Community-based Tuberculosis Tracing and Preventive Therapy

  • STATUS
    Recruiting
  • End date
    Jun 14, 2021
  • participants needed
    1500
  • sponsor
    Elizabeth Glaser Pediatric AIDS Foundation
Updated on 23 January 2021
isoniazid
rifampin

Summary

The many gaps observed in the cascade of care of tuberculosis (TB) child contacts occur mostly in the screening, preventive therapy (PT) initiation and PT completion steps and the main drivers of these gaps are considered to be the health system infrastructure, limited worker resources and parents' reluctance to bring their children to the facility for screening. There would be great advantages of using a symptom-based screening at community level where only the symptomatic contacts are referred to hospital for further evaluation and asymptomatic contacts are started on PT in the community. Household or community-based screening is likely to improve the uptake and acceptability of child contact screening and management as well as adherence to PT and to reduce cost and workload at facility level.

This study proposes to compare the cascade of care between two models for TB screening and management of household TB child contacts in two high TB burden and limited resource countries, Cameroon and Uganda. In the facility-based model, children will be screened at facility (Cameroon) or household level (Uganda) and preventive therapy initiation, refills of PT therapy and follow-up will be done at facility level. In the intervention group (community-based model), child contacts will be screened in the household by a community health worker (CHW). Those with symptoms suggestive of TB will be referred to the facility for TB investigations. Asymptomatic child contacts from high risk groups (under-5 years or HIV infected 5-14) will be initiated on PT (3 months isoniazid-rifampicin) in the household. Refills of PT therapy will also be done in the communities by the CHW. In both models, symptomatic children requiring further investigations for TB diagnosis will be referred to a health facility.

Description

The primary study objective is to compare the proportion of household child TB contacts eligible for PT (under-5 years and HIV-infected children 5-14 years without active TB) who initiate and complete PT using facility-based and decentralized community-based models of care for contact screening and management.

Secondary objectives are:

  1. To compare the facility and community-based models in terms of:
    • The full cascade of care for the initiation and completion of PT in child TB contacts < 5 years or HIV+ children 5-14 years .
    • Cascade of care for the detection and treatment of TB in child contacts (all ages):
    • PT tolerability and adherence among eligible child contacts initiated on PT.
    • Treatment uptake and outcomes for child contacts diagnosed with TB .
    • Child contact outcomes at 6 months after enrollment for all child contacts.
    • Acceptability by the parents/guardians, health personnel and community of the different models of care.
    • Cost and cost-effectiveness of the different models.
  2. To assess the number of adult contact cases diagnosed with TB through the community-based screening.
  3. To compare between the pre- (baseline assessment) and post-intervention (by model of care) data related to:
    • Children diagnosed with TB and registered at facility level and their treatment outcome.
    • Adults diagnosed with TB and registered at facility level and their treatment outcome.
    • PT initiation and outcomes.

This study will be implemented under the frame of the Catalyzing Pediatric TB Innovation (CaP TB) Project, funded by Unitaid and implemented by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF). The goal of CaP TB is to improve the pediatric TB morbidity and mortality by catalyzing the wide uptake of the new first-line fixed dose combination drugs for children and optimizing the use of these drugs through improved case detection and innovative models of care. In both models of care, contacts with TB suggestive symptoms will be investigated for TB at the cluster facility that is supported by EGPAF within the CaP TB project. In Cameroon the CaP TB project will be implemented in the Central and Littoral regions and in Uganda in the South-West region.

Details
Condition Tuberculosis, tb (tuberculosis)
Treatment Screening and initiating preventive therapy in communities
Clinical Study IdentifierNCT03832023
SponsorElizabeth Glaser Pediatric AIDS Foundation
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have Tuberculosis?
Do you have any of these conditions: tb (tuberculosis) or Tuberculosis?
Inclusion of the index cases
Age > 15 years
Newly bacteriologically confirmed TB case (less than a month since diagnosis)
Reports child contact(s)
Written informed consent given by the index case
Inclusion of contacts
Household contact
Age < 15 years
Facility-based model in Cameroon: < 5 years or HIV infected/exposed 5-14 years
Facility-based model in Uganda and community-based model on both countries <15 years
Written informed consent signed by adult contacts and by parents/guardians for children contacts
Written assent for children > 7 years

Exclusion Criteria

Exclusion of index cases
Index cases who do not have child household contacts living in the catchment area of one of the study clusters
Index cases diagnosed with rifampicin resistance, multidrug-resistant (MDR) or extensively drug-resistant (XDR) TB
Index cases that are prisoners
Exclusion of the contacts
If the contact is already on PT or on TB treatment
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note