The Health Check-Up for Expectant Moms
Condition: HIV
Study type: Interventional

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.
    

Intervention name(s): Health Check-Up for Expectant Moms
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: HIV; STIs; Health Check Up; Intervention