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Dose-ranging phase 1 study of TMC120, a promising vaginal microbicide, in HIV-negative and HIV-positive female volunteers
No full textNot the final published versionOBJECTIVE: To evaluate the short-term safety, tolerability, and systemic exposure of a vaginal microbicide gel containing the nonnucleoside reverse transcriptase inhibitor TMC120. DESIGN: Randomized, controlled, double-blind, phase 1 trial of a gel containing 3 different concentrations of TMC120 versus placebo. METHODS: Of the 48 HIV-negative and 16 HIV-positive women enrolled, 52 women received active product. Participants applied the gel twice daily for 7 days and were assessed on 6 occasions. Colposcopic evaluation was performed before and after first gel application and on day 8. Laboratory safety assessments were carried out on all visits except day 7. Plasma levels of TMC120 were measured on days 1 and 7. RESULTS: All TMC120 concentrations were well tolerated, and there were no apparent differences in safety parameters. Four women (6%) had treatment-emergent mild cervical findings (petechiae in 3 women and erythema in 1 woman) of <5 mm. Plasma levels of TMC120 were quantifiable on day 1 in 7 (13%) participants and on day 7 in 39 (75%) participants using TMC120 gel. CONCLUSIONS: The TMC120 vaginal gel was well-tolerated in this short study by HIV-negative and HIV-positive women. The implications of the absorption of TMC120 should be studied further in expanded safety and effectiveness trials
Evaluation of the resazurin assay for the detection of multidrug-resistant Mycobacterium tuberculosis in Madagascar
No full textSETTING: Multidrug-resistant (MDR) tuberculosis (TB) can jeopardise the success of national TB control programmes. Rapid, simple drug susceptibility tests applicable in developing countries would allow earlier treatment of patients with MDR infections. OBJECTIVE: To test the feasibility and performance of the resazurin microtitre assay (REMA) as an indirect test for detecting isoniazid (INH) and rifampicin (RMP) resistance of Mycobacterium tuberculosis strains in Madagascar. DESIGN: Study comparing the sensitivity and specificity of the REMA plate test with the Löwenstein-Jensen proportion method for determining the resistance of M. tuberculosis strains to INH and RMP. RESULTS: The sensitivity and specificity of the resazurin test were studied in 77 strains and were respectively 95% and 97.3% for the detection of INH resistance, and 95% and 100% for the detection of RMP resistance. The sensitivity and specificity for the identification of MDR strains were respectively 89% and 100%. CONCLUSION: The resazurin test is sensitive and specific enough for the detection of INH- and RMP-resistant strains. It is also easy to use, rapid and inexpensive, making it suitable for developing countries. Its usefulness for national drug resistance surveys should be assessed
Résistance primaire et acquise aux antituberculeux des souches de Mycobacterium tuberculosis isolées au Rwanda
No full textThis study was undertaken within the framework of a surveillance project on the resistance of Mycobacterium tuberculosis to first-line antituberculosis drugs in four provinces of Rwanda with a high prevalence of tuberculosis (TB). The purpose was to determine the prevalence of primary and acquired resistance of M. tuberculosis to major antituberculosis drugs. A cohort of patients (n=710) with pulmonary TB documented by positive microscopic examinations of exhaustive samples was recruited at 7 treatment centers. Sputum samples were cultured on Löwenstein-Jensen and Coletsos media. Sensitivity to antituberculosis drugs was tested using a BACTEC 460 radiometric system. M. tuberculosis was isolated in 644 of the 710 patients (90.7%). A total of 296 out of 573 tested for HIV infection (51.7%) were positive. Primary resistance to one, two, three or four antituberculosis drugs was observed in 3.5%, 2.9%, 1.4% and 5.7% respectively. The prevalence of acquired resistance to antituberculosis drugs was 11.2%. Primary monoresistance to streptomycin was the most prevalent (2.3%) followed by resistance to ethambutol (1%). The combined rate of multiresistance was 11.6% with 7% involving new cases and 25.5% involving retreatment. This study showed that the rates of primary and acquired resistance to first-line antituberculosis drugs were high and that TB was associated with HIV infection. The National TB Control Program must implement measures to coordinate diagnosis and management of TB and HIV infection
Cuba's international cooperation in health: an overview
No full textIn the first years after Cuba's 1959 revolution, the island's new government provided international medical assistance to countries affected by natural disasters or armed conflicts. Step by step, a more structural complementary program for international collaboration was put in place. The relief operations after Hurricane Mitch, which struck Central America in 1998, were pivotal. From November 1998 onward, the "Integrated Health Program" was the cornerstone of Cuba's international cooperation. The intense cooperation with Hugo Chávez's Venezuela became another cornerstone. Complementary to the health programs abroad, Cuba also set up international programs at home, benefiting tens of thousands of foreign patients and disaster victims. In a parallel program, medical training is offered to international students in the Latin American Medical School in Cuba and, increasingly, also in their home countries. The importance and impact of these initiatives, however, cannot and should not be analyzed solely in public health terms
