelines do not address the optimal implementation of contact investigation. The standard of care (SOC) in most settings, passive referral of pediatric contacts to the clinic by the index TB patient, has largely remained unsuccessful in practice. In 2017, the WHO estimated only 23% of eligible child contacts were started on TB preventive therapy. Household contact investigation has been shown to have a higher yield in active TB case finding, but is labor intensive, and may be challenging to implement in densely populated urban settings or informal settlements/slums. The WHO recently endorsed the use of a new TPT regimen (rifapentine and isoniazid weekly (3HP)) for both children and adults in high burden settings, and the programmatic roll out of this regimen offers the opportunity to simultaneously examine new strategies to improve the identification and treatment of pediatric TB household contacts.
Objective: To compare the effectiveness of community-based versus facility-based child contact investigation and delivery of TB preventive care to inform the optimal implementation strategy for investigating pediatric household TB contacts.
Study Design: Cluster-randomized trial in 32 clinics (16 clinics per arm) divided equally among South Africa and Ethiopia (8 clinics per arm per country).
Methods: Newly diagnosed qualifying TB index patients (determined by South African or Ethiopian National TB guidelines) and participants' household child contacts will be recruited to participate. Local staff, including the relevant nurses and community health workers in the intervention and control clinics, will be trained to conduct contact investigation with a symptom-based approach for all child contacts under 15 years old in home and at the clinic. Data will be collected using routine medical files and then retrospectively abstracted by the research team. Thirty-two primary health clinics will be stratified (by TB case notification and by country) and randomized in 1:1 fashion to either community-based or facility-based delivery of care. Household child contacts under 15 years of age who screen negative for TB disease will be initiated on TPT by a healthcare worker (nurse, community health worker, etc.) either in the home or clinic setting. Children in the intervention arm who screen positive will first be sent to the nurse at the clinic for repeat screening. Children who have a persistently positive screen in the intervention arm and those with a positive screen in the control arm using South Africa's or Ethiopia's pediatric symptom screening tool will be referred to a physician at the district hospital for further investigation of TB disease, as is the standard of care in both settings. Investigators will compare clinic-level outcomes including proportion of household TB contacts under 15 years of age that were screened, initiated on TPT, and who completed TPT, and reasons for not completing TPT including loss to follow up and incident TB disease while on TPT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Community-Based TPT Initiation | Experimental | Other: Community-Based TPT InitiationAll TB index patients who agree to participate will have a home visit by clinic staff who will perform: (1) contact enumeration (2) TB symptom screening of all children <15 years (3) Initiation of TPT for all asymptomatic children and (4) Referral of all symptomatic children less than 15 years, including those living with HIV. HIV testing will be offered to all child contacts 12 months of age and older. Those children less than 12 months will be referred to the clinic for HIV testing, if indicated by local guidelines. In South Africa, these home visits will occur by a combination of community health workers and professional nurses. In Ethiopia, home visits will occur by health extension workers supported by nurses. |
| Facility-Based TPT Initiation | No intervention | –Children less than 15 years living in the home of TB index patients who agree to participate in the study will be referred to clinic for TB symptom screening and initiation of TPT for all asymptomatic child contacts. Symptomatic child contacts will be referred to a physician for evaluation, as is currently the standard of care. Additionally, child contacts identified in any maternal and child health program will be referred to the TB clinic for TB symptom screening. HIV testing will be offered at the clinic for all child contacts and will be performed according to local guideline. |
Who may qualify
- Ages
- 0 days to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Adult pulmonary TB patient being treated for pulmonary TB disease (with bacteriologic confirmation including smear, GeneXpert® MTB/RIF and/or liquid mycobacterial culture) in one of the participating clinics
- Willing to have a home visit and disclose their diagnosis to household members
- Lives in the catchment areas of a study clinic
- Age 18 years or older
- Provides informed consent
Key exclusion criteria (7 listed)
- Extrapulmonary TB with no evidence of concurrent pulmonary TB
- Evidence of rifampin and/or isoniazid resistance on GeneXpert® MTB/RIF or drug sensitivity testing performed on M. tuberculosis isolates identified on culture
- Household has already participated in study (more than one index patient in the household) and child contacts under 15 years have already been evaluated and remain on TPT and/or TB treatment
- Household child contact of a drug-resistant TB index patient. (Drug resistance defined either by the presence of rifampin resistance on GeneXpert® MTB/RIF OR drug sensitivity testing on isolates identified by culture).
- Household child contact of a drug-resistant TB index patient. (Drug resistance defined either by the presence of rifampin resistance on GeneXpert® MTB/RIF OR drug sensitivity testing on isolates identified by culture).
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 |
|---|---|---|
| Community-Based TPT InitiationCommunity-based care delivery model for pediatric tuberculosis evaluation and initiation of preventive therapy | Other | Community-Based TPT Initiation |
Primary outcome
The cluster-level ratio of the number of household child contacts less than 15 years of age initiated on TB preventive therapy (TPT) per index patient, comparing the intervention to the control arm
Time frame: 4 months
TPT includes 3 months of weekly rifapentine and isoniazid, 3 months of daily rifampin and isoniazid or 6 months of isoniazid
26 secondary outcomes
The cluster-level ratio of the number of household child contacts less than 15 years of age identified per index patient, comparing the intervention to the control arm
Time frame: 4 months
The cluster-level proportions of estimated child contacts under 15 years who are identified
Time frame: 6 months
The cluster-level proportions of estimated child contacts under 15 years who are screened
Time frame: 6 months
The cluster-level proportions of estimated child contacts under 15 years who are initiated on TB preventive therapy
Time frame: 6 months
The cluster-level proportions of estimated child contacts under 15 years who complete TB preventive therapy
Time frame: 6 months
The cluster-level ratio of the number of household child contacts less than 15 years of age initiated on TB preventive therapy per index patient, comparing the intervention to the control arm in South Africa
Time frame: 4 months
The cluster-level ratio of the number of household child contacts less than 15 years of age initiated on TB preventive therapy per index patient, comparing the intervention to the control arm in Ethiopia
Time frame: 4 months
The cluster-level ratio of the number of household child contacts less than 15 years of age initiated on TB preventive therapy per index patient, comparing the intervention to the control arm among those less than 5 years of age
Time frame: 4 months
The proportion of child contacts, by study arm, who discontinued TPT due to incident TB
Time frame: 6 months
The proportion of child contacts, by study arm, who discontinued TPT due to pregnancy
Time frame: 6 months
The proportion of child contacts, by study arm, who discontinued TPT due to severe malaria
Time frame: 6 months
The proportion of child contacts, by study arm, who discontinued TPT due to a side effect
Time frame: 6 months
The proportion of child contacts, by study arm, who were lost to follow up
Time frame: 6 months
The proportion of children, by study arm, who were HIV-tested
Time frame: 3 months
The proportion of newly diagnosed HIV-positive children, by study arm, who are referred for initiation of antiretroviral therapy by the community health team
Time frame: 3 months
The proportion of newly diagnosed HIV-positive children, by study arm, who are initiated on antiretroviral therapy
Time frame: 3 months
The proportion of identified child contacts in the intervention arm whose caregiver agrees for them to be screened by community-based healthcare workers in their home
Time frame: 4 months
Mean number of attempted household visits per household
Time frame: 6 months
Mean duration of time per household visit
Time frame: 6 months
The proportion of TB contacts initiated on the correct TPT regimen by age and HIV status
Time frame: 6 months
The proportion of TPT initiations with the correct dose for weight
Time frame: 6 months
Proportion of TB index patient households in the intervention arm who refused a household visit due to stigma
Time frame: 6 months
Proportion of TB index patient households in the intervention arm who refused a household visit due to lack of time
Time frame: 6 months
Proportion of TB index patient households in the intervention arm who refused a household visit due to well status of the child
Time frame: 6 months
Proportion of TB index patient households in the intervention arm who do not receive a home visit because the family and/or child was not home on three separate attempts
Time frame: 6 months
Proportion of TB index patient households in the intervention arm who refused a household visit due to fear of disclosure
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 14 Aug 2023.
- Derived from this study: PubMed 40376825Salazar-Austin N, Cohn S, Nonyane BAS, Mulder C, Mulatu F, Bayu S, Bizuayehu M, Conradie G, Malhotra A, Phan P, Morfin NH, Borsboom S, Mitiku P, Fulas D, Tulema M, Golub JE, Chaisson RE, Churchyard G, Bedru A. Effectiveness of a Home-based Approach to Child Contact Investigation and Tuberculosis Preventive Treatment Management by Community Health Workers in Ethiopia: A Pragmatic Cluster-randomized Trial. Clin Infect Dis. 2025 Dec 24;81(5):e385-e392. doi: 10.1093/cid/ciaf203.
- Derived from this study: PubMed 40305495Malhotra A, Bedru A, Mulatu F, Nonyane BAS, Cohn S, Mulder C, Bayu S, Borsboom S, Conradie G, Golub JE, Chaisson RE, Churchyard G, Dowdy DW, Sohn H, Salazar-Austin N. Cost and cost-effectiveness of pediatric home-based versus facility-based TB Preventive Treatment in Ethiopia (CHIP-TB). PLOS Glob Public Health. 2025 Apr 30;5(4):e0004466. doi: 10.1371/journal.pgph.0004466. eCollection 2025.
- 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.
- Derived from this study: PubMed 37491264Malhotra A, Nonyane BAS, Shirey E, Mulder C, Hippner P, Mulatu F, Ratshinanga A, Mitiku P, Cohn S, Conradie G, Chihota V, Chaisson RE, Churchyard GJ, Golub J, Dowdy D, Sohn H, Charalambous S, Bedru A, Salazar-Austin N. Pragmatic cluster-randomized trial of home-based preventive treatment for TB in Ethiopia and South Africa (CHIP-TB). Trials. 2023 Jul 25;24(1):475. doi: 10.1186/s13063-023-07514-7.
- 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 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-Based TPT Initiation in people with Tuberculosis, run by Johns Hopkins University at 1 site in Ethiopia.
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 16 inclusion and 7 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 14 Aug 2023. 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 Ethiopia. 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?
The cluster-level ratio of the number of household child contacts less than 15 years of age initiated on TB preventive therapy (TPT) per index patient, comparing the intervention to the control arm (time frame: 4 months). 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 NCT04369326, which also lists 4 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 14 Aug 2023.