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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607689823876 Date of Registration: 29/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving Linkage to Treatment Among DR-TB Patients Through WhatsApp Messages, SMS Reminders, and Phone Calls in Nigeria
Official scientific title Effectiveness of Multi-Channel Digital Support on Pre-Treatment Loss to Follow-Up Among DR-TB Patients in Nigeria
Brief summary describing the background and objectives of the trial Tuberculosis (TB) remains a major global public health challenge, particularly with the increasing burden of drug-resistant tuberculosis (DR-TB). Even after being diagnosed of DRTB, some patients despite availability of free medicines for treatment, may not be willing to be put on treatment, for various reasons including belief system, logistics cost, poor health system affecting linkage to care, and several other reason. These groups of patients are referred to as pre-treatment loss to follow-up (LFU). The proportion loss to follow up in the selected states is about 24%. This contributes to ongoing disease transmission, poor treatment outcomes, and increased mortality. This study is aimed to check the effectiveness of using digital adherence technologies such as WhatsApp messages, SMS reminders, and phone calls, to support patients’ linkage to care. However, evidence on their effectiveness in reducing pre-treatment LFU in Nigeria remains limited. The objectives are; i. To assess whether multi-channel digital support influences the proportion of DR-TB patients who are lost to follow-up before treatment initiation. ii. To compare the time from diagnosis to treatment initiation (median days) between intervention and control groups. iii. To compare the proportion of patients initiating treatment within 7 days and within 14 days of diagnosis between intervention and control groups. iv. To examine the relationship between patient characteristics and pre-treatment loss to follow-up.
Type of trial RCT
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 Supportive care
Anticipated trial start date 25/05/2026
Actual trial start date
Anticipated date of last follow up 28/02/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multi Channel Digital Communication Support Participants in the intervention arm will receive structured digital follow-up via WhatsApp messages, SMS reminders, and phone calls for up to 30 days post-diagnosis when result was received. Contact frequency will be daily during the first week, every other day during the second week, and twice weekly thereafter until treatment initiation or completion of the 30-day follow-up period, whichever comes first. The number of contacts will vary depending on participant responsiveness and treatment initiation status. Intervention lasts until treatment initiation or up to 30 days after enrolment, whichever comes first. Experimental Group (Intervention Arm) Following DR-TB diagnosis, participants in the intervention arm will receive a structured multi-channel digital follow-up package aimed at supporting and encouraging timely initiation of treatment. The intervention includes WhatsApp messages, SMS reminders, and phone calls delivered by trained research assistants. Communication will include reminders to initiate treatment, follow-up prompts, and brief supportive messages addressing barriers to care and reinforcing linkage to treatment. Contact frequency will be scheduled as follows: daily contact during the first week, every other day during the second week, and thereafter twice weekly up to 30 days post-enrolment if treatment initiation has not occurred. The intervention will continue until treatment initiation or for up to 30 days, whichever comes first. 175
Control Group Standard of Care Participants will receive the routine standard of care provided under the National Tuberculosis and Leprosy Control Programme (NTBLCP) guidelines. No additional structured digital follow-up, reminders, or scheduled communication will be administered as part of the study intervention Participants will receive routine standard care and will be followed for up to 30 days after communication of the diagnostic result or until treatment initiation, whichever occurs first. Control Group (Standard Care Arm) Participants in the control group will receive the standard of care under the National Tuberculosis and Leprosy Control Programme (NTBLCP) in Nigeria. This includes diagnosis of DR-TB, communication of results to the patient through routine facility procedures, and referral for initiation of appropriate treatment according to national guidelines. No additional structured digital follow-up or reminder system will be provided beyond routine care. 175 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Have a bacteriologically confirmed diagnosis of DR-TB (rifampicin-resistant TB or multidrug-resistant TB). 2. Are newly diagnosed during the study period and not yet enrolled in DR-TB treatment at the time of first contact. 3. Are aged 15 years or older 4. Provide informed consent for participation in the study 1. Have already been initiated on DR-TB treatment before study enrolment. 2. Have drug-susceptible TB 3. Are unable to provide reliable contact information (phone number) for follow-up through WhatsApp, SMS, or calls. 4. Decline participation or withdraw consent. 5. Clinically diagnosed without bacteriological confirmation. 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 80 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 27/01/2026 RESEARCH ETHICS COMMITTEE UNIVERSITY OF PORT HARCOURT RESEARCH MANAGEMENT AND DEVELOPMENT
Ethics Committee Address
