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Abstract:
After almost a decade of stable HIV infection rates, in 2001, several US cities reported a marked increase in risk taking among MSM, as well as a rise in STDs in this population. Of most concern, significant coinfection of STDs were reported in previously diagnosed HIV+MSM. In response, the CDC published two national alerts calling for "immediate action," and prioritizing prevention and outreach to HIV+MSM as "critical." Unfortunately, no scientifically validated interventions targeting HIV+MSM have been published. Thus, the purpose of this study is to respond to this crisis by studying how best to target HIV+MSM (separately or with other MSM) and by developing and testing a new intervention to lower HIV+ MSM's risk behavior (Positive Sexual Health).

We aim to implement and evaluate the long term effectiveness of an innovative intervention strategy on the unsafe sex behaviors and risk cofactors of HIV positive men who have sex with men (HIV+MSM). In the first phase of the study, a consultant team of HIV+MSM will adapt the content of an existing sexual health intervention for MSM, called Man to Man Sexual Health Seminars, to address the specific sexual health concerns, needs and behaviors of HIV+MSM. In the second phase, we will conduct two pilots: a pre pilot of the revised curriculum, called Positive Sexual Health, with 30 HIV+MSM, followed by a pilot of the full trial on a sample of 60 HIV+MSM and 20 HIV negative (HIV-) or HIV unsure MSM. Following further refinement, the third phase is a randomized controlled 3 arm trial of intervention efficacy (N=580 HIV+MSM and 216 HIV-/HIV unsure MSM).

In 5 cities where increases in STDs among HIV+MSM have been documented, participants will be randomized by racial/ethnicity strata to one of the three arms of the trail: Positive Sexual Health (comprehensive sexual health HIV prevention intervention for HIV+MSM only and tailored to address HIV prevention from an HIV+ person's perspective), Man to Man (a comprehensive sexual health HIV prevention intervention for all MSM) or Men Speaking Out (a 3-hour video control condition). Immediately post-intervention, all subjects will complete a survey examining attitudinal change and evaluating the intervention. Participants will be followed up at 6, 12, and 18 months. Using this design, we aim to test 2 hypotheses:

1. that at 12 and 18 month follow-up, HIV+MSM who experience the sexual health interventions will report significantly lower rates of unsafe sex and lower scores on the risk cofactors than the control group; and
2. that the sexual health intervention that targets HIV+MSM exclusively will be significantly more effective at lowering HIV+MSM's risk behavior than the intervention targeting all MSM. Should these hypotheses be confirmed, recommendations for undertaking primary HIV prevention targeting HIV+MSM will be developed.

Funding Source and Contact:
This study was funded from National Institutes of Health (specifically the National Institute of Child Development and the National Institute of Mental Health) request for proposals (FRP):PAS-00-136: Demographic research on sexual behaviors re: HIV.

Governance: This study is being conducted under the oversight and approval of the University of Minnesota IRB Human Subjects Protection Program.

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