Showing papers in "The Open Aids Journal in 2010"

The UNITAID Patent Pool Initiative: Bringing Patents Together for the Common Good

Abstract: Developing and delivering appropriate, affordable, well-adapted medicines for HIV/AIDS remains an urgent challenge: as first-line therapies fail, increasing numbers of people require costly second-line therapy; one-third of ARVs are not available in pediatric formulations; and certain key first- and second-line triple fixed-dose combinations do not exist or sufficient suppliers are lacking. UNITAID aims to help solve these problems through an innovative initiative for the collective management of intellectual property (IP) rights - a patent pool for HIV medicines. The idea behind a patent pool is that patent holders - companies, governments, researchers or universities - voluntarily offer, under certain conditions, the IP related to their inventions to the patent pool. Any company that wants to use the IP to produce or develop medicines can seek a license from the pool against the payment of royalties, and may then produce the medicines for use in developing countries (conditional upon meeting agreed quality standards). The patent pool will be a voluntary mechanism, meaning its success will largely depend on the willingness of pharmaceutical companies to participate and commit their IP to the pool. Generic producers must also be willing to cooperate. The pool has the potential to provide benefits to all.

Socio-Demographic Determinants of Condom Use Among Sexually Active Young Adults in Rural KwaZulu-Natal, South Africa

Abstract: Aim: To investigate patterns, levels and socio-demographic determinants of condom use and consistency of use among young adults aged 15-24 years. Background: Condoms are known to prevent HIV infection. However, HIV prevalence and incidence remain high. Methods: This study was conducted in the Africa Centre Demographic Surveillance Area (ACDSA) in rural KwaZulu- Natal. Analysis focused on resident young adults aged 15-24 years in 2005. In univariable and multivariable analyses, determinants of condom use and consistency of use among 15-24 year olds were estimated using data collected in 2005. 'Ever' condom use was defined as the proportion who reported having used a condom; consistent use among those ever using as "always" using condoms with most recent partner in the last year. Results: 3,914 participants aged 15-24 years reported ever having sex, of whom 52% reported condom use. Adjusting for age, sex, number of partners, residence of partner, partner age difference, type of partner and socio-economic status (SES), having an older partner decreased likelihood (aOR=0.69, p<0.01), while belonging to a household in a higher SES increased likelihood of ever using condoms (aOR=1.82, p<0.01). Being female (aOR=0.61 p<0.01) and having a regular partner (aOR=0.65 p<0.01) were independently associated with low consistent condom use. Conclusions: In this rural South African setting, condom use remains low, especially among females and with an older partner, situations commonly associated with increased HIV acquisition. Targeted supportive interventions to increase condom use need to be developed if HIV prevention programmes are to be successful.

Adaptation of a Couple-Based HIV Intervention for Methamphetamine-Involved African American Men who have Sex with Men

Abstract: In the U.S., incidence of HIV infection among men who have sex with men (MSM) has steadily increased since the 1990s. This points to a need for innovation to address both emerging trends as well as longer-standing disparities in HIV risk and transmission among MSM, such as the elevated rates of HIV/STIs among African American MSM and methamphetamine users. While couple-based sexual risk reduction interventions are a promising avenue to reduce HIV/STI transmission, prior research has been almost exclusively with heterosexual couples. We sought to adapt an existing, evidence-based intervention—originally developed and tested with heterosexual couples—for a new target population consisting of African American MSM in a longer-term same-sex relationship where at least one partner uses methamphetamine. The adaptation process primarily drew from data obtained from a series of focus groups with 8 couples from the target population. Attention is given to the methods used to overcome challenges faced in this adaptation process: limited time, a lead investigator who is phenotypically different from the target population, a dearth of descriptive information on the experiences and worldviews among the target population, and a concomitant lack of topical experts. We also describe a visualization tool used to ensure that the adaptation process promotes and maintains adherence to the theory that guides the intervention and behavior change. The process culminated with an intervention adapted for the new target population as well as preliminary indications that a couple-based sexual-risk reduction intervention for African American, methamphetamine-involved male couples is feasible and attractive.

Developing a Text Messaging Risk Reduction Intervention for Methamphetamine-Using MSM: Research Note.

