CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Health Check-Up for Expectant Momsbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02120716
NCT02120716N/ACompleted

Computer Intervention for HIV/STI Risk and Drug Use During Pregnancy

Butler Hospital·interventional·Posted Apr 23, 2014·Updated Dec 12, 2018

In Brief

A clinical study evaluating Health Check-Up for Expectant Moms for HIV. Completed, enrolled 50 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 23, 2014
Enrollment StartFeb 1, 2014
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.2 years ago

Interventions

Health Check-Up for Expectant Momsbehavioral

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.