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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01970293
Other study ID # 1R01AA021732-01A1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date July 2020

Study information

Verified date September 2020
Source Butler Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date July 2020
Est. primary completion date July 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

To be eligible for the study participants must:

1. Be 18 years or older

2. Live in RI or MA within 20 miles of Providence and plan to remain in the area for the next 6 months

3. Meet DSM-IV criteria for alcohol abuse or dependence in the last six months

4. Do not expect to attend residential alcohol or drug treatment upon release

5. Report STI/HIV sexual risk defined as unprotected heterosexual sex at least three times in the three months prior to incarceration

6. Speak English.

7. Be currently held at the Rhode Island Adult Correctional Institutions Jail facility

Women will be excluded from participation if they:

1. Cannot provide the name of at least two locator persons who will know where they can be found.

Study Design


Intervention

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

Locations

Country Name City State
United States Butler Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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