HIV
Conditions
Keywords
HIV, STIs, Health Check Up, Intervention
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software | 4 month follow up | CIAS Satisfaction Measure (adapted from Ondersma et al., 2005). Self-report instrument assessing the extent to which participants found the software acceptable. Mean ratings on items including Likeability and Ease of use; scores range from 1 (low) to 5 (high) in satisfaction. HCEM Satisfaction Measure. Self-report instrument assessing the extent to which participants found specific components of the HCEM intervention acceptable (e.g., videos, resources, information); scores range from 1 (low) to 7 (high) in satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up. | 4 month follow up | Participants completed the Timeline Followback interview and self-reported their daily sex risk behavior including condomless sex |
| Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up | Baseline and 4-Month Follow-Up | The Timeline Followback approach was used to collect self-reported data regarding alcohol and/or drug use over a 4-month time period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Check-Up of Expectant Moms Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
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. | 31 |
| Time and Attention Matched Control Group Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference | 19 |
| Total | 50 |
Baseline characteristics
| Characteristic | Health Check-Up of Expectant Moms | Total | Time and Attention Matched Control Group |
|---|---|---|---|
| Age, Continuous | 25.1 Years STANDARD_DEVIATION 5.79 | 24.4 Years STANDARD_DEVIATION 5.31 | 23.2 Years STANDARD_DEVIATION 4.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 16 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 34 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 13 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) White | 7 Participants | 15 Participants | 8 Participants |
| Region of Enrollment United States | 31 participants | 50 participants | 19 participants |
| Sex: Female, Male Female | 31 Participants | 50 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 19 |
| other Total, other adverse events | 0 / 31 | 0 / 19 |
| serious Total, serious adverse events | 5 / 31 | 1 / 19 |
Outcome results
CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software
CIAS Satisfaction Measure (adapted from Ondersma et al., 2005). Self-report instrument assessing the extent to which participants found the software acceptable. Mean ratings on items including Likeability and Ease of use; scores range from 1 (low) to 5 (high) in satisfaction. HCEM Satisfaction Measure. Self-report instrument assessing the extent to which participants found specific components of the HCEM intervention acceptable (e.g., videos, resources, information); scores range from 1 (low) to 7 (high) in satisfaction.
Time frame: 4 month follow up
Population: Participants in the HCEM (intervention) condition reported on their satisfaction with the computer software and specific HCEM intervention components.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Health Check-Up of Expectant Moms | CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software | CIAS measure | 4.8 units on a scale |
| Health Check-Up of Expectant Moms | CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software | HCEM measure | 6.6 units on a scale |
Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up
The Timeline Followback approach was used to collect self-reported data regarding alcohol and/or drug use over a 4-month time period.
Time frame: Baseline and 4-Month Follow-Up
Population: The clustering within subject was accounted for using a generalized estimating equations (GEE) approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Health Check-Up of Expectant Moms | Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up | Baseline assessment | 77 percentage of participants |
| Health Check-Up of Expectant Moms | Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up | Follow-up assessment | 23 percentage of participants |
| Time and Attention Matched Control Group | Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up | Baseline assessment | 58 percentage of participants |
| Time and Attention Matched Control Group | Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up | Follow-up assessment | 42 percentage of participants |
Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up.
Participants completed the Timeline Followback interview and self-reported their daily sex risk behavior including condomless sex
Time frame: 4 month follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Health Check-Up of Expectant Moms | Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up. | 27 percentage of participants |
| Time and Attention Matched Control Group | Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up. | 5 percentage of participants |