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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.
PMCID: PMC4166980  PMID: 24928295
chemoprophylaxis; HIV prevention; MSM; preexposure prophylaxis; syphilis
2.  The other side of the bridge: exploring the sexual relationships of men who have sex with men and their female partners in Mumbai, India 
Culture, health & sexuality  2014;16(7):780-791.
Behaviourally bisexual men have been identified as a ‘bridge’ population of HIV transmission to heterosexual women in India. Little is known about the sexual relationships that these men have with their female sex partners. The primary objective of this study was to explore the sexual practices and relationship dynamics between married and unmarried behaviourally bisexual men and their female sex partners in Mumbai, India. In 2009, semi-structured qualitative interviews were conducted with 32 men who reported sex with men and women. Participants discussed a variety of sexual practices and arrangements with female sex partners. Irrespective of marital status and sexual identity, many said that they had satisfying sexual experiences and feelings of affection for female sex partners. However, sexual incompatibility between married partners was also reported. Explanations of bisexual concurrency were discussed in terms of both sexual satisfaction and sexual preference. Self-perceived HIV risk related to same-sex sexual behaviour motivated many men to use condoms with female partners. Expectations of unprotected marital sex and perceptions of partner risk were barriers to condom use. HIV prevention programmes for this population may benefit from tailored risk reduction counselling that attend to the variations of these sexual and social relationship dynamics.
PMCID: PMC4090273  PMID: 24815724
India; HIV/AIDS; bisexual men; women
3.  Antiretroviral pre-exposure prophylaxis implementation in the United States: a work in progress 
Journal of the International AIDS Society  2015;18(4Suppl 3):19980.
After the initial approval of the use of tenofovir disoproxil fumarate-emtricitabine (TDF/FTC) by the US Food and Drug Administration in 2012 for anti-HIV pre-exposure prophylaxis (PrEP), uptake was initially limited, but more recent community surveys and expert opinion suggest wider acceptance in some key populations.
Demonstration projects are underway to determine the best practices in the United States to identify at-risk individuals in primary care and sexually transmitted disease clinics who could benefit from PrEP. Studies of PrEP in combination with behavioural interventions are being evaluated. Studies to evaluate the use of PrEP by HIV-uninfected women in HIV-discordant couples interested in safe conception are also getting underway. The optimal deployment of PrEP as part of a comprehensive national HIV/AIDS strategy in the United States has been limited by lack of knowledge among some at-risk people and by some medical providers indicating that they do not feel sufficiently knowledgeable and comfortable in prescribing PrEP. Studies are underway to determine how to assist busy clinicians to determine which of their patients could benefit from PrEP. Although most federal health insurance programmes will cover most of the costs associated with PrEP, underinsured patients in states that have not enacted health reform face additional challenges in paying for PrEP medication and appropriate clinical monitoring.
PrEP implementation in the United States is a work in progress, with increasing awareness and uptake among some individuals in key populations.
PMCID: PMC4509893  PMID: 26198345
PrEP; pre-exposure prophylaxis; tenofovir-emtricitabine
4.  The promises and challenges of pre-exposure prophylaxis as part of the emerging paradigm of combination HIV prevention 
Journal of the International AIDS Society  2015;18(4Suppl 3):19949.
Towards the end of the twentieth century, significant success was achieved in reducing incidence in several global HIV epidemics through ongoing prevention strategies. However, further progress in risk reduction was uncertain. For one thing, it was clear that social vulnerability had to be addressed, through research on interventions addressing health systems and other structural barriers. As soon as antiretroviral treatment became available, researchers started to conceive that antiretrovirals might play a role in decreasing either susceptibility in uninfected people or infectiousness among people living with HIV. In this paper we focus on the origin, present status, and potential contribution of pre-exposure prophylaxis (PrEP) within the combination HIV prevention framework.
After a phase of controversy, PrEP efficacy trials took off. By 2015, daily oral PrEP, using tenofovir alone or in combination with emtricitabine, has been proven efficacious, though efficacy seems heavily contingent upon adherence to pill uptake. Initial demonstration projects after release of efficacy results have shown that PrEP can be implemented in real settings and adherence can be high, leading to high effectiveness. Despite its substantial potential, beliefs persist about unfeasibility in real-life settings due to stigma, cost, adherence, and potential risk compensation barriers.
The strategic synergy of behavioural change communication, biomedical strategies (including PrEP), and structural programmes is providing the basis for the combination HIV prevention framework. If PrEP is to ever become a key component of that framework, several negative beliefs must be confronted based on emerging evidence; moreover, research gaps regarding PrEP implementation must be filled, and appropriate prioritization strategies must be set up. Those challenges are significant, proportional to the impact that PrEP implementation may have in the global response to HIV.
PMCID: PMC4509895  PMID: 26198341
HIV prevention; pre-exposure prophylaxis; public health; health policy; antiretrovirals
5.  PrEP implementation: moving from trials to policy and practice 
Journal of the International AIDS Society  2015;18(4Suppl 3):20222.
It is increasingly clear that the HIV response will not be sustainable if the number of infections is not significantly reduced.
For two decades, research has been ongoing to identify new behavioural and biomedical strategies to prevent HIV infection. In the past few years, the efficacy of several new strategies has been demonstrated, including oral pre-exposure prophylaxis (PrEP; i.e. daily use of tenofovir/emtricitabine). Because several social, political and logistic barriers remain, however, optimal PrEP implementation will require a better dissemination of new evidence in a number of areas and additional implementation research from various disciplinary perspectives (i.e. social science, policy and ethics; health systems; and economics, including cost-effectiveness studies). Discussion of new evidence on those topics, as well as case studies of potential PrEP implementation in diverse environments, can improve the understanding of the role that PrEP may play in addressing the global HIV/AIDS epidemic.
In light of these needs, the Network for Multidisciplinary Studies in ARV-based HIV Prevention (NEMUS) and the World Health Organization (WHO) were honoured to co-organize a special issue of JIAS aimed at contributing to a scholarly discussion of current conditions surrounding PrEP implementation, potential impact and efficiency, social science concerns and the study of PrEP implementation in specific country cases. The papers included in this monograph identify and cover many of the main aspects of the complex yet promising discussions around PrEP implementation today.
This is a collection of timely contributions from global leaders in HIV research and policy that addresses geographic diversity, uses a trans-disciplinary approach and covers a variety of the complex issues raised by PrEP. As this publication will become accessible to all, we hope that it will remain a valuable resource for policy makers, programme managers, researchers and activists around the world at a moment of a paradigm shift of the global response to HIV.
PMCID: PMC4509896  PMID: 26198349
HIV; PrEP; key populations; scale-up; implementation science
6.  Lymphoma Immune Reconstitution Inflammatory Syndrome in the Center for AIDS Research Network of Integrated Clinical Systems Cohort 
In a multicenter cohort, unmasking immune reconstitution inflammatory syndrome (IRIS) was observed in 12% of HIV-associated lymphomas. Presentation and survival for lymphoma IRIS were similar to non-IRIS, with possibly increased early mortality among IRIS cases.
Background. Lymphoma incidence is increased among human immunodeficiency virus (HIV)–infected individuals soon after antiretroviral therapy (ART), perhaps due to unmasking immune reconstitution inflammatory syndrome (IRIS). Clinical characteristics and survival for unmasking lymphoma IRIS have not been described.
Methods. We studied lymphoma patients in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) from 1996 until 2011. Unmasking lymphoma IRIS was defined as lymphoma within 6 months after ART accompanied by a ≥0.5 log10 copies/mL HIV RNA reduction. Differences in presentation and survival were examined between IRIS and non-IRIS cases.
Results. Of 482 lymphoma patients, 56 (12%) met criteria for unmasking lymphoma IRIS. Of these, 12 (21%) had Hodgkin lymphoma, 22 (39%) diffuse large B-cell lymphoma, 5 (9%) Burkitt lymphoma, 10 (18%) primary central nervous system lymphoma, and 7 (13%) other non-Hodgkin lymphoma. Median CD4 cell count at lymphoma diagnosis among IRIS cases was 173 cells/µL (interquartile range, 73–302), and 48% had suppressed HIV RNA <400 copies/mL. IRIS cases were similar overall to non-IRIS cases in histologic distribution and clinical characteristics, excepting more frequent hepatitis B and C (30% vs 19%, P = .05), and lower HIV RNA at lymphoma diagnosis resulting from the IRIS case definition. Overall survival at 5 years was similar between IRIS (49%; 95% confidence interval [CI], 37%–64%) and non-IRIS (44%; 95% CI, 39%–50%), although increased early mortality was suggested among IRIS cases.
Conclusions. In a large HIV-associated lymphoma cohort, 12% of patients met a uniformly applied unmasking lymphoma IRIS case definition. Detailed studies of lymphoma IRIS might identify immunologic mechanisms of lymphoma control.
PMCID: PMC4102912  PMID: 24755860
HIV/AIDS; lymphoma; Hodgkin lymphoma; non-Hodgkin lymphoma; immune reconstitution inflammatory syndrome
7.  Knowledge, Beliefs and Practices Regarding Antiretroviral Medications for HIV Prevention: Results from a Survey of Healthcare Providers in New England 
PLoS ONE  2015;10(7):e0132398.
Antiretroviral treatment for HIV-infection before immunologic decline (early ART) and pre-exposure chemoprophylaxis (PrEP) can prevent HIV transmission, but routine adoption of these practices by clinicians has been limited.
Between September and December 2013, healthcare practitioners affiliated with a regional AIDS Education and Training Center in New England were invited to complete online surveys assessing knowledge, beliefs and practices regarding early ART and PrEP. Multivariable models were utilized to determine characteristics associated with prescribing intentions and practices.
Surveys were completed by 184 practitioners. Respondent median age was 44 years, 58% were female, and 82% were white. Among ART-prescribing clinicians (61% of the entire sample), 64% were aware that HIV treatment guidelines from the Department of Health and Human Services recommended early ART, and 69% indicated they would prescribe ART to all HIV-infected patients irrespective of immunologic status. However, 77% of ART-prescribing clinicians would defer ART for patients not ready to initiate treatment. Three-fourths of all respondents were aware of guidance from the U.S. Centers for Disease Control and Prevention recommending PrEP provision, 19% had prescribed PrEP, and 58% of clinicians who had not prescribed PrEP anticipated future prescribing. Practitioners expressed theoretical concerns and perceived practical barriers to prescribing early ART and PrEP. Clinicians with higher percentages of HIV-infected patients (aOR 1.16 per 10% increase in proportion of patients with HIV-infection, 95% CI 1.01–1.34) and infectious diseases specialists (versus primary care physicians; aOR 3.32, 95% CI 0.98–11.2) were more likely to report intentions to prescribe early ART. Higher percentage of HIV-infected patients was also associated with having prescribed PrEP (aOR 1.19, 95% CI 1.06–1.34), whereas female gender (aOR 0.26, 95% CI 0.10–0.71) was associated with having not prescribed PrEP.
These findings suggest many clinicians have shifted towards routinely recommending early ART, but not PrEP, so interventions to facilitate PrEP provision are needed.
PMCID: PMC4492498  PMID: 26146824
8.  Body Image Disturbance and Health Behaviors among Sexual Minority Men Living with HIV 
Body image disturbance is a common experience for sexual minority men living with HIV, and is associated with poor self-care behaviors. However, to date, no known cohesive theoretical model has been advanced to understand the possible antecedents and outcomes of body image disturbance in this population. Thus, the goal of the current study was to test a biopsychosocial model of body image and self-care behaviors among sexual minority men living with HIV.
Participants were 106 gay and bisexual men living with HIV who completed a battery of self-report measures including assessment of body image disturbance, depression, lipodystrophy, appearance orientation, condom use self-efficacy, antiretroviral therapy (ART) adherence, and HIV sexual transmission risk behaviors. Bayesian estimation was employed to assess model fit and direct and indirect pathways within the model.
The data fit the model well, with all theorized pathways being significant. Lipodystrophy severity and appearance orientation were associated with elevated body image disturbance. In turn, body image disturbance was related to poorer ART adherence and increased HIV sexual transmission risk behaviors, through the mechanisms of elevated depressive symptoms and poor condom use self-efficacy.
Elevated body image disturbance among sexual minority men living with HIV is associated with important biopsychosocial variables, which in turn are related to poorer ART adherence and increased HIV sexual transmission risk behaviors. Integrative psychosocial interventions addressing co-occurring body image disturbance, depression, and HIV self-care behaviors may be a fruitful area of future clinical practice and research.
PMCID: PMC4094355  PMID: 24977311
HIV/AIDS; Body image; ART adherence; HIV sexual transmission risk behaviors
9.  Antiretroviral Chemoprophylaxis: State of Evidence and the Research Agenda 
Oral antiretroviral preexposure prophylaxis (PrEP) has been shown to decrease human immunodeficiency virus (HIV) incidence in studies of men who have sex with men, heterosexual men and women, and injecting drug users. One study of pericoital tenofovir gel demonstrated that it reduced HIV incidence in South African women. However, other studies of African women failed to demonstrate protection with either oral tenofovir or tenofovir-emtricitabine, or daily tenofovir gel. The magnitude of PrEP protection appears to be highly correlated with medication adherence. New studies are evaluating whether different antiretrovirals, including dapivirine, rilpivirine, maraviroc, and new integrase inhibitors. Different formulations are also being evaluated, including gels, films, vaginal rings, and injectable medication. Although PrEP efficacy has been demonstrated, and several normative bodies (eg, the US Food and Drug Administration) have approved PrEP for clinical use, uptake has been slow. Reasons may include lack of sufficient provider and consumer education, residual concerns about costs, potential long-term toxicities, and behavioral disinhibition. Additional work is under way to determine how to best educate consumers and providers about optimal adherence and to use PrEP in conjunction with risk mitigation.
PMCID: PMC4141495  PMID: 24926034
PrEP; HIV prevention; HIV risk; antiretrovirals; medication adherence
10.  Management of HIV Infection in Patients With Cancer Receiving Chemotherapy 
Treating human immunodeficiency virus (HIV)-infected cancer patients simultaneously with antiretrovirals and chemotherapy is complicated. Little has been published on this topic. Clinicians should individualize decisions regarding HIV treatment according to clinical and laboratory findings, chemotherapy plan, comorbidities, potential toxic effects, and patient preference.
The optimal antiretroviral therapy (ART) regimen for human immunodeficiency virus (HIV)–infected patients with cancer remains unknown, as clinical trials are lacking and published data are insufficient to guide recommendations. When concomitant use of chemotherapy and ART is anticipated, overlap of toxic effects and drug–drug interactions between chemotherapy and ART may alter the optimal choice of ART. Prospective studies are urgently needed to further define the toxic effects of combined chemotherapy and ART in HIV-positive cancer patients. Such studies should aid the development of guidelines for treatment of this population. For now, clinicians should individualize decisions regarding treatment of HIV according to clinical and laboratory findings, cancer treatment plan (chemotherapy, radiotherapy, or surgery), liver or renal disease, potential adverse drug effects (eg, rash, gastrointestinal intolerance, bone marrow suppression), and patient preference. This review focuses on what infectious disease specialists need to know to select the most appropriate ART regimens for patients receiving chemotherapy.
PMCID: PMC4305124  PMID: 24642555
HIV; AIDS; cancer; antiretrovirals
11.  Assessing Appearance-Related Disturbances in HIV-Infected Men Who have Sex with Men (MSM): Psychometrics of the Body Change and Distress Questionnaire—Short Form (ABCD-SF) 
AIDS and behavior  2014;18(6):1075-1084.
Appearance-related disturbances are common among HIV-infected MSM; however, to date, there have been limited options in the valid assessment of this construct. The aim of the current study was to assess the structural, internal, and convergent validity of the assessment of body change distress questionnaire (ABCD) and its short version. Exploratory and confirmatory factor analyses indicated that both versions fit the data well. Four sub-factors were revealed measuring the following body disturbance constructs: (1) negative affect about appearance, (2) HIV health-related outcomes and stigma, (3) eating and exercise confusion, and (4) ART non-adherence. The subfactors and total scores revealed bivariate associations with salient health outcomes, including depressive symptoms, HIV sexual transmission risk behaviors, and ART non-adherence. The ABCD and its short form, offer valid means to assess varied aspects of body image disturbance among HIV-infected MSM, and require modest participant burden.
PMCID: PMC3962703  PMID: 24057934
HIV; MSM; Body image disturbance; Scale development; Health outcomes
12.  HIV Viremia and Incidence of Non-Hodgkin Lymphoma in Patients Successfully Treated With Antiretroviral Therapy 
Non-Hodgkin lymphoma incidence is high in HIV-infected patients successfully treated with antiretroviral therapy. HIV replication, even at low levels, may be an important modifiable risk factor for non-Hodgkin lymphoma.
Background. The incidence of non-Hodgkin lymphoma (NHL) in human immunodeficiency virus (HIV)–infected patients remains high despite treatment with antiretroviral therapy (ART).
Methods. We evaluated NHL incidence in HIV-infected patients followed in the Centers for AIDS Research Network of Integrated Clinical Systems who started combination ART and achieved suppression of HIV. We estimated the hazard ratio for NHL by time-varying HIV viremia categories, accounting for time-varying CD4 cell count using marginal structural models.
Results. We observed 37 incident NHL diagnoses during 21 607 person-years of follow-up in 6036 patients (incidence rate, 171 per 100 000 person-years; 95% confidence interval [CI], 124–236). NHL incidence was high even among patients with nadir CD4 cell count >200 cells/µL (140 per 100 000 person-years [95% CI, 80–247]). Compared with ≤50 copies/mL, hazard ratios (HRs) for NHL were higher among those with HIV viremia of 51–500 copies/mL (HR current = 1.66 [95% CI, .70–3.94]; HR 3-month lagged = 2.10 [95% CI, .84–5.22]; and HR 6-month lagged = 1.46 [95% CI, .60–3.60]) and >500 copies/mL (HR current = 2.39 [95% CI, .92–6.21]; HR 3-month lagged = 3.56 [95% CI, 1.21–10.49]; and HR 6-month lagged = 2.50 [95% CI, .91–6.84]). Current HIV RNA as a continuous variable was also associated with NHL (HR = 1.42 per log10 copies/mL [95% CI, 1.05–1.92]).
Conclusions. Our findings demonstrate a high incidence of NHL among HIV-infected patients on ART and suggest a role of HIV viremia in the pathogenesis of NHL. Earlier initiation of potent ART and maximal continuous suppression of HIV viremia may further reduce NHL risk.
PMCID: PMC4017888  PMID: 24523217
non-Hodgkin lymphoma; HIV; antiretroviral therapy; incidence; viremia
13.  Who should be offered HIV pre-exposure prophylaxis (PrEP)?: A secondary analysis of a Phase 3 PrEP efficacy trial in men who have sex with men and transgender women 
The Lancet infectious diseases  2014;14(6):468-475.
Pre-exposure prophylaxis (PrEP) has been proven to reduce HIV acquisition in men who have sex with men and transgender women (MSM/TGW). For maximal impact, PrEP should be targeted to subpopulations accounting for the largest proportion of infections (population attributable fraction, PAF) and for whom the number needed to treat (NNT) to prevent infection is lowest.
The iPrEx study was a randomized controlled efficacy trial of tenofovir-disoproxil-fumarate/emtricitabine PrEP in 2499 MSM/TGW on 4 continents. We calculated the association between demographic and risk behavior during screening with subsequent seroconversion among placebo recipients using a Poisson model, and the PAF and NNT for risk behavior subgroups.
Of 1248 placebo participants enrolled, 83 became HIV infected in follow-up. Participants reporting non-condom receptive anal intercourse (ncRAI) seroconverted significantly more often than MSM/TGW reporting no condomless anal sex (adjusted hazard ratio (AHR) 5·11, 95% CI 1·55-16·79). The overall PAF for MSM/TGW reporting ncRAI was 64% (prevalence=60%). Most of this risk came from ncRAI with unknown serostatus partners (PAF 53%, prevalence=54%, AHR 4·76); in contrast, the PAF for ncRAI with an HIV positive partner, an uncommon practice, was only 1% (prevalence 1%, AHR=7·11). The overall NNT per year for the cohort was 62 (95% CI 44-147). NNTs were lower for MSM/TGW self-reporting ncRAI, cocaine use, or a sexually transmitted infection (NNT= 36, 12, and 41 respectively). Having a single partner or non-condom insertive anal sex had the highest NNTs.
PrEP may be most effective at a population level if targeted toward MSM/TGW reporting ncRAI, even with partners perceived to be HIV negative. Substance use history and testing for STIs may also inform individual decisions to start PrEP. Considering PAF and NNT can aid in discussing the benefits and risks of PrEP with MSM/TGW.
Funded by the National Institute of Allergy and Infectious Diseases and the Bill and Melinda Gates Foundation; number NCT00458393.
PMCID: PMC4133171  PMID: 24613084
14.  Factors Associated with Anemia in HIV-infected Individuals in Southern India 
Anemia accelerates disease progression and increases mortality among HIV-infected individuals. Few studies have characterized this problem in developing countries. Hemoglobin values of adults presenting to an HIV tertiary care center in India between 1996 and 2007 were collected (n=6996). Multivariate logistic regression analysis was performed to examine associations among anemia, HIV progression, and co-morbidities. Overall anemia prevalence was 41%. Twenty percent of patients with CD4 counts >500 cells/µL were anemic, compared to 64% of those with CD4 counts <100 cells/µL (p<0.001). In multivariate analysis, CD4 count <100 cells/µL (OR:5.0, CI:4.0–6.3), underweight body-mass index (OR:4.8, CI:3.6–6.5), female gender (OR:3.1, CI:2.8–3.6), and tuberculosis (OR:1.6, CI:1.4–1.8) were significantly associated with anemia. In this setting, management of anemia should focus on antiretroviral therapy, nutritional supplementation, and tuberculosis control. The high anemia prevalence among patients meeting criteria for antiretroviral therapy highlights the need for increased access to non-AZT nucleoside reverse transcriptase inhibitors in developing countries.
PMCID: PMC4418531  PMID: 19541892
anemia; HIV; tuberculosis; India; malnutrition; resource-limited settings
15.  Body Mass Index, Depression, and Condom Use among HIV-Infected Men who have Sex with Men: A Longitudinal Moderation Analysis 
Archives of sexual behavior  2013;43(4):729-734.
Findings have been inconsistent regarding the association of obesity and sexual risk behaviors. The purpose of the current study was to assess the prospective nature of body mass index (BMI), depression, and their interaction in predicting condom use during anal intercourse among HIV-infected men who have sex with men (MSM). The sample (N = 490) was obtained from a large, HIV clinical cohort from four sites across the U.S. The following inclusion criteria were employed: identification as MSM and had completed at least one wave of patient-reported measures (e.g., depression, as measured by the PHQ-9) in the clinical cohort study. Longitudinal linear mixed-effects modeling revealed a significant BMI by depression interaction. Depressive symptoms were predictive of less frequent condom use for obese but not overweight men. Analogous results were found in regard to comparisons between normal weight and overweight men. Obesity, in the context of depression, is a risk factor for unprotected anal intercourse among HIV-infected MSM. Cognitive behavioral interventions to reduce HIV transmission risk behaviors among HIV-infected MSM should adopt an integrated perspective, combining sexual risk reduction with treatment for depression and body-related concerns.
