Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths.

BACKGROUND: Evidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices. METHODS: In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults. RESULTS: During the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year. CONCLUSIONS: In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).

Measuring intersectional HIV, sexual diversity, and gender non-conformity stigma among healthcare workers in Ghana: scale validation and correlates of stigma.

BACKGROUND: Men who have sex with men (MSM) are at heightened risk for HIV acquisition, yet they may delay or avoid HIV testing due to intersectional stigma experienced at the healthcare facility (HCF). Few validated scales exist to measure intersectional stigma, particularly amongst HCF staff. We developed the Healthcare Facility Staff Intersectional Stigma Scale (HCF-ISS) and assessed factors associated with stigma in Ghana. METHODS: We analyzed baseline data from HCF staff involved in a study testing a multi-level intervention to reduce intersectional stigma experienced by MSM. Data are from eight HCFs in Ghana (HCF Staff n = 200). The HCF-ISS assesses attitudes and beliefs towards same-sex relationships, people living with HIV (PLWH) and gender non-conformity. Exploratory factor analysis assessed HCF-ISS construct validity and Cronbach's alphas assessed the reliability of the scale. Multivariable regression analyses assessed factors associated with intersectional stigma. RESULTS: Factor analysis suggested an 18-item 3-factor scale including: Comfort with Intersectional Identities in the Workplace (6 items, Cronbach's alpha = 0.71); Beliefs about Gender and Sexuality Norms (7 items, Cronbach's alpha = 0.72); and Beliefs about PLWH (5 items, Cronbach's alpha = 0.68). Having recent clients who engage in same-gender sex was associated with greater comfort with intersectional identities but more stigmatizing beliefs about PLWH. Greater religiosity was associated with stigmatizing beliefs. Infection control training was associated with less stigma towards PLWH and greater comfort with intersectional identities. CONCLUSIONS: Achieving the goal of ending AIDS by 2030 requires eliminating barriers that undermine access to HIV prevention and treatment for MSM, including HCF intersectional stigma. The HCF-ISS provides a measurement tool to support intersectional stigma-reduction interventions.

Patient Perceptions of Three Substance Use Screening Tools for Use During Pregnancy.

OBJECTIVES: The purpose of this study was to understand pregnant women's perceptions of three validated substance use screening tools and identify a preferred tool for use during pregnancy. The three screening tools studied included the 4P's Plus, the NIDA Quick Screen/ NIDA-Modified Alcohol, Smoking and Substance Involvement Screening Test, and the Substance Use Risk Profile-Pregnancy Scale. METHODS: A total of 493 cognitive interviews were completed with a diverse sample of pregnant women presenting to two obstetrics practices in Baltimore, MD from January 2017 to January 2018. This study served as a qualitative companion to a larger study comparing the accuracy and acceptability of substance use screening tools in prenatal care. After completing each screening tool, participants were asked their perceptions of the tool and to choose their preferred tool. Interviews were recorded, transcribed verbatim, coded, and analyzed using NVivo software. RESULTS: The plurality of participants (43.4%) reported they preferred the 4P's Plus. Fewer participants preferred the NIDA Quick Screen (32.5%) and the SURP-P (24.1%). Participants felt that the 4P's Plus was both comprehensive and concise. While many participants felt that disclosure of substance use would vary by individual, participants also suggested that when screening is confidential, includes questions about a patient's background, and administered by a non-judgmental provider, pregnant people may be more likely to answer honestly. CONCLUSIONS FOR PRACTICE: The 4P's Plus is a promising and acceptable substance use screening tool for use in prenatal care. Clinicians can use several methods to increase acceptability of substance use screening and encourage disclosure of prenatal substance use.

HIV Transmission Worry Predicts Discrimination Intentions Among Nursing Students and Ward Staff in India.

