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.: PACTR201811482580522 Date of Approval: 14/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of patient education on adherence to antiretroviral therapy and its clinical outcomes among human immunodeficiency virus patients in Jos university teaching hospital, Nigeria
Official scientific title Effect of patient education on adherence to antiretroviral therapy and its clinical outcomes among human immunodeficiency virus patients in Jos university teaching hospital, Nigeria
Brief summary describing the background and objectives of the trial Background: Behavioral interventions that foster adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral therapy programs in sub-Saharan Africa is confronted with the challenge of increasing non adherence to treatment regimen and thus, the need for adherence interventions. Objective: This trial aimed at determining the effect of patient education intervention on adherence to antiretroviral therapy and clinical outcomes (CD4 count and viral load) among Human Immunodeficiency Virus positive patients in Jos University Teaching Hospital, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HIV AIDS
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 02/01/2018
Actual trial start date 02/01/2018
Anticipated date of last follow up 29/06/2018
Actual Last follow-up date 29/06/2018
Anticipated target sample size (number of participants) 224
Actual target sample size (number of participants) 212
Recruitment status Completed
Publication URL Nil
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization 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
Experimental Group Patient Education Nil 3 months Patients education based on the Information-Motivation-Behavioral Skills (IMB) model and given the participants by research assistants for 3 consecutive months after baseline data collection and followed up to 2 months and post intervention data was collected 112
Control Group Standard of care Nil 3 months Standard of care 112 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients 18 and above in the antiretroviral clinic Patients with viral load 1000 and above Patients on first line drugs Pregnant HIV patients Hospitalised or mentally unstable HIV patients Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 56 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 24/10/2017 Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia
Ethics Committee Address
Street address City Postal code Country
433400 Serdang Selangor Serdang 433400 Malaysia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to antiretroviral therepy 2
Secondary Outcome CD4 count and viral load 2
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Jos university teaching hospital Lamingo Jos 2076 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Panmial Priscilla Damulak Universiti Putra Malaysia Serdang 43400 Malaysia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Panmial Priscilla Damulak 433400 Serdang 433400 Malaysia Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Suriani Ismail Universiti Putra Malaysia Serdang 43400 Malaysia
Dr. Rosliza Abdul Manaf Universiti Putra Malaysia Serdang 43400 Malaysia
Dr. Salmiah Said Universiti Putra Malaysia Serdang 43400 Malaysia
Prof. Oche Agbaji Jos University Teaching Hospital Jos 2076 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Suriani Ismail si_suriani@upm.edu.my +60192249828 433400 Serdang Selangor
City Postal code Country Position/Affiliation
Serdang 433400 Malaysia Senior Lecturer and supervisor
Role Name Email Phone Street address
Public Enquiries Oche Agbaji agbajio@unijos.edu.ng +2348033491851 Lamingo
City Postal code Country Position/Affiliation
Jos 2079 Nigeria Senior lecturer and co supervisor
Role Name Email Phone Street address
Scientific Enquiries Rosliza Manaf rosliza_abmanaf@upm.edu.my +60175667345 433400 Serdang
City Postal code Country Position/Affiliation
Serdang Selangor 433400 Malaysia Senior lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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