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.: PACTR202004535536808 Date of Approval: 08/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Home delivery of antiretroviral therapy amidst insecurity and COVID-19 Challenges in Nigeria
Official scientific title HOME DELIVERY OF ANTIRETROVIRALS FOR HIV CLIENTS AMIDST INSECURITY AND COVID-19 CHALLENGES: A PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL.
Brief summary describing the background and objectives of the trial Background: Insecurity and Covid-19 has affected access to antiretroviral agents and it has resulted in suboptimal adherence to the antiretroviral therapy which could impact negatively on the overall treatment outcomes. Objective: This study will evaluate the effectiveness, cost-benefit, and feasibility of a home-based antiretroviral delivery model in Anambra State, Nigeria. Method/Design: The study is a randomized, non-blinded, controlled, and parallel-group trial, which will be conducted in two HIV treatment hospitals in Anambra State, Nigeria. Participants will be randomized into the intervention and control arm. Home delivery personnel will be trained to deliver the ARV drugs at 3 monthly intervals to the homes of those in the intervention group while those in the control group (Facility-based services group) will receive ARVs at the HIV treatment hospital. The study was approved by Nnamdi Azikiwe University Teaching Hospital Health Research Ethics Committee (NAUTHHREC) (NAUTH/CS/66/VOL.13/VER III/23/2020/011) on 02/10/2020 and the trial registration number is PACTR202004535536808 approved on 08/04/2020. The interim analysis will be done on the 12th month and the final analysis will be done on the 24th month. Results: The interim analysis will be done on the 12th month and the final analysis will be done on the 24th month. Conclusions: The results of this study could provide the rationale for a larger study involving various geo-political zones in Nigeria to examine the effectiveness of the home delivery model.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ARTHD 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 20/06/2020
Actual trial start date 26/05/2021
Anticipated date of last follow up 10/05/2023
Actual Last follow-up date 10/08/2023
Anticipated target sample size (number of participants) 264
Actual target sample size (number of participants) 316
Recruitment status Active, not recruiting
Publication URL Non yet
Secondary Ids Issuing authority/Trial register
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 Home Delivery of Antiretrovirals 2 years Enrolled participants will be directed to the research assistant responsible for introducing the study to the enrollees and obtain a written consent the participant. Participants with signed consents will be sent to the physician who will examine the patients and request for a base line viral load. Based on the physician’s examination and assessment findings, the Home Delivery Personnel(HDP) will deliver a three months ARV package to a chosen delivery point of choice (which may be home or a nearby place) by each of the patients in the intervention group. The delivery points are chosen and the drugs delivered in a way to ensure confidentiality. Patients in this arm are advised to visit the hospital every six months for viral load and CD4 cell count unless there is a problem requiring physician’s attention. Meanwhile, the HDP will be trained on interviewing the patients on each day of delivery using short structured interviews while monitoring for adverse drug reaction, disease progression and adherence support. The HDP after each delivery reports back to the physician who then decides on whether to schedule the patient on appointment. On the other hand, the control group receives their drug in the facility as usual but assesses the viral load and CD4 count every six months as in the intervention group. The drugs to be delivered by the HDP will be prepackaged in suitable package with patients’ identifiers and delivered to the patients using delivery motorcycle. The participant in the intervention arm is advised to contact a designated number (Nurse) if he/she notices any challenge before his next delivery date. Routine data will be collected and the patient is at liberty to withdraw from the trial at any time. 158
Control Group Facility Delivery of Antiretroviral 2 years The control group receives their drug(antiretrovirals) based on presccription in the facility as usual and assesses the viral load and CD4 count every six months. 158 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i) Age ≥ 18years ii) Stable patients who commenced ART for ≥ 6months and have suppressed viral load iii) Reside within the State iv) Give informed consent i) Pregnancy at time of the enrollment ii) Age < 18years iii) Newly commenced on ART iv) Defaulters v) Unsuppressed viral load (>20 copies /mil) vi) Withdrawal of consent vii) Reside outside the state 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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
No 24/02/2020 Nnamdi Azikiwe Teaching Hospital Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe Teaching Hospital Nnewi Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Difference between the HIV viral loads of the two groups (≤ 20 copies /ml 12 months and 24 months
Secondary Outcome The cost incurred in delivering care in both arms 12 months and 24 months
Secondary Outcome Cost-effectiveness of home based delivery compared to facilty based delivery 12 months and 24 months
Secondary Outcome Client satisfaction with the services . 12 months and 24 months
Secondary Outcome Willingness-to-pay for home based delivery 12 months and 24 months
Secondary Outcome Adherence at 3 month interval
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
NACA approved HIV treatment centre No 1 Limca Road Old Onitsha-Enugu Road, Onitsha and No 1 Km 3 Old Onitsha-Enugu Road, Ikenga Ogidi respectively Onitsha and Ogidi 434221 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nnenna Ajagu NO. 12 Garden Avenue, Agbani. Enugu Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nnamdi Azikiwe University Awka-Enugu Express Way Awka 5025 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr. Obinna Ikechukwu Ekwunife Nnnamdi Azikiwe University Awka 5025 Nigeria
Dr Sunday Nduka Nnnamdi Azikiwe University Awka 5025 Nigeria
Yohanna Avong Institutue of Human Virology Abuja Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ajagu Nnenna ajagunnenna@yahoo.com 2348035460931 No. 8 Gardern Avenue Agbani
City Postal code Country Position/Affiliation
Enugu 0166610 Nigeria Lecturer II
Role Name Email Phone Street address
Scientific Enquiries Nduka Sunday so.nduka@unizik.edu.ng 2348033644385 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka 5025 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Ekwunife Obinna oi.ekwunife@unizik.ng 234706232501 Nnamdi Azikiwe University
City Postal code Country Position/Affiliation
Awka 5025 Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD will include participants demographic data, drug regime, viral load result and drug refill tracker Statistical Analysis Plan,Study Protocol IDP for our article will be available 3 months to 5 years following publication The IDP and additional document will be available to clinical researchers who provide methodological sound proposal.The IDP should be used to achieve the aim of the proposal and the request should be directed to ajagunnenna@yahoo.com. A data assess agreement has to be signed in other to gain assess. Data will be available 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