Health facility stigma impedes HIV care and treatment. Worry of contracting HIV while caring for people living with HIV is a key driver of health facility stigma, however evidence for this relationship is largely cross-sectional. This study evaluates this relationship longitudinally amongst nursing students and ward staff in India. Worry of contracting HIV and other known predictors of intent to discriminate were collected at baseline and 6 months in 916 nursing students and 747 ward staff. Using fixed effects regression models, we assessed the effect of key predictors on intent to discriminate over a 6-month period. Worry of contracting HIV predicted intent to discriminate for nursing students and ward staff in care situations with low and high-risk for bodily fluid exposure, confirming prior cross-sectional study results and underscoring the importance of addressing worry of contracting HIV as part of health facility HIV stigma-reduction interventions.

Prenatal Substance Use and Perceptions of Parent and Partner Use Using the 4P's Plus Screener.

Background Prenatal substance use screening is recommended. The 4 P's Plus screener includes questions on perceived problematic substance use in parents and partner that are not considered in risk stratification. Objectives This research examined the: (1) prevalence of self-reported problematic parental and partner substance use and associations with biochemically-verified prenatal substance use; (2) utility of self-reported perceptions of parent/partner substance use as proxies for prenatal substance use; and (3) degree to which the sensitivity of the 4P's Plus can be augmented with consideration of parent/partner questions in risk stratification. Methods A convenience sample of 500 pregnant women was recruited between January 2017 and January 2018. Participants completed the 4P's Plus and provided urine for drug testing. Diagnostic utility of problematic parent/partner substance use questions was assessed, then compared to the 4P's Plus used as designed, and to the 4P's Plus used with these 2 questions included in risk stratification. Results Half (51%) of respondents reported either partner or parental problematic substance use. When partner or parent problematic substance use were considered as proxies for prenatal substance use, sensitivity was 65% and specificity was 55%. When used as intended, sensitivity was 94% and specificity was 29%. Including partner/parent questions increased sensitivity to 96% but lowered specificity (19%). Partner substance use and combined partner/parent use were associated with prenatal substance use [adjusted odds ratio (aOR): 2.0 (1.2, 2.4; p = 0.006); aOR = 1.6 (1.1, 2.5, p = 0.04)]. Conclusions for Practice Sensitivity of the 4P's Plus may improve with inclusion of self-reported problematic partner/parent substance use items in risk stratification.

Cigarette Smoking Status and Substance Use in Pregnancy.

Objectives Substance use during pregnancy is a significant public health issue. Prenatal substance use increased in the past decade while prenatal cigarette smoking has remained stable. Co-use of tobacco and other drugs is a concern because of potential additive risks. This study aims to describe the prevalence rates of substance use among pregnant women and examine the association between smoking status (nonsmoker, recent quitter and current smoker) and other drug use. Methods In this cross-sectional study, pregnant women (n = 500) were recruited from two obstetric practices to complete three substance use screeners and have their urine tested for 12 different drug classes, including cannabis, opioids and cocaine. Participants were divided into three groups based on survey responses: nonsmokers, recent quitters (smoked in the month prior to pregnancy but not past month) and current smokers (past-month). Results Approximately 29% of participants reported smoking in the month before pregnancy. During pregnancy, 17, 12 and 71% were current smokers, recent quitters and nonsmokers respectively. Overall prevalence of illicit or prescription drug use in pregnancy was 27%. Cannabis was the most common drug used in pregnancy with prevalence of 22%, followed by opioids (4%), cocaine (1%), tricyclic antidepressants (TCAs) (1%), amphetamines (1%), and benzodiazepines (1%). On multivariable logistic regression, smoking in pregnancy was associated with a positive urine drug screen; with adjusted odds ratio (aOR) 4.7 (95% CI 2.6-8.3) for current smokers and 1.6 (95% CI 0.8-3.3) for recent quitters. Factors negatively associated with positive drug screen were second and third trimester pregnancies, 0.5 (0.3-0.9) and 0.3 (0.2-0.6) respectively; and employment, 0.5 (0.3-0.8). Conclusions for Practice Co-use of tobacco and illicit drugs, particularly cannabis, is relatively high during pregnancy. Additional research is needed to understand the health implications of co-use versus use of tobacco only. Given the strong association between smoking and other drug use, clinicians should routinely assess for illicit drug use in women who smoke during pregnancy.

Recurrence of cervical intraepithelial lesions after thermo-coagulation in HIV-positive and HIV-negative Nigerian women.

