An Innovative HIV Prevention Intervention Using Social Networking Technology
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| First Received Date ICMJE | June 22, 2011 | ||||
| Last Updated Date | June 24, 2011 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
feasibility and acceptability of intervention delivery [ Time Frame: 1 month ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01381653 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Innovative HIV Prevention Intervention Using Social Networking Technology | ||||
| Official Title ICMJE | An Innovative HIV Prevention Intervention Using Social Networking Technology | ||||
| 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. |
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| 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Behavioral: HIV prevention intervention
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.
Other Name: Reductions in sexual risk and substance use |
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| Study Arm (s) | Experimental: Motivational Interviewing
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: Other: Behavioral: HIV prevention intervention |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | March 2013 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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
Exclusion Criteria: Participants will be excluded for any of the following reasons:
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. |
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| Gender | Male | ||||
| Ages | 18 Years to 29 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01381653 | ||||
| Other Study ID Numbers ICMJE | R03DA031607 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Corina Lelutiu-Weinberger/Principal Investigator, Hunter College of the City University of New York and the Center for HIV/AIDS Educational Studies and Training | ||||
| Study Sponsor ICMJE | Hunter College | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hunter College | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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