Multi-Level HIV Prevention for Pregnant Drug Abusers

NCT ID: NCT01976702

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Enhanced Behavioral Skills Training

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Enhanced Behavioral Skills Training

Intervention Type BEHAVIORAL

Interventions

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Enhanced Behavioral Skills Training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DESPR DA021521

Identifier Type: -

Identifier Source: org_study_id

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