Alcohol and Substance-Related Mental DisordersHIVNCT03323086
Women SHARE Study: Reducing Sexual Risk
A study testing Brief Intervention (BI) with Technology Extender and Brochure in people with Alcohol and Substance-Related Mental Disorders and Sexually Transmitted Diseases, run by The Miriam Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol and Substance-Related Mental Disorders, Sexually Transmitted Diseases
- What is being tested?
- Brief Intervention (BI) with Technology Extender and Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood of Southern New England
Providence, Rhode Island, 02906
About this study
Official title: Reducing Alcohol-related HIV/STI Risk for Women in Reproductive Health Clinics
This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).
Read the 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 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.
- Being tested
- Brief Intervention (BI) with Technology Extender, Brochure
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention (BI) with Technology ExtenderBehavioural
One, 45-60 minute BI, followed by three months of access to technology extenders
BrochureOther
Brochures provided one time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Providing Intervention
percentage of individuals who attended their intervention
Measured: Immediately following intervention session (post-intervention), up to 30 minutes
Secondary outcomes (5)
Session Evaluation Questionnaire
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.
Measured: Immediately following intervention session (post-intervention), up to 30 minutes
Number of Sexual Partners
The number of male partners that the participant reported having penetrative sex with.
Measured: 3-month Follow-up
Condomless Sex
The number of occasions of condomless sex
Measured: 3-month Follow-up
Alcohol Use Quantity
The average number of drinks in a week
Measured: 3-month Follow-up
Alcohol Use Binge Frequency
The number of drinking occasions (single day) when 4 or more drinks are consumed
Measured: 3-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start18 Oct 2017
- Primary completion30 Jun 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol and Substance-Related Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood of Southern New England, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Michael P. Carey, The Miriam Hospital
- Investigators
- Michael P Carey, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323086
- Sponsor's protocol ID
- 775844-4
- Other IDs
- R34AA023158
- Acronym
- HIV
- Status last verified
- Jan 2020
- First submitted
- 18 Oct 2017
- Last updated
- 7 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Alcohol-related HIV/STI Risk for Women in Reproductive Health Clinics
- ClinicalTrials.gov ID
- NCT03323086
- Acronym / sponsor ID
- HIV / 775844-4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Planned Parenthood of Southern New England, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention (BI) with Technology Extender | Experimental | Behavioral: Brief Intervention (BI) with Technology ExtenderParticipants 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. |
| Brochure | Other | Other: BrochureParticipants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Male
- Under 18 years old or older than 29 years old
- Non-English speaking
- Suicidal Ideation
- Relocating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Intervention (BI) with Technology ExtenderOne, 45-60 minute BI, followed by three months of access to technology extenders | Behavioural | Brief Intervention (BI) with Technology Extender |
| BrochureBrochures provided one time | Other | Brochure |
Primary outcome
Feasibility of Providing Intervention
Time frame: Immediately following intervention session (post-intervention), up to 30 minutes
percentage of individuals who attended their intervention
5 secondary outcomes
Session Evaluation Questionnaire
Time frame: Immediately following intervention session (post-intervention), up to 30 minutes
Number of Sexual Partners
Time frame: 3-month Follow-up
Condomless Sex
Time frame: 3-month Follow-up
Alcohol Use Quantity
Time frame: 3-month Follow-up
Alcohol Use Binge Frequency
Time frame: 3-month Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Carey, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention (BI) with Technology Extender and Brochure in people with Alcohol and Substance-Related Mental Disorders and Sexually Transmitted Diseases, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Providing Intervention (time frame: Immediately following intervention session (post-intervention), up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.