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HIV Seropositivity: HELP
Articles from Massachusetts
Based on 213 articles published since 2008
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These are the 213 published articles about HIV Seropositivity that originated from Massachusetts during 2008-2019.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4 · 5 · 6 · 7 · 8 · 9
1 Editorial Editorial Commentary: Age-Old Questions: When to Start Antiretroviral Therapy and in Whom? 2015

Walensky, Rochelle P / Hirsch, Martin S. ·Division of Infectious Diseases, Massachusetts General Hospital, Harvard Medical School, Boston. ·Clin Infect Dis · Pubmed #26082510.

ABSTRACT: -- No abstract --

2 Editorial The HIV-positive transplant donor--change born of necessity. 2015

Ingelfinger, Julie R / Rubin, Eric J. ·From the Department of Immunology and Infectious Diseases, Harvard School of Public Health, Boston (E.J.R.). ·N Engl J Med · Pubmed #25671260.

ABSTRACT: -- No abstract --

3 Editorial Why are we still, 20 years later, depriving human immunodeficiency virus-serodiscordant couples of equal access to fertility care? 2014

Moragianni, Vasiliki A. ·Fertility Solutions, Dedham, Massachusetts. ·Fertil Steril · Pubmed #24931207.

ABSTRACT: -- No abstract --

4 Review Association of opioid agonist therapy with the initiation of antiretroviral therapy - a systematic review. 2016

Mlunde, Linda Beatrice / Sunguya, Bruno Fokas / Mbwambo, Jessie Kazeni Kilonzo / Ubuguyu, Omary Said / Yasuoka, Junko / Jimba, Masamine. ·Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: lindasozy@gmail.com. · Department of Community Health, School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences, P.O. Box 65015, Dar es Salaam, Tanzania. Electronic address: sunguya@gmail.com. · Department of Psychiatry and Mental Health, Muhimbili National Hospital, P.O. Box 65000, Dar es Salaam, Tanzania. Electronic address: jmbwambo@gmail.com. · Department of Psychiatry and Mental Health, Muhimbili National Hospital, P.O. Box 65000, Dar es Salaam, Tanzania. Electronic address: oubuguyu@yahoo.com. · Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: jyasuoka@post.harvard.edu. · Department of Community and Global Health, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: mjimba@m.u-tokyo.ac.jp. ·Int J Infect Dis · Pubmed #27044520.

ABSTRACT: OBJECTIVES: People who inject drugs are at high risk of HIV infection but often face barriers in accessing medical care including access to antiretroviral therapy (ART). Evidence is available about the effectiveness of opioid agonist therapy on drug dependency and risk behaviors. However, it remains scattered regarding access to ART among HIV-positive people who inject drugs. We conducted a systematic review to examine the association of opioid agonist therapy with ART initiation among HIV-positive people who inject drugs. METHODS: We searched the literature for evidence from seven databases. We conducted a narrative synthesis and meta-analysis to examine the association of opioid agonist therapy with ART initiation. RESULTS: Five out of 2,901 identified studies met the inclusion criteria. Three out of five studies reported that, HIV-positive people receiving opioid agonist therapy initiated ART more than those not receiving opioid agonist therapy. In meta-analysis, opioid agonist therapy was associated with ART initiation among HIV positive people who inject drugs (pooled odds ratio: 1.68; 95% confidence interval: 1.03-2.73). CONCLUSIONS: Opioid agonist therapy is positively associated with ART initiation among HIV-positive people who inject drugs. It is important to scale up opioid agonist therapy among people who inject drugs to improve their ART initiation.

5 Review Disclosure of HIV serostatus among pregnant and postpartum women in sub-Saharan Africa: a systematic review. 2015

Tam, Melanie / Amzel, Anouk / Phelps, B Ryan. ·a Department of Global Health and Population , Harvard School of Public Health , Boston , MA , USA. ·AIDS Care · Pubmed #25636060.

ABSTRACT: Disclosure of one's HIV status can help to improve uptake and retention in prevention of mother-to-child transmission of HIV services; yet, it remains a challenge for many women. This systematic review evaluates disclosure rates among pregnant and postpartum women in sub-Saharan Africa, timing of disclosure, and factors affecting decisions to disclose. PubMed and EMBASE databases were searched to identify relevant studies published between January 2000 and April 2014. Rates of HIV serostatus disclosure to any person ranged from 5.0% to 96.7% (pooled estimate: 67.0%, 95% CI: 55.7%-78.3%). Women who chose to disclose their status did so more often to their partners (pooled estimate: 63.9%; 95% CI: 56.7%-71.1%) than to family members (pooled estimate: 40.1; 95% CI: 26.2%-54.0%), friends (pooled estimate: 6.4%; 95% CI: 3.0%-9.8%), or religious leaders (pooled estimate: 7.1%; 95% CI: 4.3%-9.8%). Most women disclosed prior to delivery. Decisions to disclose were associated with factors related to the woman herself (younger age, first pregnancies, knowing someone with HIV, lower levels of internalized stigma, and lower levels of avoidant coping), the partner (prior history of HIV testing and higher levels of educational attainment), their partnership (no history of domestic violence and financial independence), and the household (higher quality of housing and residing without co-spouses or extended family members). Interventions to encourage and support women in safely disclosing their status are needed.

6 Review The impact of antiretroviral therapy on mortality in HIV positive people during tuberculosis treatment: a systematic review and meta-analysis. 2014

Odone, Anna / Amadasi, Silvia / White, Richard G / Cohen, Theodore / Grant, Alison D / Houben, Rein M G J. ·TB Modelling Group, Centre for the Mathematical Modelling of Infectious Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom; Department of Global Health and Social Medicine, Harvard Medical School, Boston, Massachusetts, United States of America; University of Parma, School of Medicine, Parma, Italy. · University Division of Infectious and Tropical Diseases, University of Brescia and Spedali Civili General Hospital, Brescia, Italy. · TB Modelling Group, Centre for the Mathematical Modelling of Infectious Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom; TB Centre, London School of Hygiene and Tropical Medicine, London, United Kingdom. · Center for Communicable Disease Dynamics, Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, United States of America; Division of Global Health Equity, Brigham and Women's Hospital, Boston, Massachusetts, United States of America. · TB Centre, London School of Hygiene and Tropical Medicine, London, United Kingdom; Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom. ·PLoS One · Pubmed #25391135.

