Kristina Countryman

Background: Sexually transmitted infections (STIs) are at a record high in the United States and are a significant health problem for childbearing women. Rates of substance use, particularly cannabis and opioid use, have increased in recent years and are linked to negative health consequences for pregnant women and their infants. Addressing these health concerns together during this vulnerable time is a priority. Objective: This study aims to test whether the Health Check-Up for Expectant Moms (HCEM), an innovative, theory-driven, technology-delivered, and fully automated brief intervention, reduced condomless sex and STI risk, alcohol, or drug use, compared to a control condition in pregnant women seeking prenatal care. Methods: We recruited a sample of 176 pregnant women (all were at risk for alcohol or drug use or STIs during pregnancy) from clinics and using social media campaigns (Facebook and Instagram) in the state of Michigan and randomized them to the motivational interviewing-consistent HCEM intervention or to an attention-, time-, and information-matched control condition delivered using the same technology platform. We followed these women at 2 and 6 months after the initial intervention visit. Primary outcomes included self-report assessment of alcohol, drug, or cannabis use and unprotected sexual occasions during pregnancy. Results: A total of 88 women were randomized to the intervention, and 88 to the control condition. Cannabis use was the most prevalent substance reported during pregnancy; a total of 35.2% (62/176) reported recent use (within the last 90 days) at baseline, with 10.2% (18/176) reporting use in the month prior to baseline. There were significant reductions in alcohol and cannabis use over time during pregnancy (at 2 and 6 months compared to baseline) in both HCEM and control groups; however, these reductions were not significantly different between conditions (time-by-arm interaction), and most were sustained from spontaneous reductions reported in the month before study enrollment. Moreover, there were no statistically significant differences in the change pattern of condomless sex across the groups at either follow-up. Conclusions: There are many potential benefits of a technology-delivered approach to support the behavioral health of pregnant women in a private and convenient way. Our sample was largely low-risk, and as such, an intervention effect may have been impossible to observe given substantial self-change. Future trials are needed to examine efficacy in other samples of pregnant women with a higher risk of current alcohol or drug use. Trial Registration: ClinicalTrials.gov NCT03826342; https://clinicaltrials.gov/study/NCT03826342 International Registered Report Identifier (IRRID): RR2-10.2196/30367

BACKGROUND Sexually transmitted infections (STIs) are at a record high in the United States and are a significant health problem for childbearing women. Rates of substance use, particularly cannabis and opioid use, have increased in recent years and are linked to negative health consequences for pregnant women and their infants. Addressing these health concerns together during this vulnerable time is a priority. OBJECTIVE This study aims to test whether the Health Check-Up for Expectant Moms (HCEM), an innovative, theory-driven, technology-delivered, and fully automated brief intervention, reduced condomless sex and STI risk, alcohol, or drug use, compared to a control condition in pregnant women seeking prenatal care. METHODS We recruited a sample of 176 pregnant women (all were at risk for alcohol or drug use or STIs during pregnancy) from clinics and using social media campaigns (Facebook and Instagram) in the state of Michigan and randomized them to the motivational interviewing-consistent HCEM intervention or to an attention-, time-, and information-matched control condition delivered using the same technology platform. We followed these women at 2 and 6 months after the initial intervention visit. Primary outcomes included self-report assessment of alcohol, drug, or cannabis use and unprotected sexual occasions during pregnancy. RESULTS A total of 88 women were randomized to the intervention, and 88 to the control condition. Cannabis use was the most prevalent substance reported during pregnancy; a total of 35.2% (62/176) reported recent use (within the last 90 days) at baseline, with 10.2% (18/176) reporting use in the month prior to baseline. There were significant reductions in alcohol and cannabis use over time during pregnancy (at 2 and 6 months compared to baseline) in both HCEM and control groups; however, these reductions were not significantly different between conditions (time-by-arm interaction), and most were sustained from spontaneous reductions reported in the month before study enrollment. Moreover, there were no statistically significant differences in the change pattern of condomless sex across the groups at either follow-up. CONCLUSIONS There are many potential benefits of a technology-delivered approach to support the behavioral health of pregnant women in a private and convenient way. Our sample was largely low-risk, and as such, an intervention effect may have been impossible to observe given substantial self-change. Future trials are needed to examine efficacy in other samples of pregnant women with a higher risk of current alcohol or drug use. CLINICALTRIAL ClinicalTrials.gov NCT03826342; https://clinicaltrials.gov/study/NCT03826342 INTERNATIONAL REGISTERED REPORT RR2-10.2196/30367

Background: The identification of interconnected health risks during the perinatal period offers an opportunity to prevent negative maternal and infant health outcomes. Marijuana, opioid, and other substance use during pregnancy is a rapidly growing public health concern with significant and costly health consequences for the woman and the developing fetus. Pregnant persons who misuse substances are disproportionately more likely to engage in risky sexual behaviors resulting in sexually transmitted infections (STIs), which are on the rise in this population and can lead to adverse effects on maternal health and on fetal development. Objective: Our goal is to continue testing an innovative and low-cost technology-delivered intervention, the Health Check-Up for Expectant Moms (HCEM), which simultaneously targets alcohol and drug use and STI risk during pregnancy, both of which are on the rise during the COVID-19 pandemic. Methods: We describe the ways in which we have adapted the web-based HCEM intervention to continue recruitment and study enrollment during the pandemic. Results: Study recruitment, visits, and participant safety assessments were all successfully modified during the initial year of the COVID-19 pandemic. Compared to in-person recruitment that occurred prepandemic, remote recruitment yielded a greater proportion of women enrolled in the study (83/136, 61.0% vs 43/52, 83%) in a shorter period (12 months vs 7 months). Conclusions: Despite study challenges related to the pandemic, including time and effort adapting to a remote protocol, remote recruitment and visits for this study were found to constitute a successful approach. Trial Registration: ClinicalTrials.gov NCT03826342; https://clinicaltrials.gov/ct2/show/NCT03826342 International Registered Report Identifier (IRRID): DERR1-10.2196/30367

BACKGROUND The identification of interconnected health risks during the perinatal period offers an opportunity to prevent negative maternal and infant health outcomes. Marijuana, opioid, and other substance use during pregnancy is a rapidly growing public health concern with significant and costly health consequences for the woman and the developing fetus. Pregnant persons who misuse substances are disproportionately more likely to engage in risky sexual behaviors resulting in sexually transmitted infections (STIs), which are on the rise in this population and can lead to adverse effects on maternal health and on fetal development. OBJECTIVE Our goal is to continue testing an innovative and low-cost technology-delivered intervention, the Health Check-Up for Expectant Moms (HCEM), which simultaneously targets alcohol and drug use and STI risk during pregnancy, both of which are on the rise during the COVID-19 pandemic. METHODS We describe the ways in which we have adapted the web-based HCEM intervention to continue recruitment and study enrollment during the pandemic. RESULTS Study recruitment, visits, and participant safety assessments were all successfully modified during the initial year of the COVID-19 pandemic. Compared to in-person recruitment that occurred prepandemic, remote recruitment yielded a greater proportion of women enrolled in the study (83/136, 61.0% vs 43/52, 83%) in a shorter period (12 months vs 7 months). CONCLUSIONS Despite study challenges related to the pandemic, including time and effort adapting to a remote protocol, remote recruitment and visits for this study were found to constitute a successful approach. CLINICALTRIAL ClinicalTrials.gov NCT03826342; https://clinicaltrials.gov/ct2/show/NCT03826342 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30367

Background Sexually transmitted infections (STIs) are on the rise in the United States, and adolescent girls (15-19 years old) are more susceptible to acquiring STIs than their male peers. The co-occurrence of alcohol use and sexual risk taking contribute significantly to STI acquisition. Mobile health (mHealth) interventions are ideally suited for our target population and have demonstrated increases in STI testing in young people, as well as reductions in alcohol use. Objective This pilot study used both qualitative and quantitative methods to explore the views of adolescent girls (age range 15-19 years old; 74.6%, 279/374 white) on the desired qualities and content of an mHealth app for sexual health. Methods We conducted nine 60-min in-depth interviews (IDIs) to gather information and identify themes of sexual health and alcohol use, and we tested the feasibility of using a two-week social media campaign to collect survey information regarding sexual health risk in adolescent girls. Results We iteratively coded IDIs and identified major themes around pressure of alcohol use, lack of STI knowledge, male pressure to not use condoms, and pregnancy as a worse outcome than STIs. Results from the web-based survey on risky health behaviors, which was completed by 367 participants, support the use of a sexual health app designed for girls. Conclusions Future work will integrate these themes to inform the development of a culturally sensitive mHealth app to prevent STIs among adolescent girls.

Background: Few HIV interventions have demonstrated efficacy in reducing HIV risk among adolescent men who have sex with men (AMSM), and fewer still have recognized the unique needs of AMSM based on race/ethnicity or geographical setting. Recognizing that youths’ HIV vulnerability is intricately tied to their development and social context, delivering life skills training during adolescence might delay the onset or reduce the consequences of risk factors for HIV acquisition and equip AMSM with the skills to navigate HIV prevention. This protocol describes the development and testing of iREACH, an online multilevel life skills intervention for AMSM. Objective: This randomized controlled trial (RCT) aims to test the efficacy of an online-delivered life skills intervention, iREACH, on cognitive and behavioral HIV-related outcomes for AMSM. Methods: iREACH is a prospective RCT of approximately 600 cisgender adolescent males aged 13 to 18 years who report same-sex attractions. The intervention will be tested with a racial/ethnically diverse sample (≥50% racial/ethnic minority) of AMSM living in four regions in the United States: (1) Chicago to Detroit, (2) Washington, DC to Atlanta, (3) San Francisco to San Diego, and (4) Memphis to New Orleans. Results: This project is currently recruiting participants. Recruitment began in March 2018. Conclusions: iREACH represents a significant innovation in the development and testing of a tailored life skills-focused intervention for AMSM, and has the potential to fill a significant gap in HIV prevention intervention programming and research for AMSM. Registered Report Identifier: RR1-10.2196/10174

BACKGROUND Few HIV interventions have demonstrated efficacy in reducing HIV risk among adolescent men who have sex with men (AMSM), and fewer still have recognized the unique needs of AMSM based on race/ethnicity or geographical setting. Recognizing that youths’ HIV vulnerability is intricately tied to their development and social context, delivering life skills training during adolescence might delay the onset or reduce the consequences of risk factors for HIV acquisition and equip AMSM with the skills to navigate HIV prevention. This protocol describes the development and testing of iREACH, an online multilevel life skills intervention for AMSM. OBJECTIVE This randomized controlled trial (RCT) aims to test the efficacy of an online-delivered life skills intervention, iREACH, on cognitive and behavioral HIV-related outcomes for AMSM. METHODS iREACH is a prospective RCT of approximately 600 cisgender adolescent males aged 13 to 18 years who report same-sex attractions. The intervention will be tested with a racial/ethnically diverse sample (≥50% racial/ethnic minority) of AMSM living in four regions in the United States: (1) Chicago to Detroit, (2) Washington, DC to Atlanta, (3) San Francisco to San Diego, and (4) Memphis to New Orleans. RESULTS This project is currently recruiting participants. Recruitment began in March 2018. CONCLUSIONS iREACH represents a significant innovation in the development and testing of a tailored life skills-focused intervention for AMSM, and has the potential to fill a significant gap in HIV prevention intervention programming and research for AMSM. REGISTERED REPORT IDENTIFIER RR1-10.2196/10174