Substance Related DisordersPDANCT01976702
Multi-Level HIV Prevention for Pregnant Drug Abusers
A study testing Enhanced Behavioral Skills Training in people with Substance Related Disorders, run by National Institute on Drug Abuse (NIDA).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Related Disorders
- What is being tested?
- Enhanced Behavioral Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- under age 18 years
About this study
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.
- Conditions
- Substance Related Disorders
- Being tested
- Enhanced Behavioral Skills Training
- Keywords
- HIV risk behaviors, Pregnant drug abusers
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Behavioral Skills TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Behavioral Skills Training | Experimental | 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. Receives: Behavioral: Enhanced Behavioral Skills Training |
| Health Promotion Comparison | Active comparator | 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. Receives: Behavioral: Enhanced Behavioral Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual risk behavior
Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers
Measured: 6 months post intervention
Secondary outcomes (1)
Drug use risk behavior
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startOct 2006
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976702
- Sponsor's protocol ID
- DESPR DA021521
- Acronym
- PDA
- Status last verified
- Oct 2013
- First submitted
- 30 Oct 2013
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Level HIV Prevention for Pregnant Drug Abusers
- ClinicalTrials.gov ID
- NCT01976702
- Acronym / sponsor ID
- PDA / DESPR DA021521
- Conditions
- Substance Related Disorders
- Keywords
- HIV risk behaviors, Pregnant drug abusers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Oct 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Behavioral Skills Training | Experimental | Behavioral: Enhanced Behavioral Skills TrainingThe 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. |
| Health Promotion Comparison | Active comparator | Behavioral: Enhanced Behavioral Skills TrainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- under age 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Behavioral Skills Training | Behavioural | Enhanced Behavioral Skills Training, Health Promotion Comparison |
Primary outcome
Sexual risk behavior
Time frame: 6 months post intervention
Reduction in HIV sex risk and drug abuse behavior among pregnant substance abusers
1 secondary outcome
Drug use risk behavior
Time frame: 6 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Behavioral Skills Training in people with Substance Related Disorders, run by National Institute on Drug Abuse (NIDA).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual risk behavior (time frame: 6 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017; AzTrials last refreshed its copy on 1 Nov 2026.