The Health Check-Up for Expectant Moms

NCT02120716 | Completed Results DMC

• 1 other identifier: R21HD0756658
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Develop intervention content.
2. 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.
3. 3.Conduct a randomized controlled pilot study in a sample of 50 high risk (at risk for HIV/STIs and alcohol/drug use) pregnant women.
4. 4.Determine:
5. 5.feasibility of the computer based intervention
6. 6.acceptability via participant report of ease of use, helpfulness, and overall satisfaction
7. 7.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.
8. 8.Determine if the intervention condition, relative to control, will produce reductions in alcohol/drug use (frequency, quantity, and heavy drinking/use frequency).
9. 9.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

HIV

Keywords

HIV; STIs; Health Check Up; Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  4 month follow up

Secondary Outcomes (2)

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

  4 month follow up

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

  Baseline and 4-Month Follow-Up

Study Arms (2)

Health Check-Up of Expectant Moms

EXPERIMENTAL

Participants receive computer delivered intervention (Health Check-up for Expectant Moms)

Behavioral: Health Check-Up for Expectant Moms

Time and attention matched control group

NO INTERVENTION

Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference

Interventions

Health Check-Up for Expectant Moms BEHAVIORAL

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.

Health Check-Up of Expectant Moms

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Butler Hospital: lead
• Women and Infants Hospital of Rhode Island: collaborator

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• Tzilos Wernette G, Plegue M, Kahler CW, Sen A, Zlotnick C. A Pilot Randomized Controlled Trial of a Computer-Delivered Brief Intervention for Substance Use and Risky Sex During Pregnancy. J Womens Health (Larchmt). 2018 Jan;27(1):83-92. doi: 10.1089/jwh.2017.6408. Epub 2017 Oct 5.

  PMID: 28981379 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Golfo Tzilos, PhD
• Organization: University of Michigan

gtzilos@med.umich.edu

7349987120

Study Officials

• Golfo Tzilos, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

• Caron Zlotnick, PhD

  Women and Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Behavioral Medicine Research

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 23, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 12, 2018
• Results First Posted: December 12, 2018

Record last verified: 2018-12

Locations

US (1)