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(Sexpro) HIV Risk Prediction Model for Men Who Have Sex with Men in the United States

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(Sexpro) HIV Risk Prediction Model for Men Who Have Sex with Men in the United States Title: Development and Validation of the Personalized Sexual Health Promotion (SexPro) HIV Risk Prediction Model for Men Who Have Sex with Men in the United States. Authors Title Email Site Hyman Scott [email protected] Bridge HIV, San Francisco Department of (corresponding) Public Health, San Francisco, California Eric Vittinghoff [email protected] University of California, San Francisco, San Francisco, CA Risha Irvin [email protected] John’s Hopkins School of Medicine, Baltimore, Maryland Albert Liu [email protected] Bridge HIV, San Francisco Department of Public Health, San Francisco, CA LaRon Nelson [email protected] University of Rochester. Rochester, New er.edu York Carlos Del Rio [email protected] Emory University, Atlanta, Georgia Manya Magnus [email protected] George Washington University, Washington, District of Columbia Sharon [email protected] Columbia University, New York, New Mannheimer York Sheldon Fields [email protected] Charles Drew School of Medicine, Los Angeles, California Irene Kuo [email protected] George Washington University, Washington, District of Columbia Steve Shoptow [email protected] University of California, Los Angeles, California Beatrice [email protected] Instituto de Pesquisa Clinica Evandro Grinsztejn Chagas (IPEC), Rio de Janeiro, Brazil Jorge Sanchez [email protected] Asociacion Civil Impacta Salud y Educacion, Lima, Peru Steven [email protected] Fred Hutchinson Cancer Research Center, Wakefield Seattle, Washington Jonathan Fuchs [email protected] Center for Learning Innovation, San Francisco Department of Public Health, San Francisco, California Darrell Wheeler [email protected] University at Albany - SUNY Ken Mayer [email protected] Fenway Health, Boston, Massachusetts Beryl Koblin [email protected] New York Blood Center, New York, New York Susan [email protected] Bridge HIV, San Francisco Department of Buchbinder Public Health, San Francisco, CA 1 Abstract (350) Importance: Accurate HIV risk assessment for men who have sex with men (MSM) is important for appropriate targeting of efficacious HIV prevention interventions, especially for racial/ethnic groups disproportionately impacted by HIV. Objective: To develop the Sexual Health Promotion (SexPro) HIV risk assessment model for MSM and validate in modern, diverse cohorts of MSM. Design, Setting, and Participants: Data from four large longitudinal cohorts of MSM were used to develop (EXPLORE), and validate (VAX004, HPTN 061, and HVTN 505) the SexPro model. The data included visits were participants self-reported sexual risk behavior by partner HIV serostatus, substance use, and underwent HIV testing. Main Outcomes and Measures: We developed pooled logistic models for HIV infection using self-reported risk behaviors preceding each study visit to predict HIV infection at the same visit. Results: A total of 4,069 MSM were used for the development cohort, and 8,047 MSM in the three validation cohorts. The final SexPro model includes age (<35, ≥35), indicators for Black race and Latino ethnicity, number of HIV negative anal sex partners; number of condomless insertive anal intercourse episodes and both condomless and with condom receptive anal intercourse episodes; number of HIV-negative anal sex partners; and an indicator for having 1 HIV-negative partner only. Other HIV risk variables included in the model are heavy alcohol use, methamphetamine and poppers use, and self-report of gonorrhea, syphilis, chlamydia, in the 2 previous 6 months. The SexPro model showed good discrimination in the EXPLORE internal validation (cross-validated C-statistic=79.5). The C-statistics for the external validation cohorts also showed good discrimination, with C-statistics of 73.1, 71.0, 71.9 in VAX004, HPTN 061, and HVTN 505 respectively. SexPro scores of 16 or lower showed good predictive ability as a screening tool for high-risk MSM. Conclusion and Relevance : We developed and validated the SexPro model as a HIV risk assessment tool for MSM, which showed good predictive ability in modern cohorts, including the largest cohort of Black MSM in the US. This tool can be used to support uptake and targeting HIV prevention interventions such as pre-exposure prophylaxis for MSM at increased risk for HIV. 3 Introduction Men who have sex with men (MSM) are disproportionally impacted by HIV in the US, accounting for two thirds of new HIV diagnoses in United States (US), while only making up approximately 3% of the US population.(1, 2) There are important racial/ethnic disparities among MSM, with increased HIV risk among Black and Latino MSM despite similar or lower reported HIV risk behavior.(3-8) Highlighting these disparities, the Centers for Disease Control and Prevention (CDC) recently estimated the lifetime risk of HIV infection to be 1 in 6 among MSM overall, but 1 in 2, and 1 in 4 for Black MSM and Latino MSM, respectively.