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1.  Syphilis Predicts HIV Incidence Among Men and Transgender Women Who Have Sex With Men in a Preexposure Prophylaxis Trial 
Syphilis infection was associated with HIV incidence in an HIV-prevention trial that randomized participants to once-daily emtricitabine/tenofovir (FTC/TDF) vs placebo. FTC/TDF had no effect on the association between incident syphilis and HIV acquisition; syphilis infection did not decrease FTC/TDF efficacy.
Background. Syphilis infection may potentiate transmission of human immunodeficiency virus (HIV). We sought to determine the extent to which HIV acquisition was associated with syphilis infection within an HIV preexposure prophylaxis (PrEP) trial and whether emtricitabine/tenofovir (FTC/TDF) modified that association.
Methods. The Preexposure Prophylaxis Initiative (iPrEx) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men (MSM) to receive oral daily FTC/TDF or placebo. Syphilis prevalence at screening and incidence during follow-up were measured. Hazard ratios for the effect of incident syphilis on HIV acquisition were calculated. The effect of FTC/TDF on incident syphilis and HIV acquisition was assessed.
Results. Of 2499 individuals, 360 (14.4%) had a positive rapid plasma reagin test at screening; 333 (92.5%) had a positive confirmatory test, which did not differ between the arms (FTC/TDF vs placebo, P = .81). The overall syphilis incidence during the trial was 7.3 cases per 100 person-years. There was no difference in syphilis incidence between the study arms (7.8 cases per 100 person-years for FTC/TDF vs 6.8 cases per 100 person-years for placebo, P = .304). HIV incidence varied by incident syphilis (2.8 cases per 100 person-years for no syphilis vs 8.0 cases per 100 person-years for incident syphilis), reflecting a hazard ratio of 2.6 (95% confidence interval, 1.6–4.4; P < .001). There was no evidence for interaction between randomization to the FTC/TDF arm and incident syphilis on HIV incidence.
Conclusions. In HIV-seronegative MSM, syphilis infection was associated with HIV acquisition in this PrEP trial; a syphilis diagnosis should prompt providers to offer PrEP unless otherwise contraindicated.
doi:10.1093/cid/ciu450
PMCID: PMC4166980  PMID: 24928295
chemoprophylaxis; HIV prevention; MSM; preexposure prophylaxis; syphilis
2.  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.
doi:10.1093/cid/cit672
PMCID: PMC3864502  PMID: 24092804
HIV; antiretroviral; self-report; MSM; new diagnosis
3.  The Spectrum of Undiagnosed Hepatitis C Virus Infection in a US HIV Clinic 
AIDS Patient Care and STDs  2014;28(1):4-9.
Abstract
United States guidelines endorse one-time HCV antibody screening at HIV diagnosis. Rescreening HCV-seronegative patients on a regular basis is still not policy, although HIV-infected persons have reasonably substantial HCV incidence. We evaluated routine risk factor-independent HCV antibody re-testing in a Rhode Island HIV clinic. We instituted annual HCV antibody testing for HCV-seronegative patients who had not been rescreened in a year or more. Testing based on clinical suspicion continued. We conducted a chart review of new antibody-positive cases in the first year of rescreening, July 2006 to June 2007. Of 245 rescreened patients, 11 (4.5%) seroconverted. Five (45%) were female. Median time between last negative and first positive result was 32 months (range 8–98 months). Six (55%) had documented risk factors and 6 (55%) elevated ALT (>45 IU/L) between antibody tests; none prompted re-testing. One seroconverter died of hepatocellular carcinoma 3.7 years after HCV diagnosis. A twelfth was rescreened for suspected acute HCV based on ALT of 515 IU/L. He had newly detectable HCV RNA then seroconversion, and achieved SVR following 6 months of treatment in the acute phase for genotype 1 infection. Incident HCV is not uncommon among HIV-infected patients in care. Rescreening identified undiagnosed HCV in this population. HCV RNA should be checked promptly in HCV-seronegative persons with ALT elevation. We observed consequences of late diagnosis (hepatocellular carcinoma) and benefits of early diagnosis (cure with treatment of acute HCV). Adding annual rescreening to the Ryan White Program would facilitate earlier identification of undiagnosed HCV and create an instant widespread surveillance system, providing HCV incidence data.
doi:10.1089/apc.2013.0130
PMCID: PMC3894677  PMID: 24428794
4.  Examining the Correspondence between Relationship Identity and Actual Sexual Risk Behavior among HIV-Positive Men Who Have Sex with Men 
Archives of sexual behavior  2014;43(1):129-137.
Sexual behavior of men who have sex with men (MSM), within and outside of one’s primary relationship, may contribute to increased risk of HIV transmission among those living with HIV. The current study sought to understand how HIV-infected MSM report their relationship status and the degree to which this corresponds with their sexual behavior. Further, we examined rates and psychosocial associations with sexual HIV transmission risk behavior (TRB) across relationship categories. In a sample of 503 HIV-infected MSM in HIV care, 200 (39.8%) reported having a primary partner. Of these, 115 reported that their relationship was open and 85 reported that it was monogamous. Of the 85 who reported a monogamous relationship, 23 (27%) reported more than one sexual partner in the prior three months, 53 (62%) reported only one partner, and nine did not report on the number of partners in the past 3 months. Hence, there were three categories of relationships: (1) “monogamous with one sexual partner,” (2) “monogamous with more than one sexual partner,” and (3) “open relationship.” The “monogamous with more than one sexual partner” group reported higher TRB and crystal methamphetamine use compared to the “monogamous with one sexual partner” group and different patterns of relationships with TRB emerged across the three groups. Couples-based HIV prevention interventions for MSM may be enhanced by considering that there may be different definitions of monogamy among MSM, and that the context of relationship status may require tailoring interventions to meet the needs of specific subgroups of MSM couples.
doi:10.1007/s10508-013-0209-7
PMCID: PMC3947093  PMID: 24198170
HIV/AIDS; MSM; couples; sexual risk; monogamy; sexual orientation
5.  Suboptimal awareness and comprehension of published pre-exposure prophylaxis efficacy results among physicians in Massachusetts 
AIDS care  2013;26(6):684-693.
In 2010, the CAPRISA 004 and iPrEx trials (microbicide gel containing tenofovir and oral pill containing tenofovir-emtricitabine, respectively) demonstrated that antiretroviral pre-exposure prophylaxis (PrEP) reduced the risk of HIV acquisition among high-risk individuals. To determine facilitators and barriers to PrEP provision by healthcare providers, we conducted an online, quantitative survey of Massachusetts-area physicians following the publication of the CAPRISA and iPrEx results. We assessed awareness and comprehension of efficacy data, prescribing experience, and anticipated provision of oral and topical PrEP among physicians, as well as demographic and behavioral factors associated with PrEP awareness and prescribing intentions. The majority of HIV specialists and generalist physicians were aware of data from these PrEP trials and able to correctly interpret the results, however, correct interpretation of findings tended to vary according to specialty (i.e., HIV specialists had greater awareness than generalists). Additionally provider concerns regarding PrEP efficacy and safety, as well its ability to divert funds from other HIV prevention resources, were associated with decreased intentions to prescribe both oral and topical PrEP. Findings suggest that a substantial proportion of physicians who may have contact with at-risk individuals may benefit from interventions that provide accurate data on the risks and benefits of PrEP in order to facilitate effective PrEP discussions with their patients. Future studies to develop and test interventions aimed at healthcare providers should be prioritized to optimize implementation of PrEP in clinical settings.
doi:10.1080/09540121.2013.845289
PMCID: PMC4053171  PMID: 24116985
Pre-Exposure Prophylaxis; PrEP; Physicians; HIV; Prevention
6.  High Prevalence of Hepatitis Delta Virus among Patients with Chronic Hepatitis B Virus Infection and HIV-1 in an Intermediate Hepatitis B Virus Endemic Region 
We conducted a study to investigate HIV and hepatitis delta virus (HDV) coinfection among patients with chronic hepatitis B virus (HBV) infection and the triple infection’s (HIV/HBV/HDV) clinical implications in India, an intermediate HBV endemic region, with an estimated HIV-positive population of 2.5 million. A total of 450 patients (men: 270; women: 180) with chronic HBV infections and 135 healthy volunteers were screened for HIV and HDV. The incidence of the triple infection was low (4 [0.8%]) compared with dual infections of HIV-1/HBV (7 [1.5%]) and HBV/HDV (22[4.8%]). Among 21- to 40-year-olds, HBV/HDV coinfection (45.8%) and HBV/HDV/HIV-1 triple infection was predominant (75%). Among 11 patients coinfected with HIV-1/HBV, 4 (36%) were tri-infected and were also associated with chronic hepatitis and cirrhosis. The HDV coinfection was higher among patients coinfected with HBV/HIV-1, despite the declining trend in HDV infection among HIV-negative patients, as previously reported. Thus, it is important to assess the impact of HIV, chronic HBV, and HDV tri-infection in India.
doi:10.1177/2325957413488166
PMCID: PMC4114572  PMID: 23722085
coinfection in India; hepatitis delta virus (HDV); hepatitis B virus (HBV); human immunodeficiency virus (HIV)
7.  GB Virus C (GBV-C) Infection in Hepatitis C Virus (HCV) Seropositive Women with or at Risk for HIV Infection 
PLoS ONE  2014;9(12):e114467.
Background
GB virus C (GBV-C) may have a beneficial impact on HIV disease progression; however, the epidemiologic characteristics of this virus are not well characterized. Behavioral factors and gender may lead to differential rates of GBV-C infection; yet, studies have rarely addressed GBV-C infections in women or racial/ethnic minorities. Therefore, we evaluated GBV-C RNA prevalence and genotype distribution in a large prospective study of high-risk women in the US.
