Clinical trial NCT04593979: ANRS 12406 EvvA Study
Official title: Virological Failure and HIV Drug Resistance Among Adolescents Receiving Antiretroviral Treatment in Cameroon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-1-infection
Keywords: Virological failure
HIV drug resistance
Adolescents
Cameroon
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Laquinitinie de Douala
name: Franceville International Center for Medical Research, Gabon
name: Institut Pasteur
First posted: 2020-10-20
Enrollment: 289
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Viral load suppression after ≥ 6 months of antiretroviral therapy
timeFrame: Day 0
Secondary outcomes:
measure: Drug resistance after ≥ 6 months of antiretroviral therapy
timeFrame: 3 months
Other outcomes:
Locations:
city: Douala
country: Cameroon
facility: Hôpital Laquinitie de Douala
Study officials:
affiliation: Institut de Recherche pour le Developpement
name: Avelin F AGHOKENG, PhD
role: STUDY_DIRECTOR
affiliation: Hôpital Laquinitie de Douala
name: Ida C PENDA
role: PRINCIPAL_INVESTIGATOR
References: