Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

Pregnancy Clinical Trial

Official title:

Improving Alcohol and Substance Use Care Access, Outcomes, and Equity During the Reproductive Years: A Type 1 Hybrid Trial in Family Planning Clinics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05910580
• Other study ID #: AAAU3394
• Secondary ID: R01AA030529
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: Kelli S Hall, PhD MS
• Phone: 212-305-4805
• Email: ksh2110[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: - Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? - Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? - Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person SBIRT, telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

Description:

Risky alcohol and drug use are associated with severe, negative, and long-term health outcomes and disparities, including sexual and reproductive health (SRH), among reproductive aged people in the United States. High rates and sequelae of alcohol and drug use disproportionately experienced by structurally marginalized groups shape lifelong health inequities for people of racial/ethnic minority, living in poverty, and residing in under-resourced and under-served communities. Among populations at risk of pregnancy-related sequelae (predominantly those self-identifying as women and thus this study's primary focus), harmful alcohol and substance use and alcohol use disorders (AUDs)/substance use disorders (SUDs) contribute to condom and contraceptive nonuse among those not intending pregnancy, sex while intoxicated, non-consensual sex, violence/rape, sexually transmitted infections, unintended pregnancy, and maternal and infant morbidity and mortality. Family planning (FP) clinics are uniquely well-suited but entirely untapped sites for implementing and scaling integrated alcohol/substance use services. Largely community-based health centers that are publicly funded and/or serve Medicaid enrollees, FP clinics are a trusted care source and primary access point for reproductive aged women, and a safety net for the most socially disadvantaged groups. Yet few, if any, studies have rigorously evaluated interventions or implementation strategies to accelerate the uptake of alcohol/substance services in FP contexts. In obstetrics and HIV, widespread adoption of evidence-based SBIRT (screening, brief intervention, and referral to treatment) is precluded by multi-level barriers; data on specific challenges faced by FP providers are lacking. Virtually nothing is known about telemedicine, which has been rolled out for contraception and other routine visits during the pandemic, as a technological infrastructure for SBIRT. Whether and how the promising strategy of Implementation and Sustainment Facilitation (ISF) can bridge systems barriers and support scale up in FP settings is unknown. The researchers propose an explanatory, sequential, mixed methods study of alcohol and drug SBIRT in an expansive FP clinic network - a novel and highly impactful setting with a national reach of a diverse and largely structurally disadvantaged population of reproductive-aged women at greatest risk for AUDs/SUDs. The researchers will conduct a randomized Type 1 Hybrid Effectiveness-Implementation Trial within a large Northeastern regional affiliate and its four clinics of a national SRH care organization. Results will inform an evidence-based, innovative, stakeholder-driven FP SBIRT model in response to the high-level calls for integrated women's health care. With concrete guidance for scaling alcohol/ drug services in SRH settings nationally, findings will promote women's health equity across the U.S.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over the age of 18 years
• U.S. residing
• Have internet access (own a computer or smart phone)
• Screen positive to one or more risky alcohol and substance use behaviors as determined by our standardized abbreviated instruments

Exclusion Criteria:

• Not capable of communicating (reading, speaking, writing) in English or Spanish

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Contraception
• Maternal Health
• Mental Health
• Pregnancy
• Reproductive Health
• Sexual Health
• Sexually Transmitted Diseases
• Substance-Related Disorders
• Women's Health

Intervention

Behavioral:
• Screening, Brief Intervention, and Referral to Treatment (SBIRT)
See SBIRT arm description.

