Suchergebnisse

International collaborators in biomedical sciences face ethical challenges in the design, review, and conduct of research. Challenges include differences in research ethics capacity, cultural differences in interpretation and application of ethical principles, and cooperation between ethics review boards at collaborating institutions. Indiana University School of Medicine (Indianapolis, USA) and Moi University Faculty of Health Sciences (Eldoret, Kenya) developed a Memorandum of Understanding (MOU) to establish greater cooperation between their ethics review boards, followed by a joint needs assessment to assess barriers to implementing the MOU. Focus groups and interviews at each institution revealed that while each side verbalized understanding and respect for the other's culture, there were misunderstandings deeply rooted in each culture that could potentially derail the collaboration. Although the participants at each university agreed on the major principles and issues in research ethics and on the importance attributed to them, a more in-depth evaluation of the responses revealed important differences. Methods to address these misunderstandings are outlined in the recommended Best Practices.

Epidemics of both HIV/AIDS and alcohol abuse in sub-Saharan Africa have spurred the conduct of local behavioral therapy