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.: PACTR202209908422725 Date of Approval: 19/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessing the Effectiveness of Combo Pack (Pill Pack, Alarm Clock and Water Bottle) in Improving Antiretroviral Therapy Adherence among Adolescents and Young People living with HIV in Jaramogi Oginga Odinga Teaching and Referral Hospital, Ahero Sub-County hospital and Muhoroni Sub-County hospital in Kisumu County.
Official scientific title Assessing the Effectiveness of Combo Pack (Pill Pack, Alarm Clock and Water Bottle) in Improving Antiretroviral Therapy Adherence among Adolescents and Young People living with HIV in Jaramogi Oginga Odinga Teaching and Referral Hospital, Ahero Sub-County hospital and Muhoroni Sub-County hospital in Kisumu County.
Brief summary describing the background and objectives of the trial Adolescents and youth aged 15–24 years are among the populations most impacted by the global HIV epidemic, with an estimated 40% of all daily 6300 new infections occurring in this age group (Auld et al., 2014). Approximately two-thirds of the world's more than 10 million HIV-infected young people aged 15–24 years live in sub-Saharan Africa, accounting for 20% of all people living with HIV in this region (UNAIDS, 2020). Retention in care and adherence to antiretroviral therapy (ART) are critical for the optimal success of HIV treatment scale-up (Gwynn et al., 2015; Tweya et al., 2013). In Kenya, there is low rate of Antiretroviral therapy (ART) Drug adherence among adolescents and young people in Kenya is 64% (UNAIDS, 2020). Adolescents and young adults living with HIV have complex medical and psychological needs and many disengage from health services (Hughes et al., 2013; Wolf et al., 2014). Studies show that poor drug adherence among AYPs puts them at high risk of reinfection, drug resistance, disease progression, and an increased risk of death. The study seeks to improve ART adherence among adolescents and young people defaulting care and treatment in selected health facilities in Kisumu County by using a Combo Pack (Pill Pack, Alarm Clock and Water Bottle). Objectives 1. To assess the effect of Combo Pack on medication time among AYPLWH. 2. To assess the effect of Combo Pac in reducing stigma associated with use of ARVs among AYPLWH. 3. To determine the acceptability and feasibility of Combo Pack as a strategy of enhancing ART adherence among AYPLWH 4. To evaluate the information on intervention delivery approaches to inform future scale up.
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 To determine the effectiveness of a Pill Pack, Alarm Clock and Water Bottle in Enhancing ART adherence among AYPLWH in Kisumu County.
Anticipated trial start date 01/03/2022
Actual trial start date 14/03/2022
Anticipated date of last follow up 24/10/2022
Actual Last follow-up date 15/11/2022
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 726 Kenya Medical Research Institute - Scientific Ethics Review Unit
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Not applicable Not applicable 9 months This will be a prospective randomized control study. Adolescents and young people (AYP) with high viral load (>1000 copies/ml) will be recruited from Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH), Ahero Sub-County Hospital and Muhoroni sub-county hospitals. AYP will be assented and consent will be sought from a parent or guardian while young adults will be requested for a signed consent form. This process will be repeated until approximately 200 adolescents and young people have been enlisted in the study. The 200 participants will be randomly assigned to intervention group (composed of 100 AYPs) and control group (composed of 100 AYPs). Participants in the control will be excluded from the Combo Pack intervention. However they will continue to receive the health services as scheduled and data on similar variables to the intervention group will be collected. 100 Uncontrolled
Experimental Group Not applicable Not applicable 9 months This will be a prospective randomized control study. Adolescents and young people (AYP) with high viral load (>1000 copies/ml) will be recruited from Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH), Ahero Sub-County Hospital and Muhoroni sub-county hospitals. AYP will be assented and consent will be sought from a parent or guardian while young adults will be requested for a signed consent form. This process will be repeated until approximately 200 adolescents and young people have been enlisted in the study. The 200 participants will be randomly assigned to intervention group (composed of 100 AYPs) and control group (composed of 100 AYPs). Participants in the intervention will be given the Combo Package consisting of an African print bag with enough space for a water bottle, pills and an alarm clock). The Ankara/African print bag will be of small size with different shapes and prints to minimize participants being identified as adolescents and young people living with HIV (AYPLWH). 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adolescents and young people who have documented high viral load and poor ART adherence 2. Adolescents aged 15-17 years who assent to participate in the study. 3. Adolescents aged 15-17 years who have obtained Parent/Guardian consent to participate in the study. 4. Young people aged 18 – 24 years who consent to participate in the study. 1. Adolescents and young people who have documented low viral load and good ART adherence 2. Adolescents aged 15-17 years who do not assent to participate in the study. 3. Adolescents aged 15-17 years who have not obtained Parent/Guardian consent to participate in the study. 4. Young people aged 18 – 24 years who do not consent to participate in the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 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 22/06/2022 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Off Raila Odinga Way. Nairobi, Kenya. Nairobi 00200 Kenya
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 13/07/2021 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Off Raila Odinga Way. Nairobi, Kenya. Nairobi 00200 Kenya
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 04/11/2021 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Waiyaki Way, Nairobi Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Improved viral load of ≤ 500 copies 2. Improved pill uptake Baseline at month 1 and monthly for 6-9 months
Secondary Outcome 1. Participants reporting reduced stigma associated with use of ARVs. 2. Uptake of the interventions among those eligible for the study. Assessed by measuring the proportion of eligible adolescents who agree to join and remain in the study. 3. Documented barriers to and facilitators of intervention delivery among participants in the intervention arm. This will be achieved by reviewing the barriers and facilitators listed by the intervention implementers, and proportion of those enrolled in intervention arm. Acceptability will be measured at baseline month 1,reduction in stigma to be measured monthly for 9 months and Feasibility will be measured at endline month 9
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
1. Jaramogi Oginga Odinga Teaching and Referral Hospital. 2. Ahero Sub County Hospital and 3.Muhoroni SubCounty hospitals Kisumu County Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation Seattle, WA98102, USA Seattle United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Impact Research and Development Organization Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway Kisumu 40141 Kenya Grants management
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Pauline Phiona paulinephiona@gmail.com +254717143180 Ahero Kisumu
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Kenya Medical Training College.
Role Name Email Phone Street address
Public Enquiries Kawango Agot kawango@impact-rdo.org +254736505046 Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Impact Research and Development Organization
Role Name Email Phone Street address
Scientific Enquiries Charles Obonyo cobonyo@kemri.go.ke +254724993118 Off Raila Odinga Way. Nairobi, Kenya.
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Kenya Medical Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are committed to public dissemination of results of the study to participants, local stakeholders in Kenya, the global scientific community and global policymakers. Dissemination of study results will follow principles of good participatory practice. Study results will be disseminated through presentations to the relevant stakeholders, starting with the study participants, participating health facilities as well as the Ministry of Health officials in Kisumu County. Results will be published in conference abstracts and peer-reviewed journals. Statistical Analysis Plan,Study Protocol One year Upon completion of study analysis, the final dataset will be striped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Results from research conducted under this project will be shared in several ways. • Manuscripts will be submitted for publication in high-quality peer-reviewed journals • The MPI and Co-Investigator will also disseminate results from this research through presentations at public lectures, scientific institutions and meetings, as well as to the community in which the research took place as detailed in the enclosed.
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