Abstract: Men who have sex with men (MSM) who use methamphetamine experience high risks for HIV infection due to sexual transmission behaviors often engaged in when under the influence of methamphetamine. Methamphetamine-using MSM use various forms of information technology (IT) communication such as instant messaging, social networking sites, and websites to facilitate a sexual and/or drug "hook up." Given the acceptability of IT communication in their daily lives, an IT intervention represents an appropriate strategy to reach and intervene with out-of-treatment, methamphetamine-using MSM. The aim of this study was to conduct formative work to develop a text messaging intervention to reduce methamphetamine use and high-risk sexual behaviors among out-of-treatment MSM, which involved conducting focus groups, community partners' meetings, and a pre-test intervention. These activities culminated in the development of a two-week, text-messaging intervention that delivered real-time electronic correspondence based on the behavioral change theories of Social Support Theory, Health Belief Model, and Social Cognitive Theory. The focus groups, community meetings, and pre-test were used to identify the IT communication device, the text messages that best support risk reduction and healthier behavioral choices, and logo, flyer and website development. The input and feedback from the target population and community partners were critical to the successful development of a culturally appropriate intervention. The knowledge gleaned from the formative work of this study will be vitally helpful in designing future IT studies.

HIV Patient Characteristics that Affect Adherence to Exercise Programmes: An Observational Study.

Abstract: Background: Benefits of exercise for HIV-infected persons have been documented, although in clinical practice, diminished adherence to exercise limits the effectiveness of this auxiliary treatment. Exercise intervention studies carry the caveat that the results are limited to volunteers with good compliance and completion profiles. Objectives: This study aimed to identify characteristics contributing to adherence vs non-adherence to prescribed supervised 10-week 75-minute aerobic and progressive resistance exercise programme in a clinical setting that requires twice-weekly attendance at the physiotherapy gym. Study Design: This observational study was comprised of 11 males and 11 females, physician-assessed, HIV seropositive patients referred to exercise programmes in a tertiary multi-disciplinary outpatient service for HIV patients at an urban Teaching Hospital in London (UK). Measurements taken prior to the exercise programme were used as dependent variables and include CD4 count, fitness level, flexibility and perceived physical-, emotional-, functional- and psychological- well-being. Attendance records were categorised into a dichotomous independent variable of adherence based on a natural break that occurred at 8/20 attended sessions. Results: Prior-to-treatment differences in perceived physical, functional and psychological well-being exist between adherent and non-adherent patients, but no differences were found in age, CD4 count or fitness level. Perceived well- being explained 55.7% of the variances in attendance. Gender and reason for referral appear to be independent of adherence, whereas ethnicity may play an influential role. Conclusion: Perceived well-being appears to differentiate between adherent and non-adherent patients. Further studies are required to investigate other psychological characteristics and barriers to maintaining exercise.

Towards a Patent Pool for HIV Medicines: The Background.

Abstract: Recent WHO guidelines for antiretroviral therapy recommend switching to less toxic, but more expensive medicines for first-line and second-line ART, raising questions about the financial sustainability of many AIDS treatment programmes. At the same time, many key generic producing countries such as India now grant pharmaceutical product patents so competition between multiple manufacturers will not be able to play the role it has in bringing down the price of newer drugs. Overcoming these patent barriers will require a range of solutions, such as restricting patentability criteria, or compulsory licensing. One additional systematic solution is provided by the patent pool, a collective solution to the management of patent rights, initially presented by Medecins Sans Frontieres to the French Foreign Ministry and subsequently the UNITAID Executive Board in 2006. A patent pool must not be implemented at any costs, but answer medical needs, be based on economic realities and meet the access needs of the developing world, including middle-income countries.

Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) - A Strategic Option for India.

Abstract: The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable, other better formulations and second line ARVs for adults and more drugs and formulations for paediatric groups, that are still to be widely available in India and other developing countries. To examine whether strong intellectual property (IP) protection systems are to be considered important barriers for the limited or lack of access to ARVs, we studied the patent profile of the ARVs of the originator companies within and outside India. We could record 93 patents in the United States Patent & Trademark Office (USPTO). The originator companies have been also aggressively filing and enforcing patents in India. There have been a few efforts by companies like Gilead and GSK to grant licenses to generic manufacturers in developing countries, ostensibly to promote access to ARVs through lower (two-tier) pricing. These steps are considered as too little and too late. There is an urgent need to look for alternative strategies to promote access to ARVs both linked to and independent of IPRs. Patent pooling as a viable strategy mooted by the UNITAID should be seriously explored to promote access to ARVs. India is ideally suited for trying out the patent pool strategy as most of the global requirement of affordable ARV drugs for HIV/AIDS treatment is sourced from Indian generic companies.

Detection of Early Sero-Conversion HIV Infection Using the INSTI HIV-1 Antibody Point-of-Care Test.

Abstract: We compared the INSTI(TM) HIV-1 Antibody Point-of-Care (POC) Test to laboratory-based tests for detection of early sero-conversion (i.e. acute) HIV infections. Fifty-three (53) individuals with early HIV infection, (i.e. 3(rd) generation anti-HIV EIA non-reactive or reactive, HIV-1 Western Blot non-reactive or indeterminate and HIV-1 p24 antigen reactive) were tested by INSTI(TM). The INSTI(TM) test was reactive for 34/49 (sensitivity 69.4%; 95% confidence interval 54.6-81.8%) early-infected individuals whose laboratory-based 3(rd) generation HIV EIA test was reactive. Four (4) were non-reactive by both the laboratory-based EIA and INSTI(TM )tests, but were p24 antigen reactive. The INSTI(TM )POC test performs well compared with other POC tests for the detection of early sero-conversion HIV infection, but it may miss 20% to 30% of those detected by laboratory-based 3(rd) generation anti-HIV tests. Both POC and laboratory-based anti-HIV tests will fail to detect a proportion of infected individuals in the first weeks after infection.

A typology of intellectual property management for public health innovation and access: design considerations for policymakers.

Abstract: This paper seeks to set the practical discipline of public interest intellectual property (IP) management in public health into its broader policy context. The most immediate and direct impact of IP systems on public welfare results not from international standards nor from national legislation - though these norms are fundamentally important - but rather from the accumulated impact of numerous practical choices whether or not to seek IP protection; where and where not; and how any exclusive rights are deployed, by whom, and to what end. IP management is the essentially practical exercise of limited exclusive rights over protected subject matter, the judicious use of those rights to leverage outcomes that advance an institution's or a firm's objectives. Exclusive rights are used to construct and define knowledge-based relationships, to leverage access to technology and other necessary resources, and to enhance market-based incentives. IP management choices range across a broad spectrum, spanning public domain strategies, open or exclusive licensing, and strong exclusivity. The idea of 'exclusive rights', as a specific legal mechanism, can run counter to expectations of greater openness and accessibility, but actual outcomes will depend very much on how these mechanisms are used in practice. For public interest or public sector institutions concerned with health research and development, particularly the development of new medicines, IP management choices can be just as critical as they are for private firms, although a predominant institutional concentration on advancing direct public interest objectives may lead to significantly different approaches in weighing and exercising practical choices for IP management: even so, a private sector approach should not be conflated with exclusivity as an end in itself, nor need public interest IP management eschew all leverage over IP. This paper offers a tentative framework for a richer typology of those choices, to give a sense of practical options available and the factors that might guide their application, but without advocating any particular approach.

Formative Assessment of ARM-U: A Modular Intervention for Decreasing Risk Behaviors Among HIV-Positive and HIV-Negative Methamphetamine-Using MSM.

Abstract: Background: Methamphetamine is a major contributor to HIV transmission among men who have sex with men (MSM). Recent studies show that up to one-third of methamphetamine-using MSM (MUMSM) inject the drug. We developed a behavioral intervention for MUMSM to decrease unprotected anal intercourse and increase awareness of parenteral HIV transmission risk. This 6-session (3 in-person, 3 by telephone) modular intervention was designed to be tailored to participants’ HIV (+/-) and injection drug user ([IDU] yes/no) status. We present results of formative research used to evaluate the content and to assess feasibility and acceptability of this individual-level HIV risk-reduction intervention.

The Development and Implementation of an Outreach Program to Identify Acute and Recent HIV Infections in New York City.

Abstract: Introduction Since 2004, the authors have been operating First Call NYU, an outreach program to identify acute and recent HIV infections, also called primary HIV infections, among targeted at-risk communities in the New York City (NYC) metropolitan area. Materials and methodology First Call NYU employed mass media advertising campaigns, outreach to healthcare providers in NYC, and Internet-based efforts including search engine optimization (SEO) and Internet-based advertising to achieve these goals. Results Between October 2004 and October 2008, 571 individuals were screened through this program, leading to 446 unique, in-person screening visits. 47 primary HIV infections, including 14 acute and 33 recent HIV infections, were identified. Discussion Internet and traditional recruitment methods can be used to increase self-referrals for screening following possible exposure to HIV. Conclusion Community education of at-risk groups, with the goal of increased self-diagnosis of possible acute HIV infection, may be a useful addition to traditional efforts to identify such individuals.

Short and Long-Term Incidence of Tuberculosis and CD4-Cell Count Dynamic on HAART in Senegal

Abstract: Objectives: Estimate tuberculosis (TB) incidence among patients receiving HAART. Compare the dynamic of the CD4-cell count and viral load before notification of the TB with the dynamic among patients remaining free of TB. Design: Prospective cohort with ascertainment of TB cases from medical records. Methods: The first 404 adults HIV-1 infected patients enrolled in the Senegalese antiretroviral drug access initiative were eligible. CD4-cell and viral load were assessed at baseline and every 6 months. Patients receiving an antituberculosis treatment at HAART initiation were excluded from analysis. Any TB case notified after the first month of HAART was considered as an incident case. Follow-up was censored at death or at the last visit before March 31, 2008. CD4-cell trajectories until TB notification were compared to non-TB developers within two distinct periods: from HAART initiation to 24 months and after. Results: Over 404 eligible patients, 352 were included in this analysis. Median follow-up reached 73 months and 1821 person-years were accrued. Half of the 42 incident cases were notified before month 19 of HAART yielding to an overall incident rate of 2.3/100 PY (1.7-3.1). Annual incidence decreased with duration of HAART (trend in incidence: RR=0.26, p<10 -4 ). During the first period, CD4-cell count dynamic of most TB patients was identical to the dynamic among patients remaining free of TB. Most cases of the second period occurred in a context of an immunological failure. Conclusions: This study provides an estimate of TB incidence among patients on HAART in Senegal and supports two underlying mechanisms.

Antiretroviral (ARV) therapy in resource poor countries: what do we need in real life?

Abstract: Significant progresses have been made in the last 5 years towards the ultimate goal to provide universal access to care for all HIV/AIDS patients needing antiretroviral treatment in resource-poor countries. However, many barriers are still to be overcome, including () cost of care for the individual, () stigma, () lack of qualified human resources and infrastructure, especially in the rural setting, () rescue drugs for failing patients and () pediatric formulations. Priority actions to be promoted if the fight against HIV/AIDS is to be successful include: (i) promoting access to care in the rural areas, (ii) strengthening of basic health infrastructures, (iii) waiving of users' fee to get ARV, (iv) a larger variety of drugs, with particular regard to fixed dose combination third line drugs and pediatric formulations, (v) local quality training and (vi) high quality basic and translational research. While the universal access to HIV care is crucial in developing countries, a strong emphasis on prevention should be maintained along.

Patent pools: intellectual property rights and competition.

Abstract: Patent pools do not correct all problems associated with patent thickets. In this respect, patent pools might not stop the outsider problem from striking pools. Moreover, patent pools can be expensive to negotiate, can exclude patent holders with smaller numbers of patents or enable a group of major players to form a cartel that excludes new competitors. For all the above reasons, patent pools are subject to regulatory clearance because they could result in a monopoly. The aim of this article is to present the relationship between patents and competition in a broad context

Validation of Microcapillary Flow Cytometry for Community-Based CD4+ T Lymphocyte Enumeration in Remote Burkina Faso.