Results
438 hepatitis C virus (HCV) seropositive women, including 306 HIV-infected and 132 HIV-uninfected women, from the HIV Epidemiologic Research Study were evaluated for GBV-C RNA. 347 (79.2%) women were GBV-C RNA negative, while 91 (20.8%) were GBV-C RNA positive. GBV-C positive women were younger than GBV-C negative women. Among 306 HIV-infected women, 70 (22.9%) women were HIV/GBV-C co-infected. Among HIV-infected women, the only significant difference between GBV-negative and GBV-positive women was age (mean 38.4 vs. 35.1 years; p<0.001). Median baseline CD4 cell counts and plasma HIV RNA levels were similar. The GBV-C genotypes were 1 (n = 31; 44.3%), 2 (n = 36; 51.4%), and 3 (n = 3; 4.3%). The distribution of GBV-C genotypes in co-infected women differed significantly by race/ethnicity. However, median CD4 cell counts and log10 HIV RNA levels did not differ by GBV-C genotype. GBV-C incidence was 2.7% over a median follow-up of 2.9 (IQR: 1.5, 4.9) years, while GBV-C clearance was 35.7% over a median follow-up of 2.44 (1.4, 3.5) years. 4 women switched genotypes.
Conclusions
Age, injection drug use, a history of sex for money or drugs, and number of recent male sex partners were associated with GBV-C infection among all women in this analysis. However, CD4 cell count and HIV viral load of HIV/HCV/GBV-C co-infected women were not different although race was associated with GBV-C genotype.
doi:10.1371/journal.pone.0114467
PMCID: PMC4262414  PMID: 25493916
8.  Body Mass Index, Immune Status and Virological Control in HIV-Infected Men who have Sex with Men 
Background & aims
Prior cross-sectional studies have found inconsistent relationships between body mass index (BMI) and disease progression in HIV-infected individuals.
Methods
Cross-sectional and longitudinal analyses were conducted on data from a sample of 864 HIV-infected men who have sex with men (MSM) obtained from a large, nationally-distributed HIV clinical cohort.
Results
Of the 864 HIV-infected MSM, 394 (46%) were normal weight, 363 (42%) were overweight, and 107 (12%) were obese at baseline. The baseline CD4 count was 493 (SE = 9), with viral load(log10) = 2.4 (SE = .04), and 561 (65%) were virologically suppressed. Over time, controlling for viral load, HAART adherence, age, and race/ethnicity, overweight and obese HIV-infected men possessed higher CD4 counts compared to normal weight HIV-infected men. Further, overweight and obese men possessed lower viral loads compared to normal weight HIV-infected men.
Conclusions
For HIV-infected MSM, in this longitudinal cohort study, possessing a heavier than normal BMI is longitudinally associated with improved immunological health.
doi:10.1177/2325957413488182
PMCID: PMC4259246  PMID: 23719237
HIV/AIDS; Body Mass Index; Obesity; CD4; Viral Load
9.  Undisclosed Antiretroviral Drug Use in a Multinational Clinical Trial (HIV Prevention Trials Network 052) 
The Journal of Infectious Diseases  2013;208(10):1624-1628.
The HIV Prevention Trials Network 052 study enrolled serodiscordant couples. Index participants infected with human immunodeficiency virus reported no prior antiretroviral (ARV) treatment at enrollment. ARV drug testing was performed retrospectively using enrollment samples from a subset of index participants. ARV drugs were detected in 45 of 96 participants (46.9%) with an undetectable viral load, 2 of 48 (4.2%) with a low viral load, and 1 of 65 (1.5%) with a high viral load (P < .0001); they were also detected in follow-up samples from participants who were not receiving study-administered treatment. ARV drug testing may be useful in addition to self-report of ARV drug use in some clinical trial settings.
doi:10.1093/infdis/jit390
PMCID: PMC3805242  PMID: 23908493
HIV; antiretroviral drug; self-report; HPTN 052; Africa; clinical trial
10.  The disproportionate burden of HIV and STIs among male sex workers in Mexico City and the rationale for economic incentives to reduce risks 
Introduction
The objective of this article is to present the rationale and baseline results for a randomized controlled pilot trial using economic incentives to reduce HIV and sexually transmitted infection (STI) risk among male sex workers (MSWs) in Mexico City.
Methods
Participants (n=267) were tested and treated for STIs (chlamydia, gonorrhoea, syphilis and HIV) and viral hepatitis (hepatitis B and C), received HIV and STI prevention education and were randomized into four groups: (1) control, (2) medium conditional incentive ($50/six months), (3) high conditional incentive ($75/six months) and (4) unconditional incentive ($50/six months). In the conditional arms, incentives were contingent upon testing free of new curable STIs (chlamydia, gonorrhoea and syphilis) at follow-up assessments.