BACKGROUND: The burden of cervical cancer remains huge globally, more so in sub-Saharan Africa. Effectiveness of screening, rates of recurrence following treatment and factors driving these in Africans have not been sufficiently studied. The purpose of this study therefore was to investigate factors associated with recurrence of cervical intraepithelial lesions following thermo-coagulation in HIV-positive and HIV-negative Nigerian women using Visual Inspection with Acetic Acid (VIA) or Lugol's Iodine (VILI) for diagnosis. METHODS: A retrospective cohort study was conducted, recruiting participants from the cervical cancer "see and treat" program of IHVN. Data from 6 sites collected over a 4-year period was used. Inclusion criteria were: age ≥18 years, baseline HIV status known, VIA or VILI positive and thermo-coagulation done. Logistic regression was performed to examine the proportion of women with recurrence and to examine factors associated with recurrence. RESULTS: Out of 177 women included in study, 67.8 % (120/177) were HIV-positive and 32.2 % (57/177) were HIV-negative. Recurrence occurred in 16.4 % (29/177) of participants; this was 18.3 % (22/120) in HIV-positive women compared to 12.3 % (7/57) in HIV-negative women but this difference was not statistically significant (p-value 0.31). Women aged ≥30 years were much less likely to develop recurrence, adjusted OR = 0.34 (95 % CI = 0.13, 0.92). Among HIV-positive women, CD4 count <200cells/mm(3) was associated with recurrence, adjusted OR = 5.47 (95 % CI = 1.24, 24.18). CONCLUSION: Recurrence of VIA or VILI positive lesions after thermo-coagulation occurs in a significant proportion of women. HIV-positive women with low CD4 counts are at increased risk of recurrent lesions and may be related to immunosuppression.

Differences in perceptions of community stigma towards opioid use disorder between community substance use coalition members and the general public.

INTRODUCTION: To examine differences in perceptions about community stigma towards individuals with opioid use disorder (OUD) between community members involved in the opioid response (i.e., coalition members) and the general public, and how community geography may moderate this relationship. METHODS: This study administered identical cross-sectional surveys about perceived community opioid-related stigma to two distinct populations in 66 communities participating in the HEALing Communities Study prior to the intervention period (i.e., coalition members, November 2019-January 2020; residents, March-April 2020). Linear-mixed models compared survey responses of populations, including the moderating effect of community rural/urban location. RESULTS: A total of 826 coalition members and 1131 residents completed the surveys. The study found no differences between the coalition members and residents for general perceived community opioid-related stigma. In both urban and rural communities, coalition members reported greater perceived community stigma than residents reported towards medication for opioid use disorder (MOUD), naloxone, and drug treatment as an alternative to incarceration. CONCLUSION: Our findings suggest similar perceived community opioid-related stigma between coalition members and residents, yet differences emerge related to evidence-based practices (i.e., MOUD, naloxone, and drug treatment as an alternative to incarceration) to reduce opioid overdose deaths. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04111939.

Using community engagement to implement evidence-based practices for opioid use disorder: A data-driven paradigm & systems science approach.

Community-driven responses are essential to ensure the adoption, reach and sustainability of evidence-based practices (EBPs) to prevent new cases of opioid use disorder (OUD) and reduce fatal and non-fatal overdoses. Most organizational approaches for selecting and implementing EBPs remain top-down and individually oriented without community engagement (CE). Moreover, few CE approaches have leveraged systems science to integrate community resources, values and priorities. This paper provides a novel CE paradigm that utilizes a data-driven and systems science approach; describes the composition, functions, and roles of researchers in CE; discusses unique ethical considerations that are particularly salient to CE research; and provides a description of how systems science and data-driven approaches to CE may be employed to select a range of EBPs that collectively address community needs. Finally, we conclude with scientific recommendations for the use of CE in research. Greater investment in CE research is needed to ensure contextual, equitable, and sustainable access to EBPs, such as medications for OUD (MOUD) in communities heavily impacted by the opioid epidemic. A data-driven approach to CE research guided by systems science has the potential to ensure adequate saturation and sustainability of EBPs that could significantly reduce opioid overdose and health inequities across the US.

