Alcohol and Substance-Related Mental Disorders, Sexually Transmitted Diseases
Conditions
Brief summary
This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).
Detailed description
This study will assess the feasibility and acceptability, and obtain initial evidence of the efficacy, of the BI and technology extenders. At-risk women drinkers (N = 50) recruited from a reproductive health care clinic will be assessed, randomly assigned to the integrated BI or control (a Centers for Disease Control and Prevention-produced brochure with information about alcohol and women's health), and reassessed at 3 months to determine impact on alcohol use, condom use, and number of partners as well as hypothesized mediators.
Interventions
BEHAVIORALBrief Intervention (BI) with Technology Extender
One, 45-60 minute BI, followed by three months of access to technology extenders
OTHERBrochure
Brochures provided one time
Sponsors
Planned Parenthood of Southern New England
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * Age 18-29 years * Meeting NIAAA definition of at-risk drinking (\>3 drinks on any day in the last 3 months18 and/or \>7 drinks per week) * Sexual risk behavior (i.e., last 3 months: vaginal/anal intercourse with \>1 partner; vaginal/anal intercourse with a partner who has other partners; inconsistent condom use; new relationship (under 3 months)) * English speaking * Absence of acute intoxication, depression, or suicidal ideation * No plans for relocation
Exclusion criteria
* Male * Under 18 years old or older than 29 years old * Non-English speaking * Suicidal Ideation * Relocating * Clinic provider advising against recruitment in the study * Unwilling or unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Providing Intervention | Immediately following intervention session (post-intervention), up to 30 minutes | percentage of individuals who attended their intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Binge Frequency | 3-month Follow-up | The number of drinking occasions (single day) when 4 or more drinks are consumed |
| Session Evaluation Questionnaire | Immediately following intervention session (post-intervention), up to 30 minutes | Measure Name: Session Evaluation Questionnaire; Construct Assessed: Treatment Satisfaction; Minimum total scale score = 1; Maximum total scale score = 5; Scoring: averaged ratings across 4 items; Interpretation: Higher scores represent a better outcome. |
| Number of Sexual Partners | 3-month Follow-up | The number of male partners that the participant reported having penetrative sex with. |
| Condomless Sex | 3-month Follow-up | The number of occasions of condomless sex |
| Alcohol Use Quantity | 3-month Follow-up | The average number of drinks in a week |
Countries
United States
Participant flow
Pre-assignment details
50 women enrolled in the trial. Two women who enrolled withdrew prior to randomization. Thus, 48 women were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Brief Intervention (BI) With Technology Extender Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders | 26 |
| Brochure Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time | 22 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Brief Intervention (BI) With Technology Extender | Total | Brochure |
|---|---|---|---|
| Age, Continuous | 21.28 years STANDARD_DEVIATION 2.61 | 22.67 years STANDARD_DEVIATION 3.13 | 24.33 years STANDARD_DEVIATION 2.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 32 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 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 | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 16 Participants | 28 Participants | 12 Participants |
| Region of Enrollment United States | 26 participants | 48 participants | 22 participants |
| Sex: Female, Male Female | 26 Participants | 48 Participants | 22 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 / 26 | 0 / 22 |
| other Total, other adverse events | 0 / 26 | 0 / 22 |
| serious Total, serious adverse events | 0 / 26 | 0 / 22 |
Outcome results
Primary
Feasibility of Providing Intervention
percentage of individuals who attended their intervention
Time frame: Immediately following intervention session (post-intervention), up to 30 minutes
Population: 50 patients enrolled. 2 patients withdrew prior to randomization. Leaving 48 participants for this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Intervention (BI) With Technology Extender | Feasibility of Providing Intervention | 25 Participants |
| Brochure | Feasibility of Providing Intervention | 22 Participants |
Secondary
Alcohol Use Binge Frequency
The number of drinking occasions (single day) when 4 or more drinks are consumed
Time frame: 3-month Follow-up
Population: 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Intervention (BI) With Technology Extender | Alcohol Use Binge Frequency | 2.36 heavy episodic drinking days | Standard Deviation 3.27 |
| Brochure | Alcohol Use Binge Frequency | 2.00 heavy episodic drinking days | Standard Deviation 2 |
Secondary
Alcohol Use Quantity
The average number of drinks in a week
Time frame: 3-month Follow-up
Population: 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Intervention (BI) With Technology Extender | Alcohol Use Quantity | 3.23 drinks per week | Standard Deviation 3.22 |
| Brochure | Alcohol Use Quantity | 4.00 drinks per week | Standard Deviation 3.08 |
Secondary
Condomless Sex
The number of occasions of condomless sex
Time frame: 3-month Follow-up
Population: 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brief Intervention (BI) With Technology Extender | Condomless Sex | 3 events of condomless sex |
| Brochure | Condomless Sex | 5 events of condomless sex |
Secondary
Number of Sexual Partners
The number of male partners that the participant reported having penetrative sex with.
Time frame: 3-month Follow-up
Population: 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Intervention (BI) With Technology Extender | Number of Sexual Partners | 3.23 partners | Standard Deviation 3.22 |
| Brochure | Number of Sexual Partners | 4.00 partners | Standard Deviation 3.08 |
Secondary
Session Evaluation Questionnaire
Measure Name: Session Evaluation Questionnaire; Construct Assessed: Treatment Satisfaction; Minimum total scale score = 1; Maximum total scale score = 5; Scoring: averaged ratings across 4 items; Interpretation: Higher scores represent a better outcome.
Time frame: Immediately following intervention session (post-intervention), up to 30 minutes
Population: 50 patients enrolled. However, 2 patients withdrew prior to randomization and 2 withdrew post-randomization leaving a total of 46 patients who provided data at this post-intervention assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Intervention (BI) With Technology Extender | Session Evaluation Questionnaire | 4.65 units on a scale | Standard Deviation 0.36 |
| Brochure | Session Evaluation Questionnaire | 3.98 units on a scale | Standard Deviation 0.96 |