Results
Participants’ mean age was 25 years; 8% were homeless or lived in a shelter, 16% were unemployed and 21% lived in Mexico City less than 5 years. At baseline, 38% were living with HIV, and 32% tested positive for viral hepatitis or at least one STI (other than HIV). Participants had a mean of five male clients in the previous week; 18% reported condomless sex with their last client. For 37%, sex work was their main occupation and was conducted mainly on the streets (51%) or in bars/discotheques (24%) and hotels (24%). The average price for a sex transaction was $25 with a 35% higher payment for condomless sex.
Conclusions
The findings suggest that economic incentives are a relevant approach for HIV prevention among MSWs, given the market-based inducements for unprotected sex. This type of targeted intervention seems to be justified and should continue to be explored in the context of combination prevention efforts.
doi:10.7448/IAS.17.1.19218
PMCID: PMC4233212  PMID: 25399543
male sex workers; men who have sex with men; conditional cash transfer; conditional economic incentives; HIV/STI prevention; risk premium; compensating differential; Mexico
11.  Prevalence of Sexually Transmitted Diseases and Risk Behaviors from the NIMH Collaborative HIV/STD Prevention Trial 
This cross-sectional study describes the baseline prevalence and correlates of common bacterial and viral sexually transmitted diseases (STDs) and risk behaviors among individuals at high risk for HIV recruited in five low- and middle-income countries. Correlations of risk behaviors and demographic factors with prevalent STDs and the association of STDs with HIV prevalence are examined. Between 2,212 and 5,543 participants were recruited in each of five countries (China, India, Peru, Russia, and Zimbabwe). Standard protocols were used to collect behavioral risk information and biological samples for STD testing. Risk factors for HIV/STD prevalence were evaluated using logistic regression models. STD prevalence was significantly higher for women than men in all countries, and the most prevalent STD was Herpes simplex virus-type 2 (HSV-2). HIV prevalence was generally low (below 5%) except in Zimbabwe (30% among women, 11.7% among men). Prevalence of bacterial STDs was generally low (below 5% for gonorrhea and under 7% for syphilis in all sites), with the exception of syphilis among female sex workers in India. Behavioral and demographic risks for STDs varied widely across the five study sites. Common risks for STDs included female gender, increasing number of recent sex partners, and in some sites, older age, particularly for chronic STDs (i.e., HSV-2 and HIV). Prevalence of HIV was not associated with STDs except in Zimbabwe, which showed a modest correlation between HIV and HSV-2 prevalence (Pearson coefficient = .55). These findings underscore the heterogeneity of global STD and HIV epidemics and suggest that local, focused interventions are needed to achieve significant declines in these infections.
doi:10.1080/19317611.2010.494092
PMCID: PMC4230575  PMID: 25400718
HIV prevention; sexually transmitted diseases; behavioral risk factors; international
12.  Access to Healthcare, HIV/STI Testing, and Preferred Pre-Exposure Prophylaxis Providers among Men Who Have Sex with Men and Men Who Engage in Street-Based Sex Work in the US 
PLoS ONE  2014;9(11):e112425.
Background
Pre-exposure prophylaxis (PrEP) is a promising strategy for HIV prevention among men who have sex with men (MSM) and men who engage in sex work. But access will require routine HIV testing and contacts with healthcare providers. This study investigated men’s healthcare and HIV testing experiences to inform PrEP implementation.
Methods
We conducted 8 focus groups (n = 38) in 2012 and 56 in-depth qualitative interviews in 2013–14 with male sex workers (MSWs) (n = 31) and other MSM (n = 25) in Providence, RI. MSWs primarily met clients in street-based sex work venues. Facilitators asked participants about access to healthcare and HIV/STI testing, healthcare needs, and preferred PrEP providers.
Results
MSWs primarily accessed care in emergency rooms (ERs), substance use clinics, correctional institutions, and walk-in clinics. Rates of HIV testing were high, but MSWs reported low access to other STI testing, low insurance coverage, and unmet healthcare needs including primary care, substance use treatment, and mental health services. MSM not engaging in sex work were more likely to report access to primary and specialist care. Rates of HIV testing among these MSM were slightly lower, but they reported more STI testing, more insurance coverage, and fewer unmet needs. Preferred PrEP providers for both groups included primary care physicians, infectious disease specialists, and psychiatrists. MSWs were also willing to access PrEP in substance use treatment and ER settings.
Conclusions
PrEP outreach efforts for MSWs and other MSM should engage diverse providers in many settings, including mental health and substance use treatment, ERs, needle exchanges, correctional institutions, and HIV testing centers. Access to PrEP will require financial assistance, but can build on existing healthcare contacts for both populations.
doi:10.1371/journal.pone.0112425
PMCID: PMC4227700  PMID: 25386746
13.  Concurrent sexual partnerships among African American women in Philadelphia: results from a qualitative study 
Sexual health  2012;9(3):288-296.
