ANRS 12406 EvvA Study (EvvA)

Virological Failure and HIV Drug Resistance Among Adolescents Receiving Antiretroviral Treatment in Cameroon

ANRS 12406 EvvA is an observational, longitudinal and monocentric study evaluating the virological success rate in HIV-infected adolescents on antiretroviral therapy in Cameroon.

The main objective of the study is to estimate the rate of virological suppression among adolescents on antiretroviral therapy for more than 6 months in Cameroon

Study Overview

• Status: Recruiting
• Conditions: HIV-1-infection

Detailed Description

At the end of 2017, HIV-AIDS affects more than 36 million people worldwide, more than three-quarters of whom live in sub-Saharan Africa, and a quarter of the infections are among young people and adolescents. Every hour, 4 adolescents (aged 15-19) are newly infected with HIV in the world, and 3 of them are adolescents. Three infections occur in sub-Saharan Africa, and for five adolescents living with HIV, there are seven girls (aged 10 to 19) in the same situation. This gender disparity increases when adolescents reach adulthood. This group of the population may well deserve the term "key and vulnerable population". In the era of international commitment to end the AIDS epidemic by 2030, especially to stop new infections, it is essential not to neglect part of the epidemic because it would effectively represent a reservoir for maintaining the epidemic and make these eradication goals impracticable. Data on virological success among adolescents on antiretroviral treatment are generally scarce and this is much more striking in Central Africa. Also, information on the frequency of emergence of resistant viruses and the consequences for the effectiveness of available treatments is rare. However, in the absence of such data, it is difficult, if not impossible, to take the right decisions to improve the care and monitoring of adolescents. In addition, the few available data indicate high virological failure rates and high frequencies of drug resistance, which may indicate a need to further investigate virological failure events in this population.

This study will be conducted in Cameroon among 289 adolescents during 9 months, where access to biological monitoring is a major challenge, especially with low access to viral load testing. The results of this project will inform on the current state of success of ARV treatments in this population. Moreover, the other goal of this study is to conclude on the need to conduct a larger study at the national or regional level according to the results obtained

• Study Type: Observational
• Enrollment (Anticipated): 289

Contacts and Locations

• Study Contact: Name: Avelin F AGHOKENG, PhD; Phone Number: +(33)467415958; Email: avelin.aghokeng@ird.fr
• Study Contact Backup: Name: Ida C Penda, PhD; Phone Number: +(237)7770 31 55; Email: calix.penda@gmail.com

Study Locations

• Cameroon
  • Douala, Cameroon
    • Recruiting
    • Hôpital Laquinitie de Douala
    • Contact: Ida C Penda, PhD; Phone Number: +(237)7770 31 55; Email: calix.penda@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include adolescents living with HIV infection, aged 10 to 19 years and follow-up in a treatment unit in Douala, Cameroon.

Description

Inclusion Criteria:

• Being adolescent (aged 10 to 19) on antiretroviral therapy and followed at the Laquintinie Hospital (Douala Cameroon)
• HIV-1 infection
• Duration of antiretroviral therapy ≥ 6 months regardless of antiretroviral regimen
• For emancipated adolescents: obtaining informed consent signed by the adolescent
• For unemancipated adolescents:
• Obtaining informed consent signed by the legal representative (parent(s) or guardian(s))
• Obtaining the assent of adolescents able to understand the study (maturity and knowledge of HIV status)

Exclusion Criteria:

• Infection with HIV-1 or HIV-1/HIV2 co-infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral load suppression after ≥ 6 months of antiretroviral therapy	Proportion of participants with HIV-1 RNA <1000 copies / ml after ≥ 6 months of antiretroviral therapy	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug resistance after ≥ 6 months of antiretroviral therapy	Proportion of participants with HIV-1 RNA ≥ 300 copies / ml and presence of antiretroviral-resistant virus (ARV) after ≥ 6 months of antiretroviral therapy	3 months

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Institut Pasteur; Hospital Laquinitinie de Douala; Franceville International Center for Medical Research, Gabon
• Investigators: Study Director: Avelin F AGHOKENG, PhD, Institut de Recherche pour le Developpement; Principal Investigator: Ida C PENDA, Hôpital Laquinitie de Douala

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Anticipated): January 14, 2022
• Study Completion (Anticipated): January 14, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Adolescents; Virological failure; HIV drug resistance; Cameroon
• Other Study ID Numbers: ANRS 12406 EvvA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: To be decided later

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No