Background: Although teen pregnancy rates decreased dramatically in the United States over the past decade, the rates of sexually transmitted infections (STIs) among adolescents and young adults increased. STI rates disproportionately affect African American youth and young adults. Innovative, accessible, and culturally relevant sexual health interventions are urgently needed. Objective: This study aimed to identify the optimal modality for a game-based sexual health intervention; develop the educational, entertainment, and technological aspects of the serious game; and demonstrate its usability and acceptance by the target population. Methods: This project was grounded in formative data collection with community-based participatory research principles and practices combined with a user-centered design and development approach. Sexually Active Adolescent–Focused Education (SAAFE) was developed using input and feedback from African American youths aged 15 to 21 years who participated in a youth advisory board and focus group discussions to inform the co-design and cocreation of the serious game. The process was highly iterative with multiple sessions for user input following design changes. It proceeded in 3 stages. Social cognitive theory and problem-solving theory were leveraged to provide evidence-based, trauma-informed education through a serious game. Usability testing assessed the quality of user experience with the prototype. Results: Across all 3 stages, a total of 86 self-identified African American males and females aged 15 to 21 years from the District of Columbia and Birmingham, Alabama, participated. Participants requested a dating simulation game. They wanted SAAFE to be customizable, realistic, entertaining, educational, modern, and experiential, linking consequences to their gameplay decisions. Usability testing resulted in an initial System Usability Survey score of 77.7, placing the game in the 82nd percentile and above average for usability. Conclusions: Initial results suggest that the SAAFE prototype is a promising intervention to engage African American youth in sexual health education using a role-playing game. If proven efficacious, the game has the potential to meet the need for sex education, counterbalance unhealthy portrayals of sex in popular media, and respond to the disparities in the STI epidemic.

Background: The majority of women who are pregnant with opioid use disorder (OUD) also smoke tobacco but are rarely offered tobacco cessation counseling. While the effects of exposure to opioids and nicotine in utero are well-understood separately, understanding the impact of the combined exposure to these substances on neonatal outcomes is lacking. Methods: A scoping review was conducted using PubMed and Scopus databases for studies addressing the combined exposure to opioids and nicotine during pregnancy published between 1 January 1980 and 9 July 2019. A total of 29 papers met the eligibility criteria for inclusion, with nine being identified as clinical trials (three from the MOTHER study) and two as secondary data analysis of clinical trial data. Results: Neonatal outcomes for infants who had a combined exposure to opioids and nicotine in utero indicated a reduction in birth weight and birth length. Findings in infants exposed to both nicotine and opioids were mixed with regard to the duration of neonatal abstinence syndrome (NAS), the likelihood of treatment for NAS, doses of medicine used to treat NAS, and NAS scores when compared with infants who had opioid exposure without nicotine. Conclusions: The combined exposure to nicotine and opioids during pregnancy may lead to a reduction in neonatal birth weight and birth length and more severe NAS signs, compared with opioid use alone, but more research is necessary to identify the minimum dosage and length of nicotine exposure to accurately predict these outcomes.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Exclusive breastfeeding (EBF) through 6 months of age in most low- and middle-income countries (LMICs) is surprisingly low. In India, an LMIC, EBF rates fall well below the World Health Organization benchmark of 90%. There has been a relative lack of mobile health (mHealth) applications that specifically focus on leveraging the use of peer counselors (PCs) to support mothers as a means of increasing exclusive breastfeeding practices in LMICs. Objective: A key study objective was to design, develop, and test the usability of BEST4Baby, a mHealth app specifically designed to support PCs in providing in-home breastfeeding counseling support to mothers in rural India around optimal breastfeeding practices. Methods: To develop and test BEST4Baby, we applied behavioral theories (i.e., social cognitive theory and theory of planned behavior) to a user-centered design (UCD) process with an Agile development methodology. The approach involved stakeholders and PCs to guide BEST4Baby’s design and development including the app’s content and features. PCs were engaged through the use of focus groups with interactive wireframes. Their feedback helped finalize the design prior to development. During the 24-month study period, we conducted a feasibility test of the BEST4Baby app with 23 PCs that supported mothers residing in rural India in a pilot study that incorporated an intervention (n=110) and control (n=112) group. The intervention protocol required PCs to provide education and follow mothers using BEST4Baby from the late prenatal stage of pregnancy through 6 months postpartum. BEST4Baby’s usability from the PCs’ perspective was assessed using a translated System Usability Scale (SUS). Results: The findings of this study align with best practices in UCD (i.e., understand user experience, context with iterative design with stakeholders) to address EBF barriers. It led to the cultural tailoring and contextual alignment of an evidence-based WHO breastfeeding program with iterative design and Agile development of the BEST4Baby app. The approach translated to a highly usable BEST4BABY app for employment by PCs for breastfeeding counseling that has been shown to statistically increase EBF practices. PCs rated BEST4Baby as highly usable, scoring it over the 95th percentile on the SUS scale. Conclusions: Findings suggest that BEST4Baby was highly usable and accepted by PCs in supporting mothers in their EBF practices and led to positive outcomes in the intervention group’s EBF rates. The pilot demonstrated that the use of the specially designed BEST4Baby app was an important support tool for PCs during the nine home visitations.

BACKGROUND Although teen pregnancy rates decreased dramatically in the United States over the past decade, the rates of sexually transmitted infections (STIs) among adolescents and young adults increased. STI rates disproportionately affect African American youth and young adults. Innovative, accessible, and culturally relevant sexual health interventions are urgently needed. OBJECTIVE This study aimed to identify the optimal modality for a game-based sexual health intervention; develop the educational, entertainment, and technological aspects of the serious game; and demonstrate its usability and acceptance by the target population. METHODS This project was grounded in formative data collection with community-based participatory research principles and practices combined with a user-centered design and development approach. Sexually Active Adolescent–Focused Education (SAAFE) was developed using input and feedback from African American youths aged 15 to 21 years who participated in a youth advisory board and focus group discussions to inform the co-design and cocreation of the serious game. The process was highly iterative with multiple sessions for user input following design changes. It proceeded in 3 stages. Social cognitive theory and problem-solving theory were leveraged to provide evidence-based, trauma-informed education through a serious game. Usability testing assessed the quality of user experience with the prototype. RESULTS Across all 3 stages, a total of 86 self-identified African American males and females aged 15 to 21 years from the District of Columbia and Birmingham, Alabama, participated. Participants requested a dating simulation game. They wanted SAAFE to be customizable, realistic, entertaining, educational, modern, and experiential, linking consequences to their gameplay decisions. Usability testing resulted in an initial System Usability Survey score of 77.7, placing the game in the 82nd percentile and above average for usability. CONCLUSIONS Initial results suggest that the SAAFE prototype is a promising intervention to engage African American youth in sexual health education using a role-playing game. If proven efficacious, the game has the potential to meet the need for sex education, counterbalance unhealthy portrayals of sex in popular media, and respond to the disparities in the STI epidemic.