This study aims to improve sexual and reproductive health knowledge and attitudes among young people, age 12-16, living in Uttar Pradesh, India

ISRCTN	ISRCTN16503497
DOI	https://doi.org/10.1186/ISRCTN16503497
Secondary identifying numbers	IRB 21-0172

Submission date: 13/01/2022
Registration date: 24/01/2022
Last edited: 07/08/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
In India, adolescents face multiple sexual and reproductive health challenges, including but not limited to a lack of knowledge and access to family planning methods, correct knowledge of menstruation and menstrual management supplies, and widespread sexual harassment of girls in public spaces. These factors can have lifelong negative implications for young people. The Kissa Kahani intervention is a multimedia intervention that aims to improve sexual and reproductive health outcomes among young people living in India. The intervention is designed using multimedia tools, animated digital stories, games and graphic novels to raise awareness about menstruation, family planning and sexually transmitted infections, and prevention of sexual harassment. This study aims to find out whether this intervention improves sexual and reproductive health knowledge and attitudes among young people, aged 12-16 years, living in Uttar Pradesh, India

Who can participate?
Healthy boys and girls, aged 12-16 years, living in the Lucknow and Sitapur districts of Uttar Pradesh, India.

What does the study involve?
Participants are randomly allocated into four study groups (three intervention groups and one control group) using a lottery system. The intervention groups receive the intervention on one of the following curriculum topics:
1. Menstruation and its correct management
2. Family planning and sexually transmitted infections (STIs)
3. Prevention of street harassment of girls
Each study curriculum (menstruation, family planning and STIs, and sexual harassment) comprises animated digital stories, graphic novels, and a discussion guide, which aim to raise awareness about the curriculum topic and promote the adoption of correct behaviours. Participants in the first three study groups watch the animated digital stories, read the graphic novels, and engage in guided discussions.
Participants in the fourth study group (study control group) only read the graphic novels on the curriculum topics (menstruation, family planning and STIs, and street harassment). They did not watch the animated digital stories or engage in discussion groups about the curriculum topics.

What are the possible benefits and risks of participating?
There is the possibility of no direct benefit to adolescents for participating in this study. However, engaging in the Kissa Kahani intervention may teach adolescents about issues of gender equity and sexual and reproductive health, and improve their self-efficacy in addressing these issues in their lives and in their communities. Data collected from this study may be used to further refine the Kissa Kahani curriculum and scale the intervention across communities in India.

Where is the study from?
The Center for Interdiscplinary Inquiry and Innovation in Sexual and Reproductive Health (USA)

When is the study starting and how long is it expected to run for?
March 2021 to May 2022

Who is funding the study?
The Bill and Melinda Gates Foundation (USA)