Locations

Country	Name	City	State
United States	Greater Boston Health Center	Boston	Massachusetts
United States	Metro West Health Center	Marlborough	Massachusetts
United States	Western Massachusetts Health Center	Springfield	Massachusetts
United States	Central Massachusetts Health Center	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Columbia University	Emory University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Planned Parenthood League of Massachusetts, Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (31)

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Boudreaux ED, Haskins B, Harralson T, Bernstein E. The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. Drug Alcohol Depend. 2015 Oct 1;155:236-42. doi: 10.1016/j.drugalcdep.2015.07.014. Epub 2015 Jul 23. — View Citation

Chavez LJ, Kelleher KJ, Matson SC, Wickizer TM, Chisolm DJ. Mental Health and Substance Use Care Among Young Adults Before and After Affordable Care Act (ACA) Implementation: A Rural and Urban Comparison. J Rural Health. 2018 Dec;34(1):42-47. doi: 10.1111/jrh.12258. Epub 2017 Jul 7. — View Citation

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Garner BR, Gotham HJ, Chaple M, Martino S, Ford Ii JH, Roosa MR, Speck KJ, Vandersloot D, Bradshaw M, Ball EL, Toro AK, Griggs C, Tueller SJ. The implementation and sustainment facilitation strategy improved implementation effectiveness and intervention effectiveness: Results from a cluster-randomized, type 2 hybrid trial. Implement Res Pract. 2020 Jan-Dec;1:2633489520948073. doi: 10.1177/2633489520948073. Epub 2020 Sep 7. — View Citation

Garner BR, Zehner M, Roosa MR, Martino S, Gotham HJ, Ball EL, Stilen P, Speck K, Vandersloot D, Rieckmann TR, Chaple M, Martin EG, Kaiser D, Ford JH 2nd. Testing the implementation and sustainment facilitation (ISF) strategy as an effective adjunct to the Addiction Technology Transfer Center (ATTC) strategy: study protocol for a cluster randomized trial. Addict Sci Clin Pract. 2017 Nov 17;12(1):32. doi: 10.1186/s13722-017-0096-7. — View Citation

Goldstein KM, Zullig LL, Dedert EA, Alishahi Tabriz A, Brearly TW, Raitz G, Sata SS, Whited JD, Bosworth HB, Gordon AM, Nagi A, Williams JW Jr, Gierisch JM. Telehealth Interventions Designed for Women: an Evidence Map. J Gen Intern Med. 2018 Dec;33(12):2191-2200. doi: 10.1007/s11606-018-4655-8. Epub 2018 Oct 3. — View Citation

Gotham HJ, Wilson K, Carlson K, Rodriguez G, Kuofie A, Witt J. Implementing Substance Use Screening in Family Planning. J Nurse Pract. 2019;15(4):306-310.

Hadland SE, Copelas SH, Harris SK. Trajectories of Substance Use Frequency among Adolescents Seen in Primary Care: Implications for Screening. J Pediatr. 2017 May;184:178-185. doi: 10.1016/j.jpeds.2017.01.033. Epub 2017 Feb 10. — View Citation

Hall KS, Harris LH, Dalton VK. Women's Preferred Sources for Primary and Mental Health Care: Implications for Reproductive Health Providers. Womens Health Issues. 2017 Mar-Apr;27(2):196-205. doi: 10.1016/j.whi.2016.09.014. Epub 2016 Nov 4. — View Citation

Hall KS, Samari G, Garbers S, Casey SE, Diallo DD, Orcutt M, Moresky RT, Martinez ME, McGovern T. Centring sexual and reproductive health and justice in the global COVID-19 response. Lancet. 2020 Apr 11;395(10231):1175-1177. doi: 10.1016/S0140-6736(20)30801-1. No abstract available. — View Citation

Hayes DK, Robbins CL, Ko JY. Trends in Selected Chronic Conditions and Related Risk Factors Among Women of Reproductive Age: Behavioral Risk Factor Surveillance System, 2011-2017. J Womens Health (Larchmt). 2020 Dec;29(12):1576-1585. doi: 10.1089/jwh.2019.8275. Epub 2020 May 22. — View Citation

