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
  Purpose

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.


Condition Intervention
Substance Related Disorders
Behavioral: Enhanced Behavioral Skills Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multi-Level HIV Prevention for Pregnant Drug Abusers

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Drug use risk behavior [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Service utilization, social support, and individual cognitive-behavioral factors [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: October 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Behavioral: Enhanced Behavioral Skills Training

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01976702     History of Changes
Other Study ID Numbers: DESPR DA021521
Study First Received: October 30, 2013
Last Updated: October 30, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute on Drug Abuse (NIDA):
HIV risk behaviors
Pregnant drug abusers

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014