Who is the main contact?
Dr Melissa Gilliam
mgilliam@bsd.uchicago.edu

Contact information

Dr Melissa Gilliam
Principal Investigator

6030 S Ellis Ave
Chicago
60637
United States of America

Phone	+1 (0)778348462
Email	mgilliam@bsd.uchicago.edu

Ms Lee Hasselbacher
Scientific

6030 S Ellis Ave
Chicago
60637
United States of America

Phone	+1 (0)7738348462
Email	lhasselbacher@bsd.uchicago.edu

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Quality of life
Scientific title	Kissa Kahani intervention community-based testing
Study objectives	Using a multimedia intervention can help to improve sexual and reproductive health knowledge and attitudes among very young adolescents living in India.
Ethics approval(s)	Approved 25/03/2021, the University of Chicago Institutional Review Board (The University of Chicago Office of Clinical Research, Section of Regulatory Compliance, 5841 S. Maryland Ave., I-625, MC7132, Chicago, IL 60637, USA; +1 (0)773 702 6505; bsdirb@bsd.uchicago.edu), ref: FWA00005565
Health condition(s) or problem(s) studied	Adolescent sexual and reproductive health
Intervention	A randomized controlled trial was conducted of an adolescent sexual and reproductive health intervention, Kissa Kahani, in communities in Sitapur and Lucknow districts in Uttar Pradesh, India. The study was conducted by the Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health (Ci3), an academic research center based at the University of Chicago in partnership with local organizations in India: the Milaan Foundation and the Institute for Financial Management and Research. The Kissa Kahani intervention was designed based on formative research that was conducted by Ci3 researchers with young people living in Uttar Pradesh for 2 years employing traditional and non-traditional research methods: life course interviews, surveys, key informant interviews, body-mapping exercises, story circles, storytelling games, and focus group sessions to better understand the experiences of young people in Uttar Pradesh, India. The formative research phase was focused specifically on household dynamics, familial relationships, identity, educational and work experiences, access to and use of technology and health services, and gender norms. From the findings of the aforementioned formative research, the researchers have developed the Kissa Kahani intervention for girls and boys aged 12 to 14 years addressing the ecology of factors influencing young people’s reproductive health and wellbeing. Kissa Kahani is a theory-based, multimedia intervention designed to promote reproductive health and family planning, and emphasize the value of education and financial autonomy for girls in India. The intervention curriculum includes animated digital stories, games, and graphic novels on topics of menstruation, family planning and sexually transmitted infections (STIs), and street harassment. For testing of the Kissa Kahani intervention in the community, Ci3 and its Indian partners implemented and tested the Kissa Kahani intervention in communities in Sitapur and Lucknow districts in Uttar Pradesh, India. The study population included 1,200 healthy boys and girls, aged 12-16 years. The researchers studied the effects of the intervention on participating subjects' self-reported knowledge, attitudes, and self-efficacy around sexual and reproductive health (including menstrual management, family planning, and STIs), gender equity, and school attendance. The study was conducted with help from local study partners, the Milaan Foundation, and IFMR. The Milaan Foundation was responsible for the delivery of the intervention curriculum. IFMR conducted the study recruitment and data collection and analysis. Study participants were randomized into four study arms (three intervention arms and one control arm) using a lottery system. The intervention arms received the intervention on one of the following curriculum topics: 1. Menstruation and its correct management 2. Family planning (FP) and STIs 3. Prevention of street harassment of girls Each study curriculum (menstruation, FP and STIs, and sexual harassment) comprises animated digital stories, graphic novels, and a discussion guide, which aim to raise awareness about the curriculum topic and promote the adoption of correct behaviors. Participants in the first three study arms watched the animated digital stories, read the graphic novels, and engaged in guided discussions. Participants in the fourth study arm (study control group) only read the graphic novels on the curriculum topics (menstruation, FP and STIs, and street harassment). They did not watch the animated digital stories or engage in discussion groups about the curriculum topics.
Intervention type	Behavioural
Primary outcome measure	Self-reported knowledge, attitudes, and self-efficacy around sexual and reproductive health (including menstrual management, family planning, and STIs/HIV), and gender equity, measured using a pre-post questionnaire developed by the research team delivered at baseline and immediately upon completion of the intervention
Secondary outcome measures	Value of education for girls and intention to attend/complete schooling, measured using a pre-post questionnaire developed by the research team delivered at baseline and immediately upon completion of the intervention
Overall study start date	25/03/2021
Completion date	31/05/2022

Eligibility

Participant type(s)	Healthy volunteer
Age group	Child
Lower age limit	12 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	1,200
Total final enrolment	1200
Key inclusion criteria	Healthy boys and girls, aged 12-16 years, who live in Sitapur and Lucknow districts in Uttar Pradesh, India
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	01/06/2021
Date of final enrolment	31/08/2021

Locations

Countries of recruitment

India

Study participating centre

The Institute for Financial Managment and Research (Lead KREA)

LEAD at Krea University
C/O Krea University
No: 196, T.T.K. Road, Alwarpet
Chennai
600018
India

Sponsor information

Bill & Melinda Gates Foundation
Charity

PO Box 23350
Seattle
WA 98102
United States of America

Phone	+1 (0)206 7093100
Email	media@gatesfoundation.org
Website	https://ci3.uchicago.edu
"ROR"	https://ror.org/0456r8d26

Funders

Funder type

Charity

Bill and Melinda Gates Foundation
Government organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
Location: United States of America

Results and Publications

Intention to publish date	30/06/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
Publication and dissemination plan	Ci3 and its partners plan to publish the study results in a peer-reviewed medical journal. A study protocol was developed but it has not yet been published.
IPD sharing plan	All efforts will be made to keep participants’ information confidential. All documents will be kept in a locked file cabinet in a locked office in Lucknow and if applicable, the US. All electronic data will be stored encrypted in password-protected files computers in India, and/or on secure University of Chicago servers (for data accessed in the US). All data will be transcribed, verified, translated, deidentified, and analyzed by the Indian study partner, IFMR, after which they will send all records and their analysis to Ci3. This data will NOT be shared with others outside of the project team. All identifiable information will be removed by the IFMR team before sharing the data with Ci3 (including dates and zipcodes/postal addresses).

Editorial Notes

07/08/2023: The intention to publish date has been changed from 31/03/2022 to 30/06/2024.
20/01/2022: Trial's existence confirmed by the University of Chicago Institutional Review Board.