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.: PACTR202212522449333 Date of Approval: 02/12/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Exploring the effectiveness of a Medication Adherence App in improving Retention and Medication Adherence in newly diagnosed adolescents living with HIV in Benue state
Official scientific title Exploring the effectiveness of a Medication Adherence App in improving Retention and Medication Adherence in newly diagnosed adolescents living with HIV in Benue state
Brief summary describing the background and objectives of the trial Adolescents do not traditionally do well on ART. One of the most important determinants of treatment outcomes is adherence to ART, but getting adolescents to take medication regularly is sometimes an uphill task. There are many adolescent-specific issues which impact on adherence, such as peer pressure, mental health issues, and stigma. Strategies that are effective in promoting medication adherence among adults do not always work with adolescents. Healthcare workers are also not trained to handle adolescents' emotional and psychological needs. The objective of the study is to assess the effect of using the medication adherence app on the retention and medication adherence of young PLHIVs and To compare the effectiveness of the app with the information-only app the target population is ART treatment naive adolescents PLHIV 10 to 19 years in 2 facilities in Benue State, Nigeria. we will install the Lu Dedoo app medication adherence app on the phones of these adolescents and follow them up for 12 months. 1 (30 participants) cohort will have a full version of the app with interactive forums while the other cohort (30) will have a information only version of the app. Outcomes of interest are medication adherence and retention,
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 Prevention
Anticipated trial start date 01/02/2023
Actual trial start date
Anticipated date of last follow up 03/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet 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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lu dedoo Medication adherence app 24 months interactive android Medication adherence app to improve adherence. the app has interactive modules and forums for participants to interact with other android users 30
Control Group info only Medication adherence app 24 months info only medication adherence app. there are no forums on this version 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescents, ages 10 to 19 years inclusive. The patients must own and be able to operate an Android phone. The patients must either be treatment naïve (within 90 days of treatment start) or with poor adherence to ART (as noted by raised viral load or one or more missed pharmacy refill collections in the past 12 months as assessed by the healthcare workers). Adolescents must be able to give written informed consent (for adolescents <18 years, this will include adult parent/guardian written informed consent and written assent from the minor). The patients do not have the cognitive ability to give consent. Patients who are very sick. Patients who did not give consent Adolescent: 13 Year-18 Year 10 Year(s) 19 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 08/06/2022 National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
11th floor, federal secreteriat complex, Ahmadu bello way abuja 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Retention 6 months 12 months, 18 months, 24 months
Secondary Outcome Viral Suppression 12 months, 18 months, and 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Northbank General Hospital Central area, Makurdi 970101 Nigeria
bishop Murray medical Centre Central area makurdi 970101 Nigeria
FederaL Medical Centre Makurdi No1, Atiku Abubakar rpoad, old GRA Makurdi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership Francie van Zijl Drive, Parowvallei 7505 Cape Town, South Africa Cape town 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Desmond Tutu Foundation UNiversity of Cape town University of Cape Town Anzio Road, Observatory 7925 Cape town 7925 South Africa Charities/Societies/Foundation
Secondary Sponsor EDCTP Francie van Zijl Drive, Parowvallei 7505 abuja 234 South Africa Funding Agency
Secondary Sponsor APIN Public Health initiatives Plot 492, Mike Akhigbe Way, Jabi-A Abuja 907101 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olaposi olatoregun oolatoregun@apin.org.ng +2348033863419 Same global estate, Lokogoma
City Postal code Country Position/Affiliation
Abuja 970101 Nigeria Deputy Director APIN Public Heath initiation
Role Name Email Phone Street address
Public Enquiries Ubong Okon uokon@apin.org.ng +2348068393670 apo resettlement, Apo
City Postal code Country Position/Affiliation
abuja Nigeria Technical Officer APIN
Role Name Email Phone Street address
Scientific Enquiries Honey Okpe hokpe@apin.org.ng +2348036849018 Apo resettlement, Abuja
City Postal code Country Position/Affiliation
abuja 900001 Nigeria Senior Technical Officer APIN
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data for the Lu Dedoo randomised study are collected electronically using the open-access software, RedCap, hosted by the University of Cape Town. The database has been designed to minimise data errors at input (drop down menus, limitation on digits etc); and to ensure all data is collected at each visit. The project has benefited from a broader collaboration with the Biostatistics and Epidemiology Data Analytics Center (BEDAC) based at Boston University, who have offered training and support to the DTHF data manager. The Investigator and the Data Manager can perform quality checks on the database in real time. As all participant locator details are collected in a separate database, accessed only by local staff, the Lu Dedoo database contains de-identified data. Study outcomes will not be limited through any intellectual property rights. All research data generated within this project will be shared with the scientific community via article publications in high-impact open-access journals in the field, at national or international conferences or seminars. The protocol will be available through the PACTR or on request from the Investigator. Data will be findable, accessible, interoperable and re-usable as per the Pilot for Open Research data in Horizon 2020. Our docs are study protocol and infomed consent. We will share clean data at the end of the study. Study Protocol 3 years The protocol will be available through the PACTR or on request from the Investigator. Data will be findable, accessible, interoperable and re-usable as per the Pilot for Open Research data in Horizon 2020. Our docs are study protocol and infomed consent. We will share clean data at the end of the study. Access will be on request to the Principal Investigator; provision of a short concept sheet listing variable isrequired.
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