- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02120716
The Health Check-Up for Expectant Moms
Computer Intervention for HIV/STI Risk and Drug Use During Pregnancy
The objective of this study is to develop and determine feasibility of a computer-delivered intervention (Health Check-up for Expectant Moms) approach to target women at risk for HIV or other sexually transmitted infections (STIs) and alcohol/drug use during pregnancy through two phases of testing:
The development aims of this study are to:
- Develop intervention content.
- Perform a small open trial (n = 10) of the computer based intervention (Health Check-up for Expectant Moms) to assess feasibility of recruitment of target population and acceptability of the intervention and study procedures via participant report of ease of use, helpfulness, and overall satisfaction.
The pilot study aims of this study are to:
- Conduct a randomized controlled pilot study in a sample of 50 high risk (at risk for HIV/STIs and alcohol/drug use) pregnant women.
Determine:
- feasibility of the computer based intervention
- acceptability via participant report of ease of use, helpfulness, and overall satisfaction
- evidence for the hypothesized effects on outcomes: the proposed intervention, in comparison to a time-and-attention-matched control group, will produce reductions in HIV/STIs risk behavior during the follow-up assessment at 4 months.
- Determine if the intervention condition, relative to control, will produce reductions in alcohol/drug use (frequency, quantity, and heavy drinking/use frequency).
- Determine effects on process variables: if participants assigned to the intervention condition, relative to control, will demonstrate greater increases in knowledge, readiness to change and risk perceptions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02905
- Women and Infants Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Are pregnant
- Endorse having an unplanned pregnancy
- Endorse at least one unprotected sex occasion (USO) in the past 30 days
- Endorse current alcohol or drug use or are at-risk for prenatal alcohol/drug use
- Are between 18 and 50 years old.
- Are able to speak and read English sufficiently to be able to complete the study procedures.
Exclusion Criteria:
- Unable to provide informed consent
- Cannot understand English well enough to understand the consent form when read aloud or assessment instruments that are narrated by the computer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Health Check-Up of Expectant Moms
Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
|
Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet after the baseline assessment.
The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks.
Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan.
|
No Intervention: Time and attention matched control group
Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software
Time Frame: 4 month follow up
|
CIAS Satisfaction Measure (adapted from Ondersma et al., 2005). Self-report instrument assessing the extent to which participants found the software acceptable. Mean ratings on items including Likeability and Ease of use; scores range from 1 (low) to 5 (high) in satisfaction. HCEM Satisfaction Measure. Self-report instrument assessing the extent to which participants found specific components of the HCEM intervention acceptable (e.g., videos, resources, information); scores range from 1 (low) to 7 (high) in satisfaction. |
4 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up.
Time Frame: 4 month follow up
|
Participants completed the Timeline Followback interview and self-reported their daily sex risk behavior including condomless sex
|
4 month follow up
|
Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up
Time Frame: Baseline and 4-Month Follow-Up
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The Timeline Followback approach was used to collect self-reported data regarding alcohol and/or drug use over a 4-month time period.
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Baseline and 4-Month Follow-Up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Golfo Tzilos, PhD, Butler Hospital
- Principal Investigator: Caron Zlotnick, PhD, Women and Infants Hospital of Rhode Island
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R21HD0756658
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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