Effectiveness of an HIV Prevention Program That Targets the Inner Workings of High-risk Social Networks
| Tracking Information | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 24, 2008 | ||||||||||||||||||||||||
| Last Updated Date | November 10, 2011 | ||||||||||||||||||||||||
| Start Date ICMJE | July 2004 | ||||||||||||||||||||||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Frequency of high-risk sexual practices [ Time Frame: Measured at baseline and Months 12 and 24 ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00705705 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Effectiveness and usefulness of HIV prevention intervention as a public health approach for reaching population segments that remain vulnerable to HIV and other STDs [ Time Frame: Measured at baseline and Months 12 and 24 ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Effectiveness of an HIV Prevention Program That Targets the Inner Workings of High-risk Social Networks | ||||||||||||||||||||||||
| Official Title ICMJE | Targeted Social Network HIV Prevention Intervention | ||||||||||||||||||||||||
| Brief Summary | This study will determine whether an HIV prevention program that targets the inner workings of social networks at high risk for HIV and other sexually transmitted diseases is effective in reducing frequency of high-risk sexual behaviors among network members. |
||||||||||||||||||||||||
| Detailed Description | Over the past decade, the number of new HIV infections in the United States has remained on a steady level, with approximately 40,000 Americans contracting the disease each year. Risk of contracting HIV is not evenly distributed throughout the population, with groups such as intravenous drug users, men who have sex with men (MSM), and impoverished people in inner cities being disproportionately affected. Many members of these groups have already made risk-reduction behavior changes, but there are certain clusters or networks of people within these populations who remain at a greater risk of HIV infection and who account for the majority of new infections. Therefore, more effective HIV prevention approaches directed toward high-risk social networks are needed. Training social leaders within the high-risk networks to communicate HIV prevention messages directly to their members may be an effective means of reaching these vulnerable population segments. This study will evaluate the effectiveness of an HIV prevention program that targets the inner workings of high-risk social networks (particularly young MSM and young high-risk heterosexual adult men and women) in reducing frequency of risky sexual behaviors among network members. Participation in this study will last up to 2 years and will include the leaders and general members of multiple social networks. First, the eligibility of a given social network will be determined through a period of in-depth formative ethnographic research that will include a 20-minute interview with members of the social networks. During the eligibility interview, participants will be asked to provide personal information about themselves and their close friends, called a friendship group in this study. After the interview, participants will be asked to distribute a flyer about participating in the study to their friendship group. If enough members of the friendship group agree to complete the initial interview and the group meets the eligibility criteria, then members of the group will be asked to participate in the assessment interviews. The first 1-hour assessment interview will be conducted at baseline and will include two parts. During the first part of the interview, participants will complete a survey about the friendship group, including questions about their most and least trusted members and communication among group members. The second part of the interview will include taking a computer survey with questions about sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. After completing the interview, participants will undergo a brief HIV/AIDS prevention counseling session. Participants will repeat this assessment interview 12 and 24 months later. When at least half of the friendship group has completed the first assessment interview, the group will be assigned randomly to one of two conditions:
Study participation will be complete after the 24-month assessment interview. |
||||||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Phase | Phase 2 | ||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
||||||||||||||||||||||||
| Condition ICMJE | HIV Infections | ||||||||||||||||||||||||
| Intervention ICMJE |
|
||||||||||||||||||||||||
| Study Arm (s) |
|
||||||||||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||
| Enrollment ICMJE | 852 | ||||||||||||||||||||||||
| Completion Date | September 2009 | ||||||||||||||||||||||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT00705705 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | R01 MH070316, R01MH070316, DAHBR 9A-ASPQ | ||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||
| Responsible Party | Yuri A. Amirkhanian, PhD, Medical College of Wisconsin | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Medical College of Wisconsin | ||||||||||||||||||||||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||||||
| Information Provided By | Medical College of Wisconsin | ||||||||||||||||||||||||
| Verification Date | November 2011 | ||||||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||||||