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The Health Check-Up for Expectant Moms

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02120716
Enrollment
50
Registered
2014-04-23
Start date
2014-02-28
Completion date
2016-07-31
Last updated
2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, STIs, Health Check Up, Intervention

Brief 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.

Detailed description

This R21 will assess a computer-delivered screening, brief intervention and referral to treatment (SBIRT) approach, the Health Check-up for Expectant Moms (HCEM), which will address barriers in early identification and intervention with women at risk for HIV/STI primarily, integrating substance use given the well-supported relationship between these risks during pregnancy. The study will accomplish these objectives by developing and pilot testing a tailored, motivationally enhanced HIV/STI and alcohol/drug use risk reduction intervention that incorporates motivational interviewing (MI) and is consistent with the Information-Motivation-Behavior model of HIV risk behavior. The HCEM is a computer-delivered, brief intervention (one 60-minute session, plus a 15-minute booster session within one month) that is theory-driven and derived from empirical support. The study consists of the following phases: during the Development Phase, the research team will adapt the software for the computer-delivered intervention and an open trial with 10 participants. During the Pilot Study Phase, we will conduct a two-group, randomized controlled study with a sample of 50 pregnant women endorsing HIV/STI and alcohol/drug use risk. Study procedures include the following: potential participants will complete a 10-minute computer-based screener, including questions about general health, alcohol and drug use, and sexual behavior. Inclusion criteria for participation in the study include pregnant women who endorse: 1) an unplanned pregnancy, 2) at least one unprotected vaginal (or anal) sex occasion (USO) in the past 30 days, and 3) current alcohol or drug use, or at risk for prenatal alcohol/drug use. Participants who meet criteria for the study based on the screener will be consented and complete the computer-delivered baseline assessment. Study participants will complete a 60-minute, computer-delivered intervention at baseline, and a 15-minute computer-delivered booster session within one month. Participants will be randomly assigned to either the HCEM (i.e., motivational interviewing-based brief intervention) or a time-and-attention-matched control group (i.e., a brief series of videos of television shows, with subsequent ratings of subjective preference). All participants will complete a computer-delivered, follow-up assessment at four months. Results of this program of research are expected to inform the development of integrated HIV/STI and alcohol/drug use interventions that are high-reaching and widely disseminable within prenatal care.

Interventions

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

Women and Infants Hospital of Rhode Island
CollaboratorOTHER
Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. Are pregnant 2. Endorse having an unplanned pregnancy 3. Endorse at least one unprotected sex occasion (USO) in the past 30 days 4. Endorse current alcohol or drug use or are at-risk for prenatal alcohol/drug use 5. Are between 18 and 50 years old. 6. Are able to speak and read English sufficiently to be able to complete the study procedures.

Exclusion criteria

1. Unable to provide informed consent 2. Cannot understand English well enough to understand the consent form when read aloud or assessment instruments that are narrated by the computer

Design outcomes

Primary

MeasureTime frameDescription
CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software4 month follow upCIAS Satisfaction Measure (adapted from Ondersma et al., 2005). Self-report instrument assessing the extent to which participants found the software acceptable. Mean ratings on items including Likeability and Ease of use; scores range from 1 (low) to 5 (high) in satisfaction. HCEM Satisfaction Measure. Self-report instrument assessing the extent to which participants found specific components of the HCEM intervention acceptable (e.g., videos, resources, information); scores range from 1 (low) to 7 (high) in satisfaction.

Secondary

MeasureTime frameDescription
Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up.4 month follow upParticipants completed the Timeline Followback interview and self-reported their daily sex risk behavior including condomless sex
Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-UpBaseline and 4-Month Follow-UpThe Timeline Followback approach was used to collect self-reported data regarding alcohol and/or drug use over a 4-month time period.

Countries

United States

Participant flow

Participants by arm

ArmCount
Health Check-Up of Expectant Moms
Participants receive computer delivered intervention (Health Check-up for Expectant Moms) 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.
31
Time and Attention Matched Control Group
Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
19
Total50

Baseline characteristics

CharacteristicHealth Check-Up of Expectant MomsTotalTime and Attention Matched Control Group
Age, Continuous25.1 Years
STANDARD_DEVIATION 5.79
24.4 Years
STANDARD_DEVIATION 5.31
23.2 Years
STANDARD_DEVIATION 4.3
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants16 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants34 Participants11 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
11 Participants13 Participants2 Participants
Race (NIH/OMB)
More than one race
4 Participants7 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants13 Participants6 Participants
Race (NIH/OMB)
White
7 Participants15 Participants8 Participants
Region of Enrollment
United States
31 participants50 participants19 participants
Sex: Female, Male
Female
31 Participants50 Participants19 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 19
other
Total, other adverse events
0 / 310 / 19
serious
Total, serious adverse events
5 / 311 / 19

Outcome results

Primary

CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software

CIAS Satisfaction Measure (adapted from Ondersma et al., 2005). Self-report instrument assessing the extent to which participants found the software acceptable. Mean ratings on items including Likeability and Ease of use; scores range from 1 (low) to 5 (high) in satisfaction. HCEM Satisfaction Measure. Self-report instrument assessing the extent to which participants found specific components of the HCEM intervention acceptable (e.g., videos, resources, information); scores range from 1 (low) to 7 (high) in satisfaction.

Time frame: 4 month follow up

Population: Participants in the HCEM (intervention) condition reported on their satisfaction with the computer software and specific HCEM intervention components.

ArmMeasureGroupValue (MEAN)
Health Check-Up of Expectant MomsCIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM SoftwareCIAS measure4.8 units on a scale
Health Check-Up of Expectant MomsCIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM SoftwareHCEM measure6.6 units on a scale
Secondary

Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up

The Timeline Followback approach was used to collect self-reported data regarding alcohol and/or drug use over a 4-month time period.

Time frame: Baseline and 4-Month Follow-Up

Population: The clustering within subject was accounted for using a generalized estimating equations (GEE) approach.

ArmMeasureGroupValue (NUMBER)
Health Check-Up of Expectant MomsPercentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-UpBaseline assessment77 percentage of participants
Health Check-Up of Expectant MomsPercentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-UpFollow-up assessment23 percentage of participants
Time and Attention Matched Control GroupPercentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-UpBaseline assessment58 percentage of participants
Time and Attention Matched Control GroupPercentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-UpFollow-up assessment42 percentage of participants
Comparison: The reported percentages were captured at two separate time points (baseline, and at 4-Month Follow-Up).p-value: <0.01595% CI: [4.2, 33]Regression, Logistic
Secondary

Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up.

Participants completed the Timeline Followback interview and self-reported their daily sex risk behavior including condomless sex

Time frame: 4 month follow up

ArmMeasureValue (NUMBER)
Health Check-Up of Expectant MomsPercentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up.27 percentage of participants
Time and Attention Matched Control GroupPercentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up.5 percentage of participants
p-value: 0.1395% CI: [0.6, 51.2]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026