Background
African American women are disproportionately affected by HIV/AIDS. Concurrent sexual partnerships may contribute to racial disparities in HIV infection. Little is known about attitudes and practices related to concurrency among African American women and the social, structural and behavioral factors that influence concurrency.
Methods
We recruited 19 heterosexual African American women engaging in concurrent sexual partnerships from a public health clinic in Philadelphia in 2009. We conducted in-depth interviews exploring social norms, attitudes and practices about concurrency, and the structural, social and behavioral factors influencing concurrent sexual partnerships. Grounded theory guided interview protocols and data analysis.
Results
Seventeen women reported one main and one or more non-main partners; two reported no main partners. Many women used condoms more frequently with non-main than main partners, noting they trust main partners more than non-main partners. Social factors influencing concurrency included social normalization of concurrency, inability to negotiate partners’ other concurrent partnerships, being unmarried, and not trusting main and non-main partners. Not trusting partners and the community at large were the most commonly cited reasons that women engaged in concurrent partnerships. Structural factors included economic dependence on partners, partners’ dependence on women for economic support and housing, and incarceration that interrupted partnerships. Behavioral factors including alcohol and cocaine use influenced concurrency.
Conclusions
Social, structural, and behavioral factors strongly influenced these African American women’s concurrent sexual partnerships. Many evidence-based interventions (EBIs) disseminated by the US Centers for Disease Control and Prevention (CDC) focus largely on behavioral factors and may fail to address the social and structural factors influencing African American women’s sexual networks. Novel HIV prevention interventions that address the social determinants of African American women’s HIV risks in addition to conventional HIV risk- taking behaviors are urgently needed.
doi:10.1071/SH11099
PMCID: PMC4203371  PMID: 22697147
Concurrency; HIV/AIDS; Incarceration
15.  Physical Activity and Health Outcomes among HIV-infected Men who have Sex with Men: A Longitudinal Mediational Analysis 
Background
Low physical activity is associated with depression, which may in turn, negatively impact antiretroviral therapy (ART) adherence among HIV-infected individuals; however, prior studies have not investigated the relationships between physical inactivity and ART non-adherence.
Purpose
To examine the association of physical inactivity, depression, ART non-adherence, and viral load in HIV-infected men who have sex with men.
Methods
The sample (N = 860) was from a large, multicenter cohort of HIV-infected patients engaged in clinical care.
Results
Across time, depression mediated the relationship between physical inactivity and ART non-adherence, γ = .075, and the relationship between physical inactivity and viral load, γ = .05. ART non-adherence mediated the relationship between depression and viral load, γ = .002, and the relationship between physical inactivity and viral load, γ = .009.
Conclusions
Low levels of physical activity predicted increased depression and poor ART adherence over time, which subsequently predicted higher viral load.
doi:10.1007/s12160-013-9489-3
PMCID: PMC3714319  PMID: 23483379
HIV/AIDS; physical activity; depression; adherence; viral load
16.  HIV-infected Men Who Have Sex With Men Who Engage in Very High Levels of Transmission Risk Behaviours: Establishing a Context for Novel Prevention Interventions 
Psychology, health & medicine  2013;18(5):10.1080/13548506.2012.756537.
Men who have sex with men (MSM) comprise the largest risk group of individuals living with HIV in the United States and have the highest rates of new infections. A minority of HIV-infected MSM engage in unprotected anal intercourse after learning about their infection, potentially transmitting the virus to others. The current study sought to generate self-generated descriptive themes, from a group of HIV-infected MSM who reported high rates of sexual transmission risk behavior that may be relevant for understanding sexual risk in this group. Five descriptive themes emerged during content analysis: a) serostatus attribution, b) assumption of sexual partner’s responsibility for safer-sex, c) sexual sensation seeking, d) ongoing substance use, and e) dissatisfaction with current relationships. Traditional HIV transmission risk-reduction interventions that have been known to have only modest effects should be augmented by developing HIV prevention strategies for this subgroup of MSM to address these salient themes.
doi:10.1080/13548506.2012.756537
PMCID: PMC3857998  PMID: 23323526
HIV-infection; MSM; gay and bisexual men; HIV prevention; risky sexual behavior
17.  Do Ask, Do Tell: High Levels of Acceptability by Patients of Routine Collection of Sexual Orientation and Gender Identity Data in Four Diverse American Community Health Centers 
PLoS ONE  2014;9(9):e107104.
Background
The Institute of Medicine and The Joint Commission have recommended asking sexual orientation and gender identity (SOGI) questions in clinical settings and including such data in Electronic Health Records (EHRs). This is increasingly viewed as a critical step toward systematically documenting and addressing health disparities affecting lesbian, gay, bisexual, and transgender (LGBT) people. The U.S. government is currently considering whether to include SOGI data collection in the Stage 3 guidelines for the incentive program promoting meaningful use of EHR. However, some have questioned whether acceptable standard measures to collect SOGI data in clinical settings exist.
