TuberculosisNCT02662829
Preventing Childhood Tuberculosis in Lesotho (PREVENT Study)
A study testing Community-based intervention in people with Tuberculosis, run by Columbia University at 10 sites in Lesotho.
Trial summary
Lesotho, a small, landlocked country completely surrounded by South Africa, is among the world's poorest nations with one of the world's most severe epidemics of tuberculosis (TB) and HIV. TB incidence is the world's highest and approximately 76% of TB patients are HIV coinfected. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Community-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 10 sitesLesotho
- Study dates
- Dec 2015to Jan 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
The randomized trial will include review of medical records of all adult TB cases who start TB treatment during the study period.
Providers inclusion criteria:
- Nurse or village healthcare worker(VHW) working in a CBI clinic or VHW working in the community and affiliated with CBI clinic
- Aged 18 or older
- English- or Sesotho speaking
- Capable of informed consent
Guardians inclusion criteria:
- Guardian of a child contact
- Aged 18 or older
- English- or Sesotho speaking
- Capable of informed consent
Two groups of guardians will be enrolled: guardians who brought their children for TB screening, and guardians who did not bring their children for TB screening.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Lesotho10 sites
Berea Hospital
Berea, Berea
Holy Family Health Center
Berea, Berea
Khubetsoana Health Center
Berea, Berea
Koali Health Center
Berea, Berea
Kolojane Health Center
Berea, Berea
Maluti Hospital
Berea, Berea
Pilot Health Center
Berea, Berea
St Magdalena Health Center
Berea, Berea
St. David Health Center
Berea, Berea
St. Theresa Health Center
Berea, Berea
About this study
Lesotho, a small, landlocked country completely surrounded by South Africa, is among the world's poorest nations with one of the world's most severe epidemics of tuberculosis (TB) and HIV. TB incidence is the world's highest and approximately 76% of TB patients are HIV coinfected. Data from similar settings suggest that TB incidence in children is approximately 50% of adult TB incidence. The Lesotho National TB Program has adopted World Health Organization's (WHO) isoniazid preventive therapy (IPT) recommendations for child contacts; however, as in other countries in the region, implementation of IPT in children is limited, no clear strategies guide child contact tracing and screening, and no clear methods ensure provision of IPT in children. Thus, it is important to evaluate novel methods to prevent TB in child contacts of adult TB cases.
The purpose of the PREVENT Study is to identify an effective and acceptable intervention that addresses programmatic, structural and psychosocial barriers to contact tracing, screening, and IPT for child contacts of TB patients, with the ultimate goal of improving health outcomes among children in Lesotho. The study is a two-arm cluster randomized trial, randomized at the TB clinic level, which includes ten TB clinics in Berea district. Clinics are randomized to deliver the community-based intervention (CBI) or standard of care (SOC), with stratification by facility type. The experimental intervention will be delivered to all child contacts of adult TB patients in TB clinics randomly assigned to CBI. In TB clinics assigned to SOC, usual care procedures for contact tracing and IPT will be delivered.
Read the detailed description
The study intervention, community-based intervention (CBI), will contain multiple components, including: 1) Facility Providers. Providers will be trained on study interventions; job aids will be provided. Nurses will use a clinical algorithm based on national guidelines for intensive case finding and screening of child contacts for TB to assess patients without TB symptoms for IPT eligibility; to initiate IPT; and to monitor for side effects, TB symptoms, and adherence. If a child contact develops TB symptoms during IPT, national guidelines will be followed. HIV testing will be strongly promoted in child contacts. Use of simple available clinic IPT registers will be promoted. The PI will establish systems to track IPT use at monthly multi-disciplinary team meetings; clinic staff will review IPT monitoring data for prior months, identify challenges, and develop solutions. IPT registers will link IPT outcome data to TB register data for index cases. 2) Patients and Guardians. Nurses will explain to patients and guardians that IPT can prevent TB, promote IPT initiation, assess IPT adherence and side effects, and encourage follow-up with village health workers (VHW). Nurses will emphasize HIV testing for children. The VHW role will encompass social support, system navigation, referrals, and advocacy. VHW will follow up with guardians of children who miss appointments or report nonadherence, using scripted, illustrated flipcharts targeting children and guardians. VHW will emphasize to guardians the importance of IPT, encourage IPT and visit adherence, offer support and empathy, provide referrals, and advocate for patients. 3) Community Outreach. To investigate household contacts, VHW will visit homes of all adult TB cases at facilities assigned to CBI. All HIV-infected children and children under 5, regardless of HIV status, will be referred to health facilities. VHW will administer TB symptom screening in child contacts in the community, accompany them and their guardians to the clinic, and provide education sessions, support groups, and adherence counseling.
Study assessments include: 1) outcome data via medical records; 2) pre- and post-intervention interviews with providers; 3) post-intervention guardian interviews; and 4) program characteristics data. Stakeholders and policy makers will be engaged early in the process to help ensure successful integration of findings in programmatic contexts. A dissemination strategy will be developed in consultation with stakeholders and will help ensure scaling up of the intervention, if found effective.
All clinical care, including implementation of the combination intervention package at sites randomized to CIP, will be performed by Lesotho Ministry of Health clinic staff (nurses and VHW). All study procedures, including participant interviews, medical record abstraction, and program characteristics surveys will be performed by study staff.
- Conditions
- Tuberculosis
- Being tested
- Community-based intervention, Standard of care
- Keywords
- Lesotho, tuberculosis, TB, HIV, adherence, community-based intervention, retention
- 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 interventionBehavioural
Also called CBI
Standard of careOther
Also called SOC
| Study group | Role | What they receive |
|---|---|---|
| Community-based intervention (CBI) | Experimental | 1. Nurse training and mentorship in TB prevention using clinical algorithm based on national guidelines.
2. Health education using a treatment literacy curriculum for parents and guardians.
3. Community outreach by trained village health workers. Receives: Behavioral: Community-based intervention |
| Standard of Care (SOC) | Active comparator | At SOC clinics, patients will receive usual care for management of contact tracing, screening, and IPT provision. Childhood TB in Lesotho is managed by nurses in health centers. Per national guidelines, TB patients are asked to bring in child contacts, who are screened using a simple symptom questionnaire. Children who screen negative are assessed for IPT eligibility. Absent contra-indications (eg, active hepatitis, regular alcohol consumption, peripheral neuropathy), nurses counsel children and guardians on IPT benefits, potential side effects, and importance of adherence. Children requiring chest x-rays or gastric lavage and HIV-infected children under age 1 are referred to the hospital. After initiation, patients and guardians return to the clinic monthly for monitoring for side effects, TB symptoms, adherence, and 30-day supply of isoniazid. If adherence problems are noted, the nurse counsels patient and guardian as appropriate. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield of child contacts
Number of child contacts per pulmonary TB case screened, based on review of clinic registers
Measured: 3 years
Percentage of IPT initiation
Percentage of child contacts identified through contact tracing of new adult TB cases during observation period who initiate IPT, based on review of clinic registers
Measured: 3 years
Percentage of IPT completion
Percentage of child contacts who complete IPT of those who initiate as determined by provider and recorded in clinic charts
Measured: Up to 9 months after IPT initiation
Secondary outcomes (1)
Percentage of HIV testing
Percentage of child contacts identified through contact tracing of new adult TB cases during observation period who are tested for HIV, based on review of clinic registers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2019
- Study completionJan 2019
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 TuberculosisStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Masking
- None (open label)
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yael Hirsch-Moverman, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662829
- Sponsor's protocol ID
- AAAN7358
- Other IDs
- K01AI104351
- Status last verified
- Apr 2022
- First submitted
- 15 Jan 2016
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Hirsch-Moverman Y, Howard AA, Frederix K, Lebelo L, Hesseling A, Nachman S, Mantell JE, Lekhela T, Maama LB, El-Sadr WM. The PREVENT study to evaluate the effectiveness and acceptability of a community-based intervention to prevent childhood tuberculosis in Lesotho: study protocol for a cluster randomized controlled trial. Trials. 2017 Nov 21;18(1):552. doi: 10.1186/s13063-017-2184-0.
PubMed 29157275
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Childhood Tuberculosis in Lesotho (PREVENT Study)
- ClinicalTrials.gov ID
- NCT02662829
- Acronym / sponsor ID
- AAAN7358
- Conditions
- Tuberculosis
- Keywords
- Lesotho, tuberculosis, TB, HIV, adherence, community-based intervention, retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 26 Jan 2016 (estimated)
- 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.
Lesotho, a small, landlocked country completely surrounded by South Africa, is among the world's poorest nations with one of the world's most severe epidemics of tuberculosis (TB) and HIV. TB incidence is the world's highest and approximately 76% of TB patients are HIV coinfected. Data from similar settings suggest that TB incidence in children is approximately 50% of adult TB incidence. The Lesotho National TB Program has adopted World Health Organization's (WHO) isoniazid preventive therapy (IPT) recommendations for child contacts; however, as in other countries in the region, implementation of IPT in children is limited, no clear strategies guide child contact tracing and screening, and no clear methods ensure provision of IPT in children. Thus, it is important to evaluate novel methods to prevent TB in child contacts of adult TB cases.
The purpose of the PREVENT Study is to identify an effective and acceptable intervention that addresses programmatic, structural and psychosocial barriers to contact tracing, screening, and IPT for child contacts of TB patients, with the ultimate goal of improving health outcomes among children in Lesotho. The study is a two-arm cluster randomized trial, randomized at the TB clinic level, which includes ten TB clinics in Berea district. Clinics are randomized to deliver the community-based intervention (CBI) or standard of care (SOC), with stratification by facility type. The experimental intervention will be delivered to all child contacts of adult TB patients in TB clinics randomly assigned to CBI. In TB clinics assigned to SOC, usual care procedures for contact tracing and IPT will be delivered.
Detailed description
The study intervention, community-based intervention (CBI), will contain multiple components, including: 1) Facility Providers. Providers will be trained on study interventions; job aids will be provided. Nurses will use a clinical algorithm based on national guidelines for intensive case finding and screening of child contacts for TB to assess patients without TB symptoms for IPT eligibility; to initiate IPT; and to monitor for side effects, TB symptoms, and adherence. If a child contact develops TB symptoms during IPT, national guidelines will be followed. HIV testing will be strongly promoted in child contacts. Use of simple available clinic IPT registers will be promoted. The PI will establish systems to track IPT use at monthly multi-disciplinary team meetings; clinic staff will review IPT monitoring data for prior months, identify challenges, and develop solutions. IPT registers will link IPT outcome data to TB register data for index cases. 2) Patients and Guardians. Nurses will explain to patients and guardians that IPT can prevent TB, promote IPT initiation, assess IPT adherence and side effects, and encourage follow-up with village health workers (VHW). Nurses will emphasize HIV testing for children. The VHW role will encompass social support, system navigation, referrals, and advocacy. VHW will follow up with guardians of children who miss appointments or report nonadherence, using scripted, illustrated flipcharts targeting children and guardians. VHW will emphasize to guardians the importance of IPT, encourage IPT and visit adherence, offer support and empathy, provide referrals, and advocate for patients. 3) Community Outreach. To investigate household contacts, VHW will visit homes of all adult TB cases at facilities assigned to CBI. All HIV-infected children and children under 5, regardless of HIV status, will be referred to health facilities. VHW will administer TB symptom screening in child contacts in the community, accompany them and their guardians to the clinic, and provide education sessions, support groups, and adherence counseling.
Study assessments include: 1) outcome data via medical records; 2) pre- and post-intervention interviews with providers; 3) post-intervention guardian interviews; and 4) program characteristics data. Stakeholders and policy makers will be engaged early in the process to help ensure successful integration of findings in programmatic contexts. A dissemination strategy will be developed in consultation with stakeholders and will help ensure scaling up of the intervention, if found effective.
All clinical care, including implementation of the combination intervention package at sites randomized to CIP, will be performed by Lesotho Ministry of Health clinic staff (nurses and VHW). All study procedures, including participant interviews, medical record abstraction, and program characteristics surveys will be performed by study staff.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-based intervention (CBI) | Experimental | Behavioral: Community-based intervention1. Nurse training and mentorship in TB prevention using clinical algorithm based on national guidelines. 2. Health education using a treatment literacy curriculum for parents and guardians. 3. Community outreach by trained village health workers. |
| Standard of Care (SOC) | Active comparator | Other: Standard of careAt SOC clinics, patients will receive usual care for management of contact tracing, screening, and IPT provision. Childhood TB in Lesotho is managed by nurses in health centers. Per national guidelines, TB patients are asked to bring in child contacts, who are screened using a simple symptom questionnaire. Children who screen negative are assessed for IPT eligibility. Absent contra-indications (eg, active hepatitis, regular alcohol consumption, peripheral neuropathy), nurses counsel children and guardians on IPT benefits, potential side effects, and importance of adherence. Children requiring chest x-rays or gastric lavage and HIV-infected children under age 1 are referred to the hospital. After initiation, patients and guardians return to the clinic monthly for monitoring for side effects, TB symptoms, adherence, and 30-day supply of isoniazid. If adherence problems are noted, the nurse counsels patient and guardian as appropriate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 interventionAlso: CBI | Behavioural | Community-based intervention (CBI) |
| Standard of careAlso: SOC | Other | Standard of Care (SOC) |
Primary outcome
Yield of child contacts
Time frame: 3 years
Number of child contacts per pulmonary TB case screened, based on review of clinic registers
Percentage of IPT initiation
Time frame: 3 years
Percentage of child contacts identified through contact tracing of new adult TB cases during observation period who initiate IPT, based on review of clinic registers
Percentage of IPT completion
Time frame: Up to 9 months after IPT initiation
Percentage of child contacts who complete IPT of those who initiate as determined by provider and recorded in clinic charts
1 secondary outcome
Percentage of HIV testing
Time frame: 3 years
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 6 Apr 2022.
- Derived from this study: PubMed 29157275Hirsch-Moverman Y, Howard AA, Frederix K, Lebelo L, Hesseling A, Nachman S, Mantell JE, Lekhela T, Maama LB, El-Sadr WM. The PREVENT study to evaluate the effectiveness and acceptability of a community-based intervention to prevent childhood tuberculosis in Lesotho: study protocol for a cluster randomized controlled trial. Trials. 2017 Nov 21;18(1):552. doi: 10.1186/s13063-017-2184-0.
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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.
Yael Hirsch-Moverman, PhD principal investigator
Columbia University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based intervention in people with Tuberculosis, run by Columbia University at 10 sites in Lesotho.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Lesotho. 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?
Yield of child contacts (time frame: 3 years). The study lists 3 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 NCT02662829, 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 6 Apr 2022.