PMCID: PMC3933471  PMID: 23979782
HIV/AIDS; Depression; Obesity; Sexual Risk; Body Mass Index; Condom Use
16.  Phase I/II Randomized Trial of Safety and Immunogenicity of LIPO-5 Alone, ALVAC-HIV (vCP1452) Alone, and ALVAC-HIV (vCP1452) Prime/LIPO-5 Boost in Healthy, HIV-1-Uninfected Adult Participants 
Clinical and Vaccine Immunology : CVI  2014;21(11):1589-1599.
Finding an effective human immunodeficiency virus type 1 (HIV-1) vaccine remains a major global health priority. In a phase I/II, placebo-controlled trial, healthy, HIV-1-negative adults were randomized to receive one of 5 vaccine regimens: LIPO-5 (combination of 5 lipopeptides) alone (250 μg), ALVAC-HIV (vCP1452) alone, or 3 groups of ALVAC-HIV (vCP1452) followed by ALVAC-HIV (vCP1452) plus LIPO-5 (250, 750, and 2,500 μg). Only 73/174 participants (42%) received all four vaccinations due to a study halt related to myelitis. There were no significant differences in systemic reactions between groups or in local reactogenicity between groups receiving ALVAC-HIV (vCP1452). Significant differences in local reactogenicity occurred between groups receiving LIPO-5 (P ≤ 0.05). Gag and Env antibodies were undetectable by ELISA 2 weeks after the fourth vaccination for all but one recipient. Antibodies to Gag and Env were present in 32% and 24% of recipients of ALVAC-HIV (vCP1452) alone and in 47% and 35% of ALVAC-HIV (vCP1452)+LIPO recipients, respectively. Coadministration of LIPO-5 did not significantly increase the response rate compared to ALVAC-HIV (vCP1452) alone, nor was there a significant relationship between dose and antibody responses among ALVAC-HIV (vCP1452)+LIPO groups. Over 90% of study participants had no positive gamma interferon (IFN-γ) enzyme-linked immunosorbent spot assay (ELISpot) responses to any peptide pool at any time point. The study was halted due to a case of myelitis possibly related to the LIPO-5 vaccine; this case of myelitis remains an isolated event. In general, there was no appreciable cell-mediated immunity detected in response to the vaccines used in this study, and antibody responses were limited. The clinical trial is registered on with registry number NCT00076063.
PMCID: PMC4248765  PMID: 25253665
17.  Optimizing Content for Pre-Exposure Prophylaxis (PrEP) Counseling for Men who have Sex with Men: Perspectives of PrEP Users and High-risk PrEP Naïve Men 
AIDS and behavior  2014;18(5):871-879.
Existing trials of antiretroviral (ARV) medication as chemoprophylaxis against HIV reveal that the degree of protection is primarily dependent on product adherence. However, there is a lack of data on targets for behavioral interventions to improve adherence to ARV as prevention. Information from individuals who have used ARV as pre-exposure prophylaxis (PrEP) can inform behavioral intervention development. Thirty-nine HIV-uninfected MSM at high risk for HIV acquisition participated in one of four semi-structured focus groups. Two of the focus groups consisted of MSM who had been prescribed and used PrEP in the context of a clinical trial; the other two consisted of high-risk MSM who had not previously used PrEP. An in-depth, within-case/across-case content analysis resulted in six descriptive themes potentially salient for a PrEP adherence behavioral intervention: (1) motivations to use PrEP, (2) barriers to PrEP use, (3) facilitators to PrEP use, (4) sexual decision-making in the context of PrEP, (5) prospective PrEP education content, and, (6) perceived effective characteristics of PrEP delivery personnel. Addressing these themes in behavioral interventions in the context of prescribing PrEP may result in the optimal “packaging” public health programs that implement PrEP for high-risk MSM.
PMCID: PMC4265582  PMID: 24077928
Pre-exposure Prophylaxis (PrEP); antiretroviral therapy for prevention; ART; HIV Prevention; MSM; adherence
18.  Disparities in the Quality of HIV Care When Using US Department of Health and Human Services Indicators 
Althoff, Keri N. | Rebeiro, Peter | Brooks, John T. | Buchacz, Kate | Gebo, Kelly | Martin, Jeffrey | Hogg, Robert | Thorne, Jennifer E. | Klein, Marina | Gill, M. John | Sterling, Timothy R. | Yehia, Baligh | Silverberg, Michael J. | Crane, Heidi | Justice, Amy C. | Gange, Stephen J. | Moore, Richard | Kitahata, Mari M. | Horberg, Michael A. | Kirk, Gregory D. | Benson, Constance A. | Bosch, Ronald J. | Collier, Ann C. | Boswell, Stephen | Grasso, Chris | Mayer, Kenneth H. | Hogg, Robert S. | Richard Harrigan, P. | Montaner, Julio SG | Cescon, Angela | Samji, Hasina | Brooks, John T. | Buchacz, Kate | Gebo, Kelly A. | Moore, Richard D. | Moore, Richard D. | Carey, John T. | Horberg, Michael A. | Silverberg, Michael J. | Thorne, Jennifer E. | Goedert, James J. | Jacobson, Lisa P. | Klein, Marina B. | Rourke, Sean B. | Burchell, Ann N. | Rachlis, Anita R. | Hunter-Mellado, Robert F. | Mayor, Angel M. | Gill, M.John | Deeks, Steven G. | Martin, Jeffrey N. | Saag, Michael S. | Mugavero, Michael J. | Willig, James | Eron, Joseph J. | Napravnik, Sonia | Kitahata, Mari M. | Crane, Heidi M. | Justice, Amy C. | Dubrow, Robert | Fiellin, David | Sterling, Timothy R. | Haas, David | Bebawy, Sally | Turner, Megan | Gange, Stephen J. | Anastos, Kathryn | Moore, Richard D. | Saag, Michael S. | Gange, Stephen J. | Kitahata, Mari M. | Althoff, Keri N. | McKaig, Rosemary G. | Justice, Amy C. | Freeman, Aimee M. | Moore, Richard D. | Freeman, Aimee M. | Lent, Carol | Kitahata, Mari M. | Van Rompaey, Stephen E. | Crane, Heidi M. | Morton, Liz | McReynolds, Justin | Lober, William B. | Gange, Stephen J. | Althoff, Keri N. | Abraham, Alison G. | Lau, Bryan | Zhang, Jinbing | Jing, Jerry | Golub, Elizabeth | Modur, Shari | Hanna, David B. | Rebeiro, Peter | Wong, Cherise | Mendes, Adell
We estimated US Department of Health and Human Services (DHHS)–approved human immunodeficiency virus (HIV) indicators. Among patients, 71% were retained in care, 82% were prescribed treatment, and 78% had HIV RNA ≤200 copies/mL; younger adults, women, blacks, and injection drug users had poorer outcomes. Interventions are needed to reduce retention- and treatment-related disparities.
PMCID: PMC3967825  PMID: 24463281
HIV; quality of care; retention in care; antiretroviral therapy; HIV RNA suppression
19.  Factors Associated with Amplified HIV Transmission Behavior among American Men who have Sex with Men Engaged in Care: Implications for Clinical Providers 
The HIV epidemic continues unabated in the United States, with men who have sex with men (MSM) being most frequently infected.
To understand the biological and behavioral risk factors associated with increased HIV transmission efficiency, that is HIV transmission risk behavior in the context of uncontrolled HIV replication or intercurrent sexually transmitted infections.
Participants were 201 HIV-infected MSM who received their primary care at an HIV ambulatory care center in Boston. Logistic regression models were conducted to determine factors associated with engaging in behavior associated with potentially amplified transmission.
In the final model, heavy alcohol use (AOR: 3.27; 95% CI 1.37–7.79), as well as stimulant drug use (crystal meth, crack, or other cocaine; AOR: 3.00; CI 1.32–6.84), having at least a college degree (OR: 2.74; CI: 1.15–6.54), and decreased duration of HIV infection (OR: 0.91; CI: 0.85–0.97) were each uniquely associated with enhanced HIV transmission behavior.
HIV primary care providers should routinely assess patients for potential HIV transmission behaviors, particularly those who are younger and more recently diagnosed with HIV, who drink alcohol heavily, and who use any nonprescription drugs, particularly stimulants, in order to decrease the spread of HIV.
PMCID: PMC3880641  PMID: 23873338
HIV transmission; MSM; primary care
20.  Testosterone replacement therapy among HIV-infected men in the CFAR Network of Integrated Clinical Systems 
AIDS (London, England)  2015;29(1):77-81.
The objectives of this study were to determine the rate of testosterone replacement therapy (TRT) initiation, TRT predictors and associated monitoring in HIV-infected men.
A multisite cohort study.
We examined TRT initiation rates and monitoring among adult HIV-infected men in routine care at seven sites in the Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) from 1996 to 2011. We determined TRT predictors using Cox regression modelling.
