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Clinical Trials/NCT01976702
NCT01976702
Completed
Not Applicable

Multi-Level HIV Prevention for Pregnant Drug Abusers

National Institute on Drug Abuse (NIDA)0 sites250 target enrollmentOctober 2006
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ConditionsSubstance Related Disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Related Disorders
Sponsor
National Institute on Drug Abuse (NIDA)
Enrollment
250
Primary Endpoint
Sexual risk behavior
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
May 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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?"

Exclusion Criteria

  • •under age 18 years

Outcomes

Primary Outcomes

Sexual risk behavior

Time Frame: 6 months post intervention

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

Secondary Outcomes

  • Drug use risk behavior(6 months post intervention)

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