The Health Check-Up for Expectant Moms
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|ClinicalTrials.gov Identifier: NCT02120716|
Recruitment Status : Completed
First Posted : April 23, 2014
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Health Check-Up for Expectant Moms||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Computer Intervention for HIV/STI Risk and Drug Use During Pregnancy|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: Health Check-Up of Expectant Moms
Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
Behavioral: 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
- 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.
- 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
- Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up [ Time Frame: Baseline and 4-Month Follow-Up ]The Timeline Followback approach was used to collect self-reported data regarding alcohol and/or drug use over a 4-month time period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120716
|United States, Rhode Island|
|Women and Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|Principal Investigator:||Golfo Tzilos, PhD||Butler Hospital|
|Principal Investigator:||Caron Zlotnick, PhD||Women and Infants Hospital of Rhode Island|