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1.  Nondisclosure of HIV Status in a Clinical Trial Setting: Antiretroviral Drug Screening Can Help Distinguish Between Newly Diagnosed and Previously Diagnosed HIV Infection 
In The HIV Prevention Trials Network 061 study, 155 human immunodeficiency virus (HIV)–infected men reported no prior HIV diagnosis; 83 of those men had HIV RNA levels of <1000 copies/mL at enrollment. Antiretroviral drug testing revealed that 65 of the 83 (78.3%) men were on antiretroviral treatment. Antiretroviral drug testing can help distinguish between newly diagnosed and previously diagnosed HIV infection.
PMCID: PMC3864502  PMID: 24092804
HIV; antiretroviral; self-report; MSM; new diagnosis
2.  Neighborhood-Level Correlates of Consistent Condom Use among Men Who have Sex with Men: A Multi-Level Analysis 
AIDS and behavior  2008;14(4):974-985.
There is growing evidence that the neighborhood environment influences sexual behavior and related outcomes, but little work has focused specifically on men who have sex with men (MSM). Using interview data from a probability sample of 385 young MSM living in New York City, recruited at public venues in 1999 and 2000 as part of the Young Men’s Survey-New York City, and data on neighborhood characteristics obtained from the U.S. Census 2000, we conducted multi-level analyses of the associations between neighborhood-level characteristics and consistent condom use during anal intercourse, while controlling for individual-level sociodemographic and other factors. After adjusting for individual-level factors, neighborhood-level gay presence remained significantly and positively associated with consistent condom use during anal intercourse. This finding suggests that neighborhoods with a significant gay presence may have norms that act to discourage high risk sexual activity.
PMCID: PMC4226223  PMID: 18712593
Sexual HIV risk behavior; MSM; Urban neighborhood; Multi-level analysis; Condom use; Neighborhood environment
3.  Condom Use and Concurrent Partnering among Heterosexually Active, African American Men: A Qualitative Report 
African Americans are overrepresented among heterosexual cases of HIV/AIDS in the USA. Inconsistent condom use and concurrent partnering are two sexual behaviors driving the heterosexual HIV epidemic in the African American community. To inform the development of an HIV prevention behavioral intervention to decrease concurrent partnering and increase condom use among African American heterosexual men, we conducted formative research, including 61 structured interviews, 5 focus groups with 25 men, and 30 in-depth qualitative interviews between July and December 2009. We used a grounded theoretical approach and categorizing strategies to code and analyze the qualitative data. Results around condom use confirmed earlier findings among heterosexual men in general: condoms diminish pleasure, interfere with erection, and symbolize infidelity. Although valued by some as a form of disease prevention and pregnancy prevention, condoms are often used only with specific types of female partners, such as new or casual partners, or due to visual risk assessment. Sex partner concurrency was described as normative and ascribed to men’s “natural” desire to engage in a variety of sexual activities or their high sex drive, with little recognition of the role it plays in the heterosexual HIV epidemic. Fatherhood emerged among many men as a crucial life event and compelling motivation for reducing sexual risk behavior. Based on these results, we conclude that existing HIV prevention efforts to improve attitudes towards and motivate use of condoms either have not reached or have not been successful with African American heterosexual men. In designing behavioral interventions to decrease concurrent partnering and increase condom use, addressing negative attitudes towards condoms and partner risk assessment is critical, as is integrating novel motivational approaches related to identity as fathers and men in the African American community.
PMCID: PMC3795194  PMID: 22869516
HIV/AIDS; Sexual risk behavior; African Americans; Heterosexual men
4.  Concurrent Partnerships and HIV Risk among Men Who Have Sex with Men in New York City 
Sexually transmitted diseases  2014;41(3):200-208.
Concurrent partnerships are a significant public health concern among men who have sex with men (MSM). This study describes the prevalence of concurrency and its association with serodiscordant/serostatus unknown unprotected anal or vaginal intercourse (SDUI) among MSM in New York City.
1,458 MSM completed a social and sexual network inventory about their male and female sex partners, including concurrency, in the last 3 months. Logistic regression identified factors associated with SDUI.
Median age was 29 years. 23.5% reported being HIV+. The men reported mean 3.2 male partners in last 3 months. 16.6% reported having recent SDUI. 63.2% described having concurrent sex partners (individual concurrency based on overlapping dates of relationships); 71.5% reported having partners whom they believed had concurrent partners (perceived partner concurrency); 56.1% reported that both they and their partners had concurrent partners (reciprocal concurrency). Among HIV+ men by self-report, having SDUI was positively associated with individual concurrency, any alcohol use during sex, having more male sex partners, and not having a main partner. Among self-reported HIV- men, having SDUI was positively associated with perceived partner concurrency, lower education level, any alcohol and drug use during sex, having more male sex partners, and having an anonymous partner.
Concurrency was common among MSM. The association of SDUI with individual and perceived partner concurrency, along with substance use during sex, having an anonymous partner, and having many sex partners likely further increases HIV acquisition and transmission risk among MSM. HIV prevention interventions should address concurrency among MSM.
PMCID: PMC4171743  PMID: 24521727
5.  Behavioral risk assessment in HIV Vaccine Trials Network (HVTN) clinical trials: A qualitative study exploring HVTN staff perspectives 
Vaccine  2013;31(40):4398-4405.
In HIV vaccine trials, the collection and analysis of participant behavior data associated with risk of acquiring HIV-infection is important for a number of reasons. Although the rationale for behavioral risk assessment in HIV vaccine clinical trials is clear, consistent collection of behavioral data over time and across protocols has been challenging for the HIV Vaccine Trials Network (HVTN). Integrating biomedical and behavioral research within the same preventive vaccine clinical trial has proven difficult. The HVTN conducted an internal landscape analysis to: (1) evaluate the challenges of behavioral risk assessment in HIV vaccine trials and observational studies; (2) explore the impact of the Step Study on behavioral risk assessment measures; and (3) identify strategies to overcome existing challenges and improve the quality of data resulting from behavioral risk analysis. These analyses of behavioral risk within the HVTN revealed several challenges and recommendations for improved behavioral risk data collection in future protocols. The recommendations for improvement include: (1) establishment of protocol-specific behavioral risk working groups that include social and behavioral experts; (2) provision of behavioral rationale and objectives to the development team; (3) creation of a template for geographic- and population-specific assessment of low and high risk behaviors; and (4) pilot testing of behavioral risk assessments. Results also underscored the need for routinely conducted analyses of behavioral data.
PMCID: PMC3894148  PMID: 23859840
Biomedical interventions; HIV; Risk behavior; Vaccine clinical trials
6.  Sources of Racial/Ethnic Differences in Awareness of HIV Vaccine Trials 
American journal of public health  2014;104(8):e112-e118.
We explored the relative effects of 2 awareness components—exposure and attention—on racial/ethnic differences in HIV vaccine trial awareness among men who have sex with men (MSM).
Surveys assessing awareness of and attitudes toward HIV vaccine trials were administered to 1723 MSM in 6 US cities. Proxy measures of exposure included use of HIV resources and other health care services, community involvement, income, and residence. Attention proxy measures included research attitudes, HIV susceptibility, and HIV message fatigue. Using logistic regression models, we assessed the extent to which these proxies accounted for racial/ethnic differences in vaccine trial awareness.
White MSM reported significantly (P < .01) higher rates of HIV vaccine trial awareness (22%) compared with Latino (17%), Black (13%) and “other” (13%) MSM. Venue-based exposure proxies and research-directed attitudinal attention proxies were significantly associated with awareness, but only accounted for the White-Latino disparity in awareness. No proxies accounted for the White-Black or White- “other” differentials in awareness.
Sources of disparities in awareness of HIV vaccine trials remain to be explained. Future trials seeking to promote diverse participation should explore additional exposure and attention mediators.
PMCID: PMC4103242  PMID: 24922153
7.  A randomized trial of enhanced HIV risk reduction and vaccine trial education interventions among HIV-negative, high-risk women who use non-injection drugs: The UNITY Study 
Limited data are available on interventions to reduce sexual risk behaviors and increase knowledge of HIV vaccine trial concepts in high risk populations eligible to participate in HIV vaccine efficacy trials.
The UNITY Study was a two-arm randomized trial to determine the efficacy of enhanced HIV risk reduction and vaccine trial education interventions to reduce the occurrence of unprotected vaginal sex acts and increase HIV vaccine trial knowledge among 311 HIV-negative non-injection drug using women. The enhanced vaccine education intervention using pictures along with application vignettes and enhanced risk reduction counseling consisting of three one-on-one counseling sessions were compared to standard conditions. Follow-up visits at one week and one, six and twelve months after randomization included HIV testing and assessment of outcomes.
During follow up, the percent of women reporting sexual risk behaviors declined significantly, but did not differ significantly by study arm. Knowledge of HIV vaccine trial concepts significantly increased but did not significantly differ by study arm. Concepts about HIV vaccine trials not adequately addressed by either condition included those related to testing a vaccine for both efficacy and safety, guarantees about participation in future vaccine trials, assurances of safety, medical care, and assumptions about any protective effect of a test vaccine.
Further research is needed to boost educational efforts and strengthen risk reduction counseling among high-risk non-injection drug using women.
PMCID: PMC4154582  PMID: 20190585
HIV; vaccines; behavioral intervention; women; substance use
8.  Anal Sex Role Segregation and Versatility among Men Who Have Sex with Men: EXPLORE Study 
Anal sex role patterns and correlates during unprotected anal sex were examined longitudinally among HIV-negative men who have sex with men (MSM). 9.6% were exclusively receptive, 16.7% exclusively insertive, and 63.0% versatile. Versatility was more likely with primary and HIV-negative/unknown status partners and among younger men and substance users, but less likely among Blacks and with higher number of partners. Exclusively receptive role was more likely with HIV-negative/unknown status partners and among younger men and substance users, but less likely with higher number of partners. Examining anal sex role patterns helps understand the factors that drive the epidemic among MSM.
PMCID: PMC3804162  PMID: 23945255
Role Segregation; Versatility; Anal Sex Role; men who have sex with men; HIV
9.  Safety and Comparative Immunogenicity of an HIV-1 DNA Vaccine in Combination with Plasmid Interleukin 12 and Impact of Intramuscular Electroporation for Delivery 
The Journal of Infectious Diseases  2013;208(5):818-829.
Background. DNA vaccines have been very poorly immunogenic in humans but have been an effective priming modality in prime-boost regimens. Methods to increase the immunogenicity of DNA vaccines are needed.
Methods. HIV Vaccine Trials Network (HVTN) studies 070 and 080 were multicenter, randomized, clinical trials. The human immunodeficiency virus type 1 (HIV-1) PENNVAX®-B DNA vaccine (PV) is a mixture of 3 expression plasmids encoding HIV-1 Clade B Env, Gag, and Pol. The interleukin 12 (IL-12) DNA plasmid expresses human IL-12 proteins p35 and p40. Study subjects were healthy HIV-1–uninfected adults 18–50 years old. Four intramuscular vaccinations were given in HVTN 070, and 3 intramuscular vaccinations were followed by electroporation in HVTN 080. Cellular immune responses were measured by intracellular cytokine staining after stimulation with HIV-1 peptide pools.
Results. Vaccination was safe and well tolerated. Administration of PV plus IL-12 with electroporation had a significant dose-sparing effect and provided immunogenicity superior to that observed in the trial without electroporation, despite fewer vaccinations. A total of 71.4% of individuals vaccinated with PV plus IL-12 plasmid with electroporation developed either a CD4+ or CD8+ T-cell response after the second vaccination, and 88.9% developed a CD4+ or CD8+ T-cell response after the third vaccination.
Conclusions. Use of electroporation after PV administration provided superior immunogenicity than delivery without electroporation. This study illustrates the power of combined DNA approaches to generate impressive immune responses in humans.
