Golfo Tzilos Wernette

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

Introduction: Cannabis use during pregnancy is rising, in part due to an increased perception of safety and legalization across the country. National guidelines recommend that clinicians universally screen for substance use, including cannabis use, during pregnancy. Methods: This is a longitudinal study assessing cannabis use frequency and reasons for use at baseline and patient‐clinician communication at 4 study timepoints. Data are drawn from a randomized controlled trial testing an innovative, technology‐delivered brief intervention, Health Check‐up for Expectant Moms , with 176 pregnant cisgender women (mean age, 30.2; SD, 5.02; 25.6% Black) reporting substance use risk, condomless sex, and multiple sexual partners. We used t ‐tests, chi‐square tests, Fisher's exact tests, and logistic regression to analyze the data. Results: Overall, 18.2% (n = 32) self‐reported current cannabis use at baseline, and 26.1% (n = 46) reported past year use. The most cited reason for use was relaxation or tension relief. Black women were significantly more likely than White women to have reported being talked to by their clinician about cannabis use in general during pregnancy and breastfeeding at every timepoint (all timepoints P ≤ .01). Clustered logistic regression analysis also showed higher odds for Black women to have been talked to about cannabis use in general compared with White women (adjusted odds ratio, 4.09; 95% CI, 2.29‐7.32; P < .0001), and this significance prevailed even after adjusting for prior cannabis use. Discussion: Seeking relaxation or tension relief was the most cited reason for use during pregnancy. Results suggest a racial bias that led to significantly more Black women being asked about cannabis use during pregnancy or breastfeeding at every timepoint, as compared with White women. There is a need for systemic and clinician‐level improvement in universal screening and counseling.

Purpose: This study evaluated the efficacy of an online intervention targeting intimate partner violence (IPV) in perinatal women, S trength for U in R elationship E mpowerment (SURE), relative to an attention, time, and information-matched control, on IPV severity, positive affect and well-being, and perceived emotional support across a 12-month follow-up. Methods: Perinatal women ( N = 122) who reported past 12-month IPV and recently engaged in mental health treatment were randomized to SURE ( n = 65) or control ( n = 57). SURE participants received a 40-minute online intervention based in motivational interviewing and empowerment. Control participants viewed a 40-minute online video of popular entertainment, followed by questions about preferences. Both conditions also included a brief 10-15-minute telephone-delivered booster session one month after the online session. Follow-up assessments occurred at 6 weeks, and 3-, 6-, and 12-months since the baseline visit. Results: Both interventions exhibited a significant drop in IPV severity from baseline to 12-month follow-up, with no significant differences between arms (range of standardized effect sizes for the time by group interaction = 0.20–1.65). Significant intervention effects were found for both positive affect and well-being (range of standardized effect sizes for the time by group interaction = -0.04-1.62) and perceived emotional support (range of standardized effect sizes for the time by group interaction = 0.65–2.10), where participants in SURE exhibited significant increases in both outcomes, while control participants did not. Conclusion: Results suggest that SURE provides a good model for an online intervention for perinatal women who have sought mental health services.

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

The impact of the COVID-19 pandemic on recruitment has been significant, including the recruitment of pregnant individuals with behavioral health risk factors. The objective of this manuscript is to highlight our response to the methodological challenges created by the pandemic and how we leveraged technology to adapt and expand our recruitment procedures for the Health Check-up for Expectant Moms, a technology-delivered behavioral skills intervention aimed at empowering and motivating pregnant women engaging in substance use and sexual health risks (e.g., condomless sex, multiple partners) to reduce their likelihood of STIs and substance use during pregnancy. After the onset of the pandemic, we transitioned from in-person recruitment to remote clinic recruitment (e.g., by phone, text messaging, and e-mail) as well as social media campaigns via Facebook® and Instagram® with a confidential web-based screening questionnaire for our study targeting pregnant women in 27 counties of Michigan. For remote recruitment, we contacted 6238 women; 1360 completed the study screening questionnaire (mean age = 31.5; SD = 4.6), 90 were eligible, and 73 were enrolled (6% eligibility). For social media recruitment, we had 2512 completing the pre-screening questionnaire. Of these, 501 (mean age = 31.9; SD = 4.6) went on to complete the full study screening questionnaire, 25 women were eligible, and 20 were enrolled (5%). Our 5% eligibility rate from our social media campaign is on par with our remote and in-clinic recruitment methods yet took far less time (15 weeks vs. 150 weeks vs. 48 weeks, respectively). Despite study recruitment challenges related to the pandemic, remote recruitment—particularly social media—was found to be a successful approach, may have a broader reach, and a cost-effective alternative to active recruitment.

Background: Women of childbearing age (aged 18-44 years) face multiple barriers to receiving screening and treatment for unhealthy alcohol and substance use, depression, and anxiety, including lack of screening in the primary care setting and lack of support in accessing care. The Women Empowered to Connect with Addiction Resources and Engage in Evidence-based Treatment (WE-CARE) mobile app was developed to test universal screening with women of childbearing age and linkage to care after an anonymous assessment. Objective: In this study, we aimed to investigate the feasibility and acceptability of providing anonymous screening instruments through mobile phones for alcohol and substance use, as well as depression and anxiety, for women of childbearing age. Methods: We used agile development principles based on previous formative research to test WE-CARE mobile health app with women of childbearing age (N=30) who resided in 1 of 6 counties in central Florida. WE-CARE included screening instruments (for alcohol, substance use, depression, and anxiety), a moderated discussion forum, educational microlearning videos, a frequently asked questions section, and resources for linkage to treatment. Individuals were recruited using flyers, academic listserves, and a commercial human subject recruiting company (Prolific). Upon completion of the screening instruments, women explored the educational and linkage to care features of the app and filled out a System Usability Scale to evaluate the mobile health app’s usability and acceptability. Postpilot semistructured interviews (n=4) were conducted to further explore the women’s reactions to the app. Results: A total of 77 women downloaded the application and 30 completed testing. Women of childbearing age gave the WE-CARE app an excellent System Usability Scale score of 86.7 (SD 12.43). Our results indicate elevated risk for substance use in 18 of the 30 (60%) participants, 9/18 (50%) also had an elevated risk for anxiety or depression, and 11/18 (61%) had an elevated risk for substance use, anxiety, or depression. Participants reported that WE-CARE was easy to navigate and use but they would have liked to see more screening questions and more educational content. Linkage to care was an issue; however, as none of the women identified as “at-risk” for substance use disorders contacted the free treatment clinic for further evaluation. Conclusions: The mobile health app was highly rated for acceptability and usability, but participants were not receptive to seeking help at a treatment center after only a few brief encounters with the app. The linkage to care design features was likely insufficient to encourage them to seek treatment. The next version of WE-CARE will include normative scores for participants to self-evaluate their screening status compared with their age- and gender-matched peers and enhanced linkages to care features. Future development will focus on enhancing engagement to improve change behaviors and assess readiness for change.

Introduction: Cigarette smoking is the leading cause of preventable death in the United States. We evaluate the feasibility and acceptability of a digital incentive-based intervention for tobacco cessation among Medicaid beneficiaries with a pilot micro-randomized trial.Methods: Participants (N=37; 63.9% annual income <$15,000), self-enrolled across community-based health centers, were incentivized monetarily to submit breath samples twice daily for four weeks, with additional incentives for negative samples (≤6 parts per million carbon monoxide). Participants were randomized twice daily with fixed probability (0.48) to be sent motivational messages or not via an app. We evaluate acceptability and feasibility of the program. Using a generalization of regression suitable for a binary outcome, we examine the average effect of delivering a message (vs. no message) on proximal sample submissions and smoking status.Results: Thirty-three participants who completed a post-test assessment (97.1%) reported would recommend the program to others. Participants submitted samples during 69.5% of submission windows and 61.3% of participants were smoke free at post-test. After adjusting for previous sample submission, participants were 7% more likely (risk ratio (RR) 1.073; 95% confidence interval [CI]: [1.010,1.140]) to submit a sample after a motivational message was delivered (vs. not delivered). Participants were 7% less likely (RR 0.931; 95%CI: [0.827,1.048]) to submit a positive sample (vs. negative), although not statistically significant.Conclusions: The results support the incorporation of motivational messages into research involving incentive-based treatments for tobacco cessation.

BACKGROUND Women of childbearing age (WOCA,18-44 years of age) face multiple barriers to receiving screening and treatment for unhealthy alcohol and substance use, depression, and anxiety, including lack of screening in the primary care setting and lack of support in accessing care. The Women Empowered to Connect with Addiction Resources and Engage in Evidence-based Treatment (WE-CARE) mobile app was developed to test universal screening with WOCA and linkage to care after an assessment for substance use disorder (SUD). OBJECTIVE In this study, we aimed to investigate the feasibility and acceptability of providing anonymous screening instruments for alcohol and substance use, as well as depression and anxiety, for women of childbearing age through mobile phones. METHODS We used Agile development principles based on prior formative research to create an alpha version of a WE-CARE mobile health application that was piloted with WOCA (N = 30) who resided in one of six counties in Central Florida. WE-CARE included screening instruments (for substance use, depression, and anxiety), a moderated discussion forum, educational micro-learning videos, an FAQ section, and resources for linkage to treatment. Individuals were recruited using flyers, academic listservs, and a commercial human subject survey company (Prolific). Upon completion of the screening instruments, women explored the educational and linkage to care features of the app and filled out a System Usability Scale (SUS) to evaluate the mobile health app’s usability and acceptability. Post-pilot semi-structured interviews (n = 4) were conducted to further explore the women’s reactions to the application. RESULTS Seventy-seven women downloaded the application and 30 completed testing. WOCA gave the WE-CARE app an excellent SUS score of 86.7 + 12.43 (SD). Out of the 30 participants (African American (N=1, 3.3%), Hispanic (N=6, 20%), more than one race (N=5,16.7%), White (N=14, 46.7%), Unknown (N=7, 23.3%)), 60% (n=18) had results indicating elevated risk for substance use, 50% of these 18 (n=9/18) indicated elevated risk also for anxiety or depression, and 61% (n=11/18) indicated elevated risk for substance use and/or anxiety or depression. Participants reported that WE-CARE was easy to navigate and use but they would like to see more screening questions and more educational content. However, linkage to care was an issue, as none of the women identified as ‘at-risk’ for SUDs contacted the free treatment clinic for further evaluation. CONCLUSIONS The mobile health application was highly rated for acceptability and usability, but participants were not receptive to seeking help at a treatment center after only a few brief encounters with the application. The linkage to care design features was likely insufficient to encourage them to seek treatment. The beta version of WE-CARE will include normative scores for participants to self-evaluate their screening status compared to their age- and gender-matched peers and enhanced linkages to care features. Future development will focus on improving engagement to change behaviors and assess readiness for change.

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