HIV Infections Clinical Trial
Official title:
Targeted Social Network HIV Prevention Intervention
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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