Validation of the NIDA-modified ASSIST as a Screening Tool for Prenatal Drug Use in an Urban Setting in the United States.

BACKGROUND: Screening for prenatal drug use is recommended. The NIDA-modified Alcohol, Smoking, and Substance Involvement Screening Test (NM-ASSIST) is a screener for drug use that has not yet been validated with pregnant women. This study aims to assess the substance-specific diagnostic validity of the NM-ASSIST (not including tobacco or alcohol) in pregnant women and determine optimal cut-points for substance-specific substance involvement (SI) scores. METHODS: Five hundred (500) pregnant women were recruited from 2 obstetric practices as part of a larger study of substance use screeners. Participants completed the NM-ASSIST, and provided urine and hair samples for testing. Receiver-operating characteristic curves were derived to determine the optimal SI score cut-points for each drug. FINDINGS: Prevalence estimates of prenatal drug use as determined by hair/urine drug testing were: cannabis (32.0%), cocaine (9.9%), benzodiazepines (1.0%), prescription opioids (4.3%), and street opioids (1.7%). The proportion of participants screening positive based on optimal SI score cut-points were as follows: cannabis (39.1%), cocaine (2.3%), benzodiazepines (0.8%), prescription opioids (2.7%), and street opioids (1.7%). There were no screen positives for amphetamines, but 6 (1.2%) women had a positive amphetamine hair or urine test. Optimal cut-points to identify prenatal drug use were: cannabis, 2 (area under the curve [AUC] 0.87; sensitivity 0.82; specificity 0.85; diagnostic odds ratio [DOR] 26.9); cocaine, 2 (AUC 0.58; sensitivity 0.17; specificity 0.99; DOR 29.0); benzodiazepines, 15 (AUC 0.59; sensitivity 0.20; specificity 0.99; DOR 38.8); prescription opioids, 3 (AUC 0.61; sensitivity 0.25; specificity 0.98; DOR 18.3); and street opioids, 4 (AUC 0.55; sensitivity 0.13; specificity 0.99; DOR 9.3). CONCLUSIONS: The NM-ASSIST reliably distinguished pregnant women who use cannabis from those who do not, but performed poorly for all other substances. More research is needed to identify screeners that reliably detect all prenatal drug use. Although more cost-prohibitive, a combination of self-report and toxicological screening may be preferable for detecting prenatal drug use.

Associations among experienced and internalized stigma, social support, and depression among male and female sex workers in Kenya.

OBJECTIVES: This study (1) estimated the association between experienced sex work-related stigma and moderate-to-severe depressive symptoms (hereafter depression), (2) examined independent associations between internalized stigma, experienced stigma, and depression among sex workers, and (3) investigated the potential modifying role of social support. METHODS: A cross-sectional survey was conducted among 729 male and female sex workers in Kenya. RESULTS: The prevalence of depression was 33.9%, and nearly all participants reported at least one of the experienced and internalized stigma items. Increasing levels of experienced stigma was associated with an increased predicted prevalence of depression [aPD 0.15 (95% CI 0.11-0.18)]. Increasing internalized stigma was independently associated with higher experienced stigma and depression and appeared to account for 25.5% of the shared variance between experienced stigma and depression after adjustment for confounders. Social support from same-sex sex workers did not appear to modify the association between experienced stigma and depression. CONCLUSIONS: Addressing the high levels of stigma that sex workers face and their mental health needs should be a public health and human rights imperative.

Prenatal Practice Staff Perceptions of Three Substance Use Screening Tools for Pregnant Women.