Methods
In order to better understand how a diverse group of patients would respond if SOGI questions were asked in primary care settings, 301 randomly selected patients receiving primary care at four health centers across the U.S. were asked SOGI questions and then asked follow-up questions. This sample was mainly heterosexual, racially diverse, and geographically and regionally broad.
Results
There was a strong consensus among patients surveyed about the importance of asking SOGI questions. Most of the LGBT respondents thought that the questions presented on the survey allowed them to accurately document their SOGI. Most respondents—heterosexual and LGBT—answered the questions, and said that they would answer such questions in the future. While there were some age-related differences, respondents of all ages overwhelmingly expressed support for asking SOGI questions and understood the importance of providers' knowing their patients' SOGI.
Conclusions
Given current deliberations within national health care regulatory bodies and the government's increased attention to LGBT health disparities, the finding that patients can and will answer SOGI questions has important implications for public policy. This study provides evidence that integrating SOGI data collection into the meaningful use requirements is both acceptable to diverse samples of patients, including heterosexuals, and feasible.
doi:10.1371/journal.pone.0107104
PMCID: PMC4157837  PMID: 25198577
18.  Sources of Racial/Ethnic Differences in Awareness of HIV Vaccine Trials 
American journal of public health  2014;104(8):e112-e118.
Objectives
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).
Methods
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.
Results
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.
Conclusions
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.
doi:10.2105/AJPH.2014.301893
PMCID: PMC4103242  PMID: 24922153
19.  Sexual risk behavior among HIV-uninfected men who have sex with men (MSM) participating in a tenofovir pre-exposure prophylaxis (PrEP) randomized trial in the United States 
Objective
To evaluate for changes in sexual behaviors associated with daily pill-use among MSM participating in a PrEP trial.
Design
Randomized, double-blind, placebo-controlled trial. Participants were randomized 1:1:1:1 to receive tenofovir disoproxil fumarate or placebo at enrollment or after a 9-month delay and followed for 24 months.
Methods
400 HIV-negative MSM reporting anal sex with a man in the past 12 months and meeting other eligibility criteria enrolled in San Francisco, Atlanta, and Boston. Sexual risk was assessed at baseline and quarterly visits using Audio Computer-Assisted Self-Interview. The association of pill-taking with sexual behavior was evaluated using logistic and negative-binomial regression for repeated measures.
Results
Overall indices of behavioral risk declined or remained stable during follow-up. Mean numbers of partners and proportion reporting unprotected anal sex (UAS) declined during follow-up (p<0.05), and mean UAS episodes remained stable. During the initial 9 months, changes in risk practices were similar in the group that began pills immediately vs. those in the delayed arm. These indices of risk did not differ significantly after initiation of pill-use in the delayed arm or continuation of study medication in the immediate arm. Use of poppers, amphetamines, and sexual performance-enhancing drugs were independently associated with one or more indices of sexual risk.
Conclusions
There was no evidence of risk compensation among HIV-uninfected MSM in this clinical trial. Monitoring for risk compensation should continue now that PrEP has been shown to be efficacious in MSM and other populations and will be provided in open-label trials and other contexts.
doi:10.1097/QAI.0b013e31828f097a
PMCID: PMC3904758  PMID: 23481668
risk compensation; behavioral disinhibition; sexual risk behavior; PrEP; MSM
20.  Psychosocial risk factors for HIV sexual risk among Indian men who have sex with men 
AIDS care  2013;25(9):1109-1113.
Indian men who have sex with men (MSM) are at increased risk for HIV compared to the general Indian population. Psychosocial factors may be uniquely associated with HIV risk among Indian MSM and may moderate the beneficial impact of standard HIV prevention approaches. Psychiatric diagnostic interviews and psychosocial and sexual risk assessments were conducted among 150 MSM in Mumbai, India. Logistic regression was employed to examine the association of psychiatric disorders and psychosocial problems to recent sexual risk behavior. Twenty-five percent of participants reported engaging in unprotected anal sex (UAS) during their last sexual contact with a man. Men who were married to a woman were more likely to have engaged in UAS during their last sexual contact with a man (35% vs. 17%, p = 0.018). In multivariable models, significant predictors of engaging in UAS were current major depression (adjusted odds ratio [AOR] = 2.61; 95% confidence interval [CI] 1.07, 6.39) and number of stressful life events (AOR = 0.91; 95% CI 0.83, 0.99). Alcohol dependence, anxiety, and self-esteem were not associated with engaging in UAS. Indian MSM with depression are at higher odds of engaging in UAS compared to MSM without depression. HIV prevention programs for Indian MSM may benefit from incorporating treatment or triage for mental health problems.
doi:10.1080/09540121.2012.749340
PMCID: PMC3708996  PMID: 23339580
men who have sex with men (MSM); Mumbai; India; mental health; depression; minority stress; HIV
21.  Incidence and Timing of Cancer in HIV-Infected Individuals Following Initiation of Combination Antiretroviral Therapy 
Kaposi sarcoma and lymphoma rates were highest immediately after antiretroviral therapy (ART) initiation, particularly among patients with low CD4 cell counts, whereas other cancers increased with time on ART. Calendar year of ART initiation was not associated with subsequent cancer incidence.
Background
Cancer is an important cause of morbidity and mortality in individuals infected with human immunodeficiency virus (HIV), but patterns of cancer incidence after combination antiretroviral therapy (ART) initiation remain poorly characterized.
Methods
We evaluated the incidence and timing of cancer diagnoses among patients initiating ART between 1996 and 2011 in a collaboration of 8 US clinical HIV cohorts. Poisson regression was used to estimate incidence rates. Cox regression was used to identify demographic and clinical characteristics associated with cancer incidence after ART initiation.
Results
At initiation of first combination ART among 11 485 patients, median year was 2004 (interquartile range [IQR], 2000–2007) and median CD4 count was 202 cells/mm3 (IQR, 61–338). Incidence rates for Kaposi sarcoma (KS) and lymphomas were highest in the first 6 months after ART initiation (P < .001) and plateaued thereafter, while incidence rates for all other cancers combined increased from 416 to 615 cases per 100 000 person-years from 1 to 10 years after ART initiation (average 7% increase per year; 95% confidence interval, 2%–13%). Lower CD4 count at ART initiation was associated with greater risk of KS, lymphoma, and human papillomavirus–related cancer. Calendar year of ART initiation was not associated with cancer incidence.
Conclusions
KS and lymphoma rates were highest immediately following ART initiation, particularly among patients with low CD4 cell counts, whereas other cancers increased with time on ART, likely reflecting increased cancer risk with aging. Our results underscore recommendations for earlier HIV diagnosis followed by prompt ART initiation along with ongoing aggressive cancer screening and prevention efforts throughout the course of HIV care.
doi:10.1093/cid/cit369
PMCID: PMC3739467  PMID: 23735330
HIV-associated malignancies; AIDS-defining cancer; non-AIDS-defining cancer; combination antiretroviral therapy
22.  Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial 
The Lancet. Infectious diseases  2014;14(4):281-290.
Summary
Background
Use of antiretroviral treatment for HIV-1 infection has decreased AIDS-related morbidity and mortality and prevents sexual transmission of HIV-1. However, the best time to initiate antiretroviral treatment to reduce progression of HIV-1 infection or non-AIDS clinical events is unknown. We reported previously that early antiretroviral treatment reduced HIV-1 transmission by 96%. We aimed to compare the effects of early and delayed initiation of antiretroviral treatment on clinical outcomes.
Methods
The HPTN 052 trial is a randomised controlled trial done at 13 sites in nine countries. We enrolled HIV-1-serodiscordant couples to the study and randomly allocated them to either early or delayed antiretroviral treatment by use of permuted block randomisation, stratified by site. Random assignment was unblinded. The HIV-1-infected member of every couple initiated antiretroviral treatment either on entry into the study (early treatment group) or after a decline in CD4 count or with onset of an AIDS-related illness (delayed treatment group). Primary events were AIDS clinical events (WHO stage 4 HIV-1 disease, tuberculosis, and severe bacterial infections) and the following serious medical conditions unrelated to AIDS: serious cardiovascular or vascular disease, serious liver disease, end-stage renal disease, new-onset diabetes mellitus, and non-AIDS malignant disease. Analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00074581.
Findings
1763 people with HIV-1 infection and a serodiscordant partner were enrolled in the study; 886 were assigned early antiretroviral treatment and 877 to the delayed treatment group (two individuals were excluded from this group after randomisation). Median CD4 counts at randomisation were 442 (IQR 373–522) cells per μL in patients assigned to the early treatment group and 428 (357–522) cells per μL in those allocated delayed antiretroviral treatment. In the delayed group, antiretroviral treatment was initiated at a median CD4 count of 230 (IQR 197–249) cells per μL. Primary clinical events were reported in 57 individuals assigned to early treatment initiation versus 77 people allocated to delayed antiretroviral treatment (hazard ratio 0·73, 95% CI 0·52–1·03; p=0·074). New-onset AIDS events were recorded in 40 participants assigned to early antiretroviral treatment versus 61 allocated delayed initiation (0·64, 0·43–0·96; p=0·031), tuberculosis developed in 17 versus 34 patients, respectively (0·49, 0·28–0·89, p=0·018), and primary non-AIDS events were rare (12 in the early group vs nine with delayed treatment). In total, 498 primary and secondary outcomes occurred in the early treatment group (incidence 24·9 per 100 person-years, 95% CI 22·5–27·5) versus 585 in the delayed treatment group (29·2 per 100 person-years, 26·5–32·1; p=0·025). 26 people died, 11 who were allocated to early antiretroviral treatment and 15 who were assigned to the delayed treatment group.
