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.: PACTR202202576294489 Date of Approval: 21/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MEDICATION ADHERENCE AND ANTERETROVIRAL THERAPY RETENTION AMONG YOUNG PEOPLE LIVING WITH HUMAN IMMUNODEFICIENCY-VIRUS IN NIGERIA
Official scientific title INFLUENCE OF PEER EDUCATION AND TEXT MESSAGES ON MEDICATION ADHERENCE AND RETENTION AMONG YOUTHS LIVING WITH HUMAN IMMUNODEFICIENCY-VIRUS IN NIGER STATE, NIGERIA
Brief summary describing the background and objectives of the trial The main objective of this study is to evaluate the influence of peer-led health education and text messages in improving ART retention and adherence among young people (18-24 years) living with HIV in Niger State Nigeria The specific objectives are to: 1. determine the effect of text messages on knowledge and perception on medication adherence among youths living with HIV immediately after six weeks intervention 2. determine the effect of peer education on knowledge and perception on ART retention rate among youths living with HIV immediately after six weeks intervention 3. determine the effect of text messages on knowledge and perception on ART retention rate among youths living with HIV immediately after six weeks intervention 4. determine the effect of the combination of peer education and text messages on knowledge and perception on medication adherence among youths living with HIV immediately after six weeks intervention 5. determine the effect of the combination of peer education and text messages on knowledge and perception on ART retention rate among youths living with HIV immediately after six weeks intervention 6. ascertain the effect of peer education on medication adherence practices and ART retention rate among youths living with HIV after six weeks follow up 7. ascertain the effect of text messages on medication adherence practices and ART retention rate among youths living with HIV after six weeks follow up 8. ascertain the effect of the combination of peer education and text messages on medication adherence practices and ART rete
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
Purpose of the trial Education /Training
Anticipated trial start date 21/02/2022
Actual trial start date
Anticipated date of last follow up 28/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 208
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Parallel: different groups receive different interventions at same time during study 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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Peer Education and Text Messages Weekly Peer Education Session and one way short Text messages Six weeks This is the combination of peer-led HIV education will be conducted for a maximum of on one hour weekly for 6 consecutive weeks while the text message will be the short one-way text message less than 160 characters which will not specify HIV or ART to maintain confidentiality of HIV Status. 52
Experimental Group Text messages Weekly Six weeks The text message will be the short one-way text message less than 160 characters which will not specify HIV or ART to maintain confidentiality of HIV Status. 52
Control Group Standard of Care As decided by the clinicians As long as the client is on treatment The participants in the control group will receive standard of care which entails provision of ART, screening for co-infections, HIV education messages and usually personal counselling of effects of the medication prior to dispensing of the medicines. 52 Active-Treatment of Control Group
Experimental Group Peer Education I hour weekly 6 weeks The peer-led HIV education will be conducted for a maximum of on one hour weekly for 6 consecutive weeks 52
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. HIV-infected and know their status b. 18-24 years old c. Actively on ART for at least six months. Clients in care for at least six months will be chosen to enable us calculate a baseline figure for treatment adherence and retention in care d. YLHIV Planning to receive HIV care from the same facility in Niger state during the period of the study e. Owns and have daily access to a cell phone f. YLHIV who consent and are ready to participate in the study a. Clients outside the age bracket (18-24 years) b. Clients who have been on ART for less than six month c. Enrolled in any other ART adherence intervention study d. Planning to move outside Niger state within the next 6 months e. YLHIV who would not give their consent or unable to give consent due to limitations ranging from mental, cognitive or physical illness or cultural restrictions. Adult: 19 Year-44 Year 18 Year(s) 24 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 16/12/2021 Babcock University Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Babcock University, Ilishan-Remo, Ogun State Ilishan-Remo 121103 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Medication Adherence and ART Retention 6 weeks
Secondary Outcome ART retention 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Comprehensive HIV treatment centers Niger State Minna Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Olugbenga Asaolu Babcock University IlishanRemo Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Olugbenga Asaolu Babcock University IlishanRemo Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olugbenga Asaolu gbengasaolu@gmail.com +2348065206663 Babcock University
City Postal code Country Position/Affiliation
IlishanRemo Nigeria Doctoral Researcher
Role Name Email Phone Street address
Public Enquiries Stephen Kolawole drstevekola@gmail.com +234906252229 Babcock university
City Postal code Country Position/Affiliation
IlishanRemo Nigeria Research Coordinator
Role Name Email Phone Street address
Scientific Enquiries Catherine Agbede eagleolu@yahoo.com +2348059774081 Babcock University
City Postal code Country Position/Affiliation
IlishanRemo Nigeria Project Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified data will be shared in the technical report and manuscripts to be published from this research work Informed Consent Form Two months This will be a controlled access and the data will be analyzed by the principal investigator. Only STATA analysis do-files will be sent to manuscript reviewers anytime they request for it.
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