HIV Clinical Trial
Official title:
Prevention of HIV Infection in High-Risk Social Networks of African American MSM
During the formative research phase, investigators will undertake formative studies to
locate, understand, and characterize high-risk social networks of African American MSM in the
community; gain community participation, involvement, and input; and undertake interviews
with key informants and community members to gain information needed to pilot test study
recruitment procedures, measures, and intervention content.
During a 4-year main outcome trial phase, the investigators will enroll 24 separate
sociocentric ("bounded") social networks composed predominantly of Black MSM. Each
sociocentric network will consist of the ring of friends surrounding an initial high-risk
index as well as all friends surrounding persons in this second ring and then friends
surrounding a successive third snowball ring of enrollees. Each 3-ring sociocentric network
is expected to consist of approximately 40 unique members (n=24 networks, each with 40
members = approximately 960 individual participants).
All participants will be assessed at baseline to measure sexual practices, substance use, and
other risk characteristics over the past 3 months; asked to provide biological specimens to
be tested for HIV and other sexually transmitted diseases (STDs); and counseled in HIV/STD
risk reduction. STDs will be treated and those with HIV will be referred for treatment.
The investigators will identify the individuals in intervention condition networks with the
greatest number of reciprocal interconnections and the most favorable sociometric standing in
the network. These individuals--expected to constitute approximately 20% of the sociocentric
network and designated as network leaders--will be recruited to attend a 9-session program
that provides training and guidance in how to deliver on-going, theoretically-based, and
culturally tailored risk reduction advice and counseling to other members within the same
network.
Six and 18 months following the intervention, all participants will be reassessed on risk
behavior and STD/HIV laboratory measures as well as measures of intervention exposure, with
positive STD and HIV cases respectively treated or referred to care at each assessment point.
Outcome analyses will test whether there is greater reduction in high-risk sexual practices,
substance use associated with risky sex, and HIV/STD incidence within social networks in the
intervention condition. The primary trial endpoints are reductions in prevalence and
frequency of unprotected anal intercourse with nonexclusive partners, increased condom use,
and lower incidence on a composite biological measure of new HIV/STD disease during the
followup period.
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