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Brief Intervention to Reduce STDs in ER Drug Users (SAFE)

Primary Purpose

Sexually Transmitted Infection

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
brief motivation intervention
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexually Transmitted Infection focused on measuring cocaine, heroin, STIs, HIV, brief motivational intervention, voluntary testing and counseling

Eligibility Criteria

18 Years - 54 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brief motivation intervention

control group

Arm Description

Brief motivation intervention was implemented with enrollees identified with heroin and cocaine use who were allocated to the experimental group. The aim was to test the ability of a peer-delivered intervention to reduce risk of HIV and STIs related to sexual behaviors (condom use and sex while high on drugs.

Care as usual.

Outcomes

Primary Outcome Measures

unprotected sexual acts

Secondary Outcome Measures

sex acts while high on drugs

Full Information

First Posted
June 22, 2011
Last Updated
December 17, 2016
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01379599
Brief Title
Brief Intervention to Reduce STDs in ER Drug Users
Acronym
SAFE
Official Title
Brief Intervention to Reduce STDs in ER Drug Users
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infection
Keywords
cocaine, heroin, STIs, HIV, brief motivational intervention, voluntary testing and counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1030 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief motivation intervention
Arm Type
Experimental
Arm Description
Brief motivation intervention was implemented with enrollees identified with heroin and cocaine use who were allocated to the experimental group. The aim was to test the ability of a peer-delivered intervention to reduce risk of HIV and STIs related to sexual behaviors (condom use and sex while high on drugs.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Care as usual.
Intervention Type
Behavioral
Intervention Name(s)
brief motivation intervention
Other Intervention Name(s)
Brief Negotiation Interview, Safe Sex: Brief Negotiation Interview (SS-BNI), motivational interviewing
Intervention Description
Brief motivation intervention consisting of brief psychosocial counseling (20 minutes at the time of an ER visit)
Primary Outcome Measure Information:
Title
unprotected sexual acts
Time Frame
1 year
Secondary Outcome Measure Information:
Title
sex acts while high on drugs
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Bernstein, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
de-identified may be shared on request
Citations:
PubMed Identifier
22506942
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.
Results Reference
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PubMed Identifier
23618318
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.
Results Reference
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PubMed Identifier
24330568
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.
Results Reference
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PubMed Identifier
22261830
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.
Results Reference
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Brief Intervention to Reduce STDs in ER Drug Users

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