Abstract: Background: CD4+ T lymphocyte enumeration plays a critical role in the initiation and monitoring of HIV- infected patients on antiretroviral therapy. There is an urgent need for low-cost CD4+ enumeration technologies, particularly for use in dry, dusty climates characteristic of many small cities in Sub-Saharan Africa. Design: Cross-sectional study Methods: Blood samples from 98 HIV-infected patients followed in a community HIV clinic in Ouahigouya, Burkina Faso were obtained for routine CD4+ T lymphocyte count monitoring. The blood samples were divided into two aliquots, on which parallel CD4+ measurements were performed using microcapillary (Guava EasyCD4) and dedicated (Becton Dickinson FACSCount) CD4+ enumeration systems. Spearman rank correlation coefficient was calculated, and the sensitivity, specificity and positive predictive value (PPV) for EasyCD4 <200 cells/� L were determined compared to the reference standard FACSCount CD4 <200 cells/� L. Results: Mean CD4 counts for the EasyCD4 and FACSCount were 313.75 cells/� L and 303.47 cells/� L, respectively. The Spearman rank correlation coefficient was 0.92 (p<0.001). Median values using EasyCD4 were higher than those with the FACSCount (p=0.004). For a CD4<350 cells/uL, sensitivity of the EasyCD4 was 93.9% (95%CI 85.2-98.3%), specificity was 90.6% (95% CI 75.0-98.0%), and PPV was 95.4% (95%CI 87.1-99.0%). Conclusion: Use of the EasyCD4 system was feasible and highly accurate in the harsh conditions of this remote city in Sub-Saharan Africa, demonstrating acceptable sensitivity and specificity compared to a standard operating system. Microcapillary flow cytometry offers a cost-effective alternative for community-based, point-of-care CD4+ testing and could play a substantial role in scaling up HIV care in remote, resource-limited settings.

Toward a Better Understanding of Non-Addicted, Methamphetamine-Using, Men who Have Sex with Men (MSM) in Atlanta.

Abstract: Methamphetamine use has increasingly become linked with sexual risk behaviors among men have sex with men (MSM). Yet, the majority of research has been done with methamphetamine dependent MSM or with samples in which addiction to the substance was not evaluated. Furthermore, research with methamphetamine-using MSM in the Southern U.S. is lacking. In this study, focus groups and in-depth interviews were conducted in order to understand the motives, context, and other facilitators and barriers of methamphetamine use among non-addicted MSM residing in Atlanta. Participants included 30 non-addicted, methamphetamine-using MSM and 16 local mental and public health officials. Findings from the first of this two-phase formative research project will result in the initial development of a community-tested, culturally-specific social marketing campaign and an individual-based intervention based in HIV-testing facilities.

Effect of Maternal HIV-1 Status and Antiretroviral Drugs on Haematological Profiles of South African Infants in Early Life

Abstract: Maternal HIV-1 status and antiretroviral drug exposure may influence the haematological profiles of infants. We recruited infants from 118 uninfected control women and from 483 HIV-1 infected women who received no antiretroviral drugs (n=28), or received single-dose Nevirapine (sdNVP) (n=424) or triple-drug combination therapy (n=31) to reduce HIV-1 transmission. Blood was drawn from infants within 24 hours of delivery or 6-12 weeks post-delivery and full blood counts performed using a fully automated AcT-5-diff haematology analyser and reference controls. Exposed uninfected (EU; no NVP) differed from control infants only in having lower basophil counts and percentages. In all infant groups, leukocyte profiles showed characteristic quantitative changes with age in the first 6 weeks of life. HIV-1 infected infants displayed by 6 weeks elevations in white blood cells, lymphocyte, monocyte and basophil counts, and monocyte and basophil percentages, when compared to EU infants. At birth EU NVP-treated infants exhibited elevated monocyte percentages and counts and basophil counts that did not persist at 6 weeks. Interestingly, EU newborns of mothers with high CD4 counts (> 500 cells/μl) that had taken sdNVP had significantly elevated white blood cell, monocyte and basophil counts when compared to newborn infants of mothers with similar CD4 counts that had not taken sdNVP; this was not evident in infants of mothers with CD4 counts <200 cells/μl. These previously undescribed features may affect immune response capability in early life and clinical consequences of such changes need to be further investigated.

Technology development through pooling ARV drug patents: a vision from China.

Abstract: Unaffordable prices still bar the end-users in China from accessing ARV drugs. Patent protection of ARV drugs has dramatically limited the availability of these lifesaving drugs to AIDS patients in China. The way Chinese government can go to breakthrough the ARV drug patents are suggested as: Make more generic drugs available through compulsory licensing, impartment from other countries or building ARVs plants by partnerships between governments or generic drug companies. Do a thorough and detailed research on the patent application of ARV drugs to find out the loophole. Try patent pool to make AIDS medicines more affordable and appropriate for patients.

Implications of patent pools on innovation regarding antiretrovirals.

Abstract: Patent pools have been promoted as an innovative means of promoting the production of fixed-dose combination antiretroviral medicines (ARVs), which can be particularly appropriate for resource-poor settings. An important question, however, is what are the implications of patent pools on innovation for creating new and improved antiretrovirals. Indeed, given the continuing mutation of HIV and growing resistance to existing treatments, continued innovation in ARV development is vital for addressing these challenges. Would patent pools be a hindrance or rather a stimulus for further innovation? This question is particularly relevant in light of UNITAID’s initiative to create a patent pool for ARV development, focusing on pediatric formulations and new combinations, by the end of 2009. In this article, the author argues that a voluntary and well-designed patent pool, involving both innovative and generic manufacturers, focused on developing fixed-dose combinations for resource-poor markets with the greatest need, could actually stimulate increased innovation to meet these needs. Indeed, by bringing together the major ARV producers worldwide to collaborate on developing products which will meet the needs of the poorest, an ARV patent pool could create significant public health benefits. UNITAID has taken the lead in designing and implementing such a pool and UNITAID’s experience will have important lessons for policy-makers in the future.

Efficacy and Safety of Abacavir/Lamivudine/Zidovudine Plus Tenofovir in HBV/HIV-1 Coinfected Adults: 48-Week Data.

Abstract: In HBV/HIV-coinfected patients, the risk of end-stage liver disease and death is increased. This open-label, prospective, pilot study evaluated abacavir/lamivudine/zidovudine twice daily plus tenofovir once daily in HBV/HIV- coinfected antiretroviral-naive subjects. Nine adults (8 males) enrolled, with baseline mean HIV-1 RNA = 4.5 log10 copies/mL, HBV DNA = 9.0 log10 copies/mL, and median CD4 count =158 cells/mm 3 . No subject had baseline ALT >5x ULN. Six subjects completed the study: 1 withdrew due to non-treatment-related toxoplasmosis and 2 were lost-to-follow-up. At week 48, 100% (6/6) of remaining subjects had � 2 log10 decrease in HBV DNA, and 100% (6/6) and 83% (5/6) had HIV- 1 RNA <400 and <50 copies/mL, respectively. Median change from baseline in CD4 count was 157 cells/mm 3 . One subject experienced treatment-related grade 3 leukopenia. These results demonstrate that abacavir/lamivudine/zidovudine and tenofovir were well tolerated with sustained HIV-1 and HBV antiviral activity through 48 weeks in HBV/HIV- coinfected, antiretroviral-naive subjects.

Using a modified intervention mapping approach to develop and refine a single-session motivational intervention for methamphetamine-using men who have sex with men.

Abstract: There is an ongoing need for the development and adaptation of behavioral interventions to address behaviors related to acquisition and transmission of infectious diseases and for preventing the onset of chronic diseases. This paper describes the application of an established systematic approach to the development of a behavioral intervention to reduce sexual risk behaviors for HIV among men who have sex with men and who use methamphetamine. The approach includes six steps: (1) a needs assessment; (2) preparing matrices of proximal program objectives; (3) selecting theory-based methods and practical strategies; (4) producing program components and materials; (5) planning for program adoption, implementation, and sustainability; and (6) planning for evaluation. The focus of this article is on the intervention development process; therefore the article does not describe steps 5 and 6. Overall the process worked well, although it had to be adapted to fit the sequence of events associated with a funded research project. This project demonstrates that systematic approaches to intervention development can be applied even in research projects where some of the steps occur during the proposal writing process rather than during the actual project. However, intervention developers must remain flexible and be prepared to adapt the process to the situation. This includes being ready to make choices regarding intervention efficacy versus feasibility and being willing to select the best intervention that is likely to be delivered with available resources rather than an ideal intervention that may not be practical.

Designing ARVs Patent Pool Up to Trade & Policy Evolutionary Dynamics.

Abstract: Patent pools for second and third-line Fixed Dose Combination (FDC) antiretroviral drugs (ARVs) should not be delayed as they are instrumental to urgent public health needs in the under-served markets. Nonetheless, multinational originator companies still seem to perceive patent pooling for ARVs as a minefield that would offer the generic competitors lots of deeply exploitable opportunities, to the detriment of patent owner’s rights. This paper analyses the brand industry concerns, while looking for a strategy up to a really equitable and free world market, without any discrimination between end-users in wealthy and resource-limited countries. This strategy would urge partnerships between originator companies first to make newer FDC ARVs quickly available and allow patent pool agreements with generic counterparts to be negotiated straight afterwards. The patent pool strategy highlighted in this paper would assert the primacy of health over for-profit policies, while aligning with the 61st WHO’s Assembly recommendations and G7, G8 and World Trade Organisation’s warnings and pledges against trade protectionism.

Developing Innovative Intervention Approaches for Methamphetamine-Using Men who have Sex with Men Not Currently in Drug Treatment

Abstract: Men who have sex with men (MSM) continue to be disproportionately affected by HIV and AIDS. The U.S. Centers for Disease Control and Prevention (CDC) estimates that MSM account for 48% of all men living with HIV and 53% of all new HIV infections in the United States in 2007 [1], and the number of incident cases among MSM continue to increase in the U.S. while incidence has been flat or declining for other risk groups [2]. Further, MSM are at elevated risk for HIV infection throughout the world [3]. Several U.S. studies [4-6] suggest that unprotected anal sex accounts for the acquisition of most HIV infections among MSM, and situational factors play an important role in understanding sexual risk taking. One such factor is the use of methamphetamine during sex. Methamphetamine, a central nervous system stimulant, has been consistently linked to unprotected anal sex among MSM [7] as well as to acquisition of HIV [8]. Methamphetamine use has distinct, long lasting cognitive effects that can lead to sexual disinhibition and impaired judgment, and is often associated with poor adherence to medication regimens [9-11]. Methamphetamine-using MSM are up to 4 times more likely to engage in unprotected anal sex, compared to substance-using MSM who do not use methamphetamine [10]. In a longitudinal study of more than 4000 HIV-negative MSM, Koblin and her colleagues found that prospectively, methamphetamine was an independent risk factor for HIV seroconversion [8]. HIV-positive MSM who use methamphetamine (compared to MSM who do not) are also more susceptible to acquiring other STDs and possibly infecting their sexual partners because methamphetamine also functions as an immunosuppressive drug that decreases CD4 levels while increasing viral load [12]. Although several reviews and summaries have highlighted the efficacy of HIV behavioral interventions for MSM [13-15], CDC has only identified a small number of evidence-based interventions for MSM that reduce sexual risk behavior and none target substance-using men [16]. Behavioral HIV prevention may be particularly challenging for substance-using MSM due to competing physical and emotional needs [17], as well as direct and indirect effects of methamphetamine use. Prior studies have reported on a successful intensive drug treatment model for methamphetamine users to reduce drug use and related harms [18]. In addition, a study of methamphetamine-using MSM found four different treatment-based approaches that successfully reduced sexual risk behavior and methamphetamine use from baseline, but there were no difference between groups in sexual risk reduction [19]. Thus, there remains a need for researchers to develop, implement, and evaluate the efficacy of behavioral HIV prevention interventions for substance-using MSM. In 2006, the CDC Division of HIV/AIDS Prevention announced a scientific initiative to fund formative research and pilot testing of four interventions for methamphetamine-using MSM not currently in drug treatment (CDC PS06-007). This was partly in response to research recommendations from a CDC national consultation on methamphetamine use and risk for HIV and STD transmission [7]. The goal was to demonstrate, through pilot testing, promising interventions for reducing risk for HIV acquisition and transmission. This approach would allow for relatively rapid development, design, and preliminary testing of multiple approaches simultaneously. It was intended that the research program would identify the most promising approaches. Then, these interventions may be further tested with more costly randomized-control trials that would be separately funded by federal or non-federal funders. Four of the following five papers presented here represent interventions that were funded through this funding announcement; the fifth paper represents a seed grant partially funded by CDC. This special issue is devoted specifically to the development and design of interventions for methamphetamine-using MSM who were not currently in drug treatment. As such, the papers focus on innovative formative research, intervention design, and preliminary testing intended to evaluate the feasibility and acceptability of the interventions for the target population, as well as pilot testing of interventions. The papers presented here are not intended to provide behavioral outcome assessments, but to focus on critical developmental work that is often not thoroughly described. We hope to underscore the importance of balancing theoretical and practical issues when designing and testing interventions for such high-risk populations.

