Multi-Level HIV Prevention for Pregnant Drug Abusers

Study Overview
=================
Brief Summary
-----------------
This 5 year study, targeting Pregnant Drug Abusers in treatment, is a randomized trial of an Enhanced Behavioral Skills Training (E-BST) intervention compared to a time-and attention-matched Health Promotion Comparison (HPC) condition. E-BST is an adaptation of the original BST intervention (Eldridge, St. Lawrence et al., 1997), designed to strengthen relationship-based social competency skills of the original BST that were crucial in sustaining adherence to protective behavior.

Official Title
-----------------
Multi-Level HIV Prevention for Pregnant Drug Abusers

Conditions
-----------------
Substance Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Enhanced Behavioral Skills Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older a recent history (within the past year) of using illicit substances 12-32 weeks pregnant and not planning to terminate the pregnancy able to read English Informed Consent form; understand and provided written informed consent have competency in conversational English which is required to complete assessments and to participate in the intervention groups have a stable living arrangement and provide contact information currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention currently not showing symptoms of a major psychiatric disorder/ including psychosis, or a high risk for suicidality report at least one episode of unprotected vaginal/anal sex since becoming pregnant answer Yes to this question: Do you plan to be in the area for the next 12 months? agree to a urine test at the time of each interview to detect the presence of drugs Exclusion Criteria: under age 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Behavioral Skills Training<br>The Enhanced Behavioral Skills Training (E-BST) will include four 90-minute group sessions and two 60-minute individual sessions regarding HIV prevention and diminishing risk behavior, enhancing communication skills, improving the use of support services, and enhancing the use of resources in their community. | Behavioral: Enhanced Behavioral Skills Training<br> <br> |
| Active Comparator: Health Promotion Comparison<br>The Health Promotion Comparison (HPC)condition will receive one video-based HIV prevention session, 3 video-based 90-minute group sessions and an additional 2 60-minute sessions with discussions on relevant topics unrelated to HIV. | Behavioral: Enhanced Behavioral Skills Training<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual risk behavior | Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers | 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use risk behavior |  | 6 months post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV risk behaviors, Pregnant drug abusers