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1.  Correlates of Unprotected Vaginal or Anal Intercourse with Women among Substance-Using Men Who Have Sex with Men 
AIDS and behavior  2013;17(3):889-899.
The role men who have sex with men and women (MSMW) play in heterosexual HIV transmission is not well understood. We analyzed baseline data from Project MIX, a behavioral intervention study of substance-using men who have sex with men (MSM), and identified correlates of unprotected vaginal intercourse, anal intercourse, or both with women (UVAI). Approximately 10% (n=194) of the men reported vaginal sex, anal sex, or both with a woman; of these substance-using MSMW, 66% (129) reported UVAI. Among substance-using MSMW, multivariate analyses found unemployment relative to full/part-time employment (OR=2.28; 95% CI 1.01, 5.17), having a primary female partner relative to no primary female partner (OR=3.44; CI 1.4, 8.46), and higher levels of treatment optimism (OR=1.73; 95% CI 1.18, 2.54) increased odds of UVAI. Strong feelings of connection to a same-race gay community (OR=0.71; 95% CI 0.56, 0.91) and Viagra use (OR=0.31; 95% CI 0.10, 0.95) decreased odds of UVAI. This work suggests that although the proportion of substance-using MSM who also have sex with women is low, these men engage in unprotected sex with women, particularly with primary female partners. This work highlights the need for further research with the substance using MSMW population to inform HIV prevention interventions specifically for MSMW.
doi:10.1007/s10461-012-0357-0
PMCID: PMC3693735  PMID: 23229336
bisexual; heterosexual; HIV; MSMW; condom usage
2.  Recruitment of urban US women at risk for HIV infection and willingness to participate in future HIV vaccine trials 
AIDS and behavior  2013;17(2):760-772.
Enrollment of US women with sufficient risk of HIV infection into HIV vaccine efficacy trials has proved challenging. A cohort of 799 HIV-negative women, aged 18-45, recruited from three US cities was enrolled to assess recruitment strategies based on geographic risk pockets, social and sexual networks and occurrence of sexual concurrency and to assess HIV seroincidence during follow-up (to be reported later). Among enrolled women, 90% lived or engaged in risk behaviors within a local risk pocket, 64% had a male partner who had concurrent partners and 50% had a male partner who had been recently incarcerated. Nearly half (46%) were recruited through peer referral. At enrollment, 86% of women said they were willing to participate in a vaccine efficacy trial. Results indicate that participant and partner risk behaviors combined with a peer referral recruitment strategy may best identify an at-risk cohort willing to participate in future trials.
doi:10.1007/s10461-012-0351-6
PMCID: PMC3562410  PMID: 23090677
HIV vaccine trial preparedness; United States women; peer referral; respondent driven sampling; sexual concurrency; willingness to participate
3.  Concomitant Socioeconomic, Behavioral, and Biological Factors Associated with the Disproportionate HIV Infection Burden among Black Men Who Have Sex with Men in 6 U.S. Cities 
PLoS ONE  2014;9(1):e87298.
Background
American Black men who have sex with men (MSM) are disproportionately affected by HIV, but the factors associated with this concentrated epidemic are not fully understood.
Methods
Black MSM were enrolled in 6 US cities to evaluate a multi-component prevention intervention, with the current analysis focusing on the correlates of being newly diagnosed with HIV compared to being HIV-uninfected or previously diagnosed with HIV.
Results
HPTN 061 enrolled 1553 Black MSM whose median age was 40; 30% self-identified exclusively as gay or homosexual, 29% exclusively as bisexual, and 3% as transgender. About 1/6th (16.2%) were previously diagnosed with HIV (PD); of 1263 participants without a prior HIV diagnosis 7.6% were newly diagnosed (ND). Compared to PD, ND Black MSM were younger (p<0.001); less likely to be living with a primary partner (p<0.001); more likely to be diagnosed with syphilis (p<0.001), rectal gonorrhea (p = 0.011) or chlamydia (p = 0.020). Compared to HIV-uninfected Black MSM, ND were more likely to report unprotected receptive anal intercourse (URAI) with a male partner in the last 6 months (p<0.001); and to be diagnosed with syphilis (p<0.001), rectal gonorrhea (p = 0.004), and urethral (p = 0.025) or rectal chlamydia (p<0.001). They were less likely to report female (p = 0.002) or transgender partners (p = 0.018). Multivariate logistic regression analyses found that ND Black MSM were significantly more likely than HIV-uninfected peers to be unemployed; have STIs, and engage in URAI. Almost half the men in each group were poor, had depressive symptoms, and expressed internalized homophobia.
Conclusions
ND HIV-infected Black MSM were more likely to be unemployed, have bacterial STIs and engage in URAI than other Black MSM. Culturally-tailored programs that address economic disenfranchisement, increase engagement in care, screen for STIs, in conjunction with safer sex prevention interventions, may help to decrease further transmission in this heavily affected community.
doi:10.1371/journal.pone.0087298
PMCID: PMC3909083  PMID: 24498067
4.  “Straight Talk” for African American heterosexual men: Results of a single-arm behavioral intervention trial 
AIDS care  2012;25(5):627-631.
In the United States, heterosexual transmission is the second leading cause of HIV/AIDS, and two-thirds of all heterosexually acquired cases diagnosed between 2005 and 2008 occurred among African Americans. Few HIV prevention interventions have been designed specifically for African American heterosexual men not seeking clinical treatment. Here we report results of a single-arm intervention trial of a theory-based HIV prevention intervention designed to increase condom use, reduce concurrent partnering and increase HIV testing, among heterosexually active, African American men living in high HIV prevalence areas of New York City. We tested our hypothesis using McNemar discordant pairs exact test for binary variables and paired t-tests for continuous variables. We observed statistically significant declines in mean number of total and new female partners, unprotected sex partners and partner concurrency in both primary and non-primary sex partnerships between baseline and three months post-intervention.
doi:10.1080/09540121.2012.722605
PMCID: PMC3693736  PMID: 23005899
5.  Performance of a Limiting-Antigen Avidity Enzyme Immunoassay for Cross-Sectional Estimation of HIV Incidence in the United States 
PLoS ONE  2013;8(12):e82772.
Background
A limiting antigen avidity enzyme immunoassay (HIV-1 LAg-Avidity assay) was recently developed for cross-sectional HIV incidence estimation. We evaluated the performance of the LAg-Avidity assay alone and in multi-assay algorithms (MAAs) that included other biomarkers.
Methods and Findings
Performance of testing algorithms was evaluated using 2,282 samples from individuals in the United States collected 1 month to >8 years after HIV seroconversion. The capacity of selected testing algorithms to accurately estimate incidence was evaluated in three longitudinal cohorts. When used in a single-assay format, the LAg-Avidity assay classified some individuals infected >5 years as assay positive and failed to provide reliable incidence estimates in cohorts that included individuals with long-term infections. We evaluated >500,000 testing algorithms, that included the LAg-Avidity assay alone and MAAs with other biomarkers (BED capture immunoassay [BED-CEIA], BioRad-Avidity assay, HIV viral load, CD4 cell count), varying the assays and assay cutoffs. We identified an optimized 2-assay MAA that included the LAg-Avidity and BioRad-Avidity assays, and an optimized 4-assay MAA that included those assays, as well as HIV viral load and CD4 cell count. The two optimized MAAs classified all 845 samples from individuals infected >5 years as MAA negative and estimated incidence within a year of sample collection. These two MAAs produced incidence estimates that were consistent with those from longitudinal follow-up of cohorts. A comparison of the laboratory assay costs of the MAAs was also performed, and we found that the costs associated with the optimal two assay MAA were substantially less than with the four assay MAA.
Conclusions
The LAg-Avidity assay did not perform well in a single-assay format, regardless of the assay cutoff. MAAs that include the LAg-Avidity and BioRad-Avidity assays, with or without viral load and CD4 cell count, provide accurate incidence estimates.
doi:10.1371/journal.pone.0082772
PMCID: PMC3873916  PMID: 24386116
6.  Methods to Measure the Impact of Home, Social, and Sexual Neighborhoods of Urban Gay, Bisexual, and Other Men Who Have Sex with Men 
PLoS ONE  2013;8(10):e75878.
Men who have sex with men (MSM) accounted for 61% of new HIV diagnoses in the United States in 2010. Recent analyses indicate that socio-structural factors are important correlates of HIV infection. NYCM2M was a cross-sectional study designed to identify neighborhood-level characteristics within the urban environment that influence sexual risk behaviors, substance use and depression among MSM living in New York City. The sample was recruited using a modified venue-based time-space sampling methodology and through select websites and mobile applications.
This paper describes novel methodological approaches used to improve the quality of data collected for analysis of the impact of neighborhoods on MSM health. Previous research has focused predominately on residential neighborhoods and used pre-determined administrative boundaries (e.g., census tracts) that often do not reflect authentic and meaningful neighborhoods. This study included the definition and assessment of multiple neighborhoods of influence including where men live (home neighborhood), socialize (social neighborhood) and have sex (sexual neighborhood). Furthermore, making use of technological advances in mapping, we collected geo-points of reference for each type of neighborhood and identified and constructed self-identified neighborhood boundary definitions. Finally, this study collected both perceived neighborhood characteristics and objective neighborhood conditions to create a comprehensive, flexible and rich neighborhood-level set of covariates. This research revealed that men perceived their home, social and sexual neighborhoods in different ways. Few men (15%) had the same home, social and sexual neighborhoods; for 31%, none of the neighborhoods was the same. Of the three types of neighborhoods, the number of unique social neighborhoods was the lowest; the size of sexual neighborhoods was the smallest. The resultant dataset offers the opportunity to conduct analyses that will yield context-specific and nuanced understandings of the relations among neighborhood space, and the well-being and health of urban MSM.
doi:10.1371/journal.pone.0075878
PMCID: PMC3797712  PMID: 24146785
7.  Sociodemographic and Risk Behavior Characteristics Associated with Unprotected Sex with Women among Black Men Who Have Sex with Men and Women in New York City 
AIDS care  2012;24(9):1111-1119.
The objectives of this cross-sectional study were to compare sociodemographic and risk behavior characteristics between black men who have sex with both men and women (MSMW) and those who have sex with men only (MSMO) and assess factors associated with having any unprotected vaginal and/or anal intercourse (UVAI) with women in the last 3 months. Data from 326 black men who reported recent unprotected anal intercourse (UAI) with a man in an HIV behavioral intervention study in New York City were analyzed. Baseline characteristics were compared between MSMW and MSMO, and factors associated with having any UVAI in the past 3 months with women among MSMW were evaluated. In total, 26.8% reported having sex with both men and women in the last 3 months. MSMW were less likely to be HIV-infected, use amyl nitrates, and have unprotected receptive anal sex with most recent male partner. MSMW were more likely to be over 40 years old and use heroin. 55.6% of MSMW reported having UVAI with women in the last 3 months. Compared to MSMW having only protected sex, MSMW having any UVAI with women were less likely to be HIV-infected and to disclose having sex with men to female partners; they were more likely to have greater than 4 male sex partners in the last 3 months. In conclusion, HIV prevention interventions among black MSMW should directly address the risk of HIV transmission to both their female and male partners. Disclosure of bisexuality to female partners may be an important component of future prevention efforts.
doi:10.1080/09540121.2012.672723
PMCID: PMC3704079  PMID: 22533637
Black MSMW; men who have sex with men and women; bisexuality; HIV/AIDS
8.  Sexual risk behaviors, circumcision status and pre-existing immunity to adenovirus type 5 among men who have sex with men participating in a randomized HIV-1 vaccine efficacy trial: Step Study 
Background
The Step Study found that men who had sex with men (MSM) who received an adenovirus type 5 (Ad5) vector-based vaccine and were uncircumcised or had prior Ad5 immunity had a higher HIV incidence than MSM who received placebo. We investigated whether differences in HIV exposure, measured by reported sexual risk behaviors, may explain the increased risk.
Methods
Among 1,764 MSM in the trial, 724 were uncircumcised, 994 had prior Ad5 immunity and 560 were both uncircumcised and had prior Ad5 immunity. Analyses compared sexual risk behaviors and perceived treatment assignment among vaccine and placebo recipients, determined risk factors for HIV acquisition and examined the role of insertive anal intercourse in HIV risk among uncircumcised men.
Findings
Few sexual risk behaviors were significantly higher in vaccine vs. placebo recipients at baseline or during follow-up. Among uncircumcised men, vaccine recipients at baseline were more likely to report unprotected insertive anal intercourse with HIV negative partners (25.0% vs. 18.1%; p=0.03). Among uncircumcised men who had prior Ad5 immunity, vaccine recipients were more likely to report unprotected insertive anal intercourse with partners of unknown HIV status (46.0% vs. 37.5%; p=0.05). Vaccine recipients remained at higher risk of HIV infection compared to placebo recipients (HR =2.8; 95% CI:1.7, 6.8) controlling for potential confounders.
Interpretation
These analyses do not support a behavioral explanation for the increased HIV infection rates observed among uncircumcised men in the Step Study. Identifying biologic mechanisms to explain the increased risk is a priority.
This study is registered with ClinicalTrials.gov, number NCT00095576.
doi:10.1097/QAI.0b013e31825325aa
PMCID: PMC3392543  PMID: 22421748
HIV vaccines; gay men; sexual behaviors
9.  Correlates of HIV Acquisition in a Cohort of Black Men Who Have Sex with Men in the United States: HIV Prevention Trials Network (HPTN) 061 
PLoS ONE  2013;8(7):e70413.
Background
Black men who have sex with men (MSM) in the United States (US) are affected by HIV at disproportionate rates compared to MSM of other race/ethnicities. Current HIV incidence estimates in this group are needed to appropriately target prevention efforts.
Methods
From July 2009 to October 2010, Black MSM reporting unprotected anal intercourse with a man in the past six months were enrolled and followed for one year in six US cities for a feasibility study of a multi-component intervention to reduce HIV infection. HIV incidence based on HIV seroconversion was calculated as number of events/100 person-years. Multivariate proportional hazards modeling with time-dependent covariates was used to identify correlates of HIV acquisition.
Results
Of 1,553 Black MSM enrolled, 1,164 were HIV-uninfected at baseline and included in follow-up. Overall annual HIV incidence was 3.0% (95% confidence interval (CI): 2.0, 4.4%) and 5.9% among men ≤30 years old (95% CI: 3.6, 9.1%). Men ≤30 years old reported significantly higher levels of sexual risk and were more likely to have a sexually transmitted infection diagnosed during follow-up. Younger men also were more likely to not have a usual place for health care, not have visited a health care provider recently, and to have unmet health care needs. In multivariate analysis, age ≤30 years (hazard ratio (HR): 3.4; 95% CI: 1.4, 8.3) and unprotected receptive anal intercourse with HIV-positive or unknown status partners (HR: 4.1; 95% CI: 1.9, 9.1) were significantly associated with HIV acquisition.
Conclusion
In the largest cohort of prospectively-followed Black MSM in the US, HIV incidence was high, particularly among young men. Targeted, tailored and culturally appropriate HIV prevention strategies incorporating behavioral, social and biomedical based interventions are urgently needed to lower these rates.
doi:10.1371/journal.pone.0070413
PMCID: PMC3724810  PMID: 23922989
10.  Correction: What Drives the US and Peruvian HIV Epidemics in Men Who Have Sex with Men (MSM)? 
PLoS ONE  2013;8(7):10.1371/annotation/9a6a0c8e-2d01-4f36-9ab8-f9fdfce6497b.
doi:10.1371/annotation/9a6a0c8e-2d01-4f36-9ab8-f9fdfce6497b
PMCID: PMC3714381
11.  What Drives the US and Peruvian HIV Epidemics in Men Who Have Sex with Men (MSM)? 
PLoS ONE  2012;7(11):e50522.
In this work, we estimate the proportions of transmissions occurring in main vs. casual partnerships, and by the sexual role, infection stage, and testing and treatment history of the infected partner, for men who have sex with men (MSM) in the US and Peru. We use dynamic, stochastic models based in exponential random graph models (ERGMs), obtaining inputs from multiple large-scale MSM surveys. Parallel main partnership and casual sexual networks are simulated. Each man is characterized by age, race, circumcision status, sexual role behavior, and propensity for unprotected anal intercourse (UAI); his history is modeled from entry into the adult population, with potential transitions including HIV infection, detection, treatment, AIDS diagnosis, and death. We implemented two model variants differing in assumptions about acute infectiousness, and assessed sensitivity to other key inputs. Our two models suggested that only 4–5% (Model 1) or 22–29% (Model 2) of HIV transmission results from contacts with acute-stage partners; the plurality (80–81% and 49%, respectively) stem from chronic-stage partners and the remainder (14–16% and 27–35%, respectively) from AIDS-stage partners. Similar proportions of infections stem from partners whose infection is undiagnosed (24–31%), diagnosed but untreated (36–46%), and currently being treated (30–36%). Roughly one-third of infections (32–39%) occur within main partnerships. Results by country were qualitatively similar, despite key behavioral differences; one exception was that transmission from the receptive to insertive partner appears more important in Peru (34%) than the US (21%). The broad balance in transmission contexts suggests that education about risk, careful assessment, pre-exposure prophylaxis, more frequent testing, earlier treatment, and risk-reduction, disclosure, and adherence counseling may all contribute substantially to reducing the HIV incidence among MSM in the US and Peru.
doi:10.1371/journal.pone.0050522
PMCID: PMC3510067  PMID: 23209768
12.  Challenges for HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men in the United States 
PLoS Medicine  2012;9(8):e1001286.
In light of recent research, Gordon Mansergh and colleagues discuss barriers to effective implementation of HIV pre-exposure prophylaxis for men who have sex with men.
doi:10.1371/journal.pmed.1001286
PMCID: PMC3424255  PMID: 22927797
13.  Childhood Sexual Abuse Is Highly Associated With HIV Risk–Taking Behavior and Infection Among MSM in the EXPLORE Study 
Background
Previous studies have found high rates of childhood sexual abuse (CSA) among US men who have sex with men (MSM). CSA history has been associated with a variety of negative effects later in life including behaviors that place MSM at greater risk for HIV acquisition and transmission. The present analysis is the first to examine the longitudinal association between CSA and HIV infection, unprotected anal sex, and serodiscordant unprotected anal sex, as well as mediators of these relationships among a large sample of HIV-uninfected MSM.
Methods
The EXPLORE Study was a behavioral intervention trial conducted in 6 US cities over 48 months with HIV infection as the primary efficacy outcome. Behavioral assessments were done every 6 months via confidential computerized assessments. Longitudinal regression models were constructed, adjusting for randomization arm, geographical location of study site, age at enrollment, education, and race/ethnicity.
Results
Of the 4295 participants enrolled, 39.7% had a history of CSA. Participants with a history of CSA [adjusted hazards ratio = 1.30, 95% confidence interval (CI): 1.02 to 1.69] were at increased risk for HIV infection over study follow-up. A significant association was seen between history of CSA and unprotected anal sex (adjusted odds ratio = 1.24, 95% CI: 1.12 to 1.36) and serodiscordant unprotected anal sex (adjusted odds ratio = 1.30, 95% CI: 1.18 to 1.43). Among participants reporting CSA, the EXPLORE intervention had no effect in reducing HIV infection rates. Participants reporting CSA were significantly more likely to have symptoms of depression and use nonprescription drugs.
Conclusions
A predictive relationship between a history of CSA and subsequent HIV infection was observed among this large sample of HIV-uninfected MSM. Findings indicate that HIV-uninfected MSM with CSA histories are at greater risk for HIV infection, report higher rates of HIV sexual risk behavior, and may derive less benefit from prevention programs. Future HIV prevention interventions should address the specific mental health concerns of MSM with a history of CSA.
doi:10.1097/QAI.0b013e3181a24b38
PMCID: PMC3292283  PMID: 19367173
child sexual abuse; EXPLORE; HIV; MSM; sexual risk taking
14.  Male Circumcision and Risk of HIV Acquisition among Men who have Sex with Men from the United States and Peru 
AIDS (London, England)  2011;25(4):519-523.
Objectives
To assess the association between male circumcision, insertive anal sex practices, and HIV acquisition in a cohort of men who have sex with men (MSM).
Methods
Data were from 1824 HSV-2 seropositive, HIV seronegative MSM, 1362 (75%) from Peru and 462 (25%) from the US, who participated in a randomized placebo controlled trial of HSV-2 suppression for HIV prevention (HPTN 039). Circumcision status was determined by examination at enrollment. HIV testing was done every three months for up to 18 months. Partner-specific sexual behavior for up to the last three partners during the previous three months was analyzed.
