- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01976702
Multi-Level HIV Prevention for Pregnant Drug Abusers (PDA)
January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced Behavioral Skills Training
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.
|
|
Active Comparator: Health Promotion Comparison
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual risk behavior
Time Frame: 6 months post intervention
|
Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers
|
6 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drug use risk behavior
Time Frame: 6 months post intervention
|
6 months post intervention
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Service utilization, social support, and individual cognitive-behavioral factors
Time Frame: 6 months post intervention
|
6 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
October 30, 2013
First Submitted That Met QC Criteria
October 30, 2013
First Posted (Estimate)
November 6, 2013
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DESPR DA021521
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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