Study protocol for an individually randomized control trial for India's first roleplay-based mobile game for reproductive health for adolescent girls.

BACKGROUND: Go Nisha Go™ (GNG), is a mobile game combining behavioural science, human-centric design, game-based learning, and interactive storytelling. The model uses a direct-to-consumer (DTC) approach to deliver information, products, services, interactive learning, and agency-building experiences directly to girls. The game's five episodes focus on issues of menstrual health management, fertility awareness, consent, contraception, and negotiation for delay of marriage and career. The game's effectiveness on indicators linked to these issues will be measured using an encouragement design in a randomized controlled trial (RCT). METHODS: A two-arm RCT will be conducted in three cities in India: Patna, Jaipur, and Delhi-NCR. The first arm is the treatment (encouragement) arm (n = 975) where the participants will be encouraged to download and play the game, and the second arm (n = 975) where the participants will not receive any nudges/encouragement to play the game. They may or may not have access to the game. After the baseline recruitment, participants will be randomly assigned to these two arms across the three locations. Participants of the treatment/encouragement arm will receive continuous support as part of the encouragement design to adopt, install the game from the Google Play Store at no cost, and play all levels on their Android devices. The encouragement activity will continue for ten weeks, during which participants will receive creative messages via weekly phone calls and WhatsApp messages. We will conduct the follow-up survey with all the participants (n = 1950) from the baseline survey after ten weeks of exposure. We will conduct 60 in-depth qualitative interviews (20 at each location) with a sub-sample of the participants from the encouragement arm to augment the quantitative surveys. DISCUSSION: Following pre-testing of survey tools for feasibility of methodologies, we will recruit participants, randomize, collect baseline data, execute the encouragement design, and conduct the follow-up survey with eligible adolescents as written in the study protocol. Our study will add insights for the implementation of an encouragement design in RCTs with adolescent girls in the spectrum of game-based learning on sexual and reproductive health in India. Our study will provide evidence to support the outcome evaluation of the digital mobile game app, GNG. To our knowledge this is the first ever outcome evaluation study for a game-based application, and this study is expected to facilitate scalability of a direct-to-consumer approach to improve adolescent sexual and reproductive health outcomes in India. TRIAL REGISTRATION NUMBER: ctri.nic.in: CTRI/2023/03/050447.

Our paper describes implementation of a study protocol for an outcome evaluation of a mobile game app called Go Nisha Go™, produced by the Game of Choice, Not Chance™ project, funded by USAID. Consenting adolescent girls, aged 15­19, from three cities in India will be enrolled to participate in an encouragement design led RCT. Girls will be randomly assigned to either, a) a treatment (encouragement) arm where they will be nudged to play the game for ten weeks, or b) a control arm where participants will not be provided any encouragement to download or play the game. The study will be evaluated using surveys at baseline and follow-up. The findings from this study will support the measurement of effectiveness of the digital intervention and facilitate scalability of a direct-to-consumer approach, using a game-based application to improve adolescent sexual and reproductive health outcomes in India.

A Design-Led Theory of Change for a Mobile Game App (Go Nisha Go) for Adolescent Girls in India: Multimix Methodology Study.

BACKGROUND: India has one of the largest adolescent populations in the world. Yet adolescents, particularly adolescent girls, have limited access to correct sexual and reproductive health information and services. The context in which adolescent girls live is one of gender inequity where they contend with early marriage and early pregnancy and have few opportunities for quality education and labor force participation. The digital revolution has expanded the penetration of mobile phones across India, increasingly being used by adolescent girls. Health interventions are also moving onto digital platforms. Evidence has shown that applications of game elements and game-based learning can be powerful tools in behavior change and health interventions. This provides a unique opportunity, particularly for the private sector, to reach and empower adolescent girls directly with information, products, and services in a private and fun manner. OBJECTIVE: The objective of this paper is to describe how a design-led Theory of Change (ToC) was formulated for a mobile game app that is not only underpinned by theories of various behavior change models but also identifies variables and triggers for in-game behavioral intentions that can be tracked and measured within the game and validated through a rigorous post-gameplay outcome evaluation. METHODS: We describe the use of a multimix methodology to formulate a ToC informing behavioral frameworks and co-design approaches in our proof-of-concept product development journey. This process created a statement of hypothesis and "pathways to impact" with a continuous, cumulative, and iterative design process that included key stakeholders in the production of a smartphone app. With theoretical underpinnings of social behavior and modeling frameworks, systematic research, and other creative methods, we developed a design-led ToC pathway that can delineate complex and multidisciplinary outputs for measuring impact. RESULTS: The statement of hypothesis that emerged posits that "If girls virtually experience the outcomes of choices that they make for their avatar in the mobile game, then they can make informed decisions that direct the course of their own life." Four learning pathways (DISCOVER, PLAY, DECIDE, and ACT) are scaffolded on 3 pillars of evidence, engagement, and evaluation to support the ToC-led framework. It informs decision-making and life outcomes through game-based objectives and in-game triggers that offer direct access to information, products, and services. CONCLUSIONS: This approach of using a multimix methodology for identifying varied and multidisciplinary pathways to change is of particular interest to measuring the impact of innovations, especially digital products, that do not necessarily conform with traditional behavioral change models or standard co-design approaches. We also explain the benefits of using iterative and cumulative inputs to integrate ongoing user feedback, while identifying pathways to various impacts, and not limiting it to only the design and development phase.

Detection of LOH and mitochondrial DNA alterations in ductal lavage and nipple aspirate fluids from hngh-risk patients.

We describe a method for the isolation of free DNA from ductal lavage (DL) and nipple aspirate fluid (NAF), and its evaluation for the presence of LOH at the BRCA1 and FHIT genes and for mitochondrial DNA (mtDNA) mutations at the D310 marker, to improve early detection of breast cancer. We evaluated 26 DL and six NAF samples from 14 women of known BRCA1 status, who have no clinical evidence of breast tumors: nine mutation carriers and five non-carriers. LOH studies at the BRCA1 locus were possible in 19/26 DL samples, and at the FHIT locus in 16/26 samples. In 4/9 mutation carriers we found LOH at the BRCA1 allele, and in two of these we also found LOH at the FHIT allele. In one of the mutation carriers with BRCA1 LOH, invasive breast cancer was subsequently detected, and the tumor showed the same LOH as the DL. In one of the true negatives, BRCA1 and FHIT LOH were detected. The mitochondrial studies were possible in all 26 DL samples and a somatic mutation was found in 3/9 carriers, two of whom also had LOH at the BRCA1 locus, and in none of the non-carriers. mtDNA mutation evaluation was possible in 4/6 NAF samples. The NAF and DL results were concordant. One NAF sample from a BRCA1 patient showed a mtDNA mutation. Our data demonstrates the feasibility of performing molecular studies using the free DNA present in the ductal fluid, while the intact cells can be used for cytologic studies.