Clinical trial NCT02120716: The Health Check-Up for Expectant Moms
Official title: Computer Intervention for HIV/STI Risk and Drug Use During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
STIs
Health Check Up
Intervention
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: Women and Infants Hospital of Rhode Island
First posted: 2014-04-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software
timeFrame: 4 month follow up
Secondary outcomes:
measure: Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up.
timeFrame: 4 month follow up
measure: Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up
timeFrame: Baseline and 4-Month Follow-Up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Golfo Tzilos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women and Infants Hospital of Rhode Island
name: Caron Zlotnick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.