HIVNET 015 - EXPLORE!
EXPLORE: A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV among Men who have Sex with Men (MSM)
What is HIVNET 015 or Explore Study?
The HIVNET 015 study, colloquially referred to as "Explore," is the first study to test a behavioral intervention specifically for men who have sex with men (MSM) over an extended period of time using HIV infection as the primary endpoint.
Many research studies have been conducted involving populations of MSM to identify interventions which can help MSM to reduce the frequency of sexual behaviors that put them at risk of getting HIV. Extensive changes in risk behaviors have occurred among MSM but, in recent years, HIV infections, other sexually transmitted diseases and sexual risk behaviors have been increasing, emphasizing the critical need for identifying effective prevention interventions. Explore examined the potential of one such intervention to reduce HIV infection rates among MSM.
From January 1999 to February 2001, 4,295 HIV-negative MSM were enrolled in six US cities: Boston, Chicago, Denver, New York, San Francisco and Seattle. Men were eligible if they were age 16 or older and reported having engaged in anal sex with one or more men during the past year. Study participants completed extensive questionnaires regarding sexual behaviors, alcohol and drug use, and occurrence of sexually transmitted diseases.
Following enrollment, study participants in the standard treatment arm underwent HIV testing, received HIV-prevention counseling and completed extensive questionnaires regarding sexual behaviors, alcohol and drug use, and occurrence of sexually transmitted diseases every six months. Study participants in the intervention treatment arm completed the same activities as those in the standard arm, but they received additional counseling in the form of multiple intensive behavioral counseling sessions (with motivational interviewing and cognitive behavior theory, for example, as key components) during the first three to four months of their study involvement period. Afterward, participants received "booster" sessions every three months (for up to, on average, 3.25 years).
Explore Study Sites
Explore Ancillary Studies
In addition to the conducting the main study, Explore provided an opportunity for the completion of several ancillary studies, or studies that operated within Explore and depended on the Explore cohort for study participants. The ancillary studies are:
HIVNET 015 Publications
Chesney MA, Koblin BA, Barresi PJ, Husnik MJ, Celum CL, Colfax G, Mayer K, McKirnan D, Judson FN, Huang Y, Coates TJ. An Individually Tailored Intervention for HIV Prevention: Baseline Data From the EXPLORE Study. Am J Public Health. 2003, 93: 933-8.
Koblin BA, Chesney MA, Husnik MJ, Bozeman S, Celum CL, Buchbinder S, Mayer K, McKirnan D, Judson FN, Huang Y, Coates TJ. High-Risk Behaviors Among Men Who Have Sex With Men in 6 US Cities: Baseline Data From the EXPLORE Study. Am J Public Health. 2003, 93: 926-32.
Chin-Hong PV, Vittinghoff E, Cranston RD, Buchbinder S, Cohen D, Colfax G, Da Costa M, Darragh T, Hess E, Judson F, Koblin B, Madison M, Palefsky JM. Age-Specific prevalence of anal human papillomavirus infection in HIV-negative sexually active men who have sex with men: the EXPLORE study. J Infect Dis. 2004, 190: 2070-6 PMID: 19390418.
Colfax G, Vittinghoff E, Husnik MJ, McKirnan D, Buchbinder S, Koblin B, Celum C, Chesney M, Huang Y, Mayer K, Bozeman S, Judson FN, Bryant KJ, Coates TJ, EXPLORE study team. Substance Use and Sexual Risk: A Participant- and Episode-level Analysis among a Cohort of Men Who Have Sex with Men. Am J Epidemiol. 2004, 159: 1002-12.
Colfax G, Vittinghoff E, Husnik MJ, McKirnan D, Buchbinder S, Koblin B, Celum C, Chesney M, Huang Y, Mayer K, Bozeman S, Judson FN, Bryant KJ, Coates TJ; EXPLORE Study Team. Substance use and sexual risk: A participant-and episode-level analysis among a cohort of men who have sex with men. Am J Epidemiol. 2004, 159: 1002-1012.
Koblin B, Chesney M, Coates T; EXPLORE Study Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet. 2004, 364: 41-50.
Chin-Hong PV, Vittinghoff E, Cranston RD, Browne L, Buchbinder S, Colfax G, Da Costa M, Darragh T, Benet DJ, Judson F, Koblin B, Mayer KH, Palefsky JM. Age-related prevalence of anal cancer precursors in homosexual men: the EXPLORE study. J Natl Cancer Inst. 2005, 97: 896-05.
Colfax G, Coates TJ, Husnik MJ, Huang Y, Buchbinder S, Koblin B, Chesney M, Vittinghoff E. Longitudinal patterns of methamphetamine, popper (Amyl Nitrite), and the cocaine use and high-risk sexual behavior among a cohort of San Francisco men who have sex with men. J Urban Health. 2005, 82: i62-i70.
Brown EL, Wald A, Hughes JP, Morrow RA, Krantz E, Mayer K, Buchbinder S, Koblin B, Celum C. High risk of human immunodeficiency virus in men who have sex with men with herpes simplex virus type 2 in the EXPLORE study. Am J Epidemiol. 2006, 164: 733-41 PMID 16896053.
