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)

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202402863175053

Enrollment

600

Registered

2024-02-13

Start date

2021-02-01

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

Disclosure and Adherence support

Current practice

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
- 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	—

Measure

Time frame

- 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

—

Countries

Burkina Faso, Cote Divoire, Togo

Contacts

Public ContactTanoh Kassi ;ELOM EBOUA;TAKASSI

Pediatrician CTAP;CHU Sylvanus Olympio Service de Pediatrie

ebouatk@yahoo.fr;elomtak@gmail.com+2250140465484;+22890877403

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 6, 2026