Heil SH, Jones HE, Arria A, Kaltenbach K, Coyle M, Fischer G, Stine S, Selby P, Martin PR. Unintended pregnancy in opioid-abusing women. J Subst Abuse Treat. 2011 Mar;40(2):199-202. doi: 10.1016/j.jsat.2010.08.011. Epub 2010 Oct 30. — View Citation

Hettema J, Cockrell S, Russo J, Corder-Mabe J, Yowell-Many A, Chisholm C, Ingersoll K. Missed Opportunities: Screening and Brief Intervention for Risky Alcohol Use in Women's Health Settings. J Womens Health (Larchmt). 2015 Aug;24(8):648-54. doi: 10.1089/jwh.2014.4961. Epub 2015 Jul 31. — View Citation

Iyasu S, Randall LL, Welty TK, Hsia J, Kinney HC, Mandell F, McClain M, Randall B, Habbe D, Wilson H, Willinger M. Risk factors for sudden infant death syndrome among northern plains Indians. JAMA. 2002 Dec 4;288(21):2717-23. doi: 10.1001/jama.288.21.2717. Erratum In: JAMA. 2003 Jan 15;289(3):303. — View Citation

Kellogg A, Rose CH, Harms RH, Watson WJ. Current trends in narcotic use in pregnancy and neonatal outcomes. Am J Obstet Gynecol. 2011 Mar;204(3):259.e1-4. doi: 10.1016/j.ajog.2010.12.050. — View Citation

Kesmodel U, Wisborg K, Olsen SF, Henriksen TB, Secher NJ. Moderate alcohol intake in pregnancy and the risk of spontaneous abortion. Alcohol Alcohol. 2002 Jan-Feb;37(1):87-92. doi: 10.1093/alcalc/37.1.87. — View Citation

Ko JY, Wolicki S, Barfield WD, Patrick SW, Broussard CS, Yonkers KA, Naimon R, Iskander J. CDC Grand Rounds: Public Health Strategies to Prevent Neonatal Abstinence Syndrome. MMWR Morb Mortal Wkly Rep. 2017 Mar 10;66(9):242-245. doi: 10.15585/mmwr.mm6609a2. — View Citation

Naimi TS, Lipscomb LE, Brewer RD, Gilbert BC. Binge drinking in the preconception period and the risk of unintended pregnancy: implications for women and their children. Pediatrics. 2003 May;111(5 Pt 2):1136-41. — View Citation

National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Examination of the Integration of Opioid and Infectious Disease Prevention Efforts in Select Programs. Opportunities to Improve Opioid Use Disorder and Infectious Disease Services: Integrating Responses to a Dual Epidemic. Washington (DC): National Academies Press (US); 2020 Jan 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK555809/ — View Citation

Pinedo M. Help seeking behaviors of Latinos with substance use disorders who perceive a need for treatment: Substance abuse versus mental health treatment services. J Subst Abuse Treat. 2020 Feb;109:41-45. doi: 10.1016/j.jsat.2019.11.006. Epub 2019 Nov 14. — View Citation

Rahm AK, Boggs JM, Martin C, Price DW, Beck A, Backer TE, Dearing JW. Facilitators and Barriers to Implementing Screening, Brief Intervention, and Referral to Treatment (SBIRT) in Primary Care in Integrated Health Care Settings. Subst Abus. 2015;36(3):281-8. doi: 10.1080/08897077.2014.951140. Epub 2014 Aug 15. — View Citation

Robbins C, Boulet SL, Morgan I, D'Angelo DV, Zapata LB, Morrow B, Sharma A, Kroelinger CD. Disparities in Preconception Health Indicators - Behavioral Risk Factor Surveillance System, 2013-2015, and Pregnancy Risk Assessment Monitoring System, 2013-2014. MMWR Surveill Summ. 2018 Jan 19;67(1):1-16. doi: 10.15585/mmwr.ss6701a1. Erratum In: MMWR Morb Mortal Wkly Rep. 2018 Apr 27;67(16):479. — View Citation

