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.: PACTR201506001175423 Date of Approval: 20/06/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Psychological and Educational Intervention to Improve TB Treatment Adherence
Official scientific title Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial
Brief summary describing the background and objectives of the trial This study is a cluster randomized control trial that provide depression and anxiety counseling, and adherence education intervention package to adult tuberculosis patients on treatment for at least one month prior to the study in Addis Ababa, Ethiopia based on Health Belief Model (HBM). Health behavior theory is important to plan effective interventions to achieve changes in risky health behaviors including treatment non-adherence. The aim of this study is to evaluate the impact of psychological counseling and adherence education intervention on tuberculosis treatment adherence based on six HBM domains. Thirty health centers will be selected from 53 health centers found in Addis Ababa by cluster sampling method. Selected health centers will be randomly allocated into control and intervention groups by simple random method. For each intervention and control group, 342 TB patients will be enrolled consecutively at selected health centers. Depression and anxiety counseling, and adherence education interventions will be provided for intervention group for four total months, once in a week for the first month of enrollment, and once in a month until the end of TB treatment. Daily time regimen of intervention provision will be 30 minutes based on the experience obtained from study reported from Bangladesh. In control group, the normal directly observed therapy short course strategy remains unchanged. Proportion of non-adherence, the impact of intervention and the mean difference on six HBM domains will be assessed using multiple logistic regression.
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 Education /Training
Anticipated trial start date 28/04/2014
Actual trial start date 12/05/2014
Anticipated date of last follow up 28/11/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 684
Actual target sample size (number of participants) 698
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2/2/¿/5072/227 Addis Ababa City Administration Health Bureau
SERO-160-3-2006 Ethiopian Public Health Institute
9113422001 Tehran University of Medical Sciences, International Campus
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
Randomised We generated the two comparison groups using simple randomization, with an equal allocation ratio, by randomize block design Randomization process was not cancelled because all patients on one center take the same intervention Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined psychological counseling and adherence education 30 minutes Four months Depression and anxiety counseling, and adherence education intervention provided for intervention group, once in a week for the first month of enrollment, and once in a month until the end of TB treatment. 342
Control Group Normal TB treatment strategy remain untouched Four months Following participants under normal Directly Observed Short Course Therapy (DOTS) or recomended TB treatment sterategy 330 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.TB patients aged 18 and above years 2.TB patients on full course of TB treatment for at least one month prior to the study and under normal Directly Observed Therapy Short Course (DOTS) strategy 3.TB patients who are physically, mentally capable to provide informed consent, and can follow intervention provided without any burden or support 4.TB patients who willing to participate in the study 1.TB patients who are participating in other interventional studies 2.TB patients who are not on full course of treatment under DOTS therapy 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 12/02/2014 Tehran University of Medical Sciences, International Campus, Research Ethics Review Board
Ethics Committee Address
Street address City Postal code Country
Qodas Tehran 1417653461 Iran (Islamic Republic of)
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 03/04/2014 Ethiopian Public Health Institute Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Arbegnoch Addis Ababa 1242 Ethiopia
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 29/04/2014 Addis Ababa City Administration Health Bureau, Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Addis Ababa 30738 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Treatment non-adherence level At enrollment and at end of treatment
Primary Outcome Effective treatment adherence At enrollment and end of treatment
Secondary Outcome Psychological distress impovement At enrollment and end of TB treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
30 Health Centers located in 10 sub-cities of Addis Ababa Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
KNCV TBARE/USAID through TRAC Ethiopia Jimma Road Addis Ababa 1005 Ethiopia
Ethiopian Public Health Institute Arbegnoch Addis Ababa 1242 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KNCV TBARE/USAID through TRAC Ethiopia Jimma Road Addis Ababa 1005 Ethiopia Charities/Societies/Foundation
Secondary Sponsor Prof. Davousd Shojaeizadeh Qoods Tehran Iran (Islamic Republic of) University
Primary Sponsor Ethiopian Public Health Institute Arbegnoch Addis Ababa 1242 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Dr Davousd Shojaeizadeh (PhD) Qoodas Tehran Iran (Islamic Republic of)
Dr Gholamreza Garmarodi (MD) Qoodas Tehran 1416753955 Iran (Islamic Republic of)
Dr Azar Tol (PhD) Qoodas Tehran 1416753955 Iran (Islamic Republic of)
Dr Mir Saeed Yekaninejad (PhD ) Qoodas Tehran 1416753955 Iran (Islamic Republic of)
Mr. Abebaw Kebede Arbegnoch Addis Ababa 1242 Ethiopia
Mr. Luche Tadesse Qoodas Tehran 1416753955 Iran (Islamic Republic of)
Dr Desta Kassa Arbegnoch Addis Ababa 1242 Ethiopia
Dr Eveline Klinkenberg Amsterdam Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Habteyes Tola habtetola@gmail.com +251 913 173 280 Arbegnoch
City Postal code Country Position/Affiliation
Addis Ababa 1242 Ethiopia Ethiopian Public Health Institute
Role Name Email Phone Street address
Public Enquiries Habteyes Tola habtetola@gmail.com +251 913 173 280 Arbegnoch
City Postal code Country Position/Affiliation
Addis Ababa 1242 Ethiopia Ethiopian Public Health Institute
Role Name Email Phone Street address
Scientific Enquiries Davousd Shojaeizadeh Shojae5@yahoo.com 0098919450461 Qodas
City Postal code Country Position/Affiliation
Tehran 1416753955 Iran (Islamic Republic of) Tehran University of Medical Sciences, International Campus
REPORTING
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