Street address City Postal code Country
EAST- WEST ROAD CHOBA Port Harcourt 500102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of DRTB patients lost to follow up prior to treatment initiation within 30 days of receipt of a confirmed DR-TB diagnosis by the research team. Within 30 days post-enrolment Day 0 to 30 inclusive, from the date of diagnosis receipt by the research team
Secondary Outcome 1. Tim, median days, from receipt of confirmed DRTB diagnosis by the research team to initiation of treatment in the intervention and control groups. 2. Proportion of DRTB patients initiating treatment within 7 days and within 14 days of receipt of a confirmed DRTB diagnosis by the research team in the intervention and control groups. 3. Association between patient characteristics and pre-treatment loss to follow-up before treatment initiation within 30 days, Day 0 to 30 inclusive, of receipt of a confirmed DR-TB diagnosis by the research team. Within 30 days post-enrolment Day 0 to 30 inclusive from the date of diagnosis receipt by the research team
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Akwa Ibom State Tuberculosis and Leprosy Control Programme Ministry of Health, Idongesit Nkanga State Secretariat Complex, IBB Way Uyo Nigeria
Ebonyi State Tuberculosis and Leprosy Control Programme Block 5, TBL Unit, Department of Public Health, State Ministry of Health Complex, Centenary City Abakaliki Nigeria
Delta State Tuberculosis and Leprosy Control Programme Department of Public Health, Delta State Ministry of Health, State Secretariat Complex, Asaba-Onitsha Expressway Asaba Nigeria
Edo State Tuberculosis and Leprosy Control Programme Block D, 3rd Floor, Department of Public Health, Edo State Ministry of Health, Ezoti Street Benin Nigeria
Enugu State Tuberculosis and Leprosy Control Programme Department of Public Health, Enugu State Ministry of Health, State Secretariat Complex, Independence Layout Enugu Nigeria
Lagos State Tuberculosis and Leprosy Control Programme Block 4, Lagos State Government Secretariat, Alausa Ikeja Nigeria
Ondo State Tuberculosis and Leprosy Control Programme Department of Public Health, Ondo State Ministry of Health, State Secretariat Complex Akure Nigeria
Plateau State Tuberculosis and Leprosy Control Programme Department of Public Health, Plateau State Ministry of Health, Joseph Gomwalk Secretariat Jos Nigeria
Taraba State Tuberculosis and Leprosy Control Programme Department of Public Health, Taraba State Ministry of Health, State Secretariat Complex Jalingo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ekpeno Mbet Akpanowo H 29 Ikeja Street, JEDO Estate Abuja 9000001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ekpeno Mbet Akpanowo H29 Ikeja Street, JEDO Estate Abuja Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Africa Centre of Excellence Centre for Public and Toxicological Research University of Port Harcourt EAST- WEST ROAD CHOBA P.M.B. 5323 PORT HARCOURT PORT HARCOURT Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ekpeno Akpanowo ekpenoh@gmail.com +2348068026728 H 29 Ikeja Street, JEDO Estate
City Postal code Country Position/Affiliation
Abuja Nigeria PhD Candidate Africa Centre of Excellence Centre for Public and Toxicological Research University of Port Harcourt
Role Name Email Phone Street address
Public Enquiries Ekpeno Akpanowo ekpenoh@gmail.com +2348068026728 H 29 Ikeja Street JEDO Estate
City Postal code Country Position/Affiliation
Abuja Nigeria Phd Candidate University of Port Harcourt
Role Name Email Phone Street address
Scientific Enquiries IMUMAYE OJULE inumanye.ojule@uniport.edu.ng +2348171183099 EAST- WEST ROAD CHOBA UNIVERSITY OF PORT HARCOURT
City Postal code Country Position/Affiliation
PORT HARCOURT Nigeria HOD DEPARTMENT OF PREVENTIVE AND SOCIAL MEDICINE DEPT. Africa Centre of Excellence Centre for Public and Toxicological Research University of Port Harcourt
Role Name Email Phone Street address
Scientific Enquiries IHEANYI OKONKO iheanyi.okonko@uniport.edu.ng +2348035380891 EAST- WEST ROAD CHOBA UNIVERSITY OF PORT HARCOURT, RIVERS STATE
City Postal code Country Position/Affiliation
PORT HARCOURT Nigeria Professor Department of Microbiology Africa Centre of Excellence Centre for Public and Toxicological Research University of Port Harcourt
Role Name Email Phone Street address
Scientific Enquiries UGOCHI OKENGWU ugochi.okengwu@uniport.edu.ng +2348037239313 EAST- WEST ROAD CHOBA UNIVERSITY OF PORT HARCOURT RIVERS STATE
City Postal code Country Position/Affiliation
PORT HARCOURT Nigeria Associate Professor Department of Computer Science Africa Centre of Excellence Centre for Public and Toxicological Research University of Port Harcourt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No individual participant data (deidentified IPD) or data dictionaries will be shared. Summary results, including baseline characteristics, participant flow, outcome measures, and adverse events, will be disseminated through peer-reviewed publications and trial registry postings. The study protocol and statistical analysis plan will also be made available upon reasonable request or via the trial registry. Results will be made publicly available within 12 months of study completion and will remain accessible indefinitely through publications and registry records. No additional datasets will be available for external analytical access. Informed Consent Form,Statistical Analysis Plan,Study Protocol Not applicable. No individual participant data will be shared. No individual participant data will be available for access or sharing. Only aggregated summary results will be disseminated through publications and trial registry updates.