Stanhope TJ, Gill LA, Rose C. Chronic opioid use during pregnancy: maternal and fetal implications. Clin Perinatol. 2013 Sep;40(3):337-50. doi: 10.1016/j.clp.2013.05.015. Epub 2013 Jul 4. — View Citation

Tan CH, Denny CH, Cheal NE, Sniezek JE, Kanny D. Alcohol use and binge drinking among women of childbearing age - United States, 2011-2013. MMWR Morb Mortal Wkly Rep. 2015 Sep 25;64(37):1042-6. doi: 10.15585/mmwr.mm6437a3. — View Citation

Terplan M, Lawental M, Connah MB, Martin CE. Reproductive Health Needs Among Substance Use Disorder Treatment Clients. J Addict Med. 2016 Jan-Feb;10(1):20-5. doi: 10.1097/ADM.0000000000000175. — View Citation

Thomas AG, Brodine SK, Shaffer R, Shafer MA, Boyer CB, Putnam S, Schachter J. Chlamydial infection and unplanned pregnancy in women with ready access to health care. Obstet Gynecol. 2001 Dec;98(6):1117-23. — View Citation

Wright TE, Terplan M, Ondersma SJ, Boyce C, Yonkers K, Chang G, Creanga AA. The role of screening, brief intervention, and referral to treatment in the perinatal period. Am J Obstet Gynecol. 2016 Nov;215(5):539-547. doi: 10.1016/j.ajog.2016.06.038. Epub 2016 Jul 1. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average drinks per drinking day (T0)	Average number of drinks consumed on days where individual consumed alcohol (past 30 days)	Baseline
Primary	Average drinks per drinking day (T1)	Average number of drinks consumed on days where individual consumed alcohol (past 30 days)	30 days
Primary	Average drinks per drinking day (T2)	Average number of drinks consumed on days where individual consumed alcohol (past 30 days)	3 months
Primary	Depression score (T0)	Score on the depression scale from the Patient Health Questionnaire (PHQ-9), which measures depression severity in past 14 days. Scores can range from 0 to 27, with scores of 0-4 classified as minimal depression, 5-9 as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression, and = 20 as severe depression). Each item on the scale can be scored from 0 (not at all) to 3 (nearly everyday).	Baseline
Primary	Depression score (T1)	Score on the depression scale from the Patient Health Questionnaire (PHQ-9), which measures depression severity in past 14 days. Scores can range from 0 to 27, with scores of 0-4 classified as minimal depression, 5-9 as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression, and = 20 as severe depression). Each item on the scale can be scored from 0 (not at all) to 3 (nearly everyday).	30 days
Primary	Depression score (T2)	Score on the depression scale from the Patient Health Questionnaire (PHQ-9), which measures depression severity in past 14 days. Scores can range from 0 to 27, with scores of 0-4 classified as minimal depression, 5-9 as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression, and = 20 as severe depression). Each item on the scale can be scored from 0 (not at all) to 3 (nearly everyday).	3 months
Primary	Fidelity - BIOS score for audio recordings (1)	Mean score on the first 10 items of the Brief Intervention Observation Sheet (BIOS) per provider from a sample of audio recorded brief interventions (BI). Scores can range from 0-10, with higher scores indicating better performance.	During the 12-month implementation phase
Primary	Fidelity - BIOS score for audio recordings (2)	Mean score on the 11th item of the Brief Intervention Observation Sheet (BIOS) per provider from a sample of audio recorded brief interventions (BI). The 11th item reflects how well the provider use a motivational style. Scores can range from 1-7, with higher scores indicating better performance.	During the 12-month implementation phase
Primary	Incidence of sex under influence of alcohol/drugs (T0)	Any incidence of sex under influence of alcohol/drugs in past 30 days	Baseline
Primary	Incidence of sex under influence of alcohol/drugs (T1)	Any incidence of sex under influence of alcohol/drugs in past 30 days	30 days
Primary	Incidence of sex under influence of alcohol/drugs (T2)	Any incidence of sex under influence of alcohol/drugs in past 30 days	3 months
Primary	Number of days of drug use (T0)	Number of days of drug use in past 30 days	Baseline
Primary	Number of days of drug use (T1)	Number of days of drug use in past 30 days	30 days
Primary	Number of days of drug use (T2)	Number of days of drug use in past 30 days	3 months