ABSTRACT: OBJECTIVE: To quantify the impact of antiretroviral therapy (ART) on mortality in HIV-positive people during tuberculosis (TB) treatment. DESIGN: We conducted a systematic literature review and meta-analysis. Studies published from 1996 through February 15, 2013, were identified by searching electronic resources (Pubmed and Embase) and conference books, manual searches of references, and expert consultation. Pooled estimates for the outcome of interest were acquired using random effects meta-analysis. SUBJECTS: The study population included individuals receiving ART before or during TB treatment. MAIN OUTCOME MEASURES: Main outcome measures were: (i) TB-case fatality ratio (CFR), defined as the proportion of individuals dying during TB treatment and, if mortality in HIV-positive people not on ART was also reported, (ii) the relative risk of death during TB treatment by ART status. RESULTS: Twenty-one studies were included in the systematic review. Random effects pooled meta-analysis estimated the CFR between 8% and 14% (pooled estimate 11%). Among HIV-positive TB cases, those receiving ART had a reduction in mortality during TB treatment of between 44% and 71% (RR = 0.42, 95%CI: 0.29-0.56). CONCLUSION: Starting ART before or during TB therapy reduces the risk of death during TB treatment by around three-fifths in clinical settings. National programmes should continue to expand coverage of ART for HIV positive in order to control the dual epidemic.

7 Review Using HIV viral load to guide treatment-for-prevention interventions. 2012

Novitsky, Vladimir / Essex, Max. ·Department of Immunology and Infectious Diseases, Harvard School of Public Health, Boston, Massachusetts, USA. ·Curr Opin HIV AIDS · Pubmed #22258501.

ABSTRACT: PURPOSE OF REVIEW: To provide evidence that HIV-1 RNA load can guide treatment-for-prevention interventions to mitigate the HIV epidemic. RECENT FINDINGS: Some HIV-infected individuals maintain increased levels of HIV-1 RNA load after acute infection for an extended period of time, and can disproportionately contribute to the spread of HIV in the community. The recent HIV Prevention Trials Network 052 study has demonstrated 96% efficacy for initiation of early antiretroviral treatment (ART) in HIV-1 serodiscordant couples. SUMMARY: The level of HIV-1 RNA load in plasma is the major biological predictor of virus transmission. HIV-infected individuals who maintain increased levels of HIV-1 RNA load, extended high viremics, can transmit virus at higher rates. Combinatorial ART decreases HIV replication, thus reducing rates of virus transmission. Identifying high viremics and placing them on ART seems an attractive strategy that has the potential to achieve both individual benefits by lowering risk for early onset of clinical AIDS and public health benefits by reducing HIV transmission. A key logistical challenge is to screen for high viremics among HIV-positive individuals. Efficacy of the modified treatment-for-prevention approach focused on high viremics is being evaluated in ongoing and upcoming clinical trials. If efficacious, such an approach could be used widely to mitigate and control the HIV epidemic.

8 Review Treatment-for-prevention: clinical considerations. 2012

Lockman, Shahin / Sax, Paul. ·Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA. slockman@hsph.harvard.edu ·Curr Opin HIV AIDS · Pubmed #22227588.

ABSTRACT: PURPOSE OF REVIEW: This article will discuss some of the potential clinical implications of the widespread use of antiretroviral treatment-as-prevention in patients with high CD4 cell counts, including the balance of clinical benefit vs. toxicity, adherence, drug resistance, and risk compensation. RECENT FINDINGS: Recent studies have definitively demonstrated that antiretroviral treatment (ART) markedly reduces heterosexual transmission of HIV-1 to HIV-uninfected partners among patients with CD4 counts less than 550 cells/μl. At the same time, an increasing body of evidence suggests that uncontrolled HIV replication may be associated with immune activation and inflammation, both of which increase the risk of non-HIV-related diseases; and that initiation of ART at even higher CD4 counts might improve patient outcomes. ART regimens continue to become better-tolerated, safer, and easier to take, and rates of adherence and virologic suppression also appear to be improving. Nevertheless, acceptability of and adherence to 'treatment for prevention' are unknown, and the spread of drug resistance in the setting of suboptimal adherence among less-motivated patients are substantive concerns with treatment-for-prevention. SUMMARY: Earlier ART may confer clinical benefits, and ART regimens are becoming safer and better-tolerated. However, high-quality data are urgently needed with regards to the acceptability of, adherence to, and clinical outcomes with treatment-for-prevention among patients with high CD4 counts, as well as risk compensation and the emergence and spread of drug resistance that may occur with implementation of this HIV prevention strategy.

9 Review A systematic review of behavioral and treatment outcome studies among HIV-infected men who have sex with men who abuse crystal methamphetamine. 2012

Rajasingham, Radha / Mimiaga, Matthew J / White, Jaclyn M / Pinkston, Megan M / Baden, Rachel P / Mitty, Jennifer A. ·Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA. radha.rajasingham@gmail.com ·AIDS Patient Care STDS · Pubmed #22070609.

ABSTRACT: Men who have sex with men (MSM) have the highest incidence of HIV infection in the United States. One of the contributing factors to HIV spread among this group is the use of crystal methamphetamine ("meth"). The objective was to review the behavioral impact of crystal meth use in HIV-infected MSM and potential treatment options. A systematic review of MEDLINE identified studies that evaluated the clinical effects of crystal meth on the HIV-infected MSM population. Search terms included HIV, methamphetamine, MSM, antiretroviral therapy, adherence, resistance, and treatment. U.S. citations in the English language in peer-reviewed journals until December 2010 were included. The primary author reviewed eligible articles, and relevant data including study design, sample, and outcomes were entered into an electronic data table. The 61 included studies highlight that HIV-infected MSM who use crystal meth are more likely to report high-risk sexual behaviors, incident sexually transmitted infections, and serodiscordant unprotected anal intercourse, compared to HIV-infected MSM who do not use crystal meth. Medication adherence in this population is notably low, which may contribute to transmission of resistant virus. No medications have proven effective in the treatment of crystal meth addiction, and the role of behavioral therapies, such as contingency management are still in question. HIV-infected MSM who abuse crystal meth have worse HIV-related health outcomes. Behavioral interventions have shown variable results in treating crystal meth addiction, and more investigation into rehabilitation options are needed. The results presented support efforts to develop and implement novel interventions to reduce crystal meth use in HIV-infected MSM.

10 Review Retention in HIV care between testing and treatment in sub-Saharan Africa: a systematic review. 2011

Rosen, Sydney / Fox, Matthew P. ·Center for Global Health and Development, Boston University, Boston, Massachusetts, USA. sbrosen@bu.edu ·PLoS Med · Pubmed #21811403.

ABSTRACT: BACKGROUND: Improving the outcomes of HIV/AIDS treatment programs in resource-limited settings requires successful linkage of patients testing positive for HIV to pre-antiretroviral therapy (ART) care and retention in pre-ART care until ART initiation. We conducted a systematic review of pre-ART retention in care in Africa. METHODS AND FINDINGS: We searched PubMed, ISI Web of Knowledge, conference abstracts, and reference lists for reports on the proportion of adult patients retained between any two points between testing positive for HIV and initiating ART in sub-Saharan African HIV/AIDS care programs. Results were categorized as Stage 1 (from HIV testing to receipt of CD4 count results or clinical staging), Stage 2 (from staging to ART eligibility), or Stage 3 (from ART eligibility to ART initiation). Medians (ranges) were reported for the proportions of patients retained in each stage. We identified 28 eligible studies. The median proportion retained in Stage 1 was 59% (35%-88%); Stage 2, 46% (31%-95%); and Stage 3, 68% (14%-84%). Most studies reported on only one stage; none followed a cohort of patients through all three stages. Enrollment criteria, terminology, end points, follow-up, and outcomes varied widely and were often poorly defined, making aggregation of results difficult. Synthesis of findings from multiple studies suggests that fewer than one-third of patients testing positive for HIV and not yet eligible for ART when diagnosed are retained continuously in care, though this estimate should be regarded with caution because of review limitations. CONCLUSIONS: Studies of retention in pre-ART care report substantial loss of patients at every step, starting with patients who do not return for their initial CD4 count results and ending with those who do not initiate ART despite eligibility. Better health information systems that allow patients to be tracked between service delivery points are needed to properly evaluate pre-ART loss to care, and researchers should attempt to standardize the terminology, definitions, and time periods reported.

11 Review The social determinants of HIV serostatus in sub-Saharan Africa: an inverse relationship between poverty and HIV? 2010

Fox, Ashley M. ·Department of Global Health and Population, Harvard School of Public Health, Boston, MA, USA. amfox@hsph.harvard.edu ·Public Health Rep · Pubmed #20629252.

ABSTRACT: Contrary to theories that poverty acts as an underlying driver of human immunodeficiency virus (HIV) infection in sub-Saharan Africa (SSA), an increasing body of evidence at the national and individual levels indicates that wealthier countries, and wealthier individuals within countries, are at heightened risk for HIV. This article reviews the literature on what has increasingly become known as the positive-wealth gradient in HIV infection in SSA, or the counterintuitive finding that the poor do not have higher rates of HIV. This article also discusses the programmatic and theoretical implications of the positive HIV-wealth gradient for traditional behavioral interventions and the social determinants of health literature, and concludes by proposing that economic and social policies be leveraged as structural interventions to prevent HIV in SSA.

12 Review Consequences of HIV for children: avoidable or inevitable? 2009

Desmond, Chris. ·FXB Center for Health and Human Rights, HSPH, Harvard University, 651 Huntington Avenue, Boston, MA 02115, USA. cdesmond@hsph.harvard.edu ·AIDS Care · Pubmed #22380983.

ABSTRACT: The HIV/AIDS epidemic has many serious consequences for children. These consequences are, however, rarely inevitable. Families can provide a protective barrier that deflects blows, or minimises their impact and a supportive nurturing environment that can help children recover from harm. If strong enough, and with sufficient access to quality services and support from communities, families can reduce the impacts of HIV/AIDS on children to negligible levels in most areas of impact. It is apparent that the impacts felt by children are not simply unfortunate, inevitable consequences of this epidemic. A strong and supported family with good access to quality services can deflect almost all of the impact. It is as a result of an interaction of the context of poverty, which weakens families, and a failure to adequately respond, that impacts are felt by children.

13 Review Vaccination and immunization against travel-related diseases in immunocompromised hosts. 2008

Kotton, Camille Nelson. ·Transplant Infectious Disease and Compromised Host Program, Travelers' Advice and Immunization Center, Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA. ckotton@partners.org ·Expert Rev Vaccines · Pubmed #18564020.

ABSTRACT: Immunocompromised hosts are growing in number and include transplant recipients of solid organs or hematopoietic stem cells, people who have HIV, cancer patients on chemotherapy, patients on immunomodulatory treatments for rheumatologic, gastrointestinal or other conditions, as well as those with other immunocompromising conditions. As their overall health improves, they are more likely to initiate foreign travel and have potential exposures to endemic pathogens. Immunocompromised hosts are, in general, less likely to respond to vaccines and may be more likely to have side effects from certain vaccines, such as those containing live-attenuated virus. In addition, vaccines are immunomodulatory and could theoretically impact upon immunologic conditions. This review will summarize the medical literature regarding travel-related vaccines in the adult, immunocompromised-host population. Since the research in this realm is limited and exists primarily in the setting of solid-organ and hematopoietic stem cell transplant recipients and HIV-positive subjects, this review will largely focus on these populations.

14 Clinical Trial Safety and antiviral activity of combination HIV-1 broadly neutralizing antibodies in viremic individuals. 2018

