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.: PACTR201603001403923 Date of Approval: 26/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Health education intervention program
Official scientific title Effectiveness of Health Education intervention in improving knowledge, attitude and practice regarding Tuberculosis among HIV patients in General hospital Minna, Nigeria
Brief summary describing the background and objectives of the trial TB is a disease of major public health concern especially in Nigeria where there is an upsurge due to the HIV epidemic. Nigeria is ranked 3rd among the 22 countries with the high burden of TB. The risk of developing TB among HIV patients is 20-37 times higher than those that are HIV negative. studies have shown that those that are HIV positive have limited knowledge of TB and therefore are at risk of infection and development of active tuberculosis. studies done on KAP regarding TB among HIV patients in Nigeria are largely descriptive and the effect of health education intervention has not been tested.This study is aimed on testing the effectiveness of health education intervention in improving KAP regarding TB among HIV patients. Objectives 1. To determine the predictors of KAP regarding TB among HIV patients in the control and intervention group at baseline 2. To determine the relationship between KAP regarding TB among respondents at baseline 3.To determine and compare KAP between the intervention and control group at baseline 4.To determine the socio-demographic characteristics of the respondents in the intervention and control group at baseline 5.To develop and implement health education intervention program in improving KAP regarding TB among HIV patients in the intervention group 6. To determine and compare KAP regarding TB among HIV patients in the intervention and control groups at 3, 6 and 9 months follow up period.
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 HIV/AIDS,Tuberculosis
Purpose of the trial Education /Training
Anticipated trial start date 09/10/2015
Actual trial start date 04/12/2015
Anticipated date of last follow up 09/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 226
Actual target sample size (number of participants) 226
Recruitment status Closed to recruitment,follow-up continuing
Publication URL NIL
Secondary Ids Issuing authority/Trial register
UPM/TNCPI/RMC/1.4.18.1(JKEUPM)/F2 Ethics committee for research on human subjects of University Putra Malaysia
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 randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group health education regarding positive health dignity and prevention of HIV/AIDS baseline, immediate post intervention, 3 months, 6 months and 9 months 9months health education intervention program regarding positive health dignity and prevention of HIV/AIDS. The intervention will be inform of power point presentation, posters, discussions and question and answer session.It is to be facilitated by 7 experienced and certified facilitators in HIV and TB.Questionnaire will be administered for data collection pre-intervention and post intervention,, 113 Placebo
Experimental Group health education intervention on improving knowledge, attitude and practice regarding tuberculosis baseline/immediate post intrvention, 3 months, 6 months and 9 months 9months health education intervention program regarding tuberculosis among HIV patients in general hospital ,minna. The intervention will be inform of power point presentation, posters, discussions and question and answer session.It is to be facilitated by 7 experienced and certified facilitators in HIV and TB.Questionnaire will be administered for data collection pre-intervention and post intervention,, 113
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria established for this study to obtain appropriate sample are registered HIV patients, including AIDS patients assessing treatment and care at the hospital, Age 18 years and above. HIV patient¿s co-infected with tuberculosis and psychiatric disorders/mentally unstable persons were excluded from this study. 18 Year(s) 69 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 03/07/2015 The University Research Ethics Committee. Universiti Putra Malaysia (JKEUPM)
Ethics Committee Address
Street address City Postal code Country
Universiti Putra Malalysia sedang, selangor, malaysia 43400 Malaysia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1.Improving in knowledge regarding TB among HIV patients 2. improving in positive attitude regarding tuberculosis among HIV patients 3. improvement in practice regarding TB among HIV patients. 1. immediate post intervention 2. 3 months post intervention 3. 6 months post intervention 4. 9 months post interevntion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Hospital, Minna hospital road Minna +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Niger state government, Nigeria ministry of health, new secretariat complex, bosso-paiko road, Minna, Niger state, Nigeria Minna +234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Niger state government, Nigeria ministry of health, new secretariat complex, bosso-paiko road, Minna, Niger state, Nigeria Minna +234 Nigeria Funding Agency
Primary Sponsor Niger state government, Nigeria ministry of health, new secretariat complex, bosso-paiko road, Minna, Niger state, Nigeria Minna +234 Nigeria Funding Agency
Secondary Sponsor Niger state Agency for the control of AIDS Bosso Road, opposite mypa junction, Minna Minna +234 Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
ministry of health, pmb 57, minna New secretariat complex, Bosso-Paiko Road, minna Minna +234 Nigeria
hospital management board, Niger state old secretariat complex Minna +234 Nigeria
Niger state Agency for the control of AIDS bosso road, opposite mypa junction Minna +234 Nigeria
faculty of medicine and health sciences, Universiti Putra Malaysia Universiti Putra Malaysia sedang, selagor, Malaysia 43400 Malaysia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Prof. Dr. Lekhraj Rampal Prof. Dr. Lekhraj Rampal lekhraj@upm.edu.my 0122964308
City Postal code Country Position/Affiliation
sedang, selagor, Malaysia 43400 Malaysia professor of epidemiology and bioststistics
Role Name Email Phone Street address
Public Enquiries Chindo Ibrahim Bisallah chindoibro@gmail.com +2348035955194, MTP14B, behind gidan taya, western bye pass, Tunga, Minna
City Postal code Country Position/Affiliation
Minna +234 Nigeria student/ epidemiology and biostatistics
Role Name Email Phone Street address
Scientific Enquiries Chindo Ibrahim Bisallah chindoibro@gmail.com +2348035955194, MTP14B, behind gidan taya, western bye pass, Tunga, Minna
City Postal code Country Position/Affiliation
Minna +234 Nigeria student/ epidemiology and biostatistics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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