Brief Intervention to Reduce STDs in ER Drug Users - 1
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 44 |
| Updated: | 2/7/2015 |
| Start Date: | December 2004 |
| Contact: | Anne Valentine, M.P.H. |
| Email: | anne.valentine@bmc.org |
| Phone: | (617)414-4556 |
Brief Intervention to Reduce STDs in ER Drug Users
The purpose of this study is to test whether a brief motivational interview focused on
sexual practices will facilitate behavior change, risk reduction and reduced rate of
sexually transmitted infections among emergency department patients who use heroin and
cocaine and are out-of-treatment for their substance abuse.
sexual practices will facilitate behavior change, risk reduction and reduced rate of
sexually transmitted infections among emergency department patients who use heroin and
cocaine and are out-of-treatment for their substance abuse.
Project SAFE is a multidisciplinary effort to test whether brief motivational interviewing
in an emergency department setting may encourage change in sex behaviors and thus prevent
gonorrhea, chlamydia, and HIV among male and female patients aged 18-44 years who use heroin
and/or crack/cocaine and are not in treatment. We will enroll and 1:1 randomize 3,340
patients to intervention (safe sex BNI) or control (standard counseling) over a 2.5-year
period, with 6-month and 12-month follow-up. Outcome measures include: 1) comparing
cumulative STD incidence and frequency of safe sex behavior between intervention and
standard counseling (control) groups over a one year follow-up period; 2) STD and HIV as
diagnosed by specific laboratory assay at baseline, 6-month, and 12-month follow-up;
participant self-report of sexual and drug using behavior at baseline and 6 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 cumulative incidence between intervention and control groups will be
evaluated using Poisson regression with random effects modeling if needed. Differences in
safe sex behavior between intervention and control groups will be evaluated using logistic
regression. After assessing intervention effect in the base model, we will assess
intervention effect controlling for age, gender, race, and baseline readiness to change and
sexual and drug using behavior. We will conduct exploratory analyses for the potential
interaction and mediating effects between intervention status and abstinence from drug use
on incidence of STDs and self-reported behaviors. 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.
in an emergency department setting may encourage change in sex behaviors and thus prevent
gonorrhea, chlamydia, and HIV among male and female patients aged 18-44 years who use heroin
and/or crack/cocaine and are not in treatment. We will enroll and 1:1 randomize 3,340
patients to intervention (safe sex BNI) or control (standard counseling) over a 2.5-year
period, with 6-month and 12-month follow-up. Outcome measures include: 1) comparing
cumulative STD incidence and frequency of safe sex behavior between intervention and
standard counseling (control) groups over a one year follow-up period; 2) STD and HIV as
diagnosed by specific laboratory assay at baseline, 6-month, and 12-month follow-up;
participant self-report of sexual and drug using behavior at baseline and 6 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 cumulative incidence between intervention and control groups will be
evaluated using Poisson regression with random effects modeling if needed. Differences in
safe sex behavior between intervention and control groups will be evaluated using logistic
regression. After assessing intervention effect in the base model, we will assess
intervention effect controlling for age, gender, race, and baseline readiness to change and
sexual and drug using behavior. We will conduct exploratory analyses for the potential
interaction and mediating effects between intervention status and abstinence from drug use
on incidence of STDs and self-reported behaviors. 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.
Inclusion Criteria:
- active use of heroin and/or crack/cocaine; orientation to person, place and time;
plans to remain in area; ability to provide at least one contact person for follow-up
Exclusion Criteria:
- currently in active treatment or controlled setting
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