The Health Check-Up for Expectant Moms

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Butler Hospital
Sponsor:
Collaborator:
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Golfo Tzilos, Butler Hospital
ClinicalTrials.gov Identifier:
NCT02120716
First received: April 15, 2014
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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/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.

Condition Intervention
HIV
Behavioral: Health Check-Up for Expectant Moms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Computer Intervention for HIV/STI Risk and Drug Use During Pregnancy

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Feasibility and acceptability of the HCEM [ Time Frame: 4 month follow up ] [ Designated as safety issue: No ]
    CIAS Satisfaction Measure (adapted from Ondersma et al., 2005). Self-report instrument assessing the extent to which participants found the software acceptable.

  • Reductions in HIV/STI risk behavior from baseline to follow up [ Time Frame: 4 month follow up ] [ Designated as safety issue: No ]
    The OSOM Trichomoniasis Rapid Test will be administered. Trichomoniasis is the most common nonviral STI in the world, and it increases susceptibility to, and potentially transmission of, HIV.


Secondary Outcome Measures:
  • Reductions in alcohol and drug use from baseline to follow up [ Time Frame: 4 month follow up ] [ Designated as safety issue: No ]
    Hair sample testing to provide objective corroboration of self-reported drug use.


Estimated Enrollment: 60
Study Start Date: June 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health Check-Up of Expectant Moms
Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
Behavioral: 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.
No Intervention: Time and attention matched control group
Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference

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., MI-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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02120716

Locations
United States, Rhode Island
Women and Infants Hospital Not yet recruiting
Providence, Rhode Island, United States, 02905
Contact: Cheryl Santos    401-274-1122 ext 42980    chsantos@wihri.org   
Sponsors and Collaborators
Butler Hospital
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Golfo Tzilos, PhD Butler Hospital
Principal Investigator: Caron Zlotnick, PhD Women and Infants Hospital of Rhode Island
  More Information

No publications provided

Responsible Party: Golfo Tzilos, Behavioral Medicine Research, Butler Hospital
ClinicalTrials.gov Identifier: NCT02120716     History of Changes
Other Study ID Numbers: R21HD0756658, 7R21HD075658-02
Study First Received: April 15, 2014
Last Updated: April 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:
HIV
STIs
Health Check Up
Intervention

ClinicalTrials.gov processed this record on September 18, 2014