NCT01381653

Brief Summary

An existing face-to-face HIV prevention intervention (The Young Men's Health Project, YMHP; R01DA20366) will be iteratively adapted and pilot-tested to target difficult to engage high-risk young men who have sex with men (YMSM) via online social networking and aims to reduce both high-risk sexual behavior and drug use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

June 22, 2011

Last Update Submit

May 30, 2013

Conditions

Keywords

sexual risksubstance useHIV preventionintervention acceptability and feasibilityyoung men who have sex with men

Outcome Measures

Primary Outcomes (1)

  • feasibility and acceptability of intervention delivery

    Participants (N=40) who received eight 30-minute sessions of Motivational Interviewing (to reduce substance use and sexual risk) over instant messaging on Facebook will be interviewed to evaluate the intervention delivery and structure, including their perceived connection with the counselor and concerns with receiving an intervention online.

    1 month

Study Arms (1)

Motivational Interviewing

EXPERIMENTAL

Eight 30-minute sessions utilizing Motivational Interviewing will be delivered to reduce substance use and sexual risk in a group of high risk young men who have sex with men.

Other: Behavioral: HIV prevention intervention

Interventions

Substance using HIV-negative young men who have sex with men who engage in sexual risk and use social networking (Facebook) will be recruited and enrolled in a brief intervention utilizing Motivational Interviewing over chat window to reduce their substance use and sexual risk. They will also evaluate their intervention experience at the end of their eight sessions and post-assessment.

Also known as: Reductions in sexual risk and substance use
Motivational Interviewing

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Phase I:
  • For the focus group portion of the study (N=20), we will invite former YMHP participants who declined the intervention or only completed one session, agreed to be contacted for future studies, indicated using Facebook, are still between the ages of 18-29 and live in NYC.
  • Phase II:
  • To qualify for the intervention portion of the study, participants must report
  • at least 5 days of drug use (of 1 or more of the following drugs: cocaine, methamphetamine (MA), or ecstasy (MDMA) in the prior three months;
  • high-risk sexual behavior (1 or more acts of unprotected insertive or receptive anal sex with a male partner of unknown or HIV+ serostatus), in the prior three months;
  • biologically male;
  • age 18 to 29;
  • HIV-;
  • reliable Internet access;
  • Facebook use at least four times per week;
  • able to write in English given that intervention participation involves writing;
  • NYC residency.

You may not qualify if:

  • Participants will be excluded for any of the following reasons:
  • Unstable, serious psychiatric symptoms;
  • Currently suicidal/homicidal;
  • Evidence of gross cognitive impairment;
  • Self-reported current enrollment in a drug or HIV-related intervention or research study.
  • We exclude those with serious cognitive or psychiatric impairments because this would compromise ability to participate, regardless of whether these impairments are attributed to drug use. Such impairments would make completion of assessments difficult.
  • Excluded participants will be referred to local community health and social services resources, for which we have established linkages to facilitate access to care regardless of ability to pay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter College, CUNY, Center for HIV/AIDS Educational Studies and Training

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Corina T Lelutiu-Weinberger, PhD

    Hunter College, CUNY, Center for HIV/AIDS Educational Studies and Training

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 27, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations