NCT04593979

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

October 5, 2020

Last Update Submit

April 29, 2021

Conditions

Keywords

Virological failureHIV drug resistanceAdolescentsCameroon

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Drug resistance after ≥ 6 months of antiretroviral therapy

    3 months

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Laquinitie de Douala

Douala, Cameroon

RECRUITING

Related Publications (1)

  • Djiyou ABD, Penda CI, Madec Y, Ngondi GD, Moukoko A, Varloteaux M, de Monteynard LA, Moins C, Moukoko CEE, Aghokeng AF. Viral load suppression in HIV-infected adolescents in cameroon: towards achieving the UNAIDS 95% viral suppression target. BMC Pediatr. 2023 Mar 15;23(1):119. doi: 10.1186/s12887-023-03943-0.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples

Study Officials

  • Avelin F AGHOKENG, PhD

    Institut de Recherche pour le Developpement

    STUDY DIRECTOR
  • Ida C PENDA

    Hôpital Laquinitie de Douala

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Avelin F AGHOKENG, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 20, 2020

Study Start

April 15, 2021

Primary Completion

January 14, 2022

Study Completion

January 14, 2022

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations