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  IAS 2013: 7th IAS Conference on HIV
Pathogenesis Treatment and Prevention
June 30 - July 3 2013
Kuala Lumpur, Malaysia
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MSM HIV Sex/Substance Abuse Risk Intervention in South Florida: Single 1-on-1 Session Works as Well as 4 Group Sessions in Trimming MSM Risk Behavior
 
 
  Download the PDF here
 
from jules: not addressed in this study is the risk for HCV transmission. Clearly we know that in Western Europe in numerous major cities HCV transmission is occurring among HIV+ MSM through unsafe risk behaviors but this has not been very well addressed in the USA, there have been several research papers on this topic including by Lynn Taylor MD recommending annual HCV screening for these groups, for both sex risk takers & IDUs, who continue risky behaviors but this has not yet been adequately addressed. Still, in the USA the behavior reported in the study below reflects the potential that HCV transmission can occur among these groups in the USA through risky sex behavior particularly if there is unsafe syringe sharing for recreational drug use & accompanying risky sexual behavior.
 
7th IAS Conference on HIV Pathogenesis, Treatment and Prevention, June 30-July 3, 2013, Kuala Lumpur
 
Mark Mascolini
 
A single half-hour counseling session for one person cut HIV transmission risk and substance use as well as a more complex, four-session, small-group interventions for substance-using men who have sex with men (MSM) with and without HIV infection [1]. Positive effects of both interventions did not differ by HIV status or age.
 
MSM account for more than 60% of new HIV infections in the United States, and substance-using men are among those at highest risk of HIV infection. Miami researchers noted that one third of new HIV infections in MSM can be traced to noninjection substance use. Their study randomized Miami-area substance-using MSM with or without HIV to one of two sexual and substance use risk-reduction interventions. The researchers published their results around the time of the IAS conference [2].
 
One strategy was a 90-minute, four-session, small-group, empowerment theory-based intervention; the other was a single 30-minute one-on-one resilience theory-based counseling session. Both approaches focus on individual goals, strengths, and motivations, and on building self-efficacy and positive social support connections. Participants were 18- to 55-year-old MSM who reported (1) unprotected anal intercourse in the past 90 days and (2) substance or alcohol intoxication at least 3 times in the past 30 days or marijuana use on at least 20 days in the past 30 days. Participants completed a modified version of the Global Appraisal of Individual Needs structured interview, which includes measures of (1) demographics and environment, (2) substance use, (3) mental health, and (4) sexual risk behaviors.
 
Of 515 study participants, 252 took part in group sessions and 263 had individual counseling. Age averaged about 39 in each group and education about 14 years. Most participants in the group and individual arms were white (46.4% versus 50.6%), while 29.0% and 22.8% were Hispanic and 20.2% and 21.7% were black. Almost half of the men in both groups (44.8% in group sessions and 47.9% in individual sessions) had HIV infection.
 
Substance use did not differ significantly between the two study arms. About 80% reported binge drinking in the past 90 days, and in that time 53% used amyl nitrite (poppers), 45% powder cocaine, 20% crack cocaine, 25% methamphetamine, 35% prescription sedatives, and 25% prescription opioids. Proportions of men reporting anal intercourse in the past 90 days were 35% in the group sessions and 51% in the individual session (not a significant difference). Respective rates of HIV transmission risk were 25% and 37%, and drug use during sex 68% and 60%. Anal sex partners in the past 90 days averaged 12 among men in group counseling and 14.5 among men in the individual sessions.
 
Twelve months after the interventions began, men in both groups reported significant drops in number of anal sex partners (average 11.9 to 6.7 in the group sessions and 14.5 to 9.7 with individual sessions, P < 0.001 for both improvements). Frequency of all other outcomes also fell significantly in both study arms--HIV transmission risk, unprotected anal sex, drugs used for sex, and substance dependence symptoms. See the study abstract (program abstract below, full txt attached) linked at reference 2 for the effect sizes of each outcome, all of which were moderate to large (P < 0.001 for all improvements in both groups). Results did not differ by HIV status or age, but black men reduced their health risks faster than whites or Latinos.
 
Program Abstract: The sample averaged over 17 UAI events and over 13 anal sex partners in the past 90 days at baseline. At 12 month follow-up, effect sizes for risk reduction were moderate to large: UAI -.51; anal sex partners -.53; binge drinking -.45; stimulant drug use -.41; days no substance use +.67. As well, 41% of participants had reduced their UAI events to zero.
 
The researchers suggested their findings "indicate that intervention approaches for substance-using MSM that target empowerment and resilience . . . appear to be efficacious based on pre- and post-intervention self-reports of behavior change, and may lead to more sustainable behavior change than addressing sexual risk behaviors and drug use with educational or didactic approaches."
 
Although the findings indicate that substance-using MSM "can initiate and sustain substantial risk reductions" through these interventions, the researchers caution that "the processes by which these men reduce their risks are poorly understood."
 
References
 
1. Kurtz SP, Buttram ME, Stall RD, Surratt HL. A randomized clinical trial of two interventions to reduce HIV risk and substance use among highly vulnerable MSM. 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention, June 30-July 3, 2013, Kuala Lumpur. Abstract WEPE547.
 
2. Kurtz SP, Stall RD, Buttram ME, Surratt HL, Chen M. A randomized trial of a behavioral intervention for high risk substance-using MSM. AIDS Behav. 2013 Jun 4. Epub ahead of print. http://www.ncbi.nlm.nih.gov/pubmed/23732957 am ME, Surratt HL, Chen M. A randomized trial of a behavioral intervention for high risk substance-using MSM. AIDS Behav. 2013 Jun 4. Epub ahead of print. http://www.ncbi.nlm.nih.gov/pubmed/23732957

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Discussion and Conclusions
 
Significant effect size for reductions in HIV transmission risk, unprotected anal sex, anal sex partners, drugs used for sex, and substance dependence were all moderate to large. We constructed multilevel linear models for repeated measures, controlling, successively, for age and HIV serostatus. These controls had no effect on rates of behavior change over the course of the study. Although no differences were found by study condition, both interventions addressed substance use and HIV transmission risk, by focusing on individual goals, strengths, motivations, and building positive social support connections and self-efficacy. This suggests that interventions based upon both empowerment theory and resilience theory are efficacious in reducing risk behaviors for MSM. The results indicate that intervention approaches for substance using MSM that target empowerment and resilience - the identification and achievement of life goals, building positive social relationships, broadening social engagements, and improving coping skills, self-efficacy and self worth - appear to be efficacious based on pre- and post-intervention self reports of behavior change, and may lead to more sustainable behavior change than addressing sexual risk behaviors and drug use with educational or didactic approaches. Further, our findings suggest that substance using MSM can initiate and sustain substantial risk reductions, but that the processes by which these men reduce their risks are poorly understood. Basic research that describes how these reductions occur over time may prove to be the best investment that the field could make in designing interventions for this population.
 
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A Randomized Trial of a Behavioral Intervention for High Risk Substance-Using MSM
 
Aids Behavior June 4 2013
 
Steven P. Kurtz · Ronald D. Stall · Mance E. Buttram · Hilary L. Surratt · Minxing Chen
 
".....men who have sex with men (MSM) account for more than 60 % of all new infections in the United States.......substance-using MSM are among the groups at highest risk for HIV infection in the United States.......... The study was conducted at two field offices, one in Wilton Manors (a suburb of Ft. Lauderdale) and one in Miami Beach.....about a third of new HIV infections among MSM can be attributed to non-injection substance use.......South Florida (Miami/Ft. Lauderdale) is a well-known migration destination for MSM, with the second highest proportion of same-sex households among large cities in the nation [18]. The Miami metropolitan area reports the highest HIV and AIDS incidence rates in the U.S. [19]. A recent Miami study found that almost half (45 %) of HIV-positive MSM were unaware of their infection [20]. Baseline data from the present study indicated that almost one-third of HIV-negative men who migrated to South Florida after the age of 18 seroconverted within 5 years of doing so [21], making the study site one of the highest risk settings....... Substance use was also diverse, with the large majority (81.2 %) reporting binge drinking. About two-thirds (62.3 %) reported illicit stimulant (cocaine, crack, and/or methamphetamine) use, 53.4 % amyl nitrites, 34.4 % prescription sedatives and 25 % prescription opioids. Numerous other substances were reported but did not exceed 20 % prevalence...... Black men reported 37 % higher frequency of binge drinking before or during sex than Hispanic men (p<0.05) and 44 % higher frequency than white men (p<0.01) at baseline......
 
.....By any measure, the study participants reported extraordinarily high rates of HIV risk behaviors and related psychosocial/syndemic health conditions. Participants reported an average of more than 13 anal sex partners and 16 HIV transmission risk events in the past 90 days, for an average of about one new anal sex partner and high risk HIV transmission event each week. Majorities met criteria for severe mental distress (57.9 %) and substance dependence (62.1 %), and had been victimized as minors (54.8 %)....
 
......This analysis points to several potentially important strategies for future research........ The overarching aim should be to identify the least intensive and most effective behavioral interventions that can be scaled up in community settings, as well as provide the necessary and complementary support for treatment as prevention [47], preexposure prophylaxis [48], and other emerging biological prevention approaches to be effective [49]. "

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Abstract
 
Substance-using men who have sex with men (MSM) are among the groups at highest risk for HIV infection in the United States. We report the results of a randomized trial testing the efficacy of a small group sexual and substance use risk reduction intervention based on empowerment theory compared to an enhanced efficacious control condition among 515 high risk not-in-treatment MSM substance users. Effect sizes for sexual risk and substance use outcomes were moderate to large: HIV transmission risk frequency, d = 0.71 in the control versus 0.66 in the experimental group; number of anal sex partners, d = 1.04 versus 0.98; substance dependence symptoms, d = 0.49 versus 0.53; significant differences were not observed between conditions. Black MSM reduced their risks at a greater rate than White or Latino men. The findings point to a critically important research agenda to reduce HIV transmission among MSM substance users.
 
Introduction
 
According to recent CDC estimates, men who have sex with men (MSM) account for more than 60 % of all new infections in the United States [1]. Given that the majority of all new infections in the United States occur among MSM, finding ways to identify and lower transmission rates in this group is key to lowering HIV incidence rates in the United States. We now have evidence, compiled over the past 30 years, to show that substance-using MSM are among the groups at highest risk for HIV infection in the United States [2-5]. Furthermore, two independent analyses using HIV seroconversion end-points found that about a third of new HIV infections among MSM can be attributed to non-injection substance use [6, 7]. This body of epidemiological and behavioral research makes it clear that if we are to reduce rates of HIV transmission among MSM in the United States, strategies that are specifically designed to lower risks among substance-using MSM must be an essential component of any successful response to the epidemic in this population.
 
Despite widespread agreement that substance-using MSM suffer a large proportion of new HIV infections in the United States, the vast majority of research among MSM substance users has been descriptive in nature. As such, evidenced-based risk reduction interventions for not in-treatment MSM substance users are lacking [8-11]. To date, there have been only four randomized controlled trials (RCTs) to reduce HIV risk among MSM substance users [12-14], the most recent of which is the subject of this report. The earlier RCTs testing new interventions for MSM substance users all demonstrated high levels of risk reduction in both the experimental and control conditions, but differences in behavior change reached statistical significance between conditions in only one of these studies, which was implemented among men in substance abuse treatment [13].
 
We tested the efficacy of a novel small group sexual and substance use risk reduction intervention based on psychological empowerment theory [15] compared to an enhanced efficacious [16] HIV risk-reduction counseling condition among high risk not-in-treatment MSM substance users in South Florida (Miami/Ft. Lauderdale). The small group intervention approach, and to a somewhat lesser extent the control condition, conceptualized sexual risk behaviors and substance use primarily as symptoms of underlying life problems related to the substance use, violence, and AIDS syndemic [17] present in this population. This paper presents outcome data comparing an enhanced efficacious intervention that is already part of standard HIV risk-reduction public health practice to a new intervention specifically designed for substance using MSM.
 
Site
 
South Florida (Miami/Ft. Lauderdale) is a well-known migration destination for MSM, with the second highest proportion of same-sex households among large cities in the nation [18]. The Miami metropolitan area reports the highest HIV and AIDS incidence rates in the U.S. [19]. A recent Miami study found that almost half (45 %) of HIV-positive MSM were unaware of their infection [20]. Baseline data from the present study indicated that almost one-third of HIV-negative men who migrated to South Florida after the age of 18 seroconverted within 5 years of doing so [21], making the study site one of the highest risk settings
 
The study was conducted at two field offices, one in Wilton Manors (a suburb of Ft. Lauderdale) and one in Miami Beach. The offices were located in standard business office buildings; the Wilton Manors office building was located on the site of a community based organization. Both of these neighborhoods serve as the dominant residential, gathering and recreational centers for MSM in South Florida, are located in adjoining counties, and are situated close enough to each other that there is substantial movement by MSM between the two neighborhoods.
 
Results
 
Sample Characteristics

 
Sample characteristics at baseline by study condition are shown in Table 1. The sample was diverse as to age, race/ethnicity, and serostatus, and averaged almost 2 years of college education. Substance use was also diverse, with the large majority (81.2 %) reporting binge drinking. About two-thirds (62.3 %) reported illicit stimulant (cocaine, crack, and/or methamphetamine) use, 53.4 % amyl nitrites, 34.4 % prescription sedatives and 25 % prescription opioids. Numerous other substances were reported but did not exceed 20 % prevalence.
 
By any measure, the study participants reported extraordinarily high rates of HIV risk behaviors and related psychosocial/syndemic health conditions. Participants reported an average of more than 13 anal sex partners and 16 HIV transmission risk events in the past 90 days, for an average of about one new anal sex partner and high risk HIV transmission event each week. Majorities met criteria for severe mental distress (57.9 %) and substance dependence (62.1 %), and had been victimized as minors (54.8 %). The intervention groups were not significantly different on any of these measures, except that the control group reported more frequent use of sedatives at baseline.
 
The control group also reported higher frequencies on most sexual risk measures, but these did not approach the 0.05 level of significance. As noted in the ''Methods'' section, the log transformations substantially attenuated the effect of right side outliers that predominated in the control group. Skewness in the sexual risk variables ranged from 3.37 to 5.55, and was reduced in the log-transformed variables to a range of 0.28 to 0.99.
 
Enrollment, Retention and Adverse Events
 
The participant flow chart is shown in Fig. 3. The most common reasons for failing the initial eligibility screen were: sexual risk threshold (64.5 %); substance use threshold (20.8 %); both sexual risk and substance use thresholds (13.5 %); and recent enrollment in a drug treatment or HIV prevention program (13.7 %). In total, 515 men were randomized into the study. Four hundred-twenty participants (81.6 %) completed all four assessments, 47 (9.1 %) completed baseline plus two follow-ups, 25 (4.9 %) completed baseline plus one follow-up, and 23 (4.5 %) completed only the baseline assessment. Participants lost to all follow-up and those who did not complete the 12-month assessment did not differ from other participants on measures of race/ethnicity, income, mental distress, victimization history, substance use, substance dependence, or sex risk. Men lost to all follow-up and to the 12 month assessment were about 5 years younger, on average, than other participants. Although a number of participants experienced drug overdose, medical problems and/or victimization over the course of the study, no adverse events were attributable to study participation.
 
Study Outcomes
 
Table 2 displays the results of the MLMs of longitudinal changes in the frequencies of the log transformed primary and secondary outcome measures, controlling for age, race/ethnicity, HIV serostatus, and arm, and their interactions with time. Results for the primary outcome measure, HIV transmission risk frequency, are shown in the first column. The observed decrease in HIV transmission risk events was significant at the p<0.001 level for the entire sample. Time^2, the quadratic term indicating rate of change, is also significant and indicates a nonlinear and decreasing rate of reduction in the outcome variable over time. There are no age or racial/ethnic differences at baseline, but Black men reduced their HIV transmission risk frequency at a 17 % greater rate over time than Hispanic men (p<0.01) and 18 % greater than White men (p<0.01).
 
HIV positive men had much lower rates of HIV transmission risk events than HIV-negative men at baseline (p<0.001), because the outcome variable excluded UAI events where both partners were HIV-positive. There was no difference by serostatus in rate of change in HIV transmission risk frequency over time. No significant differences in outcome between the experimental and control conditions were observed.
 
The results are similar for receptive and insertive HIV transmission risk frequencies, shown in the second and third columns of Table 2. There were two differences in the receptive transmission risk model: there was no significant difference between Black and Hispanic men in rate of behavior change; and there were no significant differences in baseline receptive transmission risk frequencies by serostatus. Change in numbers of anal sex partners is shown in column 4. The patterns are similar to those for HIV transmission risk frequency, except that HIV-positive participants reported 29 % (p<0.001) more partners at baseline compared to HIV-negative men. No significant differences in outcome between the experimental and control conditions were observed.
 
Change in frequency of using drugs/binge drinking before or during sex is shown in column 5 of Table 2. Patterns of behavior change are similar to those observed for number of anal sex partners, except that Black men reported 37 % higher frequency of binge drinking before or during sex than Hispanic men (p<0.05) and 44 % higher frequency than white men (p<0.01) at baseline. Similar to the other outcome measures, however, black men reduced their use of drugs/binge drinking for sex at a faster rate than White and Hispanic men over the course of the study. No significant differences in outcome between the experimental and control conditions were observed.
 
Change in substance dependence symptoms is shown in column 6. As for the other outcome measures, the observed decrease in symptoms was significant at the p<0.001 level for the entire sample. Time^2, the quadratic term indicating rate of change, is also significant and indicates a nonlinear and decreasing rate of reduction in the substance dependence symptoms over time. Black men reported more symptoms than White men at baseline (p<0.01). HIV positive men reported more symptoms than HIV-negative at baseline (p\0.01). No differences in rates of change by demographics were observed, and there were no significant differences in outcome between the experimental and control conditions.
 
Wave by wave changes in the mean values of primary and secondary outcome measures are shown in Table 3 (total UAI frequency is also shown to demonstrate the similar result to HIV transmission risk frequency). As indicated by the results of the multilevel models in Table 2, reductions in sexual risk behaviors, substance use, and substance dependence symptoms were greatest between baseline and 3 month follow-up, with rather modest changes thereafter.
 
Effect sizes for the changes in the log transformed primary and secondary outcome measures between baseline and 12 month follow-up by study arm are also shown in Table 3. Effect sizes were moderate to large across all outcomes, and no significant differences were observed between study conditions. The effect size for the reduction in substance dependence symptoms was moderate (0.49 in the control group vs. 0.53 in the experimental group). Effect sizes for all main sexual risk outcomes were large: HIV transmission risk frequency, 0.71-0.66; number of anal sex partners, 1.04-0.984; and frequency of using alcohol and/or drugs for sex, 0.94-1.00. Effect sizes for receptive and insertive HIV transmission risk frequencies separately were moderate.
 
Discussion
 
The risk reductions reported by the high risk MSM substance users in this study are as large or larger than those achieved by other efficacious interventions for MSM now being diffused as tools in standard public health practice [10, 30], and are particularly impressive given their achievement in such a high risk population. The results indicate that intervention approaches for substance using MSM that target empowerment and resilience-the identification and achievement of life goals, building positive social relationships, broadening social engagements, and improving coping skills, self-efficacy and self worth- appear to be efficacious based on pre- and post-intervention self reports of behavior change, and may lead to more sustainable behavior change than addressing sexual risk behaviors and drug use with educational or didactic approaches. Moreover, resilience-based interventions have demonstrated efficacy in reducing substance use and mental distress in other populations [31-34]. Although in designing the study we strongly believed that group process would be an important element in assisting high risk substance using men to legitimize, embrace and enact the proficiencies targeted by empowerment theory, men in the single-session individual counseling arm reported reductions in their sexual and substance use risk behaviors to the same extent as the men in the four-session group condition. Although a finding of no difference between arms of an RCT study is often interpreted as evidence of a failed trial of an innovative intervention, it is important to point out that in this case the comparisons were between an intervention with proven efficacy, which we enhanced based on resilience theory, and a novel intervention specifically designed for substance using MSM. As such, the new intervention did not perform at levels above and beyond one of the more powerful evidence-based risk-reduction interventions available to the field. However, the similarity of effects between study arms also suggests that brief interventions-delivered in the context of a friendly and comfortable field office staffed by MSM age peers-enable even very high risk MSM to access mechanisms to reduce risk. In this study, the brief intervention condition took *40 min to complete, and had higher uptake than the group condition. The logistics of implementing the brief individual resilience counseling condition were much simpler, and this intervention format would be much more easily implemented, scalable and sustainable in community settings.
 
Our finding that Black men reduced their sexual risk behaviors to a greater extent than White and Hispanic men, despite exhibiting no higher levels of risk at baseline, bears further investigation. Black men reported higher frequencies of using drugs/binge drinking for sex, as well as higher levels of substance dependence symptoms, than other men at baseline, but they also reduced their drugs/binge drinking- sex frequencies at a faster rate than White and Hispanic men. As reported elsewhere [35], African American/Black men in the study commonly reported the importance of social support to their health and health behaviors, including the unique support they found through their contact with project staff. Moreover, they perceived their baseline levels of social support outside of the project staff-as a group-to be much lower than among White and Hispanic men. It is possible that the supportive environment offered by the field office, including regular contact from staff and extensive referrals to health and social services, had a stronger effect on helping Black men reduce risk compared to White and Latino men. We acknowledge that a small proportion of our sample was Black MSM, potentially reducing the generalizability of this finding.
 
Limitations
 
Although the recruitment procedures resulted in a sample of a wide age range and broadly inclusive of the racial/ethnic makeup of South Florida, our ability to generalize the findings to other MSM is limited by the study eligibility requirements, including regular substance use and recent UAI. Syndemic characteristics are likely much more prevalent among high risk substance users than among MSM in general, and the study interventions may have been particularly well-suited to men with high levels of mental distress, social isolation, and victimization histories. We also note that all data are based on self-report, potentially leading to underreporting of socially undesirable behaviors.
 
Given the high levels of substance use and sexual risk behaviors we found, however, underreporting of these and other stigmatized behaviors would appear to be uncommon. Moreover, men reported reductions in substance dependence symptoms over time that accompanied their reported reductions in substance use.
 
Another limitation of the study is that the RESPECT model was enhanced to include resilience-based approaches to risk reduction, and as such was perhaps more robust than a true standard of care. As such, the efficacy of the experimental condition compared to a true standard of care cannot be measured.
 
