NCT03435783

Brief Summary

The overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (MSM) who are seeking free HIV testing. Investigators will be conducting a randomized-controlled pilot test of the intervention among MSM seeking HIV testing in community-based settings to explore its potential impact on alcohol and HIV-related behavioral outcomes. This research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk MSM engage with prevention services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable hiv-infections

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 2, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 13, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 23, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

August 2, 2017

Results QC Date

January 18, 2019

Last Update Submit

April 18, 2019

Conditions

HIV InfectionsAlcohol Abuse

Outcome Measures

Primary Outcomes (5)

  • Number of New Sex Partners, Past 30 Days

    Assessed via self-report using Timeline Follow Back (TLFB)

    Past 30 days

  • Number of Condomless Anal Sex Events, Past 30 Days

    Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.

    Past 30 days

  • Number of Drinking Days, Past 30 Days

    Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30

    Past 30 days

  • Number of Heavy Drinking Days (5 or More), Past 30 Days

    Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.

    Past 30 days

  • Average Number of Drinks Per Drinking Day

    Assessed using Timeline Follow Back (TLFB)

    Past 30 days

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Brief Electronic Intervention

Attention-matched control

ACTIVE COMPARATOR
Behavioral: Attention-Matched Control

Interventions

Brief Electronic InterventionBEHAVIORAL

The brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so.

Intervention
Attention-Matched ControlBEHAVIORAL

Participants will view a video clip on general health promotion that is a similar length as the intervention arm.

Attention-matched control

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biologically male
  • Aged 18 or older
  • Fluent English speaker
  • Unprotected anal sex with a casual male partner at least once in the past 3 months
  • Heavy alcohol use during the past 2-weeks (\>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion)
  • Breath alcohol concentration (BrAC) of .000 at the time of enrollment
  • No history of complex alcohol withdrawal
  • HIV-negative

You may not qualify if:

  • Individuals who are HIV-positive
  • Individuals who participated in other phases of the research
  • Individuals who report being coerced to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02901, United States

Location

MeSH Terms

Conditions

HIV InfectionsAlcoholism

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Tyler Wray
Organization
Brown University School of Public Health
tyler_wray@brown.edu
401-863-6659

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Randomized controlled trial where participants are assigned to either a treatment or control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 2, 2017

First Posted

February 19, 2018

Study Start

October 13, 2017

Primary Completion

March 3, 2018

Study Completion

March 3, 2018

Last Updated

April 23, 2019

Results First Posted

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)