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An Innovative HIV Prevention Intervention Using Social Networking Technology

Primary Purpose

Sexual Risk, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: HIV prevention intervention
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Risk focused on measuring sexual risk, substance use, HIV prevention, intervention acceptability and feasibility, young men who have sex with men

Eligibility Criteria

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

  1. 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;
  2. 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;
  3. biologically male;
  4. age 18 to 29;
  5. HIV-;
  6. reliable Internet access;
  7. Facebook use at least four times per week;
  8. able to write in English given that intervention participation involves writing;
  9. NYC residency.

Exclusion Criteria:

Participants will be excluded for any of the following reasons:

  1. Unstable, serious psychiatric symptoms;
  2. Currently suicidal/homicidal;
  3. Evidence of gross cognitive impairment;
  4. 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Motivational Interviewing

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2011
Last Updated
May 30, 2013
Sponsor
Hunter College of City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT01381653
Brief Title
An Innovative HIV Prevention Intervention Using Social Networking Technology
Official Title
An Innovative HIV Prevention Intervention Using Social Networking Technology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This pilot study entails a two-phase process. During Phase I, 15 former YMHP participants (intervention decliners and those who only completed one session) will participate in focus groups to advise us on the feasibility and pragmatic specifications of an HIV prevention intervention received via the IM (instant messaging) function of Facebook. Focus group transcripts will be examined to isolate key recommendations for modifying the intervention's structure and procedures. Focus groups will be reconvened for additional feedback on the modified intervention, followed by further adjustment. During Phase II, 40 high-risk YMSM (ages 18-29 and Facebook users) will be enrolled in a pilot of the modified intervention. The intervention will span 4 weeks and contain 8 bi-weekly 30 minute Motivational Interviewing (MI) chat-window sessions consisting of a sequential progression of intervention approaches tailored to each participant's readiness to change their drug use and high risk sexual behavior. Data from Phase II will include pre-post intervention behavioral risk assessments, as well as individual interviews with all 40 intervention participants for a qualitative evaluation regarding the feasibility and acceptability of the intervention's structure, and process. Findings from these interviews (and counselor focus group) will inform the fine-tuning of the intervention in preparation for a subsequent randomized control trial (RCT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Risk, Substance Use
Keywords
sexual risk, substance use, HIV prevention, intervention acceptability and feasibility, young men who have sex with men

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Behavioral: HIV prevention intervention
Other Intervention Name(s)
Reductions in sexual risk and substance use
Intervention Description
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.
Primary Outcome Measure Information:
Title
feasibility and acceptability of intervention delivery
Description
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.
Time Frame
1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corina T Lelutiu-Weinberger, PhD
Organizational Affiliation
Hunter College, CUNY, Center for HIV/AIDS Educational Studies and Training
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter College, CUNY, Center for HIV/AIDS Educational Studies and Training
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States

12. IPD Sharing Statement

Links:
URL
http://chestnyc.org/
Description
Center for HIV/AIDS Educational Studies and Training website

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An Innovative HIV Prevention Intervention Using Social Networking Technology

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