Feasibility of a Population Based Survey on HIV Prevalence in Barbados, and Population Preference for Sample Identification Method

Abstract: OBJECTIVE To predict response rate and validity of a population-based HIV prevalence survey in Barbados using oral fluid, and the method of sample identification preferred by participants. METHODS Persons age 18 to 35 randomly selected from the voters' register to participate in a study of the prevalence of chlamydia and gonorrhoea (STI) were invited to answer a questionnaire. RESULTS Of 496 persons selected for the STI study, 88 did not participate, and a further 10 did not answer the questionnaire, leaving 398 respondents. 329 persons or 66% (60% men, 73% women, p = 0.003) of the original 496 persons said that they would be willing to take part in an HIV survey using oral fluid. People indicating willingness to take part in an HIV survey did not differ significantly from non-respondents and those indicating unwillingness to participate by a number of demographic and STI risk factors including age, education level, partnership status, number of partners, condom use, drug use, and STI infection status. For persons willing to participate in a HIV survey, confidential linked sample identification was acceptable to 99.0% (95% CI +/- 1.0), and unlinked identification to 1.6% (95% CI +/- 1.3). CONCLUSION The HIV prevalence estimated by a linked survey would have a reasonable response rate and be valid, as likelihood of participation is not related to infection risk.

Achieving a dream: meeting policy goals related to improving drug access.

Abstract: International experts recognize that significant inequities exist in the accessibility of life-saving medicines among poor and vulnerable populations, especially in developing countries. This article highlights that drug access even for relatively cheap medicines is out of reach for the vast numbers of global poor. This badly affects people living with HIV/AIDS who face serious obstacles in accessing ARVs. The same concerns are attributed to neglected diseases. Despite international meetings, promises from the pharmaceutical industry and a lot of media attention little has changed in the past 20 years. The accessibility gap to life-saving drugs could be reduced by the UNITAID initiative to pool patents for the many different ARVs, but the reality is that UNITAID is still a promise. To surmount this global problem of inequity requires a rethinking of traditional models of drug access and health objectives that should not be compromised by commercial interests.

Measuring the Quality of Data Collection in a Large Observational Cohort of HIV and AIDS

Abstract: The aim of this study was to examine the quality of data collection by studying the validity of collected data. Data were extracted from the clinic charts of two anonymous outpatients by 38 data collectors. A standard for the data to be collected was determined (168 items). The validity was measured by comparing the collected items with the standard; in this way, the percentages of the collected items that were ‘correct’ could be calculated. The percentage ‘correct’ was higher for clinic chart 1 (mean: 83% correct, SD 7%) than for clinic chart 2 (mean: 78% correct, SD 8%). All categories contained incorrectly collected data. These data were divided into missing data, incorrect start-stop dates, and surplus collected data. Almost all start-stop dates would change into ‘correct’ if ‘monthyear’ was considered correct (instead of the standard ‘daymonthyear’). Not all data collectors used specific protocols, and sources other than the written comments were not always checked. This study shows that a high proportion of data was correctly collected. However, the collection of start-stop dates was not optimal, and the collected data included surplus and missing data. Data collectors should be more knowledgeable about HIV disease and trained in the use of difficult protocols, so that they can better recognize what data to collect and how it should be collected. Among physicians, there should be more agreement about what information to record in the charts, to facilitate data extraction for data collectors.

Patent Pools for ARVs: Industry Perspectives from ASPEN.

Abstract: Affordability through reduced pricing is only one part of enhancing access to treatment in Public Health emergencies: Supply Security and the guarantee of supply consistency is the other. To the extent that Patent Pooling is able to create Regional African Manufacturing capability, Africans will support the concept. However, to the extent that if further decentralises manufacture away from the continent and increases Africa’s dependence on imports, Patent Pooling can potentially weaken supply security and will continue to relegate Africa a Continent of dependency, rather than one that invests in its own capability. Patent Pooling, should be viewed guardedly on the African Continent and will only be embraced, provided it is consistent with the AU Heads of State call for an African Manufacturing Plan and Africa’s aspiration to more from “converting charity dollars into sustainable, long term investment dollars”.