Study design and sampling strategy
GOO
STIS, MAY
The study design was a cluster randomized trial conducted from May 2020 to April 2022. During this period, there was an ongoing COVID-19 pandemic. The schools remained closed as per guidelines from the Government of Odisha (GOO). The schools conducted online classes using various virtual platforms such as Zoom meetings, Google Meet, and YouTube. Permission was taken to assess the students through online and offline modes when required and to give education to school students through both online and offline modes depending upon the school closure. Written informed consent was taken from parents of adolescent girls, and assent was sought from adolescent girls.For sample size calculation, as per a study conducted in Gujarat in the year 2017, the proportion of participants having awareness about STIs varied between 23 and 29% [The sampling frame included all eight government girls’ high schools (GHS) in Bhubaneswar, Odisha. Schools were considered as clusters, and restrictive randomization was done to randomize eight schools at a ratio of 1:1, with four schools in each intervention and control arm. For the selection of study participants as per protocol, systematic random sampling was to be done among adolescent girls studying in ninth and tenth classes. However, due to the COVID-19 pandemic, all those who responded to the baseline questionnaire were included, and an amendment in protocol was done regarding the same and was approved by Institute Ethics Committee (IEC), AIIMS Bhubaneswar. Outcome variables included changes in KAP pertaining to domains such as puberty, menstrual health, pregnancy and contraception, STIs/RTIs, and HIV/AIDS.