NCT03323086

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 18, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
2 months until next milestone

Results Posted

Study results publicly available

January 2, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

October 18, 2017

Results QC Date

November 8, 2019

Last Update Submit

January 2, 2020

Conditions

Alcohol and Substance-Related Mental DisordersSexually Transmitted Diseases

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Providing Intervention

    percentage of individuals who attended their intervention

    Immediately following intervention session (post-intervention), up to 30 minutes

Secondary Outcomes (5)

  • Session Evaluation Questionnaire

    Immediately following intervention session (post-intervention), up to 30 minutes

  • Number of Sexual Partners

    3-month Follow-up

  • Condomless Sex

    3-month Follow-up

  • Alcohol Use Quantity

    3-month Follow-up

  • Alcohol Use Binge Frequency

    3-month Follow-up

Study Arms (2)

Brief Intervention (BI) with Technology Extender

EXPERIMENTAL

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.

Behavioral: Brief Intervention (BI) with Technology Extender

Brochure

OTHER

Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.

Other: Brochure

Interventions

Brief Intervention (BI) with Technology ExtenderBEHAVIORAL

One, 45-60 minute BI, followed by three months of access to technology extenders

Brief Intervention (BI) with Technology Extender
BrochureOTHER

Brochures provided one time

Brochure

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailssex assigned at birth
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood of Southern New England

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Michael Carey
Organization
The Miriam Hospital
michael_carey@brown.edu
401 793 8218

Study Officials

  • Michael P Carey, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Centers for Behavioral and Preventive Medicine, The Miriam Hospital

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 26, 2017

Study Start

October 18, 2017

Primary Completion

June 30, 2019

Study Completion

November 1, 2019

Last Updated

January 7, 2020

Results First Posted

January 2, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)