Clinical trial NCT03610568: Global Early Adolescent Study - Kinshasa
Official title: The Global Early Adolescent Study, Phase 2 | Kinshasa, Democratic Republic on the Congo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender Relations
Reproductive Health
Keywords: Gender Norms
Gender-Based Violence
Mental Health
Sexual & Reproductive Health
Adolescent Health
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Save the Children
name: Bill and Melinda Gates Foundation
name: Georgetown University
First posted: 2018-08-01
Enrollment: 2862
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1,400 adolescents were enrolled in the intervention group - 1,000 in-school and 400 out-of-school 1,400 adolescents were enrolled in the control group - 1,000 in-school and 400 out-of-school
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Global Early Adolescent Study (GEAS) is the first international study exploring how gender norms evolve over time and inform a spectrum of adolescent health outcomes, including sexual and mental health, through the adolescent years. Institutional Review Board (IRB) oversight for all instrument development was provided for the first phase of the GEAS under IRB #00005684. The present study is in reference to the second, longitudinal phase of the GEAS. This phase, like the first, will be conducted in multiple international sites. However, because the longitudinal phase will likely be paired with different interventions or approaches in the partner sites, protocol details will vary and thus IRB approval will be sought for each site separately. The present application is for conducting Phase 2 of the Global Early Adolescent Study in Kinshasa, Democratic Republic of the Congo (DRC). In addition to conducting the study for "pure science" purposes, the GEAS will be used to evaluate the effectiveness of an intervention implemented by Save the Children.

Detailed description: The Global Early Adolescent Study (GEAS) is the first international study exploring how gender norms evolve over time and inform a spectrum of adolescent health outcomes, including sexual and mental health, through the adolescent years. The first phase, consisting of formative research and the face validity and pilot testing of instruments among early adolescents 10-14 years of age across 15 countries, was completed in 2017.

The present study is for Phase 2 of the Global Early Adolescent Study in Kinshasa, Democratic Republic of the Congo (DRC), and covers both the intervention and control groups. The longitudinal phase explores how gender norms relate to health across the adolescent years, beginning with early adolescence (10-14 years old). The GEAS in Kinshasa has two sets of objectives:

1. To explore how perceptions of gender norms evolve across adolescence, the factors influencing these changes, and how perceptions of gender norms predict a spectrum of adolescent outcomes, and
2. Assess the impact of a gender norms transformative intervention developed and implemented by Save the Children.

The intervention, Growing Up GREAT (GUG), and evaluation components are part of a larger project, Passages, which is led by the Institute for Reproductive Health (IRH) at Georgetown University. The investigator's research partner is the Kinshasa School of Public Health (KSPH), which will implement the GEAS study. Through Passages, Johns Hopkins University (JHU) receives support primarily from USAID with additional support from the Bill and Melinda Gates Foundation as a sub-recipient of IRH. Save the Children is separately a sub-recipient of IRH. This funding supports 3 years of longitudinal research with both control and intervention groups for impact evaluation in Kinshasa.

In both an intervention and control group 1,400 young people ages 10-14 will be followed over a period of 3 years, participating in a total of 3 surveys. To gauge effectiveness of the intervention, the study will assess the following measurable primary and secondary study outcomes:

Eligibility criteria: Inclusion Criteria:

* Males and females between the ages of 10-14 years of age
* Lives within the geographic boundaries of Kimbanseke or Masina
* Lives at home with a family (biological, adoptive, or foster)
* Attends a school selected for the study

INTERVENTION GROUP ONLY

* Has indicated interest in participation in the after-school component of the intervention
* Able to assent
* Has obtained informed consent from a parent or guardian to participate in the study

Exclusion Criteria:

* Not between the ages of 10-14
* Does not live within the geographic boundaries of Kimbanseke or Masina
* Is homeless or lives on the street
* Attends a school not selected for the study, or does not attend school

INTERVENTION GROUP ONLY

* Attends a school selected for the study but has not indicated interest in participation in the after-school component of the intervention
* Unable to assent
* Has not obtained informed consent from a parent or guardian to participate in the study

Primary outcomes:
measure: Contraceptive use as assessed by self-reported use at last sex from the Global Early Adolescent Study Questionnaire
timeFrame: 3 years
measure: Exposure to gender-based violence in the past 6 months as assessed by self-report from the Global Early Adolescent Study Questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Gender-equitable attitudes and beliefs from the Global Early Adolescent Study Questionnaire
timeFrame: 3 years
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Caroline Moreau, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: