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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014