N/A
N=50
The Health Check-Up for Expectant Moms
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02120716 ↗Enrolled (actual)
50
Serious AEs
12.0%
Results posted
Dec 2018
Primary outcome: Primary: CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software — 4.8; 6.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Health Check-Up for Expectant Moms (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Butler Hospital
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software |
4.8; 6.6 | — |
| SECONDARY Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up. |
27; 5 | 0.13 |
| SECONDARY Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up |
77; 58; 23; 42 | <0.015 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02120716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.