Primary	Number of events of sex under influence of alcohol/drugs (T0)	Number of events of sex under influence of alcohol/drugs in past 30 days	Baseline
Primary	Number of events of sex under influence of alcohol/drugs (T1)	Number of events of sex under influence of alcohol/drugs in past 30 days	30 days
Primary	Number of events of sex under influence of alcohol/drugs (T2)	Number of events of sex under influence of alcohol/drugs in past 30 days	3 months
Primary	Number of recordings to achieve competency	Number of audio recordings needed to achieve competency as rated by SBIRT trainers using the Brief Intervention Observation Sheet (BIOS)	During the 6-month preparation phase
Primary	Patients receiving BI (IP)	Percent of patients in each clinic out of all who screen positive, who receive a brief intervention during the implementation phase (IP)	During the 12-month implementation phase
Primary	Patients receiving BI (SP)	Patients receiving BI (SP)	During the 12-month sustainment phase
Primary	SBIRT use (IP)	Number/proportion of providers in each clinic using SBIRT (implementation phase)	During the 12-month implementation phase
Primary	SBIRT use (SP)	Number/proportion of clinics and of providers in each clinic using SBIRT (sustainment phase)	During the 12-month sustainment phase
Secondary	AUDIT-C score (T0)	Score on screening measure for risky drinking; adjusted to past 30 days.; The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C is a modified version of the 10 question AUDIT instrument. The AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Generally, the higher the score, the more likely it is that a person's drinking is affecting his or her safety.	Baseline
Secondary	AUDIT-C score (T1)	Score on screening measure for risky drinking; adjusted to past 30 days.; The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C is a modified version of the 10 question AUDIT instrument. The AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Generally, the higher the score, the more likely it is that a person's drinking is affecting his or her safety.	30 days
Secondary	AUDIT-C score (T2)	Score on screening measure for risky drinking; adjusted to past 30 days.; The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C is a modified version of the 10 question AUDIT instrument. The AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Generally, the higher the score, the more likely it is that a person's drinking is affecting his or her safety.	3 months
Secondary	Anxiety score (T0)	Score on the Generalized Anxiety Disorder 7-item (GAD-7) scale, which measures anxiety severity. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), with higher scores indicating higher levels of anxiety based on past 14 days. A score of 0-4 is classified as minimal anxiety, 5-9 as mild anxiety, 10-14 as moderate anxiety, and as 15-21 severe anxiety.	Baseline
Secondary	Anxiety score (T1)	Score on the Generalized Anxiety Disorder 7-item (GAD-7) scale, which measures anxiety severity. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), with higher scores indicating higher levels of anxiety based on past 14 days. A score of 0-4 is classified as minimal anxiety, 5-9 as mild anxiety, 10-14 as moderate anxiety, and as 15-21 severe anxiety.	30 days
Secondary	Anxiety score (T2)	Score on the Generalized Anxiety Disorder 7-item (GAD-7) scale, which measures anxiety severity. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), with higher scores indicating higher levels of anxiety based on past 14 days. A score of 0-4 is classified as minimal anxiety, 5-9 as mild anxiety, 10-14 as moderate anxiety, and as 15-21 severe anxiety.	3 months
Secondary	BIOS score (1)	Each provider's score on the first 10 items of the Brief Intervention Observation Sheet (BIOS) on the last observation conducted during provider training. Scores can range from 0-10, with higher scores indicating better performance.	During the 6-month preparation phase
Secondary	BIOS score (2)	Each provider's score on the 11th item of the Brief Intervention Observation Sheet (BIOS) on the last observation conducted during provider training. Scores can range from 1-7, with higher scores indicating better performance.	During the 6-month preparation phase
Secondary	Days of alcohol use (T0)	Number of days of alcohol use in past 30 days	Baseline
