The Health Check-Up for Expectant Moms
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|ClinicalTrials.gov Identifier: NCT02120716|
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : July 14, 2016
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/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 :||60 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 PC 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
- Feasibility and acceptability of the HCEM [ 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.
- Reductions in HIV/STI risk behavior from baseline to follow up [ Time Frame: 4 month follow up ]The OSOM Trichomoniasis Rapid Test will be administered. Trichomoniasis is the most common nonviral STI in the world, and it increases susceptibility to, and potentially transmission of, HIV.
- Reductions in alcohol and drug use from baseline to follow up [ Time Frame: 4 month follow up ]Hair sample testing to provide objective corroboration of self-reported drug use.
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|