The contribution of international health volunteers to the health workforce in sub-Saharan Africa
No full textABSTRACT: BACKGROUND: In this paper, we aim to quantify the contribution of international health volunteers to the health workforce in sub-Saharan Africa and to explore the perceptions of health service managers regarding these volunteers. METHODS: Rapid survey among organizations sending international health volunteers and group discussions with experienced medical officers from sub-Saharan African countries. RESULTS: We contacted 13 volunteer organizations having more than 10 full-time equivalent international health volunteers in sub-Saharan Africa and estimated that they employed together 2072 full-time equivalent international health volunteers in 2005. The numbers sent by secular non-governmental organizations (NGOs) is growing, while the number sent by development NGOs, including faith-based organizations, is mostly decreasing. The cost is estimated at between US50 000 per expatriate volunteer per year. There are trends towards more employment of international health volunteers from low-income countries and of national medical staff.Country experts express more negative views about international health volunteers than positive ones. They see them as increasingly paradoxical in view of the existence of urban unemployed doctors and nurses in most countries. Creating conditions for employment and training of national staff is strongly favoured as an alternative. Only in exceptional circumstances is sending international health volunteers viewed as a defendable temporary measure. CONCLUSION: We estimate that not more than 5000 full-time equivalent international health volunteers were working in sub-Saharan Africa in 2005, of which not more than 1500 were doctors. A distinction should be made between (1) secular medical humanitarian NGOs, (2)development NGOs, and (3) volunteer organizations, as Voluntary Service Overseas (VSO) and United Nations volunteers (UNV). They have different views, undergo different trends and are differently appreciated by government officials.International health volunteers contribute relatively small numbers to the health workforce in sub-Saharan Africa, and it seems unlikely that they will do more in the future. In areas where they play a role, their contribution to service delivery is sometimes very significant
Indian community health insurance schemes provide partial protection against catastrophic health expenditure
No full textBACKGROUND: More than 72% of health expenditure in India is financed by individual households at the time of illness through out-of-pocket payments. This is a highly regressive way of financing health care and sometimes leads to impoverishment. Health insurance is recommended as a measure to protect households from such catastrophic health expenditure (CHE). We studied two Indian community health insurance (CHI) schemes, ACCORD and SEWA, to determine whether insured households are protected from CHE. METHODS: ACCORD provides health insurance cover for the indigenous population, living in Gudalur, Tamil Nadu. SEWA provides insurance cover for self employed women in the state of Gujarat. Both cover hospitalisation expenses, but only upto a maximum limit of US45, respectively.We reviewed the insurance claims registers in both schemes and identified patients who were hospitalised during the period 01/04/2003 to 31/03/2004. Details of their diagnoses, places and costs of treatment and self-reported annual incomes were obtained. There is no single definition of CHE and none of these have been validated. For this research, we used the following definition; "annual hospital expenditure greater than 10% of annual income," to identify those who experienced CHE. RESULTS: There were a total of 683 and 3152 hospital admissions at ACCORD and SEWA, respectively. In the absence of the CHI scheme, all of the patients at ACCORD and SEWA would have had to pay OOP for their hospitalisation. With the CHI scheme, 67% and 34% of patients did not have to make any out-of-pocket (OOP) payment for their hospital expenses at ACCORD and SEWA, respectively. Both CHI schemes halved the number of households that would have experienced CHE by covering hospital costs. However, despite this, 4% and 23% of households with admissions still experienced CHE at ACCORD and SEWA, respectively. This was related to the following conditions: low annual income, benefit packages with low maximum limits, exclusion of some conditions from the benefit package, and use of the private sector for admissions. CONCLUSION: CHI appears to be effective at halving the incidence of CHE among hospitalised patients. This protection could be further enhanced by improving the design of the CHI schemes, especially by increasing the upper limits of benefit packages, minimising exclusions and controlling costs