NCT01970293

Brief Summary

The primary aims of this study are to test the hypotheses that among alcohol abusing and dependent jailed women returning to the community, adding an Alcoholic Anonymous (AA) linkage intervention will result in less alcohol use at follow-up, increased AA attendance once released, and decreased HIV/STI sexual risk behavior. Additionally, this study seeks to test the hypotheses that increased AA attendance will mediate the effect of the AA linkage intervention on alcohol use and that percent days abstinent will mediate the effect of the intervention on HIV/STI sexual risk-taking outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 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

August 8, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

5.8 years

First QC Date

August 8, 2013

Last Update Submit

September 8, 2020

Conditions

Alcohol UseAA AttendanceSexual Risk Behavior

Keywords

Alcohol useSTIIncarcerated womenAA

Outcome Measures

Primary Outcomes (1)

  • Change in number of alcohol use days from baseline to 6 months

    Timeline Followback (TLFB) participant recall of alcohol use days.

    Baseline, 1, 3, and 6 months

Study Arms (2)

Introduction to AA volunteer

OTHER
Other: Introduction to AA volunteer

AA materials offered

NO INTERVENTION

Interventions

Introduction to AA volunteerOTHER

In-person, in jail introduction to an AA volunteer, who will offer assistance in attending 2 AA meetings.

Introduction to AA volunteer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible for the study participants must:
  • Be 18 years or older
  • Live in RI or MA within 20 miles of Providence and plan to remain in the area for the next 6 months
  • Meet DSM-IV criteria for alcohol abuse or dependence in the last six months
  • Do not expect to attend residential alcohol or drug treatment upon release
  • Report STI/HIV sexual risk defined as unprotected heterosexual sex at least three times in the three months prior to incarceration
  • Speak English.
  • Be currently held at the Rhode Island Adult Correctional Institutions Jail facility
  • Women will be excluded from participation if they:
  • \. Cannot provide the name of at least two locator persons who will know where they can be found.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (4)

  • Timko C, Chatav Schonbrun Y, Anderson B, Johnson JE, Stein M. Perceived Substance Use Norms Among Jailed Women with Alcohol Use Disorders. Alcohol Clin Exp Res. 2020 Sep;44(9):1834-1841. doi: 10.1111/acer.14403. Epub 2020 Sep 2.

    PMID: 32876998DERIVED

  • Schonbrun YC, Kurth M, Johnson J, Timko C, Stein M. Participant Evaluation of Twelve-Step Group Linkage for Jailed Women With Alcohol Use Disorder. Int J Offender Ther Comp Criminol. 2019 Mar;63(4):610-623. doi: 10.1177/0306624X18805598. Epub 2018 Oct 12.

    PMID: 30311822DERIVED

  • Timko C, Johnson JE, Kurth M, Schonbrun YC, Anderson BJ, Stein MD. Health Services Use Among Jailed Women with Alcohol Use Disorders. J Behav Health Serv Res. 2019 Jan;46(1):116-128. doi: 10.1007/s11414-018-9634-7.

    PMID: 30238292DERIVED

  • Hailemariam M, Stein M, Anderson B, Schonbrun YC, Moore K, Kurth M, Richie F, Johnson JE. Correlates of alcoholics anonymous affiliation among justice-involved women. BMC Womens Health. 2018 Jul 11;18(1):125. doi: 10.1186/s12905-018-0614-0.

    PMID: 29996829DERIVED

MeSH Terms

Conditions

Alcohol DrinkingSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2013

First Posted

October 28, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2019

Study Completion

July 1, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

US(1)