The Health Check-Up for Expectant Moms
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:
- Develop intervention content.
- 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:
- Conduct a randomized controlled pilot study in a sample of 50 high risk (at risk for HIV/STIs and alcohol/drug use) pregnant women.
- feasibility of the computer based intervention
- acceptability via participant report of ease of use, helpfulness, and overall satisfaction
- 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.
- Determine if the intervention condition, relative to control, will produce reductions in alcohol/drug use (frequency, quantity, and heavy drinking/use frequency).
- 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.
|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|
- 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.
- 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.
|Study Start Date:||February 2015|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02120716
|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 firstname.lastname@example.org|
|Principal Investigator:||Golfo Tzilos, PhD||Butler Hospital|
|Principal Investigator:||Caron Zlotnick, PhD||Women and Infants Hospital of Rhode Island|