Of 14 454 men meeting inclusion criteria, TRT was initiated in 1482 (10%) with an initiation rate of 19.7/1000 person-years [95% confidence interval (95% CI) 18.7–20.7]. In the multivariable model, TRT was significantly associated with age at least 35 years, white race, diagnosis of AIDS wasting, hepatitis C coinfection, protease inhibitor based antiretroviral therapy and nadir CD4+ cell count of 200 cells/µl or less. Overall, 1886 out of 14 454 (13%) had testosterone deficiency. Among those initiating TRT, 992 out of 1482 (67%) had a pre-TRT serum total testosterone measured, and deficiency [<300 ng/dl (10.4 nmol/l)] was found in 360 out of 1482 (24%). Post-TRT serum total testosterone was measured within 6 months of TRT initiation in 377 out of 1482 (25%) men.
TRT was common in HIV-infected men, though evidence for pre-TRT testosterone deficiency was lacking in 76%. Endocrine guidelines for post-TRT monitoring were uncommonly followed. Given cardiovascular and other risks associated with TRT, efforts should focus on understanding factors driving these TRT practices in HIV-infected men.
PMCID: PMC4379711  PMID: 25387318
HIV; hormone replacement therapy; hypogonadism; men’s health; patient monitoring; testosterone
22.  Intimacy versus Isolation: A Qualitative Study of Sexual Practices among Sexually Active HIV-Infected Patients in HIV Care in Brazil, Thailand, and Zambia 
PLoS ONE  2015;10(3):e0120957.
The success of global treatment as prevention (TasP) efforts for individuals living with HIV/AIDS (PLWHA) is dependent on successful implementation, and therefore the appropriate contribution of social and behavioral science to these efforts. Understanding the psychosocial context of condomless sex among PLWHA could shed light on effective points of intervention. HPTN 063 was an observational mixed-methods study of sexually active, in-care PLWHA in Thailand, Zambia, and Brazil as a foundation for integrating secondary HIV prevention into HIV treatment. From 2010–2012, 80 qualitative interviews were conducted with PLWHA receiving HIV care and reported recent sexual risk. Thirty men who have sex with women (MSW) and 30 women who have sex with men (WSM) participated in equal numbers across the sites. Thailand and Brazil also enrolled 20 biologically-born men who have sex with men (MSM). Part of the interview focused on the impact of HIV on sexual practices and relationships. Interviews were recorded, transcribed, translated into English and examined using qualitative descriptive analysis. The mean age was 25 (SD = 3.2). There were numerous similarities in experiences and attitudes between MSM, MSW and WSM across the three settings. Participants had a high degree of HIV transmission risk awareness and practiced some protective sexual behaviors such as reduced sexual activity, increased use of condoms, and external ejaculation. Themes related to risk behavior can be categorized according to struggles for intimacy and fears of isolation, including: fear of infecting a sex partner, guilt about sex, sexual communication difficulty, HIV-stigma, and worry about sexual partnerships. Emphasizing sexual health, intimacy and protective practices as components of nonjudgmental sex-positive secondary HIV prevention interventions is recommended. For in-care PLWHA, this approach has the potential to support TasP. The overlap of themes across groups and countries indicates that similar intervention content may be effective for a range of settings.
PMCID: PMC4368566  PMID: 25793283
23.  Comprehensive Transgender Healthcare: The Gender Affirming Clinical and Public Health Model of Fenway Health 
This report describes the evolution of a Boston community health center’s multidisciplinary model of transgender healthcare, research, education, and dissemination of best practices. This process began with the development of a community-based approach to care that has been refined over almost 20 years where transgender patients have received tailored services through the Transgender Health Program. The program began as a response to unmet clinical needs and has grown through recognition that our local culturally responsive approach that links clinical care with biobehavioral and health services research, education, training, and advocacy promotes social justice and health equity for transgender people. Fenway Health’s holistic public health efforts recognize the key role of gender affirmation in the care and well-being of transgender people worldwide.
PMCID: PMC4456472  PMID: 25779756
Health equity; Health care; Transgender
24.  The Adolescent and Young Adult HIV Cascade of Care in the United States: Exaggerated Health Disparities 
AIDS Patient Care and STDs  2014;28(3):128-135.
Little is known about how adolescents and young adults contribute to the declines in the cascade of care from HIV-1 diagnosis to viral suppression. We reviewed published literature from the Unites States reporting primary data for youth (13–29 years of age) at each stage of the HIV cascade of care. Approximately 41% of HIV-infected youth in the United States are aware of their diagnosis, while only 62% of those diagnosed engage medical care within 12 months of diagnosis. Of the youth who initiate antiretroviral therapy, only 54% achieve viral suppression and a further 57% are not retained in care. We estimate less than 6% of HIV-infected youth in the United States remain virally suppressed. We explore the cascade of care from HIV diagnosis through viral suppression for HIV-infected adolescents and young adults in the United States to highlight areas for improvement in the poor engagement of the infected youth population.
PMCID: PMC3948479  PMID: 24601734

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