OBJECTIVE: There is a need to identify an acceptable and comprehensive substance use screening tool for pregnant women in the United States. This qualitative study sought to better understand prenatal practice staff perceptions of three existing substance use screening tools for use among pregnant women in an outpatient practice setting. METHODS: Eight focus groups with 40 total participants were conducted with clinical and administrative staff of 2 diverse Maryland prenatal practices to determine the acceptability and usability of 3 substance use screening tools (4P's Plus, NIDA-Modified Alcohol, Smoking and Substance Involvement Screening Test, and the Substance Use Risk Profile-Pregnancy scale). The focus groups were digitally recorded, transcribed, coded, and analyzed using thematic analysis. RESULTS: Participant perceptions of screening tools were dependent upon screening tool length, tone, comprehensiveness, subjectivity, time frame of questions, and scoring and clinician instructions. Most participants preferred the 4P's Plus screening tool because it is brief, comprehensive, easy for the patient to understand, and excludes judgmental language and subjective questions. CONCLUSIONS: These results provide valuable insight into the specific needs and preferences of prenatal practice staff as it relates to prenatal substance use screening and provides evidence that the 4P's Plus may be a preferred screening tool for standardized use in prenatal care.

Community dashboards to support data-informed decision-making in the HEALing communities study.

BACKGROUND: With opioid misuse, opioid use disorder (OUD), and opioid overdose deaths persisting at epidemic levels in the U.S., the largest implementation study in addiction research-the HEALing Communities Study (HCS)-is evaluating the impact of the Communities That Heal (CTH) intervention on reducing opioid overdose deaths in 67 disproportionately affected communities from four states (i.e., "sites"). Community-tailored dashboards are central to the CTH intervention's mandate to implement a community-engaged and data-driven process. These dashboards support a participating community's decision-making for selection and monitoring of evidence-based practices to reduce opioid overdose deaths. METHODS/DESIGN: A community-tailored dashboard is a web-based set of interactive data visualizations of community-specific metrics. Metrics include opioid overdose deaths and other OUD-related measures, as well as drivers of change of these outcomes in a community. Each community-tailored dashboard is a product of a co-creation process between HCS researchers and stakeholders from each community. The four research sites used a varied set of technical approaches and solutions to support the scientific design and CTH intervention implementation. Ongoing evaluation of the dashboards involves quantitative and qualitative data on key aspects posited to shape dashboard use combined with website analytics. DISCUSSION: The HCS presents an opportunity to advance how community-tailored dashboards can foster community-driven solutions to address the opioid epidemic. Lessons learned can be applied to inform interventions for public health concerns and issues that have disproportionate impact across communities and populations (e.g., racial/ethnic and sexual/gender minorities and other marginalized individuals). TRIAL REGISTRATION: ClinicalTrials.gov (NCT04111939).

Community engagement to implement evidence-based practices in the HEALing communities study.

BACKGROUND: The implementation of evidence-based practices to reduce opioid overdose deaths within communities remains suboptimal. Community engagement can improve the uptake and sustainability of evidence-based practices. The HEALing Communities Study (HCS) aims to reduce opioid overdose deaths through the Communities That HEAL (CTH) intervention, a community-engaged, data-driven planning process that will be implemented in 67 communities across four states. METHODS: An iterative process was used in the development of the community engagement component of the CTH. The resulting community engagement process uses phased planning steeped in the principles of community based participatory research. Phases include: 0) Preparation, 1) Getting Started, 2) Getting Organized, 3) Community Profiles and Data Dashboards, 4) Community Action Planning, 5) Implementation and Monitoring, and 6) Sustainability Planning. DISCUSSION: The CTH protocol provides a common structure across the four states for the community-engaged intervention and allows for tailored approaches that meet the unique needs or sociocultural context of each community. Challenges inherent to community engagement work emerged early in the process are discussed. CONCLUSION: HCS will show how community engagement can support the implementation of evidence-based practices for addressing the opioid crisis in highly impacted communities. Findings from this study have the potential to provide communities across the country with an evidence-based approach to address their local opioid crisis; advance community engaged research; and contribute to the implementation, sustainability, and adoption of evidence-based practices. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04111939).

The Opioid-overdose Reduction Continuum of Care Approach (ORCCA): Evidence-based practices in the HEALing Communities Study.