Implications for Future Research
 
Our study results are similar in some ways to other behavioral intervention trials for substance-using MSM [12-14]. Stall et al. reported no differences in sexual risk outcomes among substance abuse treatment clients assigned in a modified random design to a standard recovery group format or a recovery group enhanced to include sexual risk reduction protocols. In a four-arm randomized trial for MSM treatment enrollees, Shoptaw and colleagues found that contingency management, with or without cognitive behavioral therapy (CBT), was more efficacious for client retention, duration and continuity of clean urines, and reducing unprotected receptive anal intercourse than CBT alone, although changes in drug use were not different across conditions. In a two-armed RCT of a group-based CBT intervention compared to a time-matched control, that also included a non-randomized third group receiving HIV testing and counseling alone, Mansergh et al. reported no statistical differences in sexual risk or substance use reduction across study arms. As the latter and the present studies are the only two of the four to target not-in-treatment MSM, clearly new behavioral approaches are needed for non-treatment populations of MSM substance users.
 
However, each of these studies demonstrated high and sustained levels of risk reduction in both the experimental and control conditions. In all of four studies, the reductions were evident at the first follow-up and sustained through the final assessment. These similarities are striking and suggest that substance using MSM can initiate and sustain substantial risk reductions, but that the processes by which these men reduce their risks are poorly understood. Basic research that describes how these reductions occur over time may prove to be the best investment that the field could make in designing interventions for this population. A more comprehensive understanding of the factors that contribute to risk reductions among high risk MSM substance users in control arms is needed to inform the design of low threshold interventions that could be broadly disseminated.
 
In the present study, one possible explanation is that both intervention conditions, despite varying significantly in dose and mode of delivery, were focused on participants' self-identification of strengths and needs, and provided high levels of social support and extensive referrals to health and social services. Other possible explanations include the experience of study enrollment alone, selfselection into research studies of participants who are ready to change, and/or reactive effects to study assessments [36-39]. Although several HIV RCT outcome reports have suggested such potentially confounding effects [14, 16, 40-43], their measurement in the HIV prevention research literature is scant (see [39, 42, 44]), and is not apparent in studies of high risk MSM substance users.
 
So-called reactive effects of research and/or clinical assessments among substance users have been recognized in the literature since at least the mid-1970s [37]. Researchers studying both substance abuse and sexual risk behaviors have attributed these behavioral responses to assessments to consciousness raising, focused attention, self-monitoring, self-efficacy, and similar phenomena [36, 37, 40, 42, 45]. Indeed, qualitative data from young adult multidrug users who recently completed a large-scale natural history study conducted by the investigators attributed their extensive reductions in substance use to increased self-awareness that emerged in response to the comprehensive health and social risk assessments [46]. Largely missing from this literature is systematic empirical evidence for how and why study assessments might produce behavior change [36, 45].
 
This analysis points to several potentially important strategies for future research designs of RCTs of interventions to assist high risk MSM reduce their health risk behaviors: (1) the inclusion of wait list and assessment-only conditions, so that enrollment, assessment and intervention effects can be clearly evaluated; and (2) more extensive qualitative data collection from study completers to contextualize motivations and mechanisms of behavior change. The overarching aim should be to identify the least intensive and most effective behavioral interventions that can be scaled up in community settings, as well as provide the necessary and complementary support for treatment as prevention [47], preexposure prophylaxis [48], and other emerging biological prevention approaches to be effective [49].
 
Conclusion
 
MSM suffer the majority of new HIV infections in the United States, and a substantial proportion of these new infections occur among substance-using MSM. The men sampled for this trial not only reside in a region characterized by one of the highest HIV incidence rates for MSM in the United States, but are men who also reported exceptionally high levels of sexual risk-taking. Given that these men reside in an area that attracts enormous numbers of gay male tourists, it is likely that the sexual risk-taking behaviors of substance-using MSM in South Florida have epidemiological repercussions not only locally but far beyond Florida's borders. We now have data from four separate studies to show that rates of sexual risk-taking among MSM substance users can be reduced to an impressive degree, and that these risk reductions are stable for relatively long periods of time. These findings-and the larger epidemiological contexts of HIV risk among substance-using MSM-suggest that interventions can be designed to reduce HIV transmission risk in this population, and, moreover, that continued attempts to lower HIV infection rates among MSM substance users could prove to be an essential tool to reduce HIV-related health disparities among the broad population of MSM in the United States.