Global Early Adolescent Study - Kinshasa — GEAS_KI  

Reproductive Health Clinical Trial

Official title: The Global Early Adolescent Study, Phase 2 | Kinshasa, Democratic Republic on the Congo

Status Completed

Clinical Trial 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.

Clinical Trial 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: ;

Related Conditions & MeSH terms

• Gender Relations
• Reproductive Health

• NCT number: NCT03610568
• Study type: Interventional
• Source: Johns Hopkins Bloomberg School of Public Health
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Completion date: December 31, 2022