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: www.pactr.org
Trial no.: PACTR201806003040425 Date of Approval: 02/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adolescent Retention and Adherence Trial
Official scientific title Conditional Economic Incentive and Motivational Interviewing to improve Adolescents¿ Retention and Adherence to Antiretroviral Therapy And HIV Care in Anambra State, South East Nigeria: A Cluster Randomized Trial
Brief summary describing the background and objectives of the trial Background: Adolescent HIV patients face enormous difficulty in accessing HIV care services. Given their vulnerability to risk-taking behaviour, this group also have worse treatment outcomes compared to other age groups. Poor treatment outcomes will impact negatively on HIV/AIDS management and control particularly in sub¿Saharan Africa (SSA) as more than eight out of ten of the world¿s HIV¿infected adolescents live in this region of the world. Limited evidence exists on the effectiveness of service delivery interventions to support adolescents¿ retention on antiretroviral therapy (ART) and adherence to ART. Objectives: This trial is designed to evaluate the impact of conditional economic incentive and motivational interviewing on adolescents¿ retention in HIV care and adherence to ART in Anambra State, south-east Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ARA TRIAL
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 01/09/2018
Actual trial start date 01/12/2018
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date 28/02/2021
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 199
Recruitment status Closed to recruitment,follow-up continuing
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 Stratified allocation where type of hospital (secondary or tertiary hospital) was used in the stratification 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 Conditional economic incentives and motivational interviewing 2 years The incentive scheme involves financial incentive of a maximum of NGN 2000 linked to achieving viral load (VL) suppression of <20 copies/mL combined with attendance for motivational interviewing (MI) with an adherence counselor trained in MI techniques 119
Control Group Usual care 2 years Routine HIV care as obtainable in the HIV treatment hospitals 127 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Hospitals that will be included will be those offering HIV adherence counselling and anti-retroviral treatment (ART) services and registered as such by National Agency for the Control of AIDS (NACA). All patients with HIV aged 10 to 19 years irrespective of CD4 cell count Patients initiated into HIV care and ART for a minimum of 6 month Patients currently off ART despite multiple attempts to restart and/or with poor adherence (<95% adherence rate) Patients willing to restart therapy and sign a patient agreement. Patients with AIDs defining disease Patients that did not give consent or those that their parents/legal guardian did not give consent 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 09/07/2018 Nnamdi Azikiwe University Teaching Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Difference between groups in the proportion with HIV viral load (VL) suppression (less than 20 copies/mL) 12 months 24 months
Secondary Outcome Average change in CD4+ count 12 months 24 months
Secondary Outcome Average change in adherence to ART (measured using pill count) 12 months 24 months
Secondary Outcome Average change in adherence to appointment with hospital for individual participants 12 months 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St Joseph Hospital Adazi Nnukwu, Anaocha LGA Adazi Nnukwu 422104 Nigeria
General Hospital Ekwulobia Off Umuch-Ekwulobia Road Ekwulobia Nigeria
Holy Rosary Specialist Hospital and Maternity Waterside Osha Mission Road, GRA Onitsha Nigeria
Regina Caeli Hospital Regina Caeli Road Awka Nigeria
Immaculate Heart Hospital Umunze Nkpor Nigeria
NAUTH Extension Neni, Anaocha LGA Nneni Nigeria
NAUTH Extension Oba, Idemili South LGA Oba Nigeria
Chukwuemeka Odimegwu Teaching Hospital Amaku Awka PMB 5022 Nigeria
General Hospital Onitsha 5 Owka Road Onitsha Nigeria
Nnamdi Azikiwe University Teaching Hospital (NAUTH) Old Oba-Nnewi Road Nnewi Nigeria
St Charles Borromeo Hospital Limca Road, Isiafor Layout, Nkpor Onitsha Nigeria
Our lady of Lourdes Ihiala LGA Ihiala Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trial Partnership 2509 AA The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nnamdi Azikiwe University Along Enugu-Onitsha Express Way Awka PMB 5025 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr. George U. Eleje Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Prof P. U. Ele Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Stephen Kalu Nnamdi Azikiwe University Teaching Hospital Nnewi Nigeria
Maureen Anetoh Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University Nnewi Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Obinna Ekwunife oi.ekwunife@unizik.edu.ng 2347062032501 Department of Clinical Pharmacy & Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Agulu Nigeria Senior Lecturer / Nnamdi Azikiwe University
Role Name Email Phone Street address
Public Enquiries Maureen Anetoh amupharm2006@yahoo.com 08035530238 Department of Clinical Pharmacy & Pharmacy Management, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Agulu 422102 Nigeria Lecturer & PhD Candidate / Nnamdi Azikiwe University
Role Name Email Phone Street address
Scientific Enquiries George Uchenna Eleje gu.eleje@unizik.edu.ng 2348068117444 Nnewi Campus/Nnamdi Azikiwe University Teaching Hospital (NAUTH),
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IDP will include patient’s demographic information, drug regimen, viral load an CD4+ count result, adherence assessment and resource use data Statistical Analysis Plan,Study Protocol IDP for our trial will be available beginning 3 months and ending 5 years following article publication. The IDP will be available to researchers who provide a methodoligcally sound proposal. The IDP should only be used to achieve aims in the approved proposal. Proposal should be directed to oi.ekwunife@unizik.edu.ng. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at http://www.ebhc-unizik.com/
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.ebhc-unizik.com/ 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 07/02/2018 Modified Others RCT
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 08/05/2018 Change ¿ to "to Hospitals that will be included will be those offering HIV adherence counselling and anti-retroviral treatment (ART) services and registered as such by National Agency for the Control of AIDS (NACA). All patients with HIV aged 10¿19 years irrespective of CD4 cell count Patients initiated into HIV care and ART for a minimum of 6 month Patients currently off ART despite multiple attempts to restart and/or with poor adherence (<95% adherence rate) Patients willing to restart therapy and sign a patient agreement. Hospitals that will be included will be those offering HIV adherence counselling and anti-retroviral treatment (ART) services and registered as such by National Agency for the Control of AIDS (NACA). All patients with HIV aged 10 to 19 years irrespective of CD4 cell count Patients initiated into HIV care and ART for a minimum of 6 month Patients currently off ART despite multiple attempts to restart and/or with poor adherence (<95% adherence rate) Patients willing to restart therapy and sign a patient agreement.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 09/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 27/05/2019 updated information - ethical clearance letter received FALSE, Nnamdi Azikiwe University Teaching Hospital Ethics Committee, Nnamdi Azikiwe University Teaching Hospital , Nnewi, 435101, Nigeria, 01 Mar 2018, , , , TRUE, Nnamdi Azikiwe University Teaching Hospital Ethics Committee, Nnamdi Azikiwe University Teaching Hospital , Nnewi, 435101, Nigeria, 01 Mar 2018, 09 Jul 2018, 0000000000, nauthemd@yahoo.co.uk, 3040_2433_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 27/05/2019 update No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 27/05/2019 update No No
Section Name Field Name Date Reason Old Value Updated Value
Reporting Plan to share IPD 04/06/2019 updated information No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 04/06/2019 update The IDP will include patient’s demographic information, drug regimen, viral load an CD4+ count result, adherence assessment and resource use data
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 04/06/2019 update IDP for our trial will be available beginning 3 months and ending 5 years following article publication.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 04/06/2019 update The IDP will be available to researchers who provide a methodoligcally sound proposal. The IDP should only be used to achieve aims in the approved proposal. Proposal should be directed to oi.ekwunife@unizik.edu.ng. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at http://www.ebhc-unizik.com/
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 04/06/2019 update http://www.ebhc-unizik.com/
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 04/06/2019 update Study Protocol, Statistical Analysis Plan
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 19/10/2020 This is the actual trial start date 01 Dec 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 19/10/2020 This date corresponds to 2yrs following the last recruited participant 28 Feb 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 19/10/2020 Recruitment now completed Not yet recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 01/07/2021 Final number of participant 199
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/07/2021 Final number of participants Experimental Group, Conditional economic incentives & motivational interviewing, , 2 years, The incentive scheme involves financial incentive of a maximum of NGN 2000 linked to achieving viral load (VL) suppression of <20 copies/mL combined with attendance for motivational interviewing (MI) with an adherence counselor trained in MI techniques, 120, Experimental Group, Conditional economic incentives and motivational interviewing, , 2 years, The incentive scheme involves financial incentive of a maximum of NGN 2000 linked to achieving viral load (VL) suppression of <20 copies/mL combined with attendance for motivational interviewing (MI) with an adherence counselor trained in MI techniques, 119,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/07/2021 Final number of participants Control Group, Usual care, , 2 years, Routine HIV care as obtainable in the HIV treatment hospitals, 120, Active-Treatment of Control Group Control Group, Usual care, , 2 years, Routine HIV care as obtainable in the HIV treatment hospitals, 127, Active-Treatment of Control Group