BACKGROUND: The number of opioid-involved overdose deaths in the United States remains a national crisis. The HEALing Communities Study (HCS) will test whether Communities That HEAL (CTH), a community-engaged intervention, can decrease opioid-involved deaths in intervention communities (n = 33), relative to wait-list communities (n = 34), from four states. The CTH intervention seeks to facilitate widespread implementation of three evidence-based practices (EBPs) with the potential to reduce opioid-involved overdose fatalities: overdose education and naloxone distribution (OEND), effective delivery of medication for opioid use disorder (MOUD), and safer opioid analgesic prescribing. A key challenge was delineating an EBP implementation approach useful for all HCS communities. METHODS: A workgroup composed of EBP experts from HCS research sites used literature reviews and expert consensus to: 1) compile strategies and associated resources for implementing EBPs primarily targeting individuals 18 and older; and 2) determine allowable community flexibility in EBP implementation. The workgroup developed the Opioid-overdose Reduction Continuum of Care Approach (ORCCA) to organize EBP strategies and resources to facilitate EBP implementation. CONCLUSIONS: The ORCCA includes required and recommended EBP strategies, priority populations, and community settings. Each EBP has a "menu" of strategies from which communities can select and implement with a minimum of five strategies required: one for OEND, three for MOUD, and one for prescription opioid safety. Identification and engagement of high-risk populations in OEND and MOUD is an ORCCArequirement. To ensure CTH has community-wide impact, implementation of at least one EBP strategy is required in healthcare, behavioral health, and criminal justice settings, with communities identifying particular organizations to engage in HCS-facilitated EBP implementation.

Model and approach for assessing implementation context and fidelity in the HEALing Communities Study.

BACKGROUND: In response to the U.S. opioid epidemic, the HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS) is a multisite, wait-listed, community-level cluster-randomized trial that aims to test the novel Communities That HEAL (CTH) intervention, in 67 communities. CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths. We present the rationale for and adaptation of the RE-AIM/PRISM framework and methodological approach used to capture the CTH implementation context and to evaluate implementation fidelity. METHODS: HCS measures key domains of the internal and external CTH implementation context with repeated annual surveys and qualitative interviews with community coalition members and key stakeholders. Core constructs of fidelity include dosage, adherence, quality, and program differentiation-the adaptation of the CTH intervention to fit each community's needs. Fidelity measures include a monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes. Training and technical assistance delivered by the research sites to the communities are tracked monthly. DISCUSSION: To help attenuate the nation's opioid epidemic, the adoption of EBPs must be increased in communities. The HCS represents one of the largest and most complex implementation research experiments yet conducted. Our systematic examination of implementation context and fidelity will significantly advance understanding of how to best evaluate community-level implementation of EBPs and assess relations among implementation context, fidelity, and intervention impact.

Accuracy of Three Screening Tools for Prenatal Substance Use.

OBJECTIVE: To compare and evaluate the accuracy of three screening tools in identifying illicit drug use and prescription drug misuse among a diverse sample of pregnant women. METHODS: This prospective cross-sectional study enrolled a consecutive sample of 500 pregnant women, stratified by trimester, receiving care in two prenatal clinical settings in Baltimore, Maryland, from January 2017 to January 2018. All participants were administered three index tests: 4P's Plus, NIDA Quick Screen-ASSIST (Modified Alcohol, Smoking and Substance Involvement Screening Test), and the SURP-P (Substance Use Risk Profile-Pregnancy) scale, and administered reference tests (urine and hair drug testing) at the in-person baseline visit. To assess test-retest reliability of the index tests, screening tool administrations were repeated 1 week later by telephone. For each screening tool, sensitivity, specificity, positive predictive value, negative predictive value and test-retest reliability were computed. Results were stratified by age, race, and trimester of pregnancy. RESULTS: Of the 500 enrolled pregnant women, 494 completed the index screening tools, 497 completed reference testing, and 453 underwent test-retest analysis. For the 4P's Plus, sensitivity=90.2% (84.5, 93.8), and specificity=29.6% (24.4, 35.2). For the NIDA Quick Screen-ASSIST, sensitivity=79.7% (71.2, 84.2), and specificity=82.8% (78.1, 87.1). For the SURP-P, sensitivity=92.4% (87.6, 95.8) and specificity=21.8% (17.4, 27.2). Test-retest reliability (phi correlation coefficients) was 0.84, 0.77, and 0.79 for the 4P's Plus, NIDA Quick Screen-ASSIST and the SURP-P, respectively. For all screening tools, there were differences in validity indices by age and race, but no differences by trimester. CONCLUSION: The SURP-P and 4P's Plus had high sensitivity and negative predictive values, making them more ideal screening tests than the NIDA Quick Screen-ASSIST. A clear recommendation for a clinically useful screening tool for prenatal substance use is crucial to allow for prompt and appropriate follow-up and intervention.

