Research

CTN-0121: Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders (SUD) among Hospitalized Patients

The National Academies of Sciences, Engineering and Medicine refer to opioid use disorder (OUD) and infectious diseases as “inextricably linked.” The OUD epidemic has contributed not only to recent outbreaks of HIV and hepatitis C virus infections across the U.S., but also -- primarily through injecting drugs -- to an increase in severe bacterial and fungal infections such as Staphylococcus aureus bacteremia, infective endocarditis, skin and soft tissue infections, bone and joint infections, and fungemia. This project will study a comprehensive, integrated hospital-based intervention to address concurrent treatment and follow-up support for people who inject drugs with infectious complications. A combined (pharmacologic/behavioral/harm reduction/low barrier communication) intervention approach will be tested to 1) initiate integrated medications for SUD in the hospital concurrently with treatment for infectious complications (e.g., treatment for bacterial, fungal and viral infections including COVID-19) and 2) rapidly transfer and retain patients in (less costly) integrated post-discharge follow-up and outpatient care. Learn more.

CTN-0104: Healthcare Provider Stigma Related to Patients with Substance Use Disorders and its Impact on Treatment and Clinical Management

Summary: The United States (U.S.) drug overdose epidemic is an escalating public health emergency, fueled largely by the prescription opioid, heroin, and synthetic opioid epidemics. Provider stigma – defined as negative attitudes, perceptions, and behaviors that providers embody and enact (sometimes subtly or involuntarily) towards their patients – has been increasingly recognized as an important and understudied barrier to the effective treatment and prevention of drug use. Understanding the science of such stigma is critical to change providers’ mindset regarding drug use as a condition that can be successfully managed in primary care in alignment with other chronic health conditions. This study will examine provider stigma by conducting a national provider survey of the general practice and emergency medicine workforces. A representative sample of physicians and dentists will be surveyed to better understand their attitudes and stigma towards patient who use drugs and its role in shaping their attitudes and treatment and referral practices concerning the provision of drug use treatment. The specific aims of this study are to: (1) Define the scope of provider stigma towards drug use by substance type and compared to other medical conditions; (2) Compare providers’ screening, treatment and referral practices for drug use to their screening, treatment and referral practices for other medical conditions; (3) Identify factors related to delivery of drug use treatment in U.S.-based primary care settings to inform educational and intervention strategies addressing provider stigma. Learn more.

Project iTest: A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs

Summary: The 2020 National HIV Strategy recognizes HIV testing and linkage to care is the foundation for consolidated HIV treatment and prevention and strongly encourages expansion of HIV testing to community-based health settings. The CDC and WHO have called for expanding HIV testing in settings where high-risk persons receive health services, including opioid treatment programs (OTPs). Persons who use opioids and other substances have high HIV risk compared with the general population, yet fewer than half of US substance use disorder (SUD) treatment programs offer on-site HIV testing and the proportion of OTPs that do has declined in the past decade. There is widespread recognition of the need for increased HIV testing and the effectiveness and cost-effectiveness of on-site HIV testing in SUD treatment programs has been demonstrated. Further, the ACA provides new opportunities to overcome testing cost barriers as HIV screening received an “A” rating from the USPSTF which makes testing eligible for reimbursement by insurers without cost sharing. To optimize this opportunity, SUD treatment programs must address and overcome organizational-level barriers to testing, including staffing, training, concerns about delivering HIV test results and linkage to care, and the need to set up systems to support reimbursement for HIV testing services. Additionally, Hepatitis C (HCV) testing is perceived as an even greater need by some SUD programs. HCV prevalence, high among opioid users, is higher than HIV prevalence and more individuals with chronic HCV infection are unaware of their infection (~50% of the 3.1 million living with HCV). Within this context, we will evaluate a 3-arm cluster-RCT to test 2 active evidence-based “practice coaching” (PC) interventions against an informational control on the provision and sustained implementation of 1) on-site HIV testing and linkage to care and 2) on-site HIV/HCV testing and linkage to care among OTP patients. In PC, change agents and key OTP staff are provided training and support to facilitate the implementation of innovation and sustain resulting improvements. Learn more.

Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP)

The objective of this study is to compare and evaluate two strategies of delivering PrEP and Hepatitis C Virus (HCV) treatment to people who inject drugs to determine the best method of providing care. Participants will be randomized to one of two treatment arms: on-site integrated care or off-site referral to specialized care. The first strategy, the on-site integrated care model, provides opioid agonist therapy (OAT) clinics and harm reduction sites/syringe access programs (SAP) with the tools to offer HIV prevention and HCV treatment on-site. The second strategy, the off-site referrals to specialized care model, connects people who are at risk for contracting HIV with patient navigators who help them access available HIV prevention care and, if necessary, HCV treatment. Learn more.

