The Health Check-Up for Expectant Moms
Completed · Not applicable
Conditions studied: HIV
In brief
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: 1. Develop intervention content. 2. 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: 1. Conduct a randomized controlled pilot study in a sample of 50 high risk (at risk for HIV/STIs and alcohol/drug use) pregnant women. 2. Determine: 1. feasibility of the computer based intervention 2. acceptability via participant report of ease of use, helpfulness, and overall satisfaction 3. 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. 3. Determine if the intervention condition, relative to control, will produce reductions in alcohol/drug use (frequency, quantity, and heavy drinking/use frequency). 4. 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.
Key facts
- Study ID
- NCT02120716
- Run by
- Butler Hospital
- People needed
- 50
- Starts
- 2014-02-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2018-12-12
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Women and Infants Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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