(9) Despite this elevated lifetime HIV risk, self-perception of HIV risk is relatively low among MSM in the US. In CDC web-based HIV surveillance study, approximately one third of MSM who had never been tested for HIV reported low perceived HIV risk as the reason for not testing.(10) However, these men reported high levels of HIV risk behavior: 56% reported more than two male anal sex partners, 37% reported condomless anal intercourse, and 35% had injected drugs. Low perceived HIV risk is even more pronounced among young MSM. In the Young Men’s Study, nearly 75% of the young MSM in this study perceived themselves at low lifetime risk for HIV, although 32% reported four or more partners in the prior six months, and 21% had been diagnosed with an STI.(11) Prior HIV risk assessment tools have been developed for clinicians, without a focus on improving self-perception of risk among MSM. Menza and colleagues developed an HIV risk assessment from a clinical cohort of 1,900 MSM who were repeat HIV testers in Seattle, Washington. (12) Based on the answers to four questions about sexual risk behavior, popper or 4 methamphetamine use, or previous sexually transmitted infection diagnosis, patients were stratified into one of four categories of HIV seroconversion risk from low (<5%) to very high (>14%). The HIV Incidence Risk Index for MSM (HIRI-MSM), developed and validated using two longitudinal cohorts of MSM in the US by the CDC, is intended to support targeting of HIV prevention interventions to MSM at elevated HIV risk.(13) Finally, the San Diego Early Test (SDET) score was developed and validated in a clinical cohort of acute and early HIV infected patients in San Diego.(14) These HIV risk tools, primary focused on clinicians, have similar ability to identify MSM at risk for HIV using a short behavioral questionnaire. However, they were developed in clinical or longitudinal cohorts of mostly White MSM in the US, and have not been validated in more contemporary cohorts, including studies which include large numbers of Black MSM, the group most disproportionally impacted by HIV in the US. The goal of this project was to develop an evidence-based Sexual Health Promotion (SexPro) HIV risk model and validate it in a large modern, diverse cohort of MSM to ensure applicability to Black and Latino MSM. This tool could be used to support self- and provider-assessment of HIV risk for MSM to appropriately target HIV prevention efforts. Methods We identified four existing longitudinal HIV prevention cohort studies of MSM in the United States for inclusion in this analysis. EXPLORE was used to develop the SexPro model, and data from VAX004 was used for initial external validation.(15, 16) Two large longitudinal HIV prevention trials, HIV Vaccines Trials Network (HVTN) 505 and HIV Prevention Trials 5 Network (HPTN) 061, the latter conducted exclusively with Black MSM, were used for additional validation in contemporaneous cohorts.(17-19) Development Cohort The EXPLORE study enrolled 4,295 MSM in six US cities from 1999-2001 into a randomized clinical trial comparing an intensive ten-session behavioral intervention to standard risk reduction counseling.(15) Participants were followed every six months until study completion in 2003. Explore enrolled HIV negative men who reported anal intercourse with at least one male partner in the past 12 months, excluding those who had been in mutually monogamous relationships. Because the study did not demonstrate efficacy against HIV acquisition, all participants were used in developing the SexPro model. Validation Cohorts Initial external validation of the model developed in EXPLORE was conducted in VAX004 trial longitudinal HIV prevention cohort study of MSM in the US. The VAX004 trial enrolled 4,643 MSM in 57 US sites from 1998-1999 in a randomized placebo-controlled efficacy trial of a recombinant gp120 HIV-1 vaccine.(16) Participants were followed at six month intervals for 36 months and the study was completed in 2002. VAX004 enrolled HIV negative men who reported anal intercourse with at least one male partner in the past 12 months, and excluded men who men who had been in mutually monogamous relationships for the previous year or reported injection drug use (IDU) at baseline. This study also failed to show efficacy against HIV acquisition, so all participants were used in validating the SexPro model. 6 HIV Prevention Trials Network (HPTN) 061 study was a multi-site cohort study designed to determine the feasibility and acceptability of a multi-component intervention for Black MSM. (18, 19) The study was conducted in six US cities and enrolled 1,553 Black MSM, including 1,164 men initially HIV-negative men who were eligible for follow-up. All study participants were followed every 6 months for 12 months total with study follow-up completed in 2013. Finally, HIV Vaccine Trials Network (HVTN) 505 enrolled 2,504 MSM and transgender women in 21 US cities from 2009-2013 in a randomized placebo-controlled trial of a DNA/rAd5 vaccine.(17) Participants were followed at three month intervals for 24 months and the vaccinations were halted in 2013 after the Data Safety Monitoring Board (DSMB) recommended halting vaccinations for lack of efficacy.
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