Casper C, Carrell D, Miller KG, Judson FD, Meier AS, Pauk JS, Morrow RA, Corey L, Wald A, Celum C. HIV serodiscordant sex partners and the prevalence of human herpesvirus 8 infection among HIV negative men who have sex with men: baseline data from the EXPLORE Study. Sex Transm Infect. 2006, 82: 229-35 PMCID: 2564745.
Koblin BA, Husnik MJ, Colfax G, Huang Y, Madison M, Mayer K, Barresi PJ, Coates TJ, Chesney MA, Buchbinder S. Risk factors for HIV infection among men who have sex with men. AIDS. 2006, 20: 731-9 PMID: 16514304.
Mimiaga MJ, Safren SA, Benet DJ, Manseau MW, DeSousa N, Mayer KH. MSM in HIV-prevention trials are sexual partners with each other: An ancillary study to the EXPLORE intervention. AIDS Behav. 2006, 10: 27-34 PMID: 16331532.
Morris SR, Klausner JD, Buchbinder SP, Wheeler SL, Koblin B, Coates T, Chesney M, Colfax GN. Prevalence and incidence of pharyngeal gonorrhea in a longitudinal sample of men who have sex with men: the EXPLORE study. Clin Infect Dis. 2006, 43: 1284-9 PMID: 17051493.
Eshleman SH, Husnik M, Hudelson S, Donnell D, Huang Y, Huang W, Hart S, Jackson JB, Coates T, Chesney M, and Koblin B. Antiretroviral drug resistance, HIV-1 tropism, and HIV-1 subtype among men who have sex with men with recent HIV-1 infection. AIDS. 2007, 21: 1165-74 PMID: 17502727.
Chin-Hong PV, Husnik M, Cranston RD, Colfax G, Buchbinder S, Da Costa M, Darragh T, Jones D Judson F, Koblin B, Mayer KH, Palefsky JM. Anal human papillomavirus infection is associated with HIV acquisition in men who have sex with men. AIDS. 2009, 23: 1135-42 PMID: 19390418.
Eshleman SH, Khaki L, Laeyendecker O, Piwowar-Manning E, Johnson-Lewis L, Husnik M, Koblin B, Coates T, Chesney M, Vallari A, Devare SG, Hackett J Jr. Detection of individuals with acute HIV-1 infection using the ARCHITECT HIV Ag/Ab Combo assay. J Acquir Immune Defic Syndr. 2009, 52: 121-4 PMCID: 2744045.
Hudelson SE, Marlowe N, Huang W, Bruce R, Church JD, Husnik M, Donnell D, Coates T, Jackson JB, Chesney M, Koblin B Eshleman SH. Analysis of HIV type 1 gp41 and enfuvirtide susceptibility among men in the United States who were HIV infected prior to availability of HIV entry inhibitors. AIDS Res Hum Retroviruses. 2009, 25: 701-5 PMCID: 2746939.
Mimiaga MJ, Noonan E, Donnell D, Safren SA, Koenen KC, Gortmaker S, O'Cleirigh C, Chesney MA, Coates TJ, Koblin BA, Mayer KH. Childhood sexual abuse is highly associated with HIV risk-taking behavior and infection among MSM in the EXPLORE Study. J Acquir Immune Defic Syndr. 2009, 51: 340-8 PMCID: 3292283.
Salomon EA, Mimiaga MJ, Husnik MJ, Welles SC, Manseau MW, Montenegro AB,Safren SA, BA Koblin, Chesney MA, Mayer KH. Depressive Symptoms, Utilization of Mental Health Care, Substance Use and Sexual Risk Among Young Men Who have Sex with Men in EXPLORE: Implications for Age-Specific Interventions. AIDS Behav. 2009, 13: 811-821 PMCID: 2718068.
Barresi P, Husnik M, Camacho M, Powell B, Gage R, LeBlanc D, Verano P, Chesney M, Koblin B. Recruitment of men who have sex with men for large HIV intervention trials: analysis of the EXPLORE Study recruitment effort. AIDS Educ Prev. 2010, 22: 28-36 PMCID: 3114877.
Donnell D, Mimiaga MJ, Mayer K, Chesney M, Koblin B, Coates T. Use of Non-Occupational Post-Exposure Prophylaxis does not Lead to an Increase in High Risk Sex Behaviors in Men Who have Sex with Men Participating in the EXPLORE Trial. AIDS Behav. 2010, 14: 1182-89 PMCID: 2944957.
Bedoya CA, Mimiaga MJ, Beauchamp G, Donnell D, Mayer KH, Safren SA. Predictors of HIV transmission risk behavior and seroconversion among Latino men who have sex with men in Project EXPLORE. AIDS Behav. 2012, 16: 608-17 PMCID: 3632284.
Cousins MM, Swan D, Magaret CA, Hoover DR, Eshleman SH.. Analysis of HIV using a high resolution melting (HRM) diversity assay: Automation of HRM data analysis enhances the utility of the assay for analysis of HIV incidence. PLoS One. 2012, 7: e51359 PMCID: 3519891.
Kalichman SC, Zohren L, Eaton LA. Setting the bar high or setting up to fail? Interpretations and implications of the EXPLORE Study (HPTN 015). AIDS Behav. 2014, 18: 625-33 PMCID: in process.