The Health Check-Up for Expectant Moms
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/14/2018 |
| Start Date: | February 2014 |
| End Date: | July 2016 |
Computer Intervention for HIV/STI Risk and Drug Use During Pregnancy
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.
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.
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.
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.
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
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