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OpenTrials
Completed

NCT Number: NCT03323086

Women SHARE Study: Reducing Sexual Risk

This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).

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Key information

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood of Southern New England

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief Intervention (BI) with Technology Extender

Behavioral

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

brochure

Other

Brochures provided one time

Primary outcomes

  1. Feasibility of Providing Intervention

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

    percentage of individuals who attended their intervention

Secondary outcomes

  1. Session Evaluation Questionnaire

    Time frame: 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.

  2. Number of Sexual Partners

    Time frame: 3-month Follow-up

    The number of male partners that the participant reported having penetrative sex with.

  3. Condomless Sex

    Time frame: 3-month Follow-up

    The number of occasions of condomless sex

  4. Alcohol Use Quantity

    Time frame: 3-month Follow-up

    The average number of drinks in a week

  5. Alcohol Use Binge Frequency

    Time frame: 3-month Follow-up

    The number of drinking occasions (single day) when 4 or more drinks are consumed

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Planned Parenthood of Southern New England

Registry information

Official study title

Reducing Alcohol-related HIV/STI Risk for Women in Reproductive Health Clinics

Acronym: HIV

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2017
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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