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
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/06/2026 I am correcting entry error and incomplete data and to provide more details Multiple DOTS facilities and DRTB treatment management centres across selected states in Nigeria, Not applicable. A multi centre study conducted across selected DOTS and DRTB treatment facilities in multiple states in Nigeria, Not applicable. A multi centre study conducted across selected DOTS and DRTB treatment facilities in multiple states in Nigeria, , Nigeria Akwa Ibom State Tuberculosis and Leprosy Control Programme, Ministry of Health, Idongesit Nkanga State Secretariat Complex, IBB Way, Uyo, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/06/2026 I am correcting entry error and incomplete data and to provide more details Ebonyi State Tuberculosis and Leprosy Control Programme, Block 5, TBL Unit, Department of Public Health, State Ministry of Health Complex, Centenary City, Abakaliki, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/06/2026 I am correcting entry error and incomplete data and to provide more details Delta State Tuberculosis and Leprosy Control Programme, Department of Public Health, Delta State Ministry of Health, State Secretariat Complex, Asaba-Onitsha Expressway, Asaba, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/06/2026 I am correcting entry error and incomplete data and to provide more details Edo State Tuberculosis and Leprosy Control Programme, Block D, 3rd Floor, Department of Public Health, Edo State Ministry of Health, Ezoti Street, Benin, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/06/2026 I am correcting entry error and incomplete data and to provide more details Enugu State Tuberculosis and Leprosy Control Programme, Department of Public Health, Enugu State Ministry of Health, State Secretariat Complex, Independence Layout, Enugu, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/06/2026 I am correcting entry error and incomplete data and to provide more details Lagos State Tuberculosis and Leprosy Control Programme, Block 4, Lagos State Government Secretariat, Alausa, Ikeja, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/06/2026 I am correcting entry error and incomplete data and to provide more details Ondo State Tuberculosis and Leprosy Control Programme, Department of Public Health, Ondo State Ministry of Health, State Secretariat Complex, Akure , , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/06/2026 I am correcting entry error and incomplete data and to provide more details Plateau State Tuberculosis and Leprosy Control Programme, Department of Public Health, Plateau State Ministry of Health, Joseph Gomwalk Secretariat, Jos, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 06/06/2026 I am correcting entry error and incomplete data and to provide more details Taraba State Tuberculosis and Leprosy Control Programme, Department of Public Health, Taraba State Ministry of Health, State Secretariat Complex, Jalingo, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 22/07/2026 Source name was wrongly captured as self funded. This has been corrected. Self Funded, H 29 Ikeja Street, JEDO Estate, Abuja, 9000001, Nigeria, Self Funded, Ekpeno Mbet Akpanowo, H 29 Ikeja Street, JEDO Estate, Abuja, 9000001, Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 06/06/2026 Name of individual sponsor was not stated Self sponsored no external sponsor, Not applicable self sponsored study, no external sponsor, Not applicable self sponsored study no external sponsor, , Nigeria, Primary Sponsor, Individual, Ekpeno Mbet Akpanowo, H29 Ikeja Street, JEDO Estate, Abuja, , Nigeria, Primary Sponsor, Individual,