TY - JOUR
T1 - Pragmatic cluster-randomized trial of home-based preventive treatment for TB in Ethiopia and South Africa (CHIP-TB)
AU - Malhotra, Akash
AU - Nonyane, Bareng Aletta Sanny
AU - Shirey, Evan
AU - Mulder, Christiaan
AU - Hippner, Piotr
AU - Mulatu, Fiseha
AU - Ratshinanga, Andani
AU - Mitiku, Petros
AU - Cohn, Silvia
AU - Conradie, Gideon
AU - Chihota, Violet
AU - Chaisson, Richard E.
AU - Churchyard, Gavin J.
AU - Golub, Jonathan
AU - Dowdy, David
AU - Sohn, Hojoon
AU - Charalambous, Salome
AU - Bedru, Ahmed
AU - Salazar-Austin, Nicole
N1 - Funding Information: NSA, AM, BASN, and ES wrote the manuscript. NSA led the protocol development and was supported by BASN, CM, PH, SC, VC, REC, GJC, JG, SC2, and AB. The study design was conceptualized by NSA, BASN, CM, PM, REC, GJC, JG, SC2, and AB. BASN worked on the statistical details of the protocol and was supported by NSA. PH, SC, GC, SC2, AB, and NSA worked on the data management aspects of the protocol. PH, FM, AR, SC2, AB, and NSA worked on data collection and quality control. GC worked on quality control. PH, FM, AR, GC, VC, JG, SC2, AB, and NSA worked on the design of the quality assessment. AM, PH, DD, HS, SC2, AB, and NSA worked on the design of the cost-effectiveness component. All authors read and approved the manuscript. Funding Information: This project is funded by UNITAID and IMPAACT4TB. NSA salary is supported by the National Institutes of Health (K23HD096973). The Aurum Institute, 29 Queens Rd, Parktown, Johannesburg, 2194, South Africa is the sponsor of the trial. The funder had no role in the writing of this manuscript after concept approval. Publisher Copyright: © 2023, The Author(s).
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background: Each year, 1 million children develop TB resulting in over 200,000 child deaths. TB preventive treatment (TPT) is highly effective in preventing TB but remains poorly implemented for household child contacts. Home-based child contact management and TPT services may improve access to care. In this study, we aim to evaluate the effectiveness and cost-effectiveness of home-based contact management with TPT initiation in two TB high-burden African countries, Ethiopia and South Africa. Methods: This pragmatic cluster randomized trial compares home-based versus facility-based care delivery models for contact management. Thirty-six clinics with decentralized TB services (18 in Ethiopia and 18 in South Africa) were randomized in a 1:1 ratio to conduct either home-based or facility-based contact management. The study will attempt to enroll all eligible close child contacts of infectious drug-sensitive TB index patients diagnosed and treated for TB by one of the study clinics. Child TB contact management, including contact tracing, child evaluation, and TPT initiation and follow-up, will take place in the child’s home for the intervention arm and at the clinic for the control arm. The primary outcome is the cluster-level ratio of the number of household child contacts less than 15 years of age in Ethiopia and less than 5 years of age in South Africa initiated on TPT per index patient, comparing the intervention to the control arm. Secondary outcomes include child contact identification and the TB prevention continuum of care. Other implementation outcomes include acceptability, feasibility, fidelity, cost, and cost-effectiveness of the intervention. Discussion: This implementation research trial will determine whether home-based contact management identifies and initiates more household child contacts on TPT than facility-based contact management. Trial registration: NCT04369326 . Registered on April 30, 2020.
AB - Background: Each year, 1 million children develop TB resulting in over 200,000 child deaths. TB preventive treatment (TPT) is highly effective in preventing TB but remains poorly implemented for household child contacts. Home-based child contact management and TPT services may improve access to care. In this study, we aim to evaluate the effectiveness and cost-effectiveness of home-based contact management with TPT initiation in two TB high-burden African countries, Ethiopia and South Africa. Methods: This pragmatic cluster randomized trial compares home-based versus facility-based care delivery models for contact management. Thirty-six clinics with decentralized TB services (18 in Ethiopia and 18 in South Africa) were randomized in a 1:1 ratio to conduct either home-based or facility-based contact management. The study will attempt to enroll all eligible close child contacts of infectious drug-sensitive TB index patients diagnosed and treated for TB by one of the study clinics. Child TB contact management, including contact tracing, child evaluation, and TPT initiation and follow-up, will take place in the child’s home for the intervention arm and at the clinic for the control arm. The primary outcome is the cluster-level ratio of the number of household child contacts less than 15 years of age in Ethiopia and less than 5 years of age in South Africa initiated on TPT per index patient, comparing the intervention to the control arm. Secondary outcomes include child contact identification and the TB prevention continuum of care. Other implementation outcomes include acceptability, feasibility, fidelity, cost, and cost-effectiveness of the intervention. Discussion: This implementation research trial will determine whether home-based contact management identifies and initiates more household child contacts on TPT than facility-based contact management. Trial registration: NCT04369326 . Registered on April 30, 2020.
KW - Contact investigation
KW - Ethiopia
KW - Household contact management
KW - Pediatric TB
KW - Pragmatic implementation trial
KW - South Africa
KW - TB preventive treatment
KW - TPT
KW - Tuberculosis
UR - http://www.scopus.com/inward/record.url?scp=85165683400&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-023-07514-7
DO - https://doi.org/10.1186/s13063-023-07514-7
M3 - Article
C2 - 37491264
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 475
ER -