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Trial record 73 of 1928 for:    Sexually Transmitted Diseases | NIH

Women SHARE Study: Reducing Sexual Risk (HIV)

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ClinicalTrials.gov Identifier: NCT03323086
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
Planned Parenthood of Southern New England
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Michael P. Carey, The Miriam Hospital

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).

Condition or disease Intervention/treatment Phase
Alcohol and Substance-Related Mental Disorders Sexually Transmitted Diseases Behavioral: Brief Intervention (BI) with Technology Extender Other: Brochure Not Applicable

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 RHFP clinic will be assessed, randomly assigned to the integrated BI or control (a CDC-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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Alcohol-related HIV/STI Risk for Women in Reproductive Health Clinics
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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.
Behavioral: Brief Intervention (BI) with Technology Extender
One, 45-60 minute BI, followed by three months of access to technology extenders

Brochure
Participants assigned to the Brochure condition will receive materials prepared by the CDC on the study topics.
Other: Brochure
Brochures provided one time




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 3 months ]
    percentage of individuals who were: eligible; consented; attended their intervention; accessed the website; and returned for the follow-up


Secondary Outcome Measures :
  1. Acceptability [ Time Frame: 3 months ]
    calculate Ms for the satisfaction surveys, and inspect responses.

  2. Number of partners [ Time Frame: 3 months ]
    The number of intimate partners reported by participant

  3. Condom use [ Time Frame: 3 months ]
    The percentage of time that condoms are used

  4. Alcohol Use Frequency [ Time Frame: 3 months ]
    The number of days alcohol is used

  5. Alcohol Use Quantity [ Time Frame: 3 months ]
    The average number of drinks in a week

  6. Alcohol Use Binge Frequency [ Time Frame: 3 months ]
    The number of drinking occasions (single day) when 4 or more drinks are consumed



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   sex assigned at birth
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323086


Contacts
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Contact: Carla Rich, LMHC 401-793-8009 Carla.Rich@lifespan.org
Contact: Michael P Carey, PhD 401-793-8218 mcarey1@lifespan.org

Locations
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United States, Rhode Island
Planned Parenthood of Southern New England Recruiting
Providence, Rhode Island, United States, 02906
Contact: Clair Kaplan, MSN    203-752-2864    clair.kaplan@ppsne.org   
Sub-Investigator: Kate B Carey, PhD         
Sub-Investigator: Kate M Guthrie, PhD         
Sponsors and Collaborators
The Miriam Hospital
Planned Parenthood of Southern New England
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Michael P Carey, PhD The Miriam Hospital

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Responsible Party: Michael P. Carey, Professor and Director, Centers for Behavioral and Preventive Medicine, The Miriam Hospital, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03323086     History of Changes
Other Study ID Numbers: 775844-4
R34AA023158 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Sexually Transmitted Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female