Secondary	Days of alcohol use (T1)	Number of days of alcohol use in past 30 days	30 days
Secondary	Days of alcohol use (T2)	Number of days of alcohol use in past 30 days	3 months
Secondary	Days of binge drinking (T0)	Number of days of binge drinking (defined as 4 or more drinks) in past 30 days	Baseline
Secondary	Days of binge drinking (T1)	Number of days of binge drinking (defined as 4 or more drinks) in past 30 days	30 days
Secondary	Days of binge drinking (T2)	Number of days of binge drinking (defined as 4 or more drinks) in past 30 days	3 months
Secondary	General self-reported health (T0)	Likert rating of general self-reported health in past 30 days	Baseline
Secondary	General self-reported health (T1)	Likert rating of general self-reported health in past 30 days	30 days
Secondary	General self-reported health (T2)	Likert rating of general self-reported health in past 30 days	3 months
Secondary	Incidence of condom nonuse (T0)	Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days	Baseline
Secondary	Incidence of condom nonuse (T1)	Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days	30 days
Secondary	Incidence of condom nonuse (T2)	Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days	3 months
Secondary	Incidence of contraceptive nonuse (T0)	Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days	Baseline
Secondary	Incidence of contraceptive nonuse (T1)	Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days	30 days
Secondary	Incidence of contraceptive nonuse (T2)	Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days	3 months
Secondary	Incidence of regretted/nonconsensual sex and sexual violence (T0)	Any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days	Baseline
Secondary	Incidence of regretted/nonconsensual sex and sexual violence (T1)	Any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days	30 days
Secondary	Incidence of regretted/nonconsensual sex and sexual violence (T2)	Any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days	3 months
Secondary	DAST-10 score (T0)	Score on the 10-item version of the Drug Abuse Screening Test (DAST-10); adjusted to 30 days.; The DAST-10 assesses drug use (not including alcohol and tobacco use) and yields a quantitative index of the degree of consequences related to drug abuse. A score of 0 is classified as no problems reported, 1-2 as a low level of problems related to drug abuse, 3-5 as moderate, 6-8 as substantial, and 9-10 as severe.	Baseline
Secondary	DAST-10 score (T1)	Score on the 10-item version of the Drug Abuse Screening Test (DAST-10); adjusted to 30 days.; The DAST-10 assesses drug use (not including alcohol and tobacco use) and yields a quantitative index of the degree of consequences related to drug abuse. A score of 0 is classified as no problems reported, 1-2 as a low level of problems related to drug abuse, 3-5 as moderate, 6-8 as substantial, and 9-10 as severe.	30 days
Secondary	DAST-10 score (T2)	Score on the 10-item version of the Drug Abuse Screening Test (DAST-10); adjusted to 30 days.; The DAST-10 assesses drug use (not including alcohol and tobacco use) and yields a quantitative index of the degree of consequences related to drug abuse. A score of 0 is classified as no problems reported, 1-2 as a low level of problems related to drug abuse, 3-5 as moderate, 6-8 as substantial, and 9-10 as severe.	3 months
Secondary	Number of events of condom nonuse (T0)	Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days	Baseline
Secondary	Number of events of condom nonuse (T1)	Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days	30 days
Secondary	Number of events of condom nonuse (T2)	Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days	3 months
Secondary	Number of events of contraceptive nonuse (T0)	Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days	Baseline
Secondary	Number of events of contraceptive nonuse (T1)	Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days	30 days
Secondary	Number of events of contraceptive nonuse (T2)	Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days	3 months
Secondary	Number of events of regretted/nonconsensual sex and sexual violence (T0)	Number of events of non-consensual sex, regretted sex, or sexual violence in past 30 days	Baseline
Secondary	Number of events of regretted/nonconsensual sex and sexual violence (T1)	Number of events of non-consensual sex, regretted sex, or sexual violence in past 30 days	30 days
Secondary	Number of events of regretted/nonconsensual sex and sexual violence (T2)	Number of events of non-consensual sex, regretted sex, or sexual violence in past 30 days	3 months
Secondary	Patients receiving referral (IP)	Percent of patients who screen at a severe level of alcohol use, who receive a referral during the implementation phase (IP)	During the 12-month implementation phase
Secondary	Patients receiving referral (SP)	Percent of patients who screen at a severe level of alcohol use, who receive a referral during the sustainment phase (SP)	During the 12-month sustainment phase
Secondary	Patients screened (IP)	Percent of patients out of all patients seen who are screened during the implementation phase (IP)	During the 12-month implementation phase
Secondary	Patients screened (SP)	Percent of patients out of all patients seen who are screened during the sustainment phase (SP)	During the 12-month sustainment phase
Secondary	Quality of life score (T0)	Score on the 12-Item Short Form Health Survey, which measures physical and mental health functioning in past 30 days. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	Baseline
Secondary	Quality of life score (T1)	Score on the 12-Item Short Form Health Survey, which measures physical and mental health functioning in past 30 days. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	30 days
Secondary	Quality of life score (T2)	Score on the 12-Item Short Form Health Survey, which measures physical and mental health functioning in past 30 days. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	3 months
Secondary	SBIRT knowledge	Score on University of Missouri-Kansas City Screening & Brief Intervention Knowledge Assessment. Will b be completed by providers undergoing training in SBIRT. Scores range from 0-20, with higher scores indicating more knowledge of SBIRT.	During the 6-month preparation phase
Secondary	STI incidence (T0)	Any incidence of a sexually transmitted infection (STI) in past 30 days	Baseline
Secondary	STI incidence (T1)	Any incidence of a sexually transmitted infection (STI) in past 30 days	30 days
Secondary	STI incidence (T2)	Any incidence of a sexually transmitted infection (STI) in past 30 days	3 months
Secondary	Unintended pregnancy (T0)	Any incidence of unintended pregnancy in past 30 days	Baseline
Secondary	Unintended pregnancy (T1)	Any incidence of unintended pregnancy in past 30 days	30 days
Secondary	Unintended pregnancy (T2)	Any incidence of unintended pregnancy in past 30 days	3 months
Secondary	Well-being score (T0)	Score on the World Health Organization-Five Well-Being Index (WHO-5), a five-item scale that measures subjective psychological well-being in past 14 days. Scores range from 0-5, with 0 representing the worst possible and 25 representing the best possible quality of life.	Baseline
Secondary	Well-being score (T1)	Score on the World Health Organization-Five Well-Being Index (WHO-5), a five-item scale that measures subjective psychological well-being in past 14 days. Scores range from 0-5, with 0 representing the worst possible and 25 representing the best possible quality of life.	30 days
Secondary	Well-being score (T2)	Score on the World Health Organization-Five Well-Being Index (WHO-5), a five-item scale that measures subjective psychological well-being in past 14 days. Scores range from 0-5, with 0 representing the worst possible and 25 representing the best possible quality of life.	3 months
Secondary	Past or current receipt of substance use treatment or services (T0)	Number of days/times the participant received treatment or counseling for alcohol or drugs or attended a self-help/mutual support meeting in past 30 days	Baseline
Secondary	Past or current receipt of substance use treatment or services (T1)	Number of days/times the participant received treatment or counseling for alcohol or drugs or attended a self-help/mutual support meeting in past 30 days	30 days
Secondary	Past or current receipt of substance use treatment or services (T2)	Number of days/times the participant received treatment or counseling for alcohol or drugs or attended a self-help/mutual support meeting in past 30 days	3 months