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The Senegalese government's highly active antiretroviral therapy initiative: an 18-month follow-up study.

OBJECTIVE: To study the feasibility, effectiveness, adherence, toxicity and viral resistance in an African government HAART initiative. METHODS: A prospective observational cohort study started in Dakar in August 1998. Initial treatment consisted of two nucleoside reverse transcriptase inhibitors and one protease inhibitor. The patients attended monthly medical examinations. Plasma HIV-1 RNA and CD4 cell counts were determined at baseline and every 6 months. Intention-to-treat analyses were performed. RESULTS: Fifty-eight treatment-naive patients, mostly infected by HIV-1 strain CRF02-AG, were enrolled. Most were at an advanced stage of HIV disease (86.2% had AIDS). Adherence was good in 87.9% of patients and treatment was effective in most of them. Thus, HIV-1 RNA was undetectable in 79.6, 71.2, 51.4 and 59.3% of patients at months 1, 6, 12 and 18, respectively and the median viral load reduction was approximately 2.5 log10 copies/ml. The CD4 cell count rose by a median of 82, 147 and 180 x 106 cells/l at months 6, 12 and 18, respectively. At the same time points, the cumulative probability of remaining alive or free of new AIDS-defining events was 94.8, 85.0 and 82.3%. Most adverse effects (80.8%) were mild or moderate and only two cases of drug resistance occurred. CONCLUSION: This study shows that HAART is feasible and well tolerated in African patients. Clinical and biological results were comparable to those seen in western cohorts, despite differences in the HIV-1 subtype distribution and an advanced disease stage when the treatment was initiated. Contrary to other recent studies in Africa, viral resistance rarely emerged.

Acquired Immunodeficiency Syndrome↗

Virologic and immunologic outcomes and programmatic challenges of an antiretroviral treatment pilot project in Abidjan, Côte d'Ivoire.

BACKGROUND: In Côbte d'Ivoire, a pilot project was developed by UNAIDS and the Ministry of Health to improve access to AIDS care, including antiretroviral therapy, for adults and children infected with HIV. This evaluation of the project is the first to provide results of a large number of HIV-infected patients receiving antiretroviral therapy in West Africa. METHODS: We evaluated records of persons who presented for care from August 1998 to August 2000 at six accredited centers in Abidjan. Patients were treated with two nucleoside reverse transcriptase inhibitors (2NRTI) or highly active antiretroviral therapy (HAART). RESULTS: Of 2878 patients who were screened, 2351 (83%) were HIV-infected and eligible (CD4 T lymphocyte count < 500 x 10(6) cells/l or plasma HIV-RNA level > 10 000 copies/ml) for antiretroviral therapy. Of those who were eligible, 81% were symptomatic, 63% had a CD4 cell count < 200 x 10(6) cells/l, 12% had previously taken antiretroviral drugs, and 56% returned to the clinic for follow-up. Of the patients screened, 768 (27%) were started on antiretroviral therapy, including 450 on HAART, 296 on 2NRTI, and 22 on other regimens. We analyzed data from 480 HIV-1-infected adults, who were naive to therapy, were prescribed HAART or 2NRTI, and had at least one clinic visit after starting therapy. In an intent-to-treat analysis of patients who received HAART, the estimated plasma HIV-1 RNA level was approximately 1.9 log10 copies/ml (80-fold) lower, while estimated CD4 cell count was > 100 x 10(6) cells/l higher than baseline values, after 1 year of therapy. Approximately 25% of adults on 2NRTI and 50% of those on HAART had < 200 copies/ml, after 1 year of therapy. The probability of an adverse event occurring within 6 months after starting therapy was 0.20. The probability of survival for at least 1 year was 0.84 (95% confidence interval, 0.80-0.89). CONCLUSION: After starting antiretroviral therapy, these HIV-1-infected patients in West Africa had similar virologic and immunologic outcomes, probability of an adverse event, and estimated survival, as patients enrolled in clinical trials in the USA and Europe. However, only one-third of eligible patients received therapy, highlighting the importance of providing adequate education and support for initiating and adhering to therapy in this and similar programmes.

Adolescent↗

Access to antiretroviral drugs and AIDS management in Senegal.

OBJECTIVES: Description and analysis of the Senegalese Antiretroviral Drug Access Initiative (ISAARV), the first governmental highly active antiretroviral therapy (HAART) treatment programme in Africa, launched in 1998. METHODS AND RESULTS: ISAARV was initially an experimental project designed to evaluate the feasibility, efficacy and acceptability of HAART in an African context. It was based on four principles: collective definition of the strategy, with involvement of the health professionals who would be called on to execute the programme; matching the objectives to available means (gradual enrollment according to drug availability); monitoring by several research programmes; and ongoing adaptation of treatment and follow-up according to the latest international recommendations. Persons qualifying for antiretroviral (ARV) therapy are selected on the basis of immunological and clinical criteria, regardless of economic and social considerations. A system of subsidies was created to favor access to ARV. Following the ARV price reductions that occurred in November 2000, 100% subsidies were created for the poorest participants. Optimal adherence was ensured by monthly follow-up by pharmacists and support groups held by social workers and patient associations. The chosen supply and distribution system allowed drug dispensing to be strictly controlled. CONCLUSION: The ISAARV programme demonstrates that HAART can be successfully prescribed in Africa. This experience has served as the basis for the creation of a national treatment programme in Senegal planned to treat 7000 patients by 2006.

Acquired Immunodeficiency Syndrome↗

Adherence to HAART and its principal determinants in a cohort of Senegalese adults.

BACKGROUND: Access to programmes providing highly active antiretroviral therapy (HAART) is recent in Africa. In Senegal, a national initiative was launched in 1998. The capacity of African patients to adhere to complex antiretroviral treatments (ARV) is largely unknown. METHODS: We assessed adherence and identified the main reasons for treatment interruption in a prospective observational cohort of patients participating in an ARV access programme in Dakar, Senegal. Adherence was estimated each month on the basis of the patients' stated consumption and on the proportion of the prescribed dose returned unused to the dispensing pharmacy. A total of 158 patients were studied between November 1999 and October 2001. RESULTS: A cross-section analysis showed that the stated level of adherence was high: on average, over the study period, the patients said they had taken 91% of each monthly dose and that they had taken the full monthly dose during two-thirds of the months studied. Adherence tended to be better among patients who were required to make little or no contribution to the cost of their treatment, through an appropriate pricing structure. Adherence was also better with efavirenz-containing regimens than with indinavir-containing regimens. CONCLUSION: These results show that adherence to HAART can be as high in Africa as that generally observed in industrialized countries, and that the cost and type of drug regimen must be taken into account when designing ARV access programmes for poor communities.

Adult↗

Research methodology: implications for CAM pain research.

The National Cancer Institute's Office of Cancer Complementary and Alternative Medicine established a series of expert panels to develop the state of the science in research methodologies in CAM cancer research. Panelists from both conventional and CAM research draw on their expertise in their relative fields to apply their knowledge and expertise to specific topic areas within cancer CAM. The first panel is focused on cancer symptom research. The discussion and conclusions raised by this panel primarily address pain research but are applicable to other symptoms as well. This article will focus on the panel presentations that are most applicable to CAM pain research in both cancer and noncareer pain populations, identifying the major challenges and conclusions offered by the panelists.

Clinical Trials as Topic↗

The evolution of government independent living policies and programmes for Canadians with disabilities.

Government policies and programmes in Canada have been slowly evolving from a focus on institutional care to traditional programmes in the community. Now, a new paradigm of services is emerging which emphasizes the concepts of independent living. This study collected extensive information from government officials and consumer groups across Canada regarding the trends in barrier-free housing, accessible transportation and personal supports from 1980 to the present time. The research documents some of the major issues with government initiatives as well as promising innovations. Although many positive changes were made during the Decade of Disabled Persons (1983-1992), many of these initiatives were eroded with major funding cutbacks in the mid- to late 1990s. This paper concludes with ways to change the present service delivery system to ensure that everyone can live independently in the community.

Activities of Daily Living↗

An evaluation of the Nashville REACH 2010 community health screening strategy.

Community-based screening is 1 of 4 strategies selected by the Nashville REACH 2010 project for reducing disparities in heart disease and diabetes among African Americans in North Nashville, Tenn. We evaluated our screening efforts by asking 4 questions: (1) Are the screening participants representative of the target population? (2) How often were screening participants with possible undiagnosed hypertension, high cholesterol, and diabetes identified? (3) How often were screening participants with an elevated risk for developing hypertension, high cholesterol, and diabetes identified? and (4) How often did we identify screening participants with known hypertension, high cholesterol, and diabetes whose disease management was suboptimal? Results from 1757 persons screened were compared to telephone surveys from 16,199 Nashville residents. Those screened were younger and healthier than the target population. Rates of potentially undiagnosed cases among African Americans were 0.8% for diabetes, 17.4% for hypertension, and 32.7% for high cholesterol. High-risk individuals were identified 13.1% of the time for diabetes, 45.3% of the time for hypertension, and 21.3% of the time for total cholesterol. Rates of poorly controlled known disease were 23.5% for diabetes, 39.0% for hypertension, and 58.2% for total cholesterol. Although we reached a younger and healthier group than the community population, community-based screenings identified many people with potential health risks. We present a model of how to organize and implement successful community-based screening.

Adult↗

Multicenter initiative seeking critical genes in respiratory papillomatosis.

