Feasibility and quality of cardiovascular disease prevention within a community-based health insurance program in rural Nigeria: an operational cohort study.

OBJECTIVE: To assess the feasibility of providing guideline-based cardiovascular disease (CVD) prevention care within the context of a community-based health insurance program (CBHI) in rural Nigeria. METHODS: A prospective operational cohort study was conducted in a primary healthcare clinic in rural Nigeria, participating in a CBHI program. The insurance program provided access to care and improved the quality of the clinics participating in the program, including CVD prevention guideline implementation. Insured adults at risk of CVD were consecutively included upon clinic attendance. The primary outcome was quality of care determined by scoring of quality indicators on patient files of the cohort, 1.5 year after guideline implementation. RESULTS: Of the 368 screened patients, 349 were included and 323 (93%) completed 1 year of follow-up. The majority of patients (331, 95%) had hypertension. Process indicators showed that 114/115 (99%) new hypertension cases had a record of CVD risk assessment and 249/333 (75%) eligible cases a record of lifestyle advice. Outcome indicators showed that in 292/328 (64%) hypertension cases, blood pressure was on target. Barriers to care included limited human resources, limited affordability of diagnostic tests and multidrug regimes for the healthcare provider, frequent doctor's appointments, and inefficient drug supplies. CONCLUSION: Implementation of CVD prevention care within the context of a CBHI program resulted in high-quality care in rural sub-Saharan Africa, comparable to high-income countries. However, guideline implementation was resource-intense and specific recommendations were not feasible. Simple models of care delivery are needed for rapid scale-up of CVD prevention services in sub-Saharan Africa.

Costs of cardiovascular disease prevention care and scenarios for cost saving: a micro-costing study from rural Nigeria.

OBJECTIVE: To assess the costs of cardiovascular disease (CVD) prevention care according to international guidelines, in a primary healthcare clinic in rural Nigeria, participating in a health insurance programme. METHODS: A micro-costing study was conducted from a healthcare provider perspective. Activities per patient per year (e.g., consultations, diagnostic tests) were based on clinical practice in the study clinic. Direct (e.g., staff, drugs) and indirect cost items (overheads) for each activity were measured. A cohort study, patient and staff observations, and interviews in the study clinic provided patient resource utilization data. Univariate sensitivity analyses were performed. Scenario analyses evaluated cost-saving options. The main outcome was the costs of CVD prevention care per patient per year. RESULTS: The costs of CVD prevention care were United States dollars (USD) 144 (range 130-158) per patient per year. Direct costs were USD 82 and indirect costs were USD 62. The main cost drivers were drugs (USD 39) and diagnostic tests (USD 36). The costs of hypertension care were USD 118 (107-132) and that of diabetes care USD 263 (236-289) per patient per year. A combination of task-shifting from doctors to nurses, reduction of appointment frequencies, and minimal organ damage screening would result in a direct cost reduction of 42%. CONCLUSION: This is the first study to report the costs of CVD prevention care in sub-Saharan Africa, based on prospectively collected operational data. The costs observed in our study are unaffordable in many countries in sub-Saharan Africa, highlighting the need for innovative financing mechanisms to fund CVD prevention care.

Perceptions of inhibitors and facilitators for adhering to hypertension treatment among insured patients in rural Nigeria: a qualitative study.

BACKGROUND: Universal health care coverage has been identified as a promising strategy for improving hypertension treatment and control rates in sub Saharan Africa (SSA). Yet, even when quality care is accessible, poor adherence can compromise treatment outcomes. To provide information for adherence support interventions, this study explored what low income patients who received hypertension care in the context of a community based health insurance program in Nigeria perceive as inhibitors and facilitators for adhering to pharmacotherapy and healthy behaviors. METHODS: We conducted a qualitative interview study with 40 insured hypertensive patients who had received hypertension care for > 1 year in a rural primary care hospital in Kwara state, Nigeria. Supported by MAXQDA software, interview transcripts were inductively coded. Codes were then grouped into concepts and thematic categories, leading to matrices for inhibitors and facilitators of treatment adherence. RESULTS: Important patient-identified facilitators of medication adherence included: affordability of care (through health insurance); trust in orthodox "western" medicines; trust in Doctor; dreaded dangers of hypertension; and use of prayer to support efficacy of pills. Inhibitors of medication adherence included: inconvenient clinic operating hours; long waiting times; under-dispensing of prescriptions; side-effects of pills; faith motivated changes of medication regimen; herbal supplementation/substitution of pills; and ignorance that regular use is needed. Local practices and norms were identified as important inhibitors to the uptake of healthier behaviors (e.g. use of salt for food preservation; negative cultural images associated with decreased body size and physical activity). Important factors facilitating such behaviors were the awareness that salt substitutes and products for composing healthier meals were cheaply available at local markets and that exercise could be integrated in people's daily activities (e.g. farming, yam pounding, and household chores). CONCLUSIONS: With a better understanding of patient perceived inhibitors and facilitators of adherence to hypertension treatment, this study provides information for patient education and health system level interventions that can be designed to improve compliance. TRIAL REGISTRATION: ISRCTN47894401 .

The discovery and development of antiretroviral agents.

Since the discovery of HIV as the causative agent of AIDS in 1983/1984, remarkable progress has been made in finding antiretroviral drugs (ARVs) that are effective against it. A major breakthrough occurred in 1996 when it was found that triple drug therapy (HAART) could durably suppress viral replication to minimal levels. It was then widely felt, however, that HAART was too expensive and complex for low- and middle-income countries, and so, with the exception of a few of these countries, such as Brazil, a massive scale-up did not begin until the WHO launched its '3 by 5' initiative and sizeable funding mechanisms, such as the Global Fund to Fight AIDS, TB and Malaria and the US President's Emergency Plan for AIDS Relief (PEPFAR), came into existence. A pivotal enabler of the scale-up was a steady lowering of drug prices through entry of generic antiretrovirals, competition between generic manufacturers and the making of volume commitments. The WHO Prequalification of Medicines Programme and the Expedited Review Provision of the US Food and Drug Administration have been important for the assurance of quality standards. Antiretroviral drug development by research-based pharmaceutical companies continues, with several important innovative products, such as long-acting agents, in the pipeline.

Effect of health insurance and facility quality improvement on blood pressure in adults with hypertension in Nigeria: a population-based study.

IMPORTANCE Hypertension is a major public health problem in sub-Saharan Africa, but the lack of affordable treatment and the poor quality of health care compromise antihypertensive treatment coverage and outcomes. OBJECTIVE To report the effect of a community-based health insurance (CBHI) program on blood pressure in adults with hypertension in rural Nigeria. DESIGN, SETTING, AND PARTICIPANTS We compared changes in outcomes from baseline (2009) between the CBHI program area and a control area in 2011 through consecutive household surveys. Households were selected from a stratified random sample of geographic areas. Among 3023 community-dwelling adults, all nonpregnant adults (aged ≥18 years) with hypertension at baseline were eligible for this study. INTERVENTION Voluntary CBHI covering primary and secondary health care and quality improvement of health care facilities. MAIN OUTCOMES AND MEASURES The difference in change in blood pressure from baseline between the program and the control areas in 2011, which was estimated using difference-in-differences regression analysis. RESULTS Of 1500 eligible households, 1450 (96.7%) participated, including 564 adults with hypertension at baseline (313 in the program area and 251 in the control area). Longitudinal data were available for 413 adults (73.2%) (237 in the program area and 176 in the control area). Baseline blood pressure in respondents with hypertension who had incomplete data did not differ between areas. Insurance coverage in the hypertensive population increased from 0% to 40.1% in the program area (n = 237) and remained less than 1% in the control area (n = 176) from 2009 to 2011. Systolic blood pressure decreased by 10.41 (95% CI, -13.28 to -7.54) mm Hg in the program area, constituting a 5.24 (-9.46 to -1.02)-mm Hg greater reduction compared with the control area (P = .02), where systolic blood pressure decreased by 5.17 (-8.29 to -2.05) mm Hg. Diastolic blood pressure decreased by 4.27 (95% CI, -5.74 to -2.80) mm Hg in the program area, a 2.16 (-4.27 to -0.05)-mm Hg greater reduction compared with the control area, where diastolic blood pressure decreased by 2.11 (-3.80 to -0.42) mm Hg (P = .04). CONCLUSIONS AND RELEVANCE Increased access to and improved quality of health care through a CBHI program was associated with a significant decrease in blood pressure in a hypertensive population in rural Nigeria. Community-based health insurance programs should be included in strategies to combat cardiovascular disease in sub-Saharan Africa.

A community-based intervention for primary prevention of cardiovascular diseases in the slums of Nairobi: the SCALE UP study protocol for a prospective quasi-experimental community-based trial.

BACKGROUND: The burden of cardiovascular disease is rising in sub-Saharan Africa with hypertension being the main risk factor. However, context-specific evidence on effective interventions for primary prevention of cardiovascular diseases in resource-poor settings is limited. This study aims to evaluate the feasibility and cost-effectiveness of one such intervention--the "Sustainable model for cardiovascular health by adjusting lifestyle and treatment with economic perspective in settings of urban poverty". DESIGN: A prospective quasi-experimental community-based intervention study. SETTING: Two slum settlements (Korogocho and Viwandani) in Nairobi, Kenya. STUDY POPULATION: Adults aged 35 years and above in the two communities. INTERVENTION: The intervention community (Korogocho) will be exposed to an intervention package for primary prevention of cardiovascular disease that comprises awareness campaigns, household screening for cardiovascular diseases risk factors, and referral and treatment of people with high cardiovascular diseases risk at a primary health clinic. The control community (Viwandani) will continue accessing the usual standard of care for primary prevention of cardiovascular diseases in Kenya. DATA: Demographic and socioeconomic data; anthropometric and clinical measurements including blood pressure. Population-based data will be collected at the baseline and endline--12 months after implementing the intervention. These data will be collected from a random sample of 1,610 adults aged 35 years and above in the intervention and control sites at both baseline and endline. Additionally, operational (including cost) and clinic-based data will be collected on an ongoing basis. MAIN OUTCOMES: (1) A positive difference in the change in the proportion of the intervention versus control study populations that are at moderate or high risk of cardiovascular disease; (2) a difference in the change in mean systolic blood pressure in the intervention versus control study populations; (3) the net cost of the complete intervention package per disability-adjusted life year gained. ANALYSIS: Primary outcomes comparing pre- and post-, and operational data will be analyzed descriptively and "impact" of the intervention will be calculated using double-difference methods. We will also conduct a cost-effectiveness analysis of the intervention using World Health Organization guidelines. DISCUSSION: The outcomes of the study will be disseminated to local policy makers and health planners. TRIAL REGISTRATION: Current controlled trials ISRCTN84424579.

Introducing a model of cardiovascular prevention in Nairobi's slums by integrating a public health and private-sector approach: the SCALE-UP study.

INTRODUCTION: Cardiovascular disease (CVD) is a leading cause of death in sub-Saharan Africa (SSA), with annual deaths expected to increase to 2 million by 2030. Currently, most national health systems in SSA are not adequately prepared for this epidemic. This is especially so in slum settlements where access to formal healthcare and resources is limited. OBJECTIVE: To develop and introduce a model of cardiovascular prevention in the slums of Nairobi by integrating public health and private sector approaches. STUDY DESIGN: Two non-profit organizations that conduct public health research, Amsterdam Institute for Global Health and Development (AIGHD) and African Population and Health Research Center (APHRC), collaborated with private-sector Boston Consulting Group (BCG) to develop a service delivery package for CVD prevention in slum settings. A theoretic model was designed based on the integration of public and private sector approaches with the focus on costs and feasibility. RESULTS: The final model includes components that aim to improve community awareness, a home-based screening service, patient and provider incentives to seek and deliver treatment specifically for hypertension, and adherence support. The expected outcomes projected by this model could prove potentially cost effective and affordable (1 USD/person/year). The model is currently being implemented in a Nairobi slum and is closely followed by key stakeholders in Kenya including the Ministry of Health, the World Health Organization (WHO), and leading non-governmental organizations (NGOs). CONCLUSION: Through the collaboration of public health and private sectors, a theoretically cost-effective model was developed for the prevention of CVD and is currently being implemented in the slums of Nairobi. If results are in line with the theoretical projections and first impressions on the ground, scale-up of the service delivery package could be planned in other poor urban areas in Kenya by relevant policymakers and NGOs.

Examining the evidence on the causal effect of HAART on transmission of HIV using the Bradford Hill criteria.

In recent years, evidence has accumulated regarding the ability of HAART to prevent HIV transmission. Early supportive evidence was derived from observational, ecological and population-based studies. More recently, a randomized clinical trial showed that immediate use of HAART led to a 96% decrease in HIV transmission events within HIV serodiscordant heterosexual couples. However, the generalizability of the effect of HAART, and the population-level impact on HIV transmission continues to generate substantial debate. We, therefore, conducted a review of the evidence regarding the preventive effect of HAART on HIV transmission within the context of the Bradford Hill criteria for causality. Taken together, we find the accumulated evidence supporting HIV treatment as prevention meets each of the Bradford Hill criteria for causality. We conclude that the opportunity cost of inaction while waiting for additional evidence on the generalizability of effect in other risk groups is too high. Efforts should be redoubled to mobilize the financial capital and political will to optimize implementation of HIV Treatment as Prevention strategies on a wide scale.

State of affairs of tuberculosis in prison facilities: a systematic review of screening practices and recommendations for best TB control.

BACKGROUND: Prisoners are at high risk of developing tuberculosis (TB), causing morbidity and mortality. Prison facilities encounter many challenges in TB screening procedures and TB control. This review explores screening practices for detection of TB and describes limitations of TB control in prison facilities worldwide. METHODS: A systematic search of online databases (e.g., PubMed and Embase) and conference abstracts was carried out. Research papers describing screening and diagnostic practices among prisoners were included. A total of 52 articles met the inclusion criteria. A meta-analysis of TB prevalence in prison facilities by screening and diagnostic tools was performed. RESULTS: The most common screening tool was symptom questionnaires (63·5%), mostly reporting presence of cough. Microscopy of sputum with Ziehl-Neelsen staining and solid culture were the most frequently combined diagnostic methods (21·2%). Chest X-ray and tuberculin skin tests were used by 73·1% and 50%, respectively, as either a screening and/or diagnostic tool. Median TB prevalence among prisoners of all included studies was 1,913 cases of TB per 100,000 prisoners (interquartile range [IQR]: 332-3,517). The overall annual median TB incidence was 7·0 cases per 1000 person-years (IQR: 2·7-30·0). Major limitations for successful TB control were inaccuracy of diagnostic algorithms and the lack of adequate laboratory facilities reported by 61·5% of studies. The most frequent recommendation for improving TB control and case detection was to increase screening frequency (73·1%). DISCUSSION: TB screening algorithms differ by income area and should be adapted to local contexts. In order to control TB, prison facilities must improve laboratory capacity and frequent use of effective screening and diagnostic tools. Sustainable political will and funding are critical to achieve this.

Implementation and effect of intensified case finding on diagnosis of tuberculosis in a large urban HIV clinic in Uganda: a retrospective cohort study.

BACKGROUND: Increased detection of tuberculosis (TB) using intensified or active case finding (ICF) is one of the cornerstones of the Stop TB Strategy, and contrasts with passive case finding (PCF) which relies on self-reported symptoms. There is no clear guidance on implementation strategies. We implemented ICF in addition to ongoing PCF in our large urban HIV clinic in July 2010 using a twice-daily announcement screen method by a trained peer educator, asking waiting patients to self-refer to a trained peer supporter for screening of TB symptoms. We sought to determine the associated effect on TB case detection. METHODS: Suspects were investigated by sputum smear, chest X-ray and ultrasound, if indicated. Routinely collected clinical and laboratory data were merged with the ICF register and TB clinic data for patients attending the clinic in 2010. We compared the yield of TB cases (defined as the prevalence of newly diagnosed TB cases in the screened population), the type of TB diagnosed and the total cost per TB case identified (in United States Dollars [USD]) for the period before and after ICF implementation. RESULTS: Of the 20,456 patients who visited the clinic in 2010, 614 were identified as TB suspects, 220 pre-ICF and 394 post-ICF (229 via PCF and 165 via ICF). The proportion diagnosed with TB dropped from 66% to 48% (60% in suspects identified through PCF and 31% through ICF). During the post-ICF period, TB suspects identified through ICF compared to PCF identification were more likely to be female, older, on ART and to have been enrolled in HIV care for a longer duration. The yield of combined PCF and ICF screening was 1.4% pre-ICF and 1.7% post-ICF with a cost per TB case identified of 12.29 USD and 21.80 USD, respectively. CONCLUSIONS: Implementation of ICF in a large HIV clinic yielded more TB suspects and cases, but substantially increased costs and was unable to capture the majority of TB suspects who were referred for diagnosis by clinicians through PCF. The overall yield of TB cases in a mature HIV clinic was low, although targeted screening of those recently enrolled in care may increase the yield.

Development and evaluation of a patient centered cardiovascular health education program for insured patients in rural Nigeria (QUICK - II).

BACKGROUND: In Sub Saharan Africa, the incidence of hypertension and other modifiable cardiovascular risk factors is growing rapidly. Poor adherence to prescribed prevention and treatment regimens by patients can compromise treatment outcomes. Patient-centered cardiovascular health education is likely to improve shortcomings in adherence. This paper describes a study that aims to develop a cardiovascular health education program for patients participating in a subsidized insurance plan in Nigeria and to evaluate the applicability and effectiveness in patients at increased risk for cardiovascular disease. DESIGN: The study has two parts. Part 1 will develop a cardiovascular health education program, using qualitative interviews with stakeholders. Part 2 will evaluate the effectiveness of the program in patients, using a prospective (pre-post) observational design. SETTING: A rural primary health center in Kwara State, Nigeria. POPULATION: For part 1: 40 patients, 10 healthcare professionals, and 5 insurance managers. For part 2: 150 patients with uncontrolled hypertension or other cardiovascular risk factors after one year of treatment. INTERVENTION: Part 2: patient-centered cardiovascular health education program. MEASUREMENTS: Part 1: Semi-structured interviews to identify stakeholder perspectives. Part 2: Pre- and post-intervention assessments including patients' demographic and socioeconomic data, blood pressure, body mass index and self-reporting measures on medication adherence and perception of care. Feasibility of the intervention will be measured using process data. OUTCOMES: For program development (part 1): overview of healthcare professionals' perceptions on barriers and facilitators to care, protocol for patient education, and protocol implementation plan.For program evaluation (part 2): changes in patients' scores on adherence to medication and life style changes, blood pressure, and other physiological and self-reporting measures at six months past baseline. ANALYSIS: Part 1: content analytic technique utilizing MAXQDA software. Part 2: univariate and multilevel analysis to assess outcomes of intervention. DISCUSSION: Diligent implementation of patient-centered education should enhance adherence to cardiovascular disease prevention and management programs in low income countries. TRIAL REGISTRATION: ISRCTN47894401.

Cardiovascular disease prevention in rural Nigeria in the context of a community based health insurance scheme: QUality Improvement Cardiovascular care Kwara-I (QUICK-I).

BACKGROUND: Cardiovascular diseases (CVD) are a leading contributor to the burden of disease in low- and middle-income countries. Guidelines for CVD prevention care in low resource settings have been developed but little information is available on strategies to implement this care. A community health insurance program might be used to improve patients' access to care. The operational research project "QUality Improvement Cardiovascular care Kwara - I (QUICK-I)" aims to assess the feasibility of CVD prevention care in rural Nigeria, according to international guidelines, in the context of a community based health insurance scheme. DESIGN: prospective observational hospital based cohort study. SETTING: a primary health care centre in rural Nigeria. STUDY POPULATION: 300 patients at risk for development of CVD (patients with hypertension, diabetes, renal disease or established CVD) who are enrolled in the Hygeia Community Health Plan. MEASUREMENTS: demographic and socio- economic data, physical and laboratory examination, CVD risk profile including screening for target organ damage. MEASUREMENTS will be done at 3 month intervals during 1 year. Direct and indirect costs of CVD prevention care will be estimated. OUTCOMES: 1) The adjusted cardiovascular quality of care indicator scores based on the "United Kingdom National Health Services Quality and Outcome Framework". 2) The average costs of CVD prevention and treatment per patient per year for patients, the clinic and the insurance company. 3) The estimated net health care costs of standard CVD prevention care per quality-adjusted life year gained. ANALYSIS: The primary outcomes, the score on CVD quality indicators and cost data will be descriptive. The quality scores and cost data will be used to describe the feasibility of CVD prevention care according to international guidelines. A cost-effectiveness analysis will be done using a Markov model. DISCUSSION: Results of QUICK-I can be used by policy makers and professionals who aim to implement CVD prevention programs in settings with limited resources. The context of the insurance program will provide insight in the opportunities community health insurance may offer to attain sustainable chronic disease management programs in low resource settings. TRIAL REGISTRATION: This protocol has been registered at ISRCTN, ID number: ISRCTN47894401.

Mortality and morbidity among HIV type-1-infected patients during the first 5 years of a multicountry HIV workplace programme in Africa.

BACKGROUND: This study aimed to evaluate the effectiveness of an HIV workplace programme in sub-Saharan Africa. METHODS: The international brewing company, Heineken, introduced an HIV workplace programme in its African subsidiaries in 2001. Beneficiaries from 16 sites in 5 countries were eligible. HIV type-1 (HIV-1)-infected individuals were assessed clinically and immunologically, and started highly active antiretroviral therapy (HAART) if they had AIDS or had a CD4+ T-cell count <300 cells/microl. In this cohort, study patients were followed-up for vital status, new AIDS events, CD4+ T-cell count and haemoglobin. RESULTS: Over the first 5 years of the programme, 431 adults were found to be HIV-1-infected. The mortality rate among those not yet taking HAART was 2.6 per 100 person-years of observation (pyo). By October 2006, 249 patients had started HAART at a median CD4+ T-cell count of 170 cells/microl; 59 (23.7%) patients were in CDC stage C. Among patients on HAART, 25 died and 7 were lost to follow-up. The mortality rate was 3.7 per 100 pyo overall, 14 per 100 pyo in the first 16 weeks and 2.5 per 100 pyo thereafter (P < 0.0001). At 4 years after start of treatment, 89% of patients were known to be alive. The CD4+ T-cell count increased by a median of 153 and 238 cells/microl after 1 and 4 years of HAART, respectively. CONCLUSIONS: In this HIV workplace programme in sub-Saharan Africa, long-term high survival was achieved.

Late entry to HIV care limits the impact of anti-retroviral therapy in The Netherlands.

OBJECTIVE: To explain differences in survival in the first three years of combination anti-retroviral therapy (cART) between HIV treatment centres in The Netherlands. METHODOLOGY/PRINCIPAL FINDINGS: We developed a mathematical simulation model, parameterised using data from the ATHENA cohort that describes patients entering care, being monitored and starting cART. Three scenarios were used to represent three treatment centres with widely varying mortality rates on cART that were differentiated by: (i) the distribution of CD4 counts of patients entering care; (ii) the age distribution of patients entering care; (iii) the average rate of monitoring the patients not on cART. At the level of the treatment centre, the fraction of Dutch MSM dying in the first three years of treatment ranged from 0% to 8%. The mathematical model captured the large variation in observed mortality between the three treatment centres. Manipulating the age-distribution of patients or the frequency of monitoring did not affect the model predictions. In contrast, when the same national average distribution of CD4 count at entry was used in all the scenarios, the variation in predicted mortality between all centres was diminished. CONCLUSIONS/SIGNIFICANCE: Patients entering care with low CD4 counts appears to be the main source of variation in the mortality rates between Dutch treatment centres. Recruiting HIV-infected individuals to care earlier could lead to substantial improvements in cART outcomes. For example, if patients were to present with at least 400 CD4 cells/mm(3), as they do already in some centres, then our model predicts that the mortality in the first three years of cART could be reduced by approximately 20%.

Implementation of an antiretroviral access program for HIV-1-infected individuals in resource-limited settings: clinical results from 4 African countries.

BACKGROUND: We assessed the effectiveness and safety of highly active antiretroviral therapy (HAART) in HIV-1-infected patients in resource-limited African countries. HIV-1 screening, therapy, counseling, monitoring, training, and education were provided free of charge. METHODS: In an open-label cohort program, 206 antiretroviral-naive HIV-1-infected patients who could not afford HAART were recruited in 4 urban clinics in Senegal, Côte d'Ivoire, Uganda, and Kenya and were treated with saquinavir boosted with ritonavir (1600/100 mg once daily), lamivudine (150 mg twice daily), and zidovudine (300 mg twice daily). The primary outcome was a plasma viral load (pVL) of <400 copies/mL after 96 weeks of treatment. Secondary analyses included CD4 cell count changes and the occurrence of treatment-emergent adverse events. RESULTS: The median age of the patient group was 36 years, 38% were male, 35% of the patients had AIDS, the median CD4 count was 119 cells/microL, and the median pVL was 304,210 copies/mL. Overall, 65%/52% (on treatment [OT]/intent to treat [ITT]) of the patients had a pVL <400 copies/mL after 96 weeks of follow-up. This proportion varied significantly between sites, however; although in Nairobi and Dakar, 51%/40% and 56%/46% (OT/ITT) were found, respectively, Abidjan and Kampala showed proportions of 69%/54% and 83%/69% (OT/ITT), respectively. The median increase in the CD4 count was 198 cells/microL (interquartile range: 86-319 cells/microL), ranging from 191 to 292 cells/microL between the sites. Fourteen patients (6.8%) died between 8 and 96 weeks of follow-up, whereas 18 (9%) developed an AIDS-defining event between 8 and 96 weeks of follow-up. Non-HIV-related serious adverse events occurred in 55 patients (26.7%), of whom 13 were diagnosed with severe anemia. Thirty-five patients (17%) changed treatment for toxicity reasons. CONCLUSIONS: Although a statistically significant difference was observed between sites with respect to virologic success, overall virologic and immunologic responses to HAART in resource-limited African settings can be as good as in Western settings. There were some difficulties (eg, laboratory, logistics, proper training) during the early phase of the program. Therefore, provision of adequate medical care, counseling, proper instruction, and education of patients and medical staff during the entire study is warranted in such programs, with special care in the early phase.

What policymakers should know about drug resistance and adherence in the context of scaling-up treatment of HIV infection.

With the imminent massive scale up of antiretroviral therapy in developing countries concerns have been raised regarding the spectre of widespread viral drug resistance. These concerns should not lead to a slowing of the pace at which these life-preserving medications are made available to the millions in need in those countries. With proper HAART regimens and proper adherence, development of drug resistance is not a common event. Increasing simplicity of antiretroviral drug regimens, as well as supportive services, promote adherence and have been shown to lead to extremely high therapeutic success rates in both developed and developing countries. Moreover, the possibility of drug resistance has not discouraged industrialized countries from offering universal access to antiretrovirals. If anything, the situation in developing countries, where few patients have been previously exposed to suboptimal drug regimens and where a public health approach may be taken to the treatment of HIV infection, is in many respects more favourable to the prevention of widespread viral drug resistance than that in the developed world. This conclusion is underscored by available evidence presented in this supplement. Experience in developing countries also suggests that greater treatment access will help alleviate HIV-related stigma and provide major new incentives for individuals to learn their serostatus, thus strengthening prevention efforts.