PMCID: PMC3733506  PMID: 23840043
vaccination; electroporation; plasmid cytokine adjuvant
10.  Associations of Sexual Victimization, Depression, and Sexual Assertiveness with Unprotected Sex: A Test of the Multifaceted Model of HIV Risk Across Gender 
This study examined whether the Multifaceted Model of HIV Risk (MMOHR) would predict unprotected sex based on predictors including gender, childhood sexual abuse (CSA), sexual victimization (SV), depression, and sexual assertiveness for condom use. A community-based sample of 473 heterosexually active men and women, aged 18–46 years completed survey measures of model variables. Gender predicted several variables significantly. A separate model for women demonstrated excellent fit, while the model for men demonstrated reasonable fit. Multiple sample model testing supported the use of MMOHR in both men and women, while simultaneously highlighting areas of gender difference. Prevention interventions should focus on sexual assertiveness, especially for CSA and SV survivors, as well as targeting depression, especially among men.
PMCID: PMC4091996  PMID: 25018617
11.  Intentions to use pre-exposure prophylaxis among current phase 2B preventive HIV-1 vaccine efficacy trial participants 
In November 2010, the iPrEx study reported that pre-exposure prophylaxis (PrEP) with daily tenofovir disoproxil fumarate/emtricitabine reduced HIV infections by 44% among men who have sex with men and subsequent trials corroborated efficacy among heterosexual men and women. During regularly scheduled follow-up visits from January-March 2011, participants in an ongoing phase 2b vaccine efficacy trial completed an anonymous web survey about PrEP. Among 376 respondents, 17% reported they were very likely to use PrEP in the next year. Non-white participants were more likely to use PrEP. Among those with some level of interest, intent to use PrEP was greatest if the drug were available through the clinical trial or health insurance. Most (91%) believed taking PrEP would not change their willingness to stay in the vaccine trial and few thought it would affect recruitment. As key stakeholders, currently enrolled trial participants can offer vital input about emerging prevention technologies that may affect the design of future HIV vaccine and non-vaccine prevention trials.
PMCID: PMC3714219  PMID: 23614998
clinical trials; HIV vaccines; pre-exposure prophylaxis; good participatory practice; HIV prevention
12.  Preparing for the unexpected: The pivotal role of social and behavioral sciences in trials of biomedical HIV prevention interventions 
A range of efficacies have been reported for biomedical HIV prevention interventions, including antiretroviral treatment, male circumcision, pre-exposure prophylaxis, microbicides and preventive vaccines. This range of efficacies likely results from the influence of multiple inputs and processes during trials, including the strength and target of the intervention, host factors, target population characteristics, level of HIV exposure and intervention dose. Expertise in social and behavioral science, in conjunction with basic science, clinical research, epidemiology, biostatistics and community, is needed to understand the influence of these inputs and processes on intervention efficacy, improve trial design and implementation, and enable interpretation of trial results. In particular, social and behavioral science provides the means for investigating and identifying populations suitable for recruitment into and retention in trials, and for developing and improving measures of HIV exposure and intervention dose, all within the larger socio-cultural context. Integration of social and behavioral science early in idea generation and study design is imperative for the successful conduct of biomedical trials and for ensuring optimal data collection approaches necessary for the interpretation of findings, particularly in cases of unexpected results.
PMCID: PMC3737568  PMID: 23764634
biomedical interventions; HIV; populations; adherence; social science; behavioral science
13.  HIV Diversity as a Biomarker for HIV Incidence Estimation: Including a High-Resolution Melting Diversity Assay in a Multiassay Algorithm 
Journal of Clinical Microbiology  2014;52(1):115-121.
Multiassay algorithms (MAAs) can be used to estimate cross-sectional HIV incidence. We previously identified a robust MAA that includes the BED capture enzyme immunoassay (BED-CEIA), the Bio-Rad Avidity assay, viral load, and CD4 cell count. In this report, we evaluated MAAs that include a high-resolution melting (HRM) diversity assay that does not require sequencing. HRM scores were determined for eight regions of the HIV genome (2 in gag, 1 in pol, and 5 in env). The MAAs that were evaluated included the BED-CEIA, the Bio-Rad Avidity assay, viral load, and the HRM diversity assay, using HRM scores from different regions and a range of region-specific HRM diversity assay cutoffs. The performance characteristics based on the proportion of samples that were classified as MAA positive by duration of infection were determined for each MAA, including the mean window period. The cross-sectional incidence estimates obtained using optimized MAAs were compared to longitudinal incidence estimates for three cohorts in the United States. The performance of the HRM-based MAA was nearly identical to that of the MAA that included CD4 cell count. The HRM-based MAA had a mean window period of 154 days and provided cross-sectional incidence estimates that were similar to those based on cohort follow-up. HIV diversity is a useful biomarker for estimating HIV incidence. MAAs that include the HRM diversity assay can provide accurate HIV incidence estimates using stored blood plasma or serum samples without a requirement for CD4 cell count data.
PMCID: PMC3911463  PMID: 24153134
14.  Feasibility of identifying a cohort of US women at high risk for HIV infection for HIV vaccine efficacy trials: Longitudinal results of HVTN 906 
Identifying cohorts of US women with HIV infection rates sufficient for inclusion in vaccine efficacy trials has been challenging. Using geography and sexual network characteristics to inform recruitment strategies, HVTN 906 determined the feasibility of recruiting a cohort of women at high risk for HIV acquisition.
HIV uninfected women who reported unprotected sex in the prior six months, resided or engaged in risk behavior in local geographical high-risk pockets and/or had a male partner who had been incarcerated, injected drugs or had concurrent partners were eligible. Behavioral risk assessment, HIV counseling and testing and pregnancy testing were done at baseline, 6, 12 and 18 months.
Among 799 women, 71% were from local high-risk pockets and had high-risk male partners. Median age was 37 years; 79% were Black; 15% Latina. Over half (55%) reported a new partner in the prior six months, 57% reported a male partner who had concurrent female sexual partners and 37% reported a male partner who had been incarcerated. Retention at 18 months was 79.5%. Annual pregnancy incidence was 12%. Annual HIV incidence was 0.31% (95% CI: 0.06, 0.91). Risk behaviors decreased between screening and six months with smaller changes thereafter.
This cohort of women recruited using new strategies based on geography and sexual network characteristics did not have an HIV incidence high enough for HIV vaccine efficacy trials, despite high baseline levels of risk and a high pregnancy rate. New strategies to identify cohorts of US women for efficacy trials are needed.
PMCID: PMC3671573  PMID: 23446497
HIV vaccine trials; United States women; heterosexual transmission
15.  Efficacy Trial of a DNA/rAd5 HIV-1 Preventive Vaccine 
The New England journal of medicine  2013;369(22):2083-2092.
A safe and effective vaccine for the prevention of human immunodeficiency virus type 1 (HIV-1) infection is a global priority. We tested the efficacy of a DNA prime–recombinant adenovirus type 5 boost (DNA/rAd5) vaccine regimen in persons at increased risk for HIV-1 infection in the United States.
At 21 sites, we randomly assigned 2504 men or transgender women who have sex with men to receive the DNA/rAd5 vaccine (1253 participants) or placebo (1251 participants). We assessed HIV-1 acquisition from week 28 through month 24 (termed week 28+ infection), viral-load set point (mean plasma HIV-1 RNA level 10 to 20 weeks after diagnosis), and safety. The 6-plasmid DNA vaccine (expressing clade B Gag, Pol, and Nef and Env proteins from clades A, B, and C) was administered at weeks 0, 4, and 8. The rAd5 vector boost (expressing clade B Gag-Pol fusion protein and Env glycoproteins from clades A, B, and C) was administered at week 24.
In April 2013, the data and safety monitoring board recommended halting vaccinations for lack of efficacy. The primary analysis showed that week 28+ infection had been diagnosed in 27 participants in the vaccine group and 21 in the placebo group (vaccine efficacy, −25.0%; 95% confidence interval, −121.2 to 29.3; P = 0.44), with mean viral-load set points of 4.46 and 4.47 HIV-1 RNA log10 copies per milliliter, respectively. Analysis of all infections during the study period (41 in the vaccine group and 31 in the placebo group) also showed lack of vaccine efficacy (P = 0.28). The vaccine regimen had an acceptable side-effect profile.
The DNA/rAd5 vaccine regimen did not reduce either the rate of HIV-1 acquisition or the viral-load set point in the population studied. (Funded by the National Institute of Allergy and Infectious Diseases; number, NCT00865566.)
