Multi-Level HIV Prevention for Pregnant Drug Abusers (PDA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT01976702
First received: October 30, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted

October 30, 2013
October 30, 2013
October 2006
May 2011   (final data collection date for primary outcome measure)
Sexual risk behavior [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers
Same as current
No Changes Posted
Drug use risk behavior [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
Same as current
Service utilization, social support, and individual cognitive-behavioral factors [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
Same as current
 
Multi-Level HIV Prevention for Pregnant Drug Abusers
Multi-Level HIV Prevention for Pregnant Drug Abusers

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Substance Related Disorders
Behavioral: Enhanced Behavioral Skills Training
  • 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.
    Intervention: Behavioral: Enhanced Behavioral Skills Training
  • 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.
    Intervention: Behavioral: Enhanced Behavioral Skills Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01976702
DESPR DA021521
Yes
National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP