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The Health Check-Up for Expectant Moms

NCT02120716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-12-12

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Butler Hospital

    lead OTHER

Principal Investigators

  • Golfo Tzilos, PhD · Butler Hospital

  • Caron Zlotnick, PhD · Women and Infants Hospital of Rhode Island

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120716 on ClinicalTrials.gov