OBJECTIVES: To determine the host genes that govern susceptibility to recurrent respiratory papillomatosis (RRP). RRP is caused by human papillomavirus (HPV) 6 and 11. Millions of babies are exposed during the birthing process, but relatively few develop the disease and the aggressiveness of the course is highly variable. Genetically encoded host susceptibility is postulated. Determining the host genes that govern susceptibility will enhance our understanding not only of RRP but also of host-viral interaction in general. STUDY DESIGN: A genome-wide association study on familial triads consisting of an RRP-affected child and his or her parents. Using the HapMap data from the human genome project, we will identify those alleles that are over-transmitted by the parents to their affected offspring as compared to those alleles that are under-transmitted. METHODS: Approximately 400 patients and their parents will be recruited through a collaboration between the Center for Genomic Sciences and the RRP Task Force. DNA will be extracted from blood specimens and viral typing will be performed on biopsy specimens. Patients will be genotyped using single nucleotide polymorphism (SNP) markers and compared to their respective parents' genotype using the transmission disequilibrium test. Both a genome scan and a candidate gene approach will be utilized. RESULTS Institutional Review Board authorization has been obtained at three hospitals and the process is underway at 18 more. Patient and parent recruitment has begun. Specimens have been forwarded to Pittsburgh, Pennsylvania, where the DNA has been extracted and is being stored. CONCLUSIONS: A novel approach combining a nationwide patient resource and the mapping power of the sub-centimorgan human haplotype map has been developed to elucidate the biological mechanisms of RRP by determining the genetically encoded susceptibilities of host-virus interaction.

Child↗

Characteristics of persons with syphilis in areas of persisting syphilis in the United States: sustained transmission associated with concurrent partnerships.

BACKGROUND AND GOAL: In areas with persistent syphilis, to characterize persons at higher risk for transmitting syphilis. STUDY DESIGN: Cohort study. Structured interviews of persons with early syphilis from four research centers were linked to outcomes of partner tracing. RESULTS: Of 743 persons with syphilis, 229 (31%) reported two or more partners in the previous month, and 57 (8%) received money or drugs for sex in the previous three months. Persons with at least one partner at an earlier stage of syphilis than themselves were defined as transmitters; 63 (8.5%) of persons with early syphilis met this definition. Having concurrent partners (two or more in one week in the last month) was independently associated with being a transmitter. CONCLUSION: Sexual network/behavioral characteristics of syphilis patients and their partners, such as concurrency, can help identify persons at higher risk for transmitting syphilis who should receive emphasis in disease prevention activities.

Adult↗

Information and surveillance systems and community health: building the public health information infrastructure.

The scope and purpose of public health injury and disease surveillance systems will expand in response to the increasing information needs of communities and health organizations. Public health leaders must focus on the entire information infrastructure. Surveillance and information systems need to evolve to include targeting and evaluating community-wide prevention programs. Standards governing exchange as well as data content will become central to these new systems and the emerging health information infrastructure. Future surveillance systems will face challenges in forming partnerships with managed care organizations, in developing new information tools, and in training the public health workforce.

Humans↗

Four years of lessons learned: The 2001-2004 Maryland influenza prevention seasons.

More than 36,000 Americans die and 200,000 more are hospitalized because of influenza every\year. Despite the wide availability of a vaccine to prevent influenza, the vast majority of Americans go unimmunized. The Maryland Department of Health and Mental Hygiene (DHMH) and the Maryland Partnership for Prevention (MPP) collect data about the state's local health departments' influenza season practices and experiences and compile them into the annual Maryland Influenza Season Final Report. The report becomes a tool for DHMH, MPP, and the state's 24 local health departments to plan improvements in influenza vaccination services. This article chronicles four influenza seasons. Influenza season challenges experienced in three of the last four influenza seasons underscore the importance of coordination and communication efforts to ensure that vaccine is efficiently delivered to the most vulnerable populations. The partnership between DHMH and MPP has facilitated access to information on ordering and administration practices, communication systems, community partnerships, and lessons learned, thus enabling the state of Maryland to continually optimize its influenza vaccination promotion efforts.

Communication↗

Key roles of government in genomics and proteomics: a public health perspective.

This paper is based on the presentation of Dr. Allan Noonan at the third biennial Asan-Harvard Medical International Symposium on "Genomics and Proteomics: Impact on Medicine and Health" that took place in Seoul, Korea, July 3-4, 2001. Dr. Noonan is a senior advisor to the Surgeon General of the United States and was representing the then Surgeon General, Dr. David Satcher. In this final presentation of the symposium, Dr. Noonan reviews the key roles of government in US health care and discusses several areas where genomic- and proteomic-based information will necessitate changes in the functions of public health. In particular, Dr. Noonan discusses the need for appropriate training to meet the challenges of the genomic future; for sensitivity in the development of policies to address the ethical, legal, and social implications of genomic information; and for dissemination of genomic information to both the professionals and the public. Dr. Noonan concludes with a vision of the genomic future of the next 30 years and a reiteration of the need for partnership among health professionals, educators, and social services professionals.

Forecasting↗

Health care reform and the pharmaceutical industry: crucial decisions are expected.

For the past 30 years, the largest growing segment of the United States economy is the health care industry. The United States is in a transitional period as American citizens born between 1946 and 1964, the Baby Boomer generation, reach retirement age. In recent years, pharmaceutical costs have been rising faster than the inflation rate, leaving the American public to ask many questions. A major area of interest to policymakers regarding the health care reform agenda is patient spending on pharmaceutical items. Government-funded programs such as Medicare and Medicaid are facing the possibility of running out of funds and require substantive reform. Pharmaceuticals are not covered under the basic Medicare programs. As a result, senior citizens are forced to cover their prescription expenses out of pocket or purchase supplemental insurance plans. This extra expense is leaving many senior citizens across the country struggling to support their ongoing medical needs.

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