Interpretation
Early initiation of antiretroviral treatment delayed the time to AIDS events and decreased the incidence of primary and secondary outcomes. The clinical benefits recorded, combined with the striking reduction in HIV-1 transmission risk previously reported, provides strong support for earlier initiation of antiretroviral treatment.
Funding
US National Institute of Allergy and Infectious Diseases.
doi:10.1016/S1473-3099(13)70692-3
PMCID: PMC4144040  PMID: 24602844
23.  Temporal Trends in Presentation and Survival for HIV-Associated Lymphoma in the Antiretroviral Therapy Era 
Background
Lymphoma is the leading cause of cancer-related death among HIV-infected patients in the antiretroviral therapy (ART) era.
Methods
We studied lymphoma patients in the Centers for AIDS Research Network of Integrated Clinical Systems from 1996 until 2010. We examined differences stratified by histology and diagnosis year. Mortality and predictors of death were analyzed using Kaplan–Meier curves and Cox proportional hazards.
Results
Of 23 050 HIV-infected individuals, 476 (2.1%) developed lymphoma (79 [16.6%] Hodgkin lymphoma [HL]; 201 [42.2%] diffuse large B-cell lymphoma [DLBCL]; 56 [11.8%] Burkitt lymphoma [BL]; 54 [11.3%] primary central nervous system lymphoma [PCNSL]; and 86 [18.1%] other non-Hodgkin lymphoma [NHL]). At diagnosis, HL patients had higher CD4 counts and lower HIV RNA than NHL patients. PCNSL patients had the lowest and BL patients had the highest CD4 counts among NHL categories. During the study period, CD4 count at lymphoma diagnosis progressively increased and HIV RNA decreased. Five-year survival was 61.6% for HL, 50.0% for BL, 44.1% for DLBCL, 43.3% for other NHL, and 22.8% for PCNSL. Mortality was associated with age (adjusted hazard ratio [AHR] = 1.28 per decade increase, 95% confidence interval [CI] = 1.06 to 1.54), lymphoma occurrence on ART (AHR = 2.21, 95% CI = 1.53 to 3.20), CD4 count (AHR = 0.81 per 100 cell/µL increase, 95% CI = 0.72 to 0.90), HIV RNA (AHR = 1.13 per log10copies/mL, 95% CI = 1.00 to 1.27), and histology but not earlier diagnosis year.
Conclusions
HIV-associated lymphoma is heterogeneous and changing, with less immunosuppression and greater HIV control at diagnosis. Stable survival and increased mortality for lymphoma occurring on ART call for greater biologic insights to improve outcomes.
doi:10.1093/jnci/djt158
PMCID: PMC3748003  PMID: 23892362
24.  Substance Use Among HIV-Infected Patients Engaged in Primary Care in the United States: Findings From the Centers for AIDS Research Network of Integrated Clinical Systems Cohort 
American journal of public health  2013;103(8):1457-1467.
Objectives
The purpose of this study was to better understand substance use behaviors and deleterious health consequences among individuals with HIV.
Methods
We examined a multicenter cohort of HIV-infected patients (n = 3413) receiving care in 4 US cities (Seattle, Birmingham, San Diego, Boston) between December 2005 and April 2010 in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS). We used generalized estimating equations to model specific substance use outcomes.
Results
Overall, 24% of patients reported recent use of marijuana; 9% reported amphetamine use, 9% reported crack–cocaine use, 2% reported opiate use, 3.8% reported injection drug use, and 10.3% reported polydrug use. In adjusted multivariable models, those who reported unprotected anal sex had higher odds of marijuana, amphetamine, injection drug, and polydrug use. An increased number of distinct vaginal sexual partners was associated with polydrug and crack–cocaine use. Nonadherence to antiretroviral therapy was associated with the use of all substances other than marijuana.
Conclusions
The co-occurrence of substance use, unprotected intercourse, and medication nonadherence could attenuate the public health benefits of test, treat, and link to care strategies. Prevention programs are needed that address these coprevalent conditions.
doi:10.2105/AJPH.2012.301162
PMCID: PMC3752382  PMID: 23763417
25.  Geography Should Not Be Destiny: Focusing HIV/AIDS Implementation Research and Programs on Microepidemics in US Neighborhoods 
American journal of public health  2014;104(5):775-780.
African Americans and Hispanics are disproportionately affected by the HIV/AIDS epidemic. Within the most heavily affected cities, a few neighborhoods account for a large share of new HIV infections.
Addressing racial and economic disparities in HIV infection requires an implementation program and research agenda that assess the impact of HIV prevention interventions focused on increasing HIV testing, treatment, and retention in care in the most heavily affected neighborhoods in urban areas of the United States.
Neighborhood-based implementation research should evaluate programs that focus on community mobilization, media campaigns, routine testing, linkage to and retention in care, and block-by-block outreach strategies.
doi:10.2105/AJPH.2013.301864
PMCID: PMC3987607  PMID: 24716570

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