Prevalence and associated birth outcomes of co-use of Cannabis and tobacco cigarettes during pregnancy.

Use of Cannabis and use of tobacco overlap, and co-use of Cannabis and tobacco has increased over the past decade among adults. The current study aims to document the prevalence and correlates of co-use of Cannabis and tobacco cigarettes among adult pregnant women utilizing secondary data from a larger study that compared and validated screeners for illicit and prescription drug use during pregnancy. Pregnant women (N = 500; 71% African American; 65% never married, average age of 28 years) were recruited from two urban University obstetric clinics between January and December 2017. Participants self-reported demographic, Cannabis, and tobacco cigarette use characteristics, and provided urine and hair samples for drug testing. Within two weeks after due date, research staff reviewed participants' electronic medical records to collect birth outcome data. Results showed that 9.0% reported co-use of Cannabis and tobacco, 12.1% reported Cannabis only use, 7.8% reported tobacco cigarette only use, and 71.1% reported no Cannabis or tobacco cigarette use in the past month. The birth outcomes to emerge as significant correlates of co-use of Cannabis and tobacco cigarettes were small head circumference, and the occurrence of birth defects, with the co-use group having the highest odds of a small head circumference [aOR: 5.7 (1.1-28.9)] and birth defects [aOR: 3.1 (1.2-8.3)] compared with other use groups. The Cannabis only group had 12 times higher odds of a stillbirth or miscarriage (aOR = 12.1). Screening and interventions to address concurrent Cannabis and tobacco use during pregnancy are needed, particularly among subpopulations with higher co-use rates. It is imperative to further explore and highlight the possible health implications of maternal co-use given the high prevalence rates found in this study sample.

Comparison and validation of screening tools for substance use in pregnancy: a cross-sectional study conducted in Maryland prenatal clinics.

INTRODUCTION: Prescription-drug use in the USA has increased by more than 60% in the last three decades. Prevalence of prescription-drug use among pregnant women is currently estimated around 50%. Prevalence of illicit drug use in the USA is 14.6% among pregnant adolescents, 8.6% among pregnant young adults and 3.2% among pregnant adults. The first step in identifying problematic drug use during pregnancy is screening; however, no specific substance-use screener has been universally recommended for use with pregnant women to identify illicit or prescription-drug use. This study compares and validates three existing substance-use screeners for pregnancy-4 P's Plus, National Institute on Drug Abuse (NIDA) Quick Screen/Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) and the Substance Use Risk Profile-Pregnancy (SURP-P) scale. METHODS AND ANALYSIS: This is a cross-sectional study designed to evaluate the sensitivity, specificity and usability of existing substance-use screeners. Recruitment occurs at two obstetrics clinics in Baltimore, Maryland, USA. We are recruiting 500 participants to complete a demographic questionnaire, NIDA Quick Screen/ASSIST, 4 P's Plus and SURP-P (ordered randomly) during their regularly scheduled prenatal appointment, then again 1 week later by telephone. Participants consent to multidrug urine testing, hair drug testing and allowing access to prescription drug and birth outcome data from electronic medical records. For each screener, reliability and validity will be assessed. Test-retest reliability analysis will be conducted by examining the results of repeated screener administrations within 1 week of original screener administrations for consistency via correlation analysis. Furthermore, we will assess if there are differences in the validity of each screener by age, race and trimester. ETHICS AND DISSEMINATION: This study is approved by the Institutional Review Board of the University of Maryland (HP-00072042), Baltimore, and Battelle Memorial Institute (0619-100106433). All participants are required to give their informed consent prior to any study procedure.