Bar-On, Yotam / Gruell, Henning / Schoofs, Till / Pai, Joy A / Nogueira, Lilian / Butler, Allison L / Millard, Katrina / Lehmann, Clara / Suárez, Isabelle / Oliveira, Thiago Y / Karagounis, Theodora / Cohen, Yehuda Z / Wyen, Christoph / Scholten, Stefan / Handl, Lisa / Belblidia, Shiraz / Dizon, Juan P / Vehreschild, Jörg J / Witmer-Pack, Maggi / Shimeliovich, Irina / Jain, Kanika / Fiddike, Kerstin / Seaton, Kelly E / Yates, Nicole L / Horowitz, Jill / Gulick, Roy M / Pfeifer, Nico / Tomaras, Georgia D / Seaman, Michael S / Fätkenheuer, Gerd / Caskey, Marina / Klein, Florian / Nussenzweig, Michel C. ·Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA. · Laboratory of Experimental Immunology, Institute of Virology, University Hospital Cologne, Cologne, Germany. · Department I of Internal Medicine, University Hospital Cologne, Cologne, Germany. · German Center for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany. · Center for Molecular Medicine Cologne (CMMC), University of Cologne, Cologne, Germany. · Praxis am Ebertplatz, Cologne, Germany. · Praxis Hohenstaufenring, Cologne, Germany. · Methods in Medical Informatics, Department of Computer Science, University of Tübingen, Tübingen, Germany. · Duke Human Vaccine Institute, Duke University, Durham, NC, USA. · Division of Infectious Diseases, Weill Cornell Medicine, New York, NY, USA. · Medical Faculty, University of Tübingen, Tübingen, Germany. · German Center for Infection Research, Partner Site Tübingen, Tübingen, Germany. · Max Planck Institute for Informatics, Saarbrücken, Germany. · Departments of Surgery, Immunology and Molecular Genetics and Microbiology, Duke University, Durham, NC, USA. · Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. · Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA. mcaskey@rockefeller.edu. · Laboratory of Experimental Immunology, Institute of Virology, University Hospital Cologne, Cologne, Germany. florian.klein@uk-koeln.de. · German Center for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany. florian.klein@uk-koeln.de. · Center for Molecular Medicine Cologne (CMMC), University of Cologne, Cologne, Germany. florian.klein@uk-koeln.de. · Laboratory of Molecular Immunology, The Rockefeller University, New York, NY, USA. nussen@rockefeller.edu. · Howard Hughes Medical Institute, The Rockefeller University, New York, NY, USA. nussen@rockefeller.edu. ·Nat Med · Pubmed #30258217.

ABSTRACT: Monotherapy of HIV-1 infection with single antiretroviral agents is ineffective because error-prone HIV-1 replication leads to the production of drug-resistant viral variants

15 Clinical Trial Universal test and treat and the HIV epidemic in rural South Africa: a phase 4, open-label, community cluster randomised trial. 2018

Iwuji, Collins C / Orne-Gliemann, Joanna / Larmarange, Joseph / Balestre, Eric / Thiebaut, Rodolphe / Tanser, Frank / Okesola, Nonhlanhla / Makowa, Thembisa / Dreyer, Jaco / Herbst, Kobus / McGrath, Nuala / Bärnighausen, Till / Boyer, Sylvie / De Oliveira, Tulio / Rekacewicz, Claire / Bazin, Brigitte / Newell, Marie-Louise / Pillay, Deenan / Dabis, François / Anonymous440929. ·Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa; Research Department of Infection and Population Health, University College London, London, UK; Department of Global Health and Infection, Brighton and Sussex Medical School, University of Sussex, Brighton, UK. · University of Bordeaux, ISPED, INSERM, Bordeaux Population Health Research Center, UMR 1219, Bordeaux, France. · Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa; Centre Population et Développement (UMR 196 Paris Descartes IRD), SageSud (ERL INSERM 1244), Institut de Recherche pour le Développement, Paris, France. · Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa. · Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa. · Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa; Research Department of Epidemiology and Public Health, University College London, London, UK; Academic Unit of Primary Care and Population Sciences and Department of Social Statistics and Demography, University of Southampton, Southampton, UK. · Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa; Department of Global Health and Population, Harvard School of Public Health, Harvard University, Boston, MA, USA; Institute of Public Health, Faculty of Medicine, Heidelberg University, Heidelberg, Germany. · Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France. · Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa; Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa. · Agence Nationale de Recherches sur le Sida et les hépatites virales (ANRS), Paris, France. · Human Development and Health, Global Health Research Institute, Faculty of Medicine, University of Southampton, Southampton, UK. · Africa Health Research Institute, Durban, KwaZulu-Natal, South Africa; Division of Infection and Immunity, University College London, London, UK. Electronic address: dpillay@ahri.org. · University of Bordeaux, ISPED, INSERM, Bordeaux Population Health Research Center, UMR 1219, Bordeaux, France. Electronic address: francois.dabis@u-bordeaux.fr. ·Lancet HIV · Pubmed #29199100.

ABSTRACT: BACKGROUND: Universal antiretroviral therapy (ART), as per the 2015 WHO recommendations, might reduce population HIV incidence. We investigated the effect of universal test and treat on HIV acquisition at population level in a high prevalence rural region of South Africa. METHODS: We did a phase 4, open-label, cluster randomised trial of 22 communities in rural KwaZulu-Natal, South Africa. We included individuals residing in the communities who were aged 16 years or older. The clusters were composed of aggregated local areas (neighbourhoods) that had been identified in a previous study in the Hlabisa subdistrict. The study statisticians randomly assigned clusters (1:1) with MapInfo Pro (version 11.0) to either the control or intervention communities, stratified on the basis of antenatal HIV prevalence. We offered residents repeated rapid HIV testing during home-based visits every 6 months for about 4 years in four clusters, 3 years in six clusters, and 2 years in 12 clusters (58 cluster-years) and referred HIV-positive participants to trial clinics for ART (fixed-dose combination of tenofovir, emtricitabine, and efavirenz) regardless of CD4 cell count (intervention) or according to national guidelines (initially ≤350 cells per μL and <500 cells per μL from January, 2015; control). Participants and investigators were not masked to treatment allocation. We used dried blood spots once every 6 months provided by participants who were HIV negative at baseline to estimate the primary outcome of HIV incidence with cluster-adjusted Poisson generalised estimated equations in the intention-to-treat population after 58 cluster-years of follow-up. This study is registered with ClinicalTrials.gov, number NCT01509508, and the South African National Clinical Trials Register, number DOH-27-0512-3974. FINDINGS: Between March 9, 2012, and June 30, 2016, we contacted 26 518 (93%) of 28 419 eligible individuals. Of 17 808 (67%) individuals with a first negative dried blood spot test, 14 223 (80%) had subsequent dried blood spot tests, of whom 503 seroconverted after follow-up of 22 891 person-years. Estimated HIV incidence was 2·11 per 100 person-years (95% CI 1·84-2·39) in the intervention group and 2·27 per 100 person-years (2·00-2·54) in the control group (adjusted hazard ratio 1·01, 95% CI 0·87-1·17; p=0·89). We documented one case of suicidal attempt in a woman following HIV seroconversion. 128 patients on ART had 189 life-threatening or grade 4 clinical events: 69 (4%) of 1652 in the control group and 59 (4%) of 1367 in the intervention group (p=0·83). INTERPRETATION: The absence of a lowering of HIV incidence in universal test and treat clusters most likely resulted from poor linkage to care. Policy change to HIV universal test and treat without innovation to improve health access is unlikely to reduce HIV incidence. FUNDING: ANRS, GiZ, and 3ie.

16 Clinical Trial Brief Report: Medication Sharing Is Rare Among African HIV-1 Serodiscordant Couples Enrolled in an Efficacy Trial of Oral Pre-exposure Prophylaxis (PrEP) for HIV-1 Prevention. 2017

Thomson, Kerry A / Haberer, Jessica E / Marzinke, Mark A / Mujugira, Andrew / Hendrix, Craig W / Celum, Connie / Ndase, Patrick / Ronald, Allan / Bangsberg, David R / Baeten, Jared M / Anonymous4680899. ·*Department of Epidemiology, University of Washington, Seattle, WA; †Center for Global Health and Department of Medicine, Massachusetts General Hospital, Boston, MA; ‡Departments of Pathology and Medicine, Johns Hopkins University, Baltimore, MD; §Department of Epidemiology and Biostatistics, Makerere University, Kampala, Uganda; ‖Division of Clinical Pharmacology and Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD; ¶Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA; #Department of Global Health, University of Washington, Seattle, WA; **Department of Medicine, University of Manitoba, Winnipeg, Canada; ††Oregon Health and Sciences University and Portland State University School of Public Health, Portland, OR; and ‡‡Departments of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA. ·J Acquir Immune Defic Syndr · Pubmed #28291050.

ABSTRACT: Sharing of pre-exposure prophylaxis (PrEP) medications is a concern for PrEP implementation. For HIV-1 serodiscordant couples, sharing may undermine the HIV-1 prevention benefit and also cause antiretroviral resistance if taken by HIV-1 infected partners. Within a PrEP efficacy trial among HIV-1 serodiscordant couples, we assessed the occurrence of PrEP sharing by self-report and plasma tenofovir concentrations in HIV-1 infected partners. PrEP sharing was self-reported at <0.01% of visits, and 0%-1.6% of randomly selected and 0% of purposively selected specimens from HIV-1 infected participants had detectable tenofovir concentrations (median: 66.5 ng/mL, range: 1.3-292 ng/mL). PrEP sharing within HIV-1 serodiscordant couples was extremely rare.

17 Clinical Trial Sequential Immunization with gp140 Boosts Immune Responses Primed by Modified Vaccinia Ankara or DNA in HIV-Uninfected South African Participants. 2016

Churchyard, Gavin / Mlisana, Koleka / Karuna, Shelly / Williamson, Anna-Lise / Williamson, Carolyn / Morris, Lynn / Tomaras, Georgia D / De Rosa, Stephen C / Gilbert, Peter B / Gu, Niya / Yu, Chenchen / Mkhize, Nonhlanhla N / Hermanus, Tandile / Allen, Mary / Pensiero, Michael / Barnett, Susan W / Gray, Glenda / Bekker, Linda-Gail / Montefiori, David C / Kublin, James / Corey, Lawrence. ·Aurum Institute for Health Research, Klerksdorp, South Africa. · School of Public Health, University of Witwatersrand, Johannesburg, South Africa. · Advancing Care and Treatment for TB and HIV, Medical Research Council Collaborating Centre, Klerksdorp, South Africa. · University of Kwa-Zulu Natal, Durban, South Africa. · Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America. · Institute of Infectious Disease and Molecular Medicine, Division of Medical Virology, University of Cape Town, Cape Town, South Africa; National Health Laboratory Services, Observatory, Cape Town, South Africa. · National Institute for Communicable Diseases, National Health Laboratory Services, Sandringham, Johannesburg, South Africa. · Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, United States of America. · Department of Laboratory Medicine, University of Washington, Seattle, WA, United States of America. · Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States of America. · Novartis Vaccines and Diagnostics, Cambridge, MA, United States of America. · South African Medical Research Council, Cape Town, South Africa. · Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Braamfontein, Johannesburg, South Africa. · Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa. · Laboratory for AIDS Vaccine Research and Development, Duke University Medical Center, Durham, NC, United States of America. ·PLoS One · Pubmed #27583368.

ABSTRACT: BACKGROUND: The safety and immunogenicity of SAAVI DNA-C2 (4 mg IM), SAAVI MVA-C (2.9 x 109 pfu IM) and Novartis V2-deleted subtype C gp140 (100 mcg) with MF59 adjuvant in various vaccination regimens was evaluated in HIV-uninfected adults in South Africa. METHODS: Participants at three South African sites were randomized (1:1:1:1) to one of four vaccine regimens: MVA prime, sequential gp140 protein boost (M/M/P/P); concurrent MVA/gp140 (MP/MP); DNA prime, sequential MVA boost (D/D/M/M); DNA prime, concurrent MVA/gp140 boost (D/D/MP/MP) or placebo. Peak HIV specific humoral and cellular responses were measured. RESULTS: 184 participants were enrolled: 52% were female, all were Black/African, median age was 23 years (range, 18-42 years) and 79% completed all vaccinations. 159 participants reported at least one adverse event, 92.5% were mild or moderate. Five, unrelated, serious adverse events were reported. The M/M/P/P and D/D/MP/MP regimens induced the strongest peak neutralizing and binding antibody responses and the greatest CD4+ T-cell responses to Env. All peak neutralizing and binding antibody responses decayed with time. The MVA, but not DNA, prime contributed to the humoral and cellular immune responses. The D/D/M/M regimen was poorly immunogenic overall but did induce modest CD4+ T-cell responses to Gag and Pol. CD8+ T-cell responses to any antigen were low for all regimens. CONCLUSIONS: The SAAVI DNA-C2, SAAVI MVA-C and Novartis gp140 with MF59 adjuvant in various combinations were safe and induced neutralizing and binding antibodies and cellular immune responses. Sequential immunization with gp140 boosted immune responses primed by MVA or DNA. The best overall immune responses were seen with the M/M/P/P regimen. TRIAL REGISTRATION: ClinicalTrials.gov NCT01418235.

18 Clinical Trial Intimate Partner Violence and Adherence to HIV Pre-exposure Prophylaxis (PrEP) in African Women in HIV Serodiscordant Relationships: A Prospective Cohort Study. 2016

Roberts, Sarah T / Haberer, Jessica / Celum, Connie / Mugo, Nelly / Ware, Norma C / Cohen, Craig R / Tappero, Jordan W / Kiarie, James / Ronald, Allan / Mujugira, Andrew / Tumwesigye, Elioda / Were, Edwin / Irungu, Elizabeth / Baeten, Jared M / Anonymous18030869. ·*Department of Epidemiology, University of Washington, Seattle, WA; †Department of Medicine and Center for Global Health, Massachusetts General Hospital, Boston, MA; ‡Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA; Departments of §Global Health; ‖Medicine, University of Washington, Seattle, WA; ¶Kenya Medical Research Institute, Nairobi, Kenya; #Division of Global Health Equity, Department of Medicine, Brigham and Women's Hospital, Boston, MA; **Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA; ††Centers for Disease Control and Prevention, Atlanta, GA; ‡‡Department of Obstetrics and Gynaecology, University of Nairobi, Nairobi, Kenya; §§Department of Medicine, University of Manitoba, Winnipeg, Canada; ‖‖Kabwohe Clinical Research Center, Kabwohe, Uganda; ¶¶Department of Reproductive Health, Moi University, Eldoret, Kenya; and ##Kenyatta National Hospital, Nairobi, Kenya. ·J Acquir Immune Defic Syndr · Pubmed #27243900.

ABSTRACT: BACKGROUND: Intimate partner violence (IPV) is associated with higher HIV incidence, reduced condom use, and poor adherence to antiretroviral therapy and other medications. IPV may also affect adherence to pre-exposure prophylaxis (PrEP). METHODS: We analyzed data from 1785 HIV-uninfected women enrolled in a clinical trial of PrEP among African HIV serodiscordant couples. Experience of verbal, physical, or economic IPV was assessed at monthly visits by face-to-face interviews. Low PrEP adherence was defined as clinic-based pill count coverage <80% or plasma tenofovir levels <40 ng/mL. The association between IPV and low adherence was analyzed using generalized estimating equations, adjusting for potential confounders. In-depth interview transcripts were examined to explain how IPV could impact adherence. RESULTS: Sixteen percent of women reported IPV during a median of 34.8 months of follow-up (interquartile range 27.0-35.0). Overall, 7% of visits had pill count coverage <80%, and 32% had plasma tenofovir <40 ng/mL. Women reporting IPV in the past 3 months had increased risk of low adherence by pill count (adjusted risk ratio 1.49, 95% confidence interval: 1.17 to 1.89) and by plasma tenofovir (adjusted risk ratio 1.51, 95% confidence interval: 1.06 to 2.15). Verbal, economic, and physical IPV were all associated with low adherence. However, the impact of IPV diminished and was not statistically significant 3 months after the reported exposure. In qualitative interviews, women identified several ways in which IPV affected adherence, including stress and forgetting, leaving home without pills, and partners throwing pills away. CONCLUSIONS: Women who reported recent IPV in the Partners PrEP Study were at increased risk of low PrEP adherence. Strategies to mitigate PrEP nonadherence in the context of IPV should be evaluated.

19 Clinical Trial HIV Transmission Risk Behavior in a Cohort of HIV-Infected Treatment-Naïve Men and Women in the United States. 2016

Landovitz, Raphael J / Tran, Thuy Tien T / Cohn, Susan E / Ofotokun, Ighovwhera / Godfrey, Catherine / Kuritzkes, Daniel R / Lennox, Jeffrey L / Currier, Judith S / Ribaudo, Heather J. ·Division of Infectious Diseases, UCLA Center for Clinical AIDS Research and Education, University of California, Los Angeles, 11075 Santa Monica Blvd, Suite 100, Los Angeles, CA, 90025, USA. rlandovitz@mednet.ucla.edu. · Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, MA, USA. · Division of Infectious Diseases, Northwestern University School of Medicine, Chicago, IL, USA. · Division of Infectious Diseases, Emory University School of Medicine, Atlanta, GA, USA. · Therapeutics Research Branch, Division of AIDS, National Institutes of Health, Bethesda, MD, USA. · Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA, USA. · Division of Infectious Diseases, UCLA Center for Clinical AIDS Research and Education, University of California, Los Angeles, 11075 Santa Monica Blvd, Suite 100, Los Angeles, CA, 90025, USA. ·AIDS Behav · Pubmed #26979419.

ABSTRACT: Antiretroviral therapy (ART) can minimize HIV transmission. Prevention benefits may be compromised by barriers to virologic suppression, and by increased condomless sex among those initiating ART. We evaluated condomless sex in a cohort of HIVinfected US individuals poised to initiate ART in a clinical trial. We assessed partner and sex act type, condom use, and perception of infectiousness. Six percent of participants reported as not infectious; men who have sex with men were more likely to perceive high infectivity. Prevalence of condomless sex was 44 %; 74 % of those also reported homosexual acquisition of HIV. Predictors of increased risk of condomless sex included greater numbers of lifetime partners, recent stimulant drug use and an HIV-positive or unknown serostatus partner. In the context of serodifferent partners, lower perception of infectiousness was also associated with a higher risk of condomless sex. Results highlight opportunities for prevention education for HIV infected individuals at ART initiation.

20 Clinical Trial HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention. 2014

Donnell, Deborah / Baeten, Jared M / Bumpus, Namandjé N / Brantley, Justin / Bangsberg, David R / Haberer, Jessica E / Mujugira, Andrew / Mugo, Nelly / Ndase, Patrick / Hendrix, Craig / Celum, Connie. ·*Department of Global Health University of Washington and Vaccine and Infectious Disease Institute Fred Hutchinson Cancer Research Center, Seattle, WA; Departments of †Global Health; ‡Medicine; §Epidemiology, University of Washington, Seattle, WA; Departments of ‖Pharmacology and Molecular Sciences; ¶Medicine, Johns Hopkins University, Baltimore, MD; #Center for Global Health, Massachusetts General Hospital and Department of Medicine, Harvard Medical School, Boston, MA; **Department of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda; ††Department of Obstetrics and Gynecology, University of Nairobi and Kenyatta National Hospital, Nairobi; and ‡‡Department of Epidemiology, Johns Hopkins University, Baltimore, MD. ·J Acquir Immune Defic Syndr · Pubmed #24784763.

ABSTRACT: BACKGROUND: Antiretroviral pre-exposure prophylaxis (PrEP) is a novel HIV prevention strategy for which adherence is a known determinant of efficacy. Blood concentrations of PrEP medications are one objective marker of adherence. METHODS: In a placebo-controlled PrEP efficacy trial of tenofovir disoproxil fumarate (TDF) and TDF with emtricitabine (FTC/TDF) among 4747 African women and men with an HIV-infected partner, we measured plasma tenofovir concentrations from participants in the active PrEP arms: 29 HIV seroconverters (cases) and 196 randomly selected controls who remained uninfected. RESULTS: Among controls, 71% of visits had tenofovir concentrations >40 ng/mL, consistent with steady-state daily dosing, compared with 21% of cases at the visit HIV was first detected. Pill count data indicated that 96% of controls and 66% of cases had >80% adherence for these same visits. The estimated protective effect of PrEP against HIV, based on concentrations >40 ng/mL, was 88% (95% confidence interval: 60 to 96, P < 0.001) for individuals receiving TDF and 91% (95% confidence interval: 47 to 98, P = 0.008) for individuals receiving FTC/TDF. Controls had consistent patterns of PrEP concentrations during follow-up; among the 81% with concentrations >40 ng/mL at month 1, 75% maintained this concentration at month 12. Only 5 of 29 seroconverters seemed to be consistently adherent to PrEP. Tenofovir concentrations >40 ng/mL were associated with older age and shorter time on study; concentrations ≤40 ng/mL occurred more commonly when participants reported no sex with their HIV-infected partner. CONCLUSIONS: Plasma concentrations of tenofovir consistent with daily dosing were highly predictive of protection from HIV acquisition. Most of those who took PrEP seemed to have high and consistent adherence.

21 Clinical Trial HIV pre-exposure prophylaxis in men who have sex with men and transgender women: a secondary analysis of a phase 3 randomised controlled efficacy trial. 2014

Buchbinder, Susan P / Glidden, David V / Liu, Albert Y / McMahan, Vanessa / Guanira, Juan V / Mayer, Kenneth H / Goicochea, Pedro / Grant, Robert M. ·Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, USA; Department of Medicine, University of California, San Francisco, CA, USA; Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA. Electronic address: susan.buchbinder@sfdph.org. · Department of Epidemiology and Biostatistics, University of California, San Francisco, CA, USA. · Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, USA; Department of Medicine, University of California, San Francisco, CA, USA. · Gladstone Institute of Virology and Immunology, San Francisco, CA, USA. · Investigaciones Médicas en Salud, Lima, Peru. · Fenway Community Health, Boston, MA, USA; Department of Medicine, Beth Israel Deaconess Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA. · University of California, San Francisco, CA, USA; Gladstone Institute of Virology and Immunology, San Francisco, CA, USA. ·Lancet Infect Dis · Pubmed #24613084.

ABSTRACT: BACKGROUND: For maximum effect pre-exposure prophylaxis should be targeted to the subpopulations that account for the largest proportion of infections (population-attributable fraction [PAF]) and for whom the number needed to treat (NNT) to prevent infection is lowest. We aimed to estimate the PAF and NNT of participants in the iPrEx (Pre-Exposure Prophylaxis Initiative) trial. METHODS: The iPrEx study was a randomised controlled efficacy trial of pre-exposure prophylaxis with coformulated tenofovir disoproxil fumarate and emtricitabine in 2499 men who have sex with men (MSM) and transgender women. Participants aged 18 years or older who were male at birth were enrolled from 11 trial sites in Brazil, Ecuador, Peru, South Africa, Thailand, and the USA. Participants were randomly assigned (1:1) to receive either a pill with active pre-exposure prophylaxis or placebo, taken daily. We calculated the association between demographic and risk behaviour during screening and subsequent seroconversion among placebo recipients using a Poisson model, and we calculated the PAF and NNT for risk behaviour subgroups. The iPrEx trial is registered with ClinicalTrials.gov, NCT00458393. FINDINGS: Patients were enrolled between July 10, 2007, and Dec 17, 2009, and were followed up until Nov 21, 2010. Of the 2499 MSM and transgender women in the iPrEx trial, 1251 were assigned to pre-exposure prophylaxis and 1248 to placebo. 83 of 1248 patients in the placebo group became infected with HIV during follow-up. Participants reporting receptive anal intercourse without a condom seroconverted significantly more often than those reporting no anal sex without a condom (adjusted hazard ratio [AHR] 5·11, 95% CI 1·55-16·79). The overall PAF for MSM and transgender women reporting receptive anal intercourse without a condom was 64% (prevalence 60%). Most of this risk came from receptive anal intercourse without a condom with partners with unknown serostatus (PAF 53%, prevalence 54%, AHR 4·76, 95% CI 1·44-15·71); by contrast, the PAF for receptive anal intercourse without a condom with an HIV-positive partner was 1% (prevalence 1%, AHR 7·11, 95% CI 0·70-72·75). The overall NNT per year for the cohort was 62 (95% CI 44-147). NNTs were lowest for MSM and transgender women self-reporting receptive anal intercourse without a condom (NNT 36), cocaine use (12), or a sexually transmitted infection (41). Having one partner and insertive anal sex without a condom had the highest NNTs (100 and 77, respectively). INTERPRETATION: Pre-exposure prophylaxis may be most effective at a population level if targeted toward MSM and transgender women who report receptive anal intercourse without a condom, even if they perceive their partners to be HIV negative. Substance use history and testing for STIs should also inform individual decisions to start pre-exposure prophylaxis. Consideration of the PAF and NNT can aid in discussion of the benefits and risks of pre-exposure prophylaxis with MSM and transgender women. FUNDING: National Institute of Allergy and Infectious Diseases and the Bill & Melinda Gates Foundation.

22 Clinical Trial What's love got to do with it? Explaining adherence to oral antiretroviral pre-exposure prophylaxis for HIV-serodiscordant couples. 2012

Ware, Norma C / Wyatt, Monique A / Haberer, Jessica E / Baeten, Jared M / Kintu, Alexander / Psaros, Christina / Safren, Steven / Tumwesigye, Elioda / Celum, Connie L / Bangsberg, David R. ·Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA 02115, USA. norma_ware@hms.harvard.edu ·J Acquir Immune Defic Syndr · Pubmed #22267018.

ABSTRACT: OBJECTIVE: Adherence may be the "Achilles heel" of pre-exposure prophylaxis (PrEP), a promising biomedical approach to HIV prevention. This article presents an explanation of PrEP adherence for African serodiscordant couples derived from qualitative data. DESIGN: Explaining quantitative findings is one way qualitative investigation contributes to research in medicine and public health. This qualitative interview study was nested in the Partners PrEP Study, a phase III randomized trial evaluating oral tenofovir and emtricitabine/tenofovir PrEP to prevent HIV acquisition by HIV-uninfected partners in serodiscordant heterosexual couples. METHODS: In-depth qualitative interviews were provided by 60 Partners PrEP Study participants in Uganda. Interviews used open-ended questions eliciting information on adherence experiences, barriers, and facilitators. An inductive approach informed by grounded theory methodology was used to analyze study data. RESULTS: The proposed explanation may be summarized as follows. Serodiscordance destabilizes couples, as the HIV-negative partner reacts with anger, fear, and sadness to the implication of infidelity represented by HIV infection. A "discordance dilemma" ensues, as the desire to avoid acquiring HIV and the advantages of preserving the relationship become competing priorities. PrEP is seen as a solution-a means of safeguarding health without ending the relationship. PrEP users benefit from the support of partners, who reinforce adherence. Where discord in the relationship persists, adherence suffers. CONCLUSIONS: PrEP adherence in serodiscordant couples may be understood as a function of the desire to reduce risk although preserving a partnered relationship. PrEP use in stable couples may be associated with improved adherence and thus, greater effectiveness.

23 Clinical Trial Quality of life among individuals with HIV starting antiretroviral therapy in diverse resource-limited areas of the world. 2012

Safren, Steven A / Hendriksen, Ellen S / Smeaton, Laura / Celentano, David D / Hosseinipour, Mina C / Barnett, Ronald / Guanira, Juan / Flanigan, Timothy / Kumarasamy, N / Klingman, Karin / Campbell, Thomas. ·Massachusetts General Hospital/Harvard Medical School, Boston, 02445, USA. ssafren@partners.org ·AIDS Behav · Pubmed #21499794.

ABSTRACT: As Antiretroviral Therapy (ART) is scaled up in low- and middle-income countries, it is important to understand Quality of Life (QOL) correlates including disease severity and person characteristics and to determine the extent of between-country differences among those with HIV. QOL and medical data were collected from 1,563 of the 1,571 participants at entry into a randomized clinical trial of ART conducted in the U.S. (n = 203) and 8 resource-limited countries (n = 1,360) in the Caribbean, South America, Asia, and Africa. Participants were interviewed prior to initiation of ART using a modified version of the ACTG SF-21, a health-related QOL measure including 8 subscales: general health perception, physical functioning, role functioning, social functioning, cognitive functioning, pain, mental health, and energy/fatigue. Other measures included demographics, CD4+ lymphocyte count, plasma HIV-1 RNA viral load. Higher quality of life in each of the 8 QOL subscales was associated with higher CD4+ lymphocyte category. General health perception, physical functioning, role functioning, and energy/fatigue varied by plasma HIV-1 RNA viral load categories. Each QOL subscale included significant variation by country. Only the social functioning subscale varied by sex, with men having greater impairments than women, and only the physical functioning subscale varied by age category. This was the first large-scale international ART trial to conduct a standardized assessment of QOL in diverse international settings, thus demonstrating that implementation of the behavioral assessment was feasible. QOL indicators at study entry varied with disease severity, demographics, and country. The relationship of these measures to treatment outcomes can and should be examined in clinical trials of ART in resource-limited settings using similar methodologies.

24 Clinical Trial Predictors of HIV transmission risk behavior and seroconversion among Latino men who have sex with men in Project EXPLORE. 2012

Bedoya, C Andres / Mimiaga, Mathew J / Beauchamp, Geetha / Donnell, Deborah / Mayer, Kenneth H / Safren, Steven A. ·Harvard Medical School/Massachusetts General Hospital, Boston, MA, USA. abedoya@partners.org ·AIDS Behav · Pubmed #21390540.

ABSTRACT: In the US, Latino MSM are disproportionately affected by HIV, yet there is a paucity of data for this risk group. To this end, we examined data on Latino and non-Latino white MSM who participated across six cities in a 2-year randomized behavioral intervention study-Project EXPLORE. At baseline, Latinos reported significantly more serodiscordant unprotected anal intercourse (SDUA) than non-Latinos. Longitudinal predictors of SDUA included marijuana, poppers, amphetamines and heavy drinking, as well as lower self-efficacy, poorer communication skills, weaker safe-sex norms and more enjoyment of risky sex. For HIV infection, Latinos had significantly higher seroconversion rate over follow-up than non-Latinos. Longitudinal predictors of seroconversion among Latinos included poppers and SDUA. Intervention effects did not significantly differ between Latino and non-Latinos. Findings support HIV intervention work with Latino MSM that includes skills training/counseling to address attitudes about safe sex and impact of substance use on HIV-risk behavior and acquisition.

25 Clinical Trial Relationship of prospective memory to neuropsychological function and antiretroviral adherence. 2009

Contardo, Christopher / Black, Anne C / Beauvais, John / Dieckhaus, Kevin / Rosen, Marc I. ·VA Boston Healthcare System, Neuropsychology Service, Boston, MA 02132, USA. chriscontardo@gmail.com ·Arch Clin Neuropsychol · Pubmed #19648150.

ABSTRACT: Prospective memory is defined as the ability to "remember to remember" something at a future time despite intervening distractions and may be particularly important in remembering to take prescribed medication among people infected with HIV. Ninety-seven HIV-positive participants in a clinical trial had their adherence measured by electronic pillcaps and were administered neuropsychological screening tests and the memory for intentions screening test (MIST). Factor analysis of the MIST and other neuropsychological measures identified four factors. Two were derived from MIST subscales and accounted for approximately 50% of the variance in cognitive functioning. Only one factor was significantly correlated with adherence, and this was a MIST factor. In this preliminary study, the MIST assessed a memory function that (a) could be distinguished from traditional retrospective recall and executive functioning and (b) was correlated with antiretroviral adherence.

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