Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202309676675265 Date of Approval: 26/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating the effect of interventions for decentralized Drug-Resistant Tuberculosis services, and contextual factors that influenced its implementation in 2 southern Nigerian states: A Quasi-experimental study
Official scientific title Effectiveness of interventions for decentralized DR-TB services and contextual factors that influence its implementation in 2 southern Nigerian states
Brief summary describing the background and objectives of the trial DR-TB services in Nigeria have traditionally been centralized with upwards referral of all DR-TB patients for management led by the state-level team, largely due to the injectable-containing treatment regimens which encouraged facility-based care. In 2013, the Nigerian National Tuberculosis and Leprosy Control Program (NTBLCP) adopted Ambulatory care for DR-TB patients (first-level decentralization of treatment), and with the advent of effective all-oral DR-TB medications, by 2018, the NTBLCP aligned with the global consensus to phase out the use of injectable-containing treatment regimens and transition DR-TB care from being facility-based to more community-based for better access to patients and treatment outcomes. However, all related primary program structures such as conducting baseline investigations, determining eligibility for DR-TB treatment regimen, logistics for medication and treatment initiation largely remained centralized. This study is being conducted as implementation research embedded within the on-going TB REACH Wave 9 innovation funding grant for the project titled, “Catalyzing improvements in DR-TB care in Nigeria: A Sustainable Patient-centered approach” with the goal to improve linkage to care so as to reduce pre-treatment loss to follow up (PTLTFU) for DR-TB patients. The specific objectives of this study are: 1. To assess the trend of DR-TB patients’ enrolment in the project states 2. To assess the effect of interventions to decentralize DR-TB services on DR-TB patients’ enrolment 3. To identify contextual factors that influence implementation of interventions to decentralize DR-TB services in the project states.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Improve access to TB care services
Anticipated trial start date 01/04/2022
Actual trial start date 01/04/2022
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 483
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Evaluation Population 15 months The interventions are as follows: 1. Devolving GxAlert to include local government TB supervisors (TBLS) and patients to reduce turnaround time of Xpert/MTB/RIF results 2. Improving tracking of patients by supporting The Global Fund-funded community-based organizations (CBOs) through output-based financial incentives 3. Improving counselling of patients through introduction of structured pre-treatment counselling and team counselling with DR-TB survivors 4. Decentralizing baseline investigations to more (pre-qualified) peripheral laboratories 5. Providing transport support to patients for baseline investigations 6. Employing mobile connectivity solutions to improve turnaround time of baseline investigations using Unstructured Supplementary Service Data (USSD) 7. Verifying reported pre-treatment deaths using verbal autopsy 8. Decentralizing treatment initiation to the LGA level 9. Engagement of a state (volunteer) liaison officer to coordinate state-wide activities. 334
Control Group Control Population 15 months No intervention (only routine DR-TB programme) 149 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals/patients diagnosed with drug-resistant Tuberculosis (DR-TB) Personnel who are involved in DR-TB programme management and/or service delivery within the project states (including frontline health workers). Individuals/patients diagnosed with drug-sensitive Tuberculosis (DS-TB) 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Month(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/06/2023 National Health Research Ethics Committee of Nigeria NHREC
Ethics Committee Address
Street address City Postal code Country
Department of Health Planning, Research and Statistics, Federal Ministry of Health, Nigeria Abuja 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Enrolment on DR-TB treatment Pre- and Post-intervention
Secondary Outcome Time to enrollment Pre- and Post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AkwaIbom State AkwaIbom State Tuberculosis, Leprsoy and Buruli Ulcer Control Programme, Ministry of Health Uyo Nigeria
Oyo State Oyo State Tuberculosis, Leprsoy and Buruli Ulcer Control Programme, Ministry of Health Ibadan Nigeria
Delta State Delta State Tuberculosis, Leprsoy and Buruli Ulcer Control Programme, Ministry of Health Asaba Nigeria
Edo State Edo State Tuberculosis, Leprsoy and Buruli Ulcer Control Programme, Ministry of Health Benin city Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Stop TB Partnership hosted by UNOPS Global Health Campus, Chemin du Pommier 40, 1218 Le Grand-Saconnex Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stop TB Partnership hosted by UNOPS Global Health Campus, Chemin du Pommier 40, 1218 Le Grand-Saconnex Geneva Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ngozi MurphyOkpala ngozi.murphyokpala@redaid-nigeria.org +2348033705461 56 Nza Street IndependenceLayout
City Postal code Country Position/Affiliation
Enugu Nigeria Medical Adviser
Role Name Email Phone Street address
Scientific Enquiries Ngozi MurphyOkpala ngozi.murphyokpala@redaid-nigeria.org +2348033705461 56 Nza Street Independence Layout
City Postal code Country Position/Affiliation
Enugu Nigeria Medical Adviser
Role Name Email Phone Street address
Public Enquiries Charles Nwafor charles.nwafor@redaid-nigeria.org +2348033456111 56 Nza Street Independence Layout
City Postal code Country Position/Affiliation
Enugu Nigeria Ag. CEO
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Informed Consent Form Beginning 3 months and ending 5 years following article publication. Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information