Results
There was no significant association between male circumcision and HIV acquisition in univariate analysis (RR=0.84, 95% CI 0.50–1.42). In a pre-specified multivariate analysis that assumed a linear relationship between the proportion of insertive acts and effect of circumcision on HIV acquisition, the interaction between circumcision and proportion of insertive acts was not significant (p=0.11). In an exploratory analysis that categorized behavior with recent partners by proportion of insertive acts (<60% or ≥60% insertive acts), circumcision was associated with a non-statistically significant 69% reduction in the risk of HIV acquisition (RR=0.31, 95% CI 0.06–1.51) among men who reported ≥60% of insertive acts with recent male partners.
Conclusion
Circumcision does not have a significant protective effect against HIV acquisition among MSM from Peru and US, although there may be reduced risk for men who are primarily insertive with their male partners. This association needs to be investigated across diverse cohorts of MSM.
doi:10.1097/QAD.0b013e328340fd81
PMCID: PMC3120051  PMID: 21099672
HIV acquisition; male circumcision; men who have sex with men
15.  One Session of TTM-Tailored Condom Use Feedback: A Pilot Study Among At Risk Women in the Bronx 
AIDS care  2011;23(1):10-15.
There is an urgent need to implement interventions to curb the spread of sexually transmitted infections (STI’s), especially HIV. Consistent condom use is an effective preventive strategy, yet especially among those at highest risk, condom use remains too low. This paper describes changes in condom use and stages of condom use over 2–3 months time following a single session with an interactive multimedia computer-delivered Transtheoretical Model (TTM) tailored expert system originally designed for at risk adolescents. The intervention provided immediate TTM-tailored feedback to diverse urban women based on their stage of condom use and other TTM variables. Previous work found this system was acceptable. These data showed that 89% of women returned for a second session 2–3 months later, further supporting this system’s utility. After just one feedback session, 21% of women not using condoms at baseline started using condoms consistently at follow-up, with a trend for a relationship to baseline stage of condom use. These results support further randomized controlled research on the reach and efficacy of computer-based TTM-tailored and individualized condom use interventions.
doi:10.1080/09540121.2010.498858
PMCID: PMC3035173  PMID: 21218272
women; stages of change; TTM-tailored intervention; Transtheoretical Model; condom use; computer-delivered intervention
16.  Use of a High Resolution Melting (HRM) Assay to Compare Gag, Pol, and Env Diversity in Adults with Different Stages of HIV Infection 
PLoS ONE  2011;6(11):e27211.
Background
Cross-sectional assessment of HIV incidence relies on laboratory methods to discriminate between recent and non-recent HIV infection. Because HIV diversifies over time in infected individuals, HIV diversity may serve as a biomarker for assessing HIV incidence. We used a high resolution melting (HRM) diversity assay to compare HIV diversity in adults with different stages of HIV infection. This assay provides a single numeric HRM score that reflects the level of genetic diversity of HIV in a sample from an infected individual.
Methods
HIV diversity was measured in 203 adults: 20 with acute HIV infection (RNA positive, antibody negative), 116 with recent HIV infection (tested a median of 189 days after a previous negative HIV test, range 14–540 days), and 67 with non-recent HIV infection (HIV infected >2 years). HRM scores were generated for two regions in gag, one region in pol, and three regions in env.
Results
Median HRM scores were higher in non-recent infection than in recent infection for all six regions tested. In multivariate models, higher HRM scores in three of the six regions were independently associated with non-recent HIV infection.
Conclusions
The HRM diversity assay provides a simple, scalable method for measuring HIV diversity. HRM scores, which reflect the genetic diversity in a viral population, may be useful biomarkers for evaluation of HIV incidence, particularly if multiple regions of the HIV genome are examined.
doi:10.1371/journal.pone.0027211
PMCID: PMC3206918  PMID: 22073290
17.  Safety and Immunogenicity of an HIV Adenoviral Vector Boost after DNA Plasmid Vaccine Prime by Route of Administration: A Randomized Clinical Trial 
PLoS ONE  2011;6(9):e24517.
Background
In the development of HIV vaccines, improving immunogenicity while maintaining safety is critical. Route of administration can be an important factor.
Methodology/Principal Findings
This multicenter, open-label, randomized trial, HVTN 069, compared routes of administration on safety and immunogenicity of a DNA vaccine prime given intramuscularly at 0, 1 and 2 months and a recombinant replication-defective adenovirus type 5 (rAd5) vaccine boost given at 6 months by intramuscular (IM), intradermal (ID), or subcutaneous (SC) route. Randomization was computer-generated by a central data management center; participants and staff were not blinded to group assignment. The outcomes were vaccine reactogenicity and humoral and cellular immunogenicity. Ninety healthy, HIV-1 uninfected adults in the US and Peru, aged 18–50 were enrolled and randomized. Due to the results of the Step Study, injections with rAd5 vaccine were halted; thus 61 received the booster dose of rAd5 vaccine (IM: 20; ID:21; SC:20). After the rAd5 boost, significant differences by study arm were found in severity of headache, pain and erythema/induration. Immune responses (binding and neutralizing antibodies, IFN-γ ELISpot HIV-specific responses and CD4+ and CD8+ T-cell responses by ICS) at four weeks after the rAd5 booster were not significantly different by administration route of the rAd5 vaccine boost (Binding antibody responses: IM: 66.7%; ID: 70.0%; SC: 77.8%; neutralizing antibody responses: IM: 11.1%; ID: 0.0%; SC 16.7%; ELISpot responses: IM: 46.7%; ID: 35.3%; SC: 44.4%; CD4+ T-cell responses: IM: 29.4%; ID: 20.0%; SC: 35.3%; CD8+ T-cell responses: IM: 29.4%; ID: 16.7%; SC: 50.0%.)
Conclusions/Significance
This study was limited by the reduced sample size. The higher frequency of local reactions after ID and SC administration and the lack of sufficient evidence to show that there were any differences in immunogenicity by route of administration do not support changing route of administration for the rAd5 boost.
Trial Registration
ClinicalTrials.gov NCT00384787
doi:10.1371/journal.pone.0024517
PMCID: PMC3171485  PMID: 21931737
18.  Three City Feasibility Study of a Body Empowerment and HIV Prevention Intervention Among Women with Drug Use Histories: Women FIT 
Journal of Women's Health  2010;19(9):1705-1713.
Abstract
Background
New intervention models are needed for HIV prevention among drug-using women.
Methods
The Women Fighting Infection Together (Women FIT) feasibility study enrolled 189 women in three U.S. cities (Providence, New York, Philadelphia) with drug-using histories, who also reported risky sexual behavior. Eligible women had participated previously in a yearlong study of HIV Counseling and Testing (HIV-CT) and limited case management. Two thirds of the sample were black, most were unemployed, and about two thirds reported prior or current crack use. Women were randomized into two groups. In one group, women participated in a manualized, four-session, peer-led, interactive group intervention that stressed body knowledge, woman-initiated HIV/sexually transmitted infection (HIV/STI) prevention, including a focus on women's health (reproductive health screening, sexual violence, self-breast examination, STI signs, symptoms), which aimed to increase comfort with and pride in their bodies. Control group women received HIV-CT enriched by female condom counseling. Outcomes included study retention, session attendance and ratings, changes in knowledge, and use of protection methods.
Results
The study successfully retained 95% of the participants for a 2-month follow-up. Positive assessments from participants and peer leaders exceeded preset thresholds for success. Pre-post changes in body knowledge (p < 0.0001) and protection methods knowledge (p < 0.01) was greater among the intervention women than the control women.
Conclusions
The body empowerment model deserves further elaboration in interventions focusing on women at high risk of HIV/STI acquisition.
doi:10.1089/jwh.2009.1778
PMCID: PMC2953934  PMID: 20662629
19.  A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial 
AIDS and behavior  2011;15(5):897-904.
High adherence and maintenance of blinding are critical for placebo-controlled efficacy trials of HIV-1 biomedical prevention strategies. We assessed adherence to study drug and factors affecting adherence, including perceived randomization group, in a post-trial questionnaire of participants who completed HPTN 039, a randomized, placebo-controlled trial of HSV-2 suppression with twice-daily acyclovir to reduce HIV-1 acquisition. Of the 3172 trial participants, 2003 (63%) completed the post-trial questionnaire. Of these 2003, 72% reported missing a dose of study drug less than twice a week. Study drug adherence was not compromised by perceived randomization or genital ulcer symptoms during the study. Alcohol use was cited as an adherence barrier in some populations. Assessment of study drug adherence during and at the end of trials can evaluate perceptions of randomization and adherence by randomization arm, help to better understand barriers to and motivations for adherence, and develop interventions to increase adherence for future trials.
doi:10.1007/s10461-010-9853-2
PMCID: PMC3076532  PMID: 21104007
Adherence; Biomedical prevention; HIV-1; Clinical trials
20.  Recruitment of men who have sex with men for large HIV intervention trials: Analysis of the EXPLORE Study recruitment effort 
Testing HIV prevention strategies requires that researchers recruit participants at high risk of HIV infection. Data from the EXPLORE Study, a behavioral intervention trial involving men who have sex with men, were used to examine the relationship between recruitment strategies and participant characteristics, sexual risk behaviors and HIV incidence. The EXPLORE Study used a wide variety of recruitment strategies; no one strategy accounted for more than 20% of enrolled men. Younger men and men of color were more likely to be recruited through club and bar outreach, friend referral and street outreach. Men reporting ten or more sexual partners were more likely to be recruited through advertising and street outreach. Men reporting unprotected sex were more likely to be recruited through clinic referrals. HIV incidence did not significantly differ by recruitment strategy. Our findings support the need for a wide range of recruitment strategies in attracting MSM at high risk for HIV into clinical studies.
doi:10.1521/aeap.2010.22.1.28
PMCID: PMC3114877  PMID: 20166785
gay men; behavioral interventions; HIV; recruitment
21.  Addressing HIV prevention research priorities in the United States 
More than half a million Americans became newly infected with HIV in the first decade of the new millennium. The domestic epidemic has had the heaviest impact on men who have sex with men (MSM) and people from racial and ethnic minority populations, particularly African-Americans. For example, Black MSM represent <1% of the U.S. population but 25% of the new HIV cases, as per CDC estimates published in 2008. While Black and Hispanic women constitute 24% of all U.S. women, they accounted for 82% of HIV cases in women in 2005, based on data from 33 states with confidential name-based reporting. There is a nearly 23-fold higher rate of AIDS diagnoses for Black women (45.5/100,000 women) and nearly 6-fold higher rate for Hispanic women (11.2/100,000) compared to the rate for white women (2.0/100,000). Investigators from the HIV Prevention Trials Network (HPTN), an NIH-sponsored collaborative clinical trials group, have crafted a domestic research agenda with community input. Two new domestic studies are in progress (2009) and a community-based clinical trial feasibility effort is in development (2010 start date). These studies focus on outreach, testing, and treatment of infected persons as a backbone for HIV prevention. Reaching persons not receiving health message and service with novel approaches to both prevention and care/treatment is an essential priority for HIV control in the U.S.; our research is designed to guide the best approaches and assess the impact of bridging treatment and prevention.
doi:10.1086/651485
PMCID: PMC2862583  PMID: 20397942
HIV; prevention; United States; homosexual; women; transmission; antiretroviral treatment; black; Hispanic
22.  Migration, Neighborhoods, and Networks: Approaches to Understanding How Urban Environmental Conditions Affect Syndemic Adverse Health Outcomes Among Gay, Bisexual and Other Men Who Have Sex with Men 
AIDS and behavior  2011;15(Suppl 1):S35-S50.
Adopting socioecological, intersectionality, and lifecourse theoretical frameworks may enhance our understanding of the production of syndemic adverse health outcomes among gay, bisexual and other men who have sex with men (MSM). From this perspective, we present preliminary data from three related studies that suggest ways in which social contexts may influence the health of MSM. The first study, using cross-sectional data, looked at migration of MSM to the gay resort area of South Florida, and found that amount of time lived in the area was associated with risk behaviors and HIV infection. The second study, using qualitative interviews, observed complex interactions between neighborhood-level social environments and individual-level racial and sexual identity among MSM in New York City. The third study, using egocentric network analysis with a sample of African American MSM in Baltimore, found that sexual partners were more likely to be found through face-to-face means than the Internet. They also observed that those who co-resided with a sex partner had larger networks of people to depend on for social and financial support, but had the same size sexual networks as those who did not live with a partner. Overall, these findings suggest the need for further investigation into the role of macro-level social forces on the emotional, behavioral, and physical health of urban MSM.
doi:10.1007/s10461-011-9902-5
PMCID: PMC3084486  PMID: 21369730
Homosexuality; Male; Urban health; Social environment
23.  Sexual Partnering and HIV Risk among Black Men Who Have Sex with Men: New York City 
Black men who have sex with men (MSM) are disproportionately affected with HIV in the US. Limited event-specific data have been reported in Black MSM to help understand factors associated with increased risk of infection. Cross-sectional National HIV Behavioral Surveillance Study data from 503 MSM who reported ≥1 male sexual partner in the past year in New York City (NYC) were analyzed. Case-crossover analysis compared last protected and last unprotected anal intercourse (UAI). A total of 503 MSM were enrolled. Among 349 tested for HIV, 18% were positive. Black MSM (N = 117) were more likely to test HIV positive and not know their HIV-positive status than other racial/ethnic groups. Case-crossover analysis of 208 MSM found that men were more likely to engage in protected anal intercourse with a first time partner and with a partner of unknown HIV status. Although Black MSM were more likely to have Black male partners, they were not more likely to have UAI with those partners or to have a partner aged >40 years. In conclusion, HIV prevalence was high among Black MSM in NYC, as was lack of awareness of HIV-positive status. Having a sexual partner of same race/ethnicity or older age was not associated with having UAI among Black MSM.
doi:10.1007/s11524-009-9416-x
PMCID: PMC2821613  PMID: 19949990
HIV infection; Sexual partnering; Black men who have sex with men; African American; Unprotected anal intercourse
24.  Detection of Individuals with Acute HIV-1 Infection using the ARCHITECT® HIV Ag/Ab Combo Assay 
Background
We evaluated use of the ARCHITECT® HIV Ag/Ab Combo assay (HIV Combo; Abbott Diagnostics; available for sale outside of the U.S. only) for detection of acute HIV infection.
Methods
Samples were obtained from a behavioral intervention study (EXPLORE). HIV-uninfected men who have sex with men were enrolled and tested for HIV infection every 6 months. Samples from seroconverters collected at their last seronegative visit (n=217) were tested individually using two HIV RNA assays. Samples with detectable HIV RNA were classified as acute and were tested with HIV Combo. Samples from the enrollment visit (n=83) and the time of HIV seroconversion (n=219) were tested with HIV Combo as controls.
Results
Twenty-one (9.7%) samples from the last seronegative visit had detectable HIV RNA and were classified as acute. HIV Combo was positive for 13 (61.9%) of the acute samples. Samples not detected by HIV Combo had viral loads of 724 to 15,130 copies/ml. Expected results were obtained for positive and negative controls tested with HIV Combo.
Conclusions
HIV Combo detected nearly two-thirds of acute HIV infections identified in this high-risk population by non-pooled, HIV RNA assays. HIV Combo may be useful for high-throughput screening to identify individuals with acute HIV infection.
doi:10.1097/QAI.0b013e3181ab61e1
PMCID: PMC2744045  PMID: 19506484
acute infection; HIV-1; HIV Ag/Ab Combo assay
25.  An Intervention to Reduce HIV Risk Behavior of Substance-Using Men Who Have Sex with Men: A Two-Group Randomized Trial with a Nonrandomized Third Group 
PLoS Medicine  2010;7(8):e1000329.
In a randomized trial of a behavioral intervention among substance-using men who have sex with men, aimed at reducing sexual risk behavior, Mansergh and colleagues fail to find evidence of a reduction in risk from the intervention.
Background
Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM), and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group.
Methods and Findings
Participants (n = 1,686) were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p<0.05) reduced risk behavior (e.g., unprotected anal sex reduced by 32% at 12-mo follow-up), but were not different (p>0.05) from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio = 1.14, confidence interval = 0.86–1.51), nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons.
Conclusions
These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to statistically indistinguishable reductions in risk outcomes by trial group. More explicit debate is needed in the behavioral intervention field about appropriate scientific designs and methods. As HIV prevention increasingly competes for behavior-change attention alongside other “chronic” diseases and mental health issues, new approaches may better resonate with at-risk groups.
Trial Registration
ClinicalTrials.gov NCT00153361
Please see later in the article for the Editors' Summary
Editors' Summary
Background
AIDS first emerged in the early 1980s among gay men living in the US. As the disease spread around the world, it became clear that AIDS also affects heterosexual men and women. Now, three decades on, more than 30 million people are infected with HIV, the virus that causes AIDS. HIV is most often spread by having unprotected sex with an infected partner and, globally, most sexual transmission of HIV now occurs during heterosexual sex. However, 5%–10% of all new HIV infections still occur in men who have sex with men (MSM, a term that encompasses gay, bisexual, transgendered, and heterosexual men who sometimes have sex with men) and, in several high-income countries, male-to-male sexual contact remains the most important HIV transmission route. In the US, for example, more than half of the approximately 50,000 people who become infected with HIV every year do so through male-to-male sexual contact.
Why Was This Study Done?
In countries where MSM are the group at highest risk of HIV infection, any intervention that reduces HIV transmission in MSM should have a major effect on the overall HIV infection rate. Among MSM, sexual behaviors that increase the risk of HIV infection (for example, not using a condom, having anal sex, having sex with a partner of unknown HIV status, and having sex with many partners) are associated with the use of alcohol and noninjection drugs (for example, inhaled amyl nitrite or poppers) during or shortly before sexual encounters. In this study (Project MIX), the researchers investigate whether a group-based behavioral intervention reduces sexual risk behavior in substance-using MSM.
What Did the Researchers Do and Find?
The researchers recruited substance-using MSM from four US cities who had had risky sex at least once in the past 6 months. Participants were randomized to a cognitive-behavioral intervention or to an attention-control group; a third, nonrandomized group of MSM formed a standard HIV counseling and testing only group. All the groups had HIV counseling and testing at the start of the study and completed a questionnaire about their substance use and sexual risk behavior during their most recent anal sex encounter. The cognitive-behavior group then received six weekly 2-hour group sessions focused on reducing substance use and sexual risk behavior by helping the men change their thinking (cognition) and behavior regarding sexual risk taking. The attention-control group received six group sessions about general MSM issues such as relationships, excluding discussion of substance use, and sexual risk behavior. The participants in both of these groups completed the questionnaire about their substance use and sexual risk behavior again at 3, 6, and 12 months after the group sessions; the participants in the standard HIV counseling and testing group completed the questionnaire again about 5 months after completing the first questionnaire (to control for the time taken by the other two groups to complete the intervention). At baseline, about 67% of the participants reported unprotected anal sex and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. At the 3-month follow-up, the incidence of sexual risk behavior had fallen to about 43% in all three groups; the incidence of substance use during sex had fallen to about 50%. Risk taking and substance use remained at these levels in the intervention and attention-control groups at the later follow-up time points.
What Do These Findings Mean?
These findings suggest that this cognitive-behavioral intervention is no better at reducing sexual risk taking among substance-using MSM than is an unrelated video-discussion group or standard HIV counseling and testing. One explanation for this negative result might be that brief counseling is especially effective with people who are ready for a change such as MSM willing to enroll in an intervention trial of this type. Alternatively, just being in the trial might have encouraged all the participants to self-report reduced risk behavior. Thus, alternative scientific designs and methods might be needed to find behavioral interventions that can effectively reduce HIV transmission among substance-using MSM and other people at high risk of HIV infection. Importantly, however, these findings raise the question of whether more extensive, multilevel interventions or broader lifestyle and positive health approaches (rather than single-level or single-subject behavioral interventions) might be needed to reduce sexual risk behavior among substance-using MSM.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000329.
Information is available from the US Department of Health and Human Services on HIV prevention programs, research, and policy
Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS
HIV InSite has comprehensive information on all aspects of HIV/AIDS, including information on HIV transmission and transmission in gay men and other MSM, on substance abuse and HIV/AIDS, and on safer sex
Information is available from Avert, an international AIDS nonprofit, on all aspects of HIV/AIDS, including information on HIV, AIDS, and men who have sex with men and on drink, drugs, and sex (in English and Spanish)
The US Centers for Disease Control and Prevention also have information for the public and for professionals about HIV/AIDS among men who have sex with men (in English and Spanish)
The US National Institute on Drug Abuse has information on HIV/AIDS and drug abuse, including a resource aimed at educating teenagers about the link between drug abuse and the spread of HIV in the US (in English and Spanish)
doi:10.1371/journal.pmed.1000329
PMCID: PMC2927550  PMID: 20811491

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