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.: PACTR201908538333264 Date of Registration: 14/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title One Dollar Incentive to Improve Tuberculosis Treatment Outcomes in a Programmatic Setting (ODITOPS trial)
Official scientific title One Dollar Incentive to Improve Tuberculosis Treatment Outcomes in a Programmatic Setting (ODITOPS trial)
Brief summary describing the background and objectives of the trial Treatment outcomes among patients receiving TB treatment from rural settings are sub-optimal in many sub-Saharan African countries including Uganda and Kenya. Care in Rural TB program is characterized by high attrition, sub-optimal TB care rates and high death rates among new and retreatment cases. The suboptimal outcomes are attributed to poor treatment adherence and failure to keep clinic appointments that emanates from financial constraint as TB is more prevalent among individuals with a low socioeconomic status. Although non-monetary interventions such as pre-treatment and continuous counseling throughout treatment promotes patient adherence and treatment completion rates, there is increasing evidence to suggest that financial incentives increase patients engagement into care and ultimately improve treatment outcomes. Incentives used in previous studies include direct payments to patients, deposit return, food incentives, transportation subsidies (reimbursement, tokens, passes, or vouchers), vouchers for material goods other than food, and packages of personal hygiene products. However, cash incentives were found to be more acceptable to patients than non-cash incentives and are likely to have a greater impact in low-income countries like Uganda where a significant proportion of the population is poor. The previous studies were mostly conducted in special populations in western countries, were retrospective and the amount of incentive used in these studies was too high to be sustainable in routine TB care for low and middle income countries (LMIC). The objective of this study is to evaluate the effect of a one dollar incentive on TB treatment outcomes in rural Uganda and Kenya
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ODITOPS
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 26/11/2018
Actual trial start date 26/11/2018
Anticipated date of last follow up 02/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 405
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
HS254ES Uganda National Council of Science and Technology
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 Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group One dollar financial incentive 1 USD given at month 0, 2, 5 and 6 to coincide with sputum monitoring clinic visits 6 months Study participants in the interventional arm receive 1USD (4,000 Uganda shillings or 100 Kenya Shillings) at scheduled visits that coincide with the routine clinic visits for sputum monitoring. This is in additional to the routine TB care at the TB treatment site 135
Control Group Routine Care Participants in the control arm receive the routine care at the tuberculosis treatment sites and are expected to keep the clinic appointments for sputum monitoring as scheduled by the TB drugs dispenser. 6 months Participants in the control arm receive the routine care at the tuberculosis treatment sites and are expected to keep the clinic appointments for sputum monitoring as scheduled by the TB drugs dispenser. 135 Active-Treatment of Control Group
Control Group Restrospective Group Routine TB care in preceeding 6 months 6 months Participants in the TB register will be consequetivdly evaluated for TB outcomes in the preceeding 6 months 135 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult patients of 18 years and above 2. Evidence of a personally signed and dated informed consent document. 3. All TB patients at initiation of treatment at the participating sites will be included in the study (bacteriologically confirmed TB, clinically diagnosed and extra pulmonary TB) 1. Patients with CNS TB or TB requiring treatment for more than 6 months 2. Also all patients with documented drug resistant TB will be excluded because their treatment duration is longer than six months and they receive food and financial incentives at the site in Uganda. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 16/07/2019 Uganda National Council of Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6 Kimera road, Ntinda Kampala 0256 Uganda
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 07/05/2018 Mount Kenya University Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
General Kago Road Thika 0254 Kenya
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 23/08/2018 The AIDS Support Organisation Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mulago hospital complex Kampala 0256 Uganda
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 17/01/2019 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Upper Kabete off Waiyaki Way Nairobi 0254 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome TB treatment success defined as the total number of patients in the study arm documented in the TB register as having cured or completed treatment divided by the total number of patients in that study arm. 8 months
Primary Outcome TB loss to follow up rate as defined by the total number of TB patients in the study arm documented in the TB register as loss to follow up divided by the total number of patients in that study arm. 8 months
Secondary Outcome TB death defined as the total number of patients in the study arm documented in the TB register as having died divided by the total number of patients in that study arm. 8 months
Secondary Outcome TB treatment failure defined as the total number of patients in the study arm documented in the TB register as a treatment failure divided by the total number of patients in that study arm. 8 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Masaka Regional Referal Hospital Masaka, Kirumba Masaka Uganda
Nyeri Country referal Hospital Kimathi Way Nyeri Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Mouth Kenya University Foundation General Kago Rd Thika Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mount Kenya University Foundation General Kago Rd Thika Kenya University
COLLABORATORS
Name Street address City Postal code Country
Elizabeth Wanjiku Ndungu General Kago Road Thika Kenya
Joseph Muchiri General Kago Road Thika Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Baluku bbjoe18@gmail.com 256706327972 Mulago Hospital Complex
City Postal code Country Position/Affiliation
Kampala Uganda Physician National Tuberculosis Treatment Center Mulago Hospital
Role Name Email Phone Street address
Scientific Enquiries Irene Andia Biraro andiaodanga@yahoo.com 256772485289 Makerere University
City Postal code Country Position/Affiliation
Kampala Uganda Senior Lecturer Makerere University College of Health Sciences
Role Name Email Phone Street address
Public Enquiries Joseph Muchiri jmuchiri@mku.ac.ke 254719802082 General Kago Road
City Postal code Country Position/Affiliation
Thika Uganda Lecturer Mount Kenya University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the initial publication article after de-identification Study Protocol 6 to 24 months after initial publication/article Investigators who provide a methodologically sound proposal will send the proposal to bbjoe18@gmail.com. They will be required to sign a data sharing agreement. and the study proposal will have to be approved by a local ethics committee in the countries where the primary study has been conducted.
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