Clinical trial NCT01379599: Brief Intervention to Reduce STDs in ER Drug Users
Official title: Brief Intervention to Reduce STDs in ER Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexually Transmitted Infection
Keywords: cocaine
heroin
STIs
HIV
brief motivational intervention
voluntary testing and counseling
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 1030
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the proposed project is to determine the effectiveness of a brief motivational intervention among Emergency Department (ED) patients who use cocaine and/or heroin to prevent Sexually Transmitted Infections (STIs) and Human Immunodeficiency Virus (HIV) by comparing cumulative incidence and frequency of safe sex behavior between intervention and standard voluntary counseling, testing and referral to substance abuse treatment (control) groups over a one year follow-up period.

Detailed description: Barriers to health care utilization limit drug users' interaction with the primary health care system, resulting in episodic health care received through Emergency Departments (ED) and Urgent Care Centers (UCC). Since 1994, the Boston Medical Center ED and UCC have provided substance abuse screening as standard of care. This program employs the Brief Negotiated Interview (BNI) to assess patient's reasons for drug use, readiness to change and offer intervention alternatives and referrals to substance treatment and other resources. Drug users' high rates of STIs, HIV, and Hepatitis C (HCV) and utilization of EDs and UCCs as usual sources of health care support the introduction of sexual behavior intervention in the ED and UCC setting. The proposed study will apply existing Brief Negotiation Interview (BNI) theory and research to a new behavioral context. The proposed project is a collaborative effort to adapt the BNI to encourage safe sex behaviors to prevent gonorrhea, chlamydia, and HIV among male and female ED and UCC patients age 18-54 years who use heroin and/or crack/cocaine and are not in treatment. We will enroll and 1:1 randomize 1,030 patients to intervention (safe sex BNI) or control (voluntary counseling and testing and referral to substance abuse treatment) over a 2.5-year period, with 6-month and 12-month follow-up. STIs and HIV will be diagnosed by specific laboratory assay at baseline, 6-month, and 12-month follow-up. Sexual and drug using behavior will be determined by participant self-report at baseline, 6-month, and 12-month follow-up on a 30 day time-line follow-up calender, with biochemical testing of hair samples for opiates and cocaine at enrollment and 12-month follow-up. Sexual behavior risk will be measured in terms of proportion of vaginal and anal sex acts protected by condom use and condom use at last sexual act, by sexual partner type. Differences in safe sex behavior between intervention and control groups will be evaluated using General Estimating Equation (GEE) modeling. After assessing intervention effect in the base model, we will assess intervention effect controlling for age, gender, race, injection use, HIV status and sexual and drug using behavior. An effective, brief intervention for safe sex behaviors to reduce STDs and HIV among drug users in ED and UCC settings may provide a sustainable intervention opportunity for drug users who are otherwise difficult to access.

Eligibility criteria: Inclusion Criteria:

* registered ER patient
* English and Spanish speakers
* 30 day use of heroin and or cocaine
* DAST score=\>3

Exclusion Criteria:

* severity of medical illness
* suicidality
* police custody
* residential substance abuse treatment
* ability to provide contact information

Primary outcomes:
measure: unprotected sexual acts
timeFrame: 1 year
Secondary outcomes:
measure: sex acts while high on drugs
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Edward Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernstein E, Heeren T, Winter M, Ashong D, Bliss C, Madico G, Ayalew B, Bernstein J. Long-term follow-up after voluntary human immunodeficiency virus/sexually transmitted infection counseling, point-of-service testing, and referral to substance abuse treatment from the emergency department. Acad Emerg Med. 2012 Apr;19(4):386-95. doi: 10.1111/j.1553-2712.2012.01314.x.
citation: Bernstein E, Ng V, McCloskey L, Vazquez K, Ashong D, Stapleton S, Cromwell J, Bernstein J. Qualitative analysis of cocaine and heroin users' main partner sex-risk behavior: is safety in love safety in health? Addict Sci Clin Pract. 2013 Apr 23;8(1):10. doi: 10.1186/1940-0640-8-10.
citation: Tassiopoulos K, Bernstein J, Bernstein E. Age and sharing of needle injection equipment in a cohort of Massachusetts injection drug users: an observational study. Addict Sci Clin Pract. 2013 Dec 13;8(1):20. doi: 10.1186/1940-0640-8-20.
citation: Bernstein E, Ashong D, Heeren T, Winter M, Bliss C, Madico G, Bernstein J. The impact of a brief motivational intervention on unprotected sex and sex while high among drug-positive emergency department patients who receive STI/HIV VC/T and drug treatment referral as standard of care. AIDS Behav. 2012 Jul;16(5):1203-16. doi: 10.1007/s10461-012-0134-0.