Effectiveness of an HIV Prevention Program That Targets the Inner Workings of High-risk Social Networks

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yuri A. Amirkhanian, PhD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00705705
First received: June 24, 2008
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: Network leader training
Behavioral: Standard HIV risk-reduction counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Targeted Social Network HIV Prevention Intervention

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Frequency of high-risk sexual practices [ Time Frame: Measured at baseline and Months 12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 852
Study Start Date: July 2004
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participating social networks will receive standard HIV risk-reduction counseling and network leadership training on HIV prevention.
Behavioral: Network leader training
Network leaders will receive a nine-session training segment designed to enable them to motivate their peer networks to reduce sexual risk. The sessions will teach the identified leader of each network how to communicate HIV prevention messages to other members of his or her personal social network. Leaders will be asked to share these messages with other members of their groups.
Behavioral: Standard HIV risk-reduction counseling
Participants will undergo interviews about their friendship groups, sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. Participants will undergo a brief session about HIV/AIDS prevention methods after the first interview.
Active Comparator: 2
Participating social networks will receive standard HIV risk-reduction counseling.
Behavioral: Standard HIV risk-reduction counseling
Participants will undergo interviews about their friendship groups, sexual behavior, substance abuse, STD treatment history, condom use, and beliefs about HIV/AIDS. Participants will undergo a brief session about HIV/AIDS prevention methods after the first interview.

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:

  • For groups assigned to Condition 1, participants will receive a phone call when it is time for their repeat assessment interviews. In addition, a computer program will identify one person as the leader of the friendship group, and this person will be asked to attend nine 3-hour meetings over 17 weeks. These meetings will train and encourage leaders to provide positive HIV/AIDS prevention advice to the members of their friendship group.
  • For groups assigned to Condition 2, participants will receive a phone call when it is time for their repeat assessment interviews. If the leadership program in Condition 1 appears to be effective, participants may be offered the same program at a later time.

Study participation will be complete after the 24-month assessment interview.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Identified by the network leader as a member of the social group (e.g., men who have sex with men, young heterosexual men and women)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705705

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53202
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Yuri A. Amirkhanian, PhD Medical College of Wisconsin
Study Director: David W. Seal, PhD Medical College of Wisconsin
Study Director: Jeffrey A. Kelly, PhD Medical College of Wisconsin
Study Director: Carol L. Galletly, JD, PhD Medical College of Wisconsin
Study Director: Laura R. Glasman, PhD Medical College of Wisconsin
Study Director: Timothy L. McAuliffe, PhD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Yuri A. Amirkhanian, PhD, Associate Professor of Psychiatry and Behavioral Medicine, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00705705     History of Changes
Other Study ID Numbers: R01 MH070316, R01MH070316, DAHBR 9A-ASPQ
Study First Received: June 24, 2008
Last Updated: November 10, 2011
Health Authority: United States: Federal Government

Keywords provided by Medical College of Wisconsin:
High-Risk Behavior
Men Who Have Sex With Men
HIV Seronegativity

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014