CTN-0064 Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.

Using the existing CTN-0049 cohort as a research platform, this RCT assessed the effectiveness of an efficacious linkage to care intervention for HIV/HCV co-infected substance users. Linkage to care was operationalized as receipt of clinical evaluation/treatment for HCV infection. Secondary objectives assessed: 1) relative success at each step in the cascade, 2) engagement in substance use treatment and HIV care, and 3) HIV viral suppression as well as 4) to examine other long-run outcomes of the CTN-0049 cohort. Results showed that the mean number of steps completed was statistically significantly higher in the intervention group vs controls, and that men in the intervention group completed a statistically significantly higher number of steps than controls. Study findings thus demonstrated that the care facilitation intervention increased progress along the HCV/HIV care continuum, as observed for men and not women, and also highlighted continued challenges to achieve individual-patient sustained virologic response and population-level HCV elimination. Learn more.

HIV Testing in Dental Care Settings

The overall goal of our project was to identify factors associated with dentists’ willingness to offer HIV testing as well as other medical preventive and screening services in the dental setting. Guided by social theory, the main study activity was to conduct a national survey with a stratified random sample representative of U.S. general dentists. We also conducted qualitative interviews with a sample of dentists in the U.S. to identify barriers and facilitators that helped inform the development of the national survey. After implementation of the survey, we identified and interviewed dentists who had experience offering rapid HIV testing in their clinical setting to query them about their experienced barriers and facilitators towards testing. Finally, we surveyed key stakeholders (i.e., dental insurance companies and consultants) to identify structural factors, particularly financial reimbursement, that may likely influence dentists' willingness to offer HIV rapid testing in their practices as well as their own attitudes about and willingness to provide reimbursement.

CTN-0049 Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users

This study evaluated the most effective strategy in achieving HIV virologic suppression among HIV-infected substance users recruited from the hospital setting who were randomly assigned to one of three treatment conditions: 1) Patient Navigator (PN); 2) Patient Navigator + Contingency Management (PN+CM); and 3) Treatment as Usual (TAU). The PN approach included five functions: 1) establishing an effective working relationship; 2) encouraging identification and use of strengths, abilities and assets; 3) supporting client control over goal setting and the search for needed resources; 4) viewing the community as a resource and identifying informal sources of support; and 5) conducting case management as an active community-based activity. For participants randomly assigned to the PN+CM study group, PNs also: 1) effectively communicated the incentive plan to the participant, 2) tracked each of the seven target behaviors that earned participant incentives, 3) verified occurrence of the target behaviors, 4) delivered incentives according to the protocol, and 5) maintained a record of incentives delivered. Results showed that there were no differences in rates of HIV viral suppression versus non-suppression or death among the 3 groups at 12 months, thereby concluding that patient navigation with or without financial incentives did not have a beneficial effect in these hospital settings. Learn more.

Project AWARE

Project Aware was a randomized controlled clinical trial in which individuals seeking medical or health services at sexually transmitted disease (STD) clinics were recruited to participate in a multi-center HIV testing and counseling study. The study assessed the relative effectiveness and cost-effectiveness of (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information only. Investigators evaluated the effect of counseling on STI incidence (primary outcome) as well as reduction of sexual risk behaviors, substance use during sex, and cost and cost effectiveness of counseling and testing (secondary outcomes). Results showed that there was no significant difference in 6-month STI incidence by study group; risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition among STD clinic patients, suggesting no added benefit from brief patient-centered risk-reduction counseling. Learn more.

CTN-0032 Rapid HIV Testing and Counseling in Drug Abuse Treatment

This was a randomized, controlled clinical trial in which adults receiving drug abuse treatment were recruited from 12 sites to participate in an HIV testing and counseling study. The purpose of this study was to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results and in reducing HIV risk behaviors: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The combined on-site rapid testing participants received more HIV test results than off-site testing referral participants, but at 6 months, there were no significant differences in unprotected intercourse episodes between the combined on-site testing arms and the referral arm or the 2 on-site testing arms. This study demonstrated on-site rapid HIV testing's value in drug treatment centers and found no additional benefit from HIV sexual risk-reduction counseling. Learn more.