PMCID: PMC4030634  PMID: 24099601
16.  Genotypic and Functional Impact of HIV-1 Adaptation to Its Host Population during the North American Epidemic 
PLoS Genetics  2014;10(4):e1004295.
HLA-restricted immune escape mutations that persist following HIV transmission could gradually spread through the viral population, thereby compromising host antiviral immunity as the epidemic progresses. To assess the extent and phenotypic impact of this phenomenon in an immunogenetically diverse population, we genotypically and functionally compared linked HLA and HIV (Gag/Nef) sequences from 358 historic (1979–1989) and 382 modern (2000–2011) specimens from four key cities in the North American epidemic (New York, Boston, San Francisco, Vancouver). Inferred HIV phylogenies were star-like, with approximately two-fold greater mean pairwise distances in modern versus historic sequences. The reconstructed epidemic ancestral (founder) HIV sequence was essentially identical to the North American subtype B consensus. Consistent with gradual diversification of a “consensus-like” founder virus, the median “background” frequencies of individual HLA-associated polymorphisms in HIV (in individuals lacking the restricting HLA[s]) were ∼2-fold higher in modern versus historic HIV sequences, though these remained notably low overall (e.g. in Gag, medians were 3.7% in the 2000s versus 2.0% in the 1980s). HIV polymorphisms exhibiting the greatest relative spread were those restricted by protective HLAs. Despite these increases, when HIV sequences were analyzed as a whole, their total average burden of polymorphisms that were “pre-adapted” to the average host HLA profile was only ∼2% greater in modern versus historic eras. Furthermore, HLA-associated polymorphisms identified in historic HIV sequences were consistent with those detectable today, with none identified that could explain the few HIV codons where the inferred epidemic ancestor differed from the modern consensus. Results are therefore consistent with slow HIV adaptation to HLA, but at a rate unlikely to yield imminent negative implications for cellular immunity, at least in North America. Intriguingly, temporal changes in protein activity of patient-derived Nef (though not Gag) sequences were observed, suggesting functional implications of population-level HIV evolution on certain viral proteins.
Author Summary
Upon HIV transmission, many – though not all – immune escape mutations selected in the previous host will revert to the consensus residue. The persistence of certain escape mutations following transmission has led to concerns that these could gradually accumulate in circulating HIV sequences over time, thereby undermining host antiviral immune potential as the epidemic progresses. As certain immune-driven mutations reduce viral fitness, their spread through the population could also have consequences for the average replication capacity and/or protein function of circulating HIV sequences. Here, we characterized HIV sequences, linked to host immunogenetic information, from patients enrolled in historic (1979–1989) and modern (2000–2011) HIV cohorts from four key cities in the North American epidemic. We reconstructed the epidemic's ancestral (founder) HIV sequence and assessed the subsequent extent to which known HIV immune escape mutations have spread in the population. Our data support the gradual spread of many - though not all - immune escape mutations in HIV sequences over time, but to an extent that is unlikely to have major immediate immunologic consequences for the North American epidemic. Notably, in vitro assessments of ancestral and patient-derived HIV sequences suggested functional implications of ongoing HIV evolution for certain viral proteins.
PMCID: PMC3998893  PMID: 24762668
17.  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.
PMCID: PMC3693735  PMID: 23229336
bisexual; heterosexual; HIV; MSMW; condom usage
18.  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.
PMCID: PMC3562410  PMID: 23090677
HIV vaccine trial preparedness; United States women; peer referral; respondent driven sampling; sexual concurrency; willingness to participate
19.  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.
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.
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.
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.
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.
PMCID: PMC3909083  PMID: 24498067
20.  “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.
PMCID: PMC3693736  PMID: 23005899
21.  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.
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.
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.
PMCID: PMC3873916  PMID: 24386116
22.  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.
PMCID: PMC3797712  PMID: 24146785
23.  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.
PMCID: PMC3704079  PMID: 22533637
Black MSMW; men who have sex with men and women; bisexuality; HIV/AIDS
24.  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 
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.
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.
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.
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, number NCT00095576.
PMCID: PMC3392543  PMID: 22421748
HIV vaccines; gay men; sexual behaviors
25.  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.
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.
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.
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.
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.
PMCID: PMC3724810  PMID: 23922989

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