search
Back to results

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

Primary Purpose

Substance Related Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Behavioral Skills Training
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Related Disorders focused on measuring HIV risk behaviors, Pregnant drug abusers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Enhanced Behavioral Skills Training

    Health Promotion Comparison

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Sexual risk behavior
    Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers

    Secondary Outcome Measures

    Drug use risk behavior

    Full Information

    First Posted
    October 30, 2013
    Last Updated
    January 10, 2017
    Sponsor
    National Institute on Drug Abuse (NIDA)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01976702
    Brief Title
    Multi-Level HIV Prevention for Pregnant Drug Abusers
    Acronym
    PDA
    Official Title
    Multi-Level HIV Prevention for Pregnant Drug Abusers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Related Disorders
    Keywords
    HIV risk behaviors, Pregnant drug abusers

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    250 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Enhanced Behavioral Skills Training
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Health Promotion Comparison
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    Enhanced Behavioral Skills Training
    Primary Outcome Measure Information:
    Title
    Sexual risk behavior
    Description
    Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers
    Time Frame
    6 months post intervention
    Secondary Outcome Measure Information:
    Title
    Drug use risk behavior
    Time Frame
    6 months post intervention
    Other Pre-specified Outcome Measures:
    Title
    Service utilization, social support, and individual cognitive-behavioral factors
    Time Frame
    6 months post intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Multi-Level HIV Prevention for Pregnant Drug Abusers

    We'll reach out to this number within 24 hrs