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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402863175053 Date of Registration: 13/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessment of a comprehensive strategy to optimize virological success in adolescents living with HIV and on antiretroviral treatment in the pediatric IeDEA West Africa collaboration: a stepped-wedge randomized cluster trial (OPTIMIZE-WA project)
Official scientific title Assessment of a comprehensive strategy to optimize virological success in adolescents living with HIV and on antiretroviral treatment in the pediatric IeDEA West Africa collaboration: a stepped-wedge randomized cluster trial (OPTIMISE-WA project ANRS 12390)
Brief summary describing the background and objectives of the trial Adolescence is a vulnerable period characterized by many physical, mental and social changes. Risky behaviors are more common in adolescence than other periods of life. In 2018, improved access to antiretroviral therapy has resulted in a decline in HIV-related mortality in all age groups, except for adolescents aged 10-19 years, especially in sub-Saharan Africa. This high mortality among adolescents living with HIV (ALHIV) is mainly due to difficulties to adhere to antiretroviral therapy, which is in turn exacerbated by the late disclosure of their HIV status, often in inadequate conditions. Since 2016, viral load measurement, a key indicator of therapeutic surveillance, became more available in West African routine care. We hypothesized that improving the conditions of HIV status disclosure to adolescents before the age of 12 would improve their mental health, and their compliance to antiretroviral therapy. We also hypothesized that interventions to strengthen adherence of those early identify with a detectable viral load during the follow-up would improve the virological response. These targeted interventions would improve the treatment outcomes and prevent the emergence of antiretroviral resistance. This should be a public health priority, especially in resource-limited countries such as West Africa where new antiretroviral treatment options are scarce. The objective of this project is to assess the social and family acceptability and the effectiveness of a package of interventions aimed at 1/ improving the quality and frequency of complete HIV status disclosure to ALHIV (before age 12), and 2/ to improve the adherence modulated according to the virological response to improve the rate of virological suppression (undetectable viral load) in adolescents treated with antiretroviral therapy in five heath care facilities in three West-African countries (Burkina Faso, Côte D’Ivoire, Togo) nested in the IeDEA West Africa pediatric cohorts.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OPTIMISE WA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial HIV status disclosure support and adherence to antiretroviral support
Anticipated trial start date 01/02/2021
Actual trial start date 01/02/2021
Anticipated date of last follow up 31/03/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 600
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Disclosure and Adherence support 24 months A stepped-wedge, cluster randomized trial will be conducted in five heath care facilities in four West-African countries (Burkina Faso, Côte D’Ivoire, Togo) participating in the observational pediatric cohort of the "International Epidemiology Databases to Evaluate AIDS (IeDEA )-West African collaboration. All consenting HIV-perinatally-infected adolescents, aged 10 and 17 years, and enrolled before 10 years of age in six IeDEA West-African IeDEA pediatric sites will be eligible. This study will be conduct over 36 months. At inclusion, adolescent HIV status disclosure will be assessed and viral load will be performed. Our intervention will combine a full HIV status disclosure support for adolescents who are unaware of their status; a comprehensive adherence to antiretroviral support guided by viral load testing after 3 months for those in virological failure with involvement of trained community health workers, peers educators. The intervention assessment will be multi-criteria: social and family acceptability of interventions, overall effectiveness will be evaluated: 1 / by the difference in proportion of adolescents in virological failure (viral load greater than 1000 copies / mL) before, and 12 months, then 18 months after implementation of the site interventions package, and 2 / by the difference in proportions of adolescents under 12 years of age informed of their HIV status before and 18 months after implementation of the intervention; cost-effectiveness analysis. 600
Control Group Current practice Throughout the control period until the cluster transitions to intervention phase. The duration of the control period will vary per cluster depending on the randomization sequence. Standard of care. 600 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- HIV-1-infected patients followed up and treated at one of the five pWADA sites. - Agreed to participate in the study and at least one parent or legal guardian has signed the informed consent form. - PLWHIV with a mental disability that makes it impossible to understand the information provided and to participate in the study. - PLWHA whose parents or legal guardian have a mental disability that makes it impossible to understand the information provided. Adolescent: 13 Year(s)-17 Year(s) 10 Year(s) 17 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 25/09/2019 COMITE NATIONAL ETHIQUE DES SCIENCES DE LA VIE ET DE LA SANTE
Ethics Committee Address
Street address City Postal code Country
Abidjan Ouagadougou 12243 Cote Divoire
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 25/03/2020 COMITE ETHIQUE POUR LA RECHERCHE EN SANTE
Ethics Committee Address
Street address City Postal code Country
Avenue du Burkina Ouagadougou 03BP70009 Burkina Faso
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 25/06/2021 COMITE DE BIOETHIQUE POUR LA RECHERCHE EN SANTE
Ethics Committee Address
Street address City Postal code Country
Angle avenue Sarakawa et avenue du 2 Fevrier Lomé BP 386 Togo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The overall effectiveness of our strategy will be evaluated: 1/ by the relative improvement in the difference in the proportion of adolescents in virological failure (viral load greater than 1000 copies/mL) before, at 12 months, and then 18 months after the implementation of the package of interventions in the sites, and, 2/ by the relative improvement in the difference in the proportions of adolescents under 12 years of age informed of their HIV infection status before, at 12 months and 18 months after the implementation of the intervention. Table 2 below shows the evaluation criteria that will be measured in the project. 12 months and 18 months
Secondary Outcome - Assessing the acceptability of family support for full disclosure of HIV status after surgery - Evaluate the effectiveness of support for disclosure in increasing the proportion of PLWHA informed of their HIV status before the age of 12. - To assess the acceptability of the strategy of comprehensive support and personalised reinforcement of adherence to treatment guided by viral load measurement - To assess the effectiveness of the intervention package in strengthening adherence and reducing the proportion of adolescents experiencing virological failure, as well as the associated factors. - To assess the effectiveness of the intervention package in improving the mental health of adolescents and the associated factors - To assess the cost and cost-benefit balance of this package of interventions 12 months and 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CIRBA Abidjan Abidjan Cote Divoire
CePreF Abidjan Abidjan Cote Divoire
CTAP Abidjan Abidjan Cote Divoire
CHUYO Ouagadougou Ouagadougou Burkina Faso
CHUSO Lome Lome Togo
FUNDING SOURCES
Name of source Street address City Postal code Country
ANRS MIE Paris Paris 75015 France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ANRS MIE Paris Paris France Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Leroy Valeriane Toulouse Toulouse France
Tanoh Kassi EBOUA Abidjan Abidjan Cote Divoire
Sylvie NGBECHE Abidjan Abidjan Cote Divoire
Kouadio KOUAKOU Abidjan Abidjan Cote Divoire
Elom TAKASSI Lome Lome Togo
Yonaba Caroline Ouagadougou Ouagadougou Burkina Faso
Sophie Desmonde Toulouse Toulouse France
Philippe Msellati Abidjan Abidjan Cote Divoire
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator DESIRE LUCIEN DAHOUROU ddahourou@yahoo.fr +22670130196 OUAGADOUGOU
City Postal code Country Position/Affiliation
OUAGADOUGOU Burkina Faso Researcher Institut de Recherche en Sciences de la Sante
Role Name Email Phone Street address
Principal Investigator VALERIANE LEROY valeriane.leroy@inserm.fr +33672432636 Toulouse
City Postal code Country Position/Affiliation
Toulouse France Researcher CERPOP UMR 1295 Inserm Universite Paul Sabatier
Role Name Email Phone Street address
Public Enquiries Tanoh Kassi EBOUA ebouatk@yahoo.fr +2250140465484 Abidjan
City Postal code Country Position/Affiliation
Abidjan Cote Divoire Pediatrician CTAP
Role Name Email Phone Street address
Scientific Enquiries Philippe Msellati pmsellati@yahoo.fr +22578003306 Abidjan
City Postal code Country Position/Affiliation
Abidjan Cote Divoire Researcher PACCI
Role Name Email Phone Street address
Public Enquiries ELOM TAKASSI elomtak@gmail.com +22890877403 Lome
City Postal code Country Position/Affiliation
Lome Togo CHU Sylvanus Olympio Service de Pediatrie
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form 12 months of the study completion date After request to study team
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