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.: PACTR202306582249091 Date of Approval: 19/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of an instructional video for production of diagnostic sputum for tuberculosis case detection in presumptive tuberculosis patients in Tanzania
Official scientific title Impact of an instructional video on quality, the quantity of sputum samples and TB case detection
Brief summary describing the background and objectives of the trial Diagnosis and the performance of laboratory testing for the detection of Mycobacterium tuberculosis depend on obtaining adequate sputum samples as well as the quality of sputum samples collected, particularly in primary health care settings. For Tuberculosis (TB) diagnosis, presumptive TB cases with coughing for more than two weeks are asked to spontaneously produce sputum from the lungs. However, in up to one-third of TB cases, an adequate biological sample is not readily available or has a very low concentration of TB bacilli because patients often give saliva from the mouth, which decreases the sensitivity of the test and subsequently results in missed diagnosis. We will examine the hypothesis that the use of an instructional video affects the diagnostic quality of sputum samples and the rates of TB case detection. Based on these hypotheses, our overall goal to is to use a culturally appropriate instructional video for the production of diagnostic sputum and evaluate its effectiveness to improve TB case detection. We have previously shown in a pilot study that the use of an instructional video resulted in increased specimen volume as well as sputum quality and increased case detection by smear microscopy. Therefore this work build on the pilot study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TB
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/11/2022
Actual trial start date 13/11/2022
Anticipated date of last follow up 31/01/2023
Actual Last follow-up date 30/04/2023
Anticipated target sample size (number of participants) 1565
Actual target sample size (number of participants) 1565
Recruitment status Completed
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sputum Instructional video A four minuter video that was shown once or twice to the presumptive TB patients A four-minute video that was shown once or twice to the presumptive patient An innovative research group in Pakistan has developed a sputum submission instructional video for improving the diagnostic quality of sputum samples (available at http://youtu.be/92dT_1kbbek). The video was adopted and translated into the local language and piloted 782
Control Group Standard of care verbal instructions for sputum production for TB case detection Four minutes of verbal instructions for sputum production for TB case detection The verbal procedures included instructions to sit or stand in an open space, to inhale deeply two to three times and to cough as hard as possible after the last breath and collect the specimen in a container. 783 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All 18 years of age and above with presumptive TB (defined as coughing >2 weeks, fever, night sweats or unexplained weight loss suggestive of TB) Severely ill patients and patients with impaired vision Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 05/10/2022 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Barak Obama Street P.O.BOX 9653 Dar es Salaam Dar es Salaam 00000 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Case detection as defined by positive sputum microscopy results. Twice Early morning and spot sputum specimen
Secondary Outcome a) Sputum volume (sufficient and insufficient volume), b) sputum quality (proportion of salivary and purulent samples) distribution of quantitative grading of sputum microscopy, Twice, Early morning and spot specimen samples
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kibaoni Health Center Ifakara District Morogoro region 0000 United Republic of Tanzania
Morogoro Refferal Hospital Morogoro district Morogoro 00000 United Republic of Tanzania
Bagamoyo district hospital Kibaha district Pwani region 00000 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Centre for Effective Global Action Univerity of California 207 Giannini Hall Berkely California CA94720 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor National Institute of Health 9000 Rockville Pike, Bethesda, Maryland Washington DC 20892 United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Marcella Alsan 79 John F. Kennedy Massachusetss 02138 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Grace Mhalu gmhalu@ihi.or.tz +255655888891 Kiko Avenue P.O.BOX 78373
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Seniour Research Scientist
Role Name Email Phone Street address
Scientific Enquiries Jerry Hella jhella@ihi.or.tz +255713787754 Kiko Avenue P.O.BOX 78373 Dar es Salaam
City Postal code Country Position/Affiliation
Dar es Salaam 0000 United Republic of Tanzania Principle Research Scientist
Role Name Email Phone Street address
Public Enquiries Priscilla Mlay pmlay@ihi.or.tz +255620704425 Kiko Avenue Mikocheni B P.O.BOX 78373
City Postal code Country Position/Affiliation
Dar es Salaam 0000 United Republic of Tanzania Seniour administrator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following the review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Transfer Agreement (DTA) according to Ifakara Health Institute policy and National Insitute for Medical Research of Tanzania Informed Consent Form,Study Protocol IPD will be shared soon after the publication of the research findings in peer-reviewed scientific journals and up to 24 months after publication De-identified data can be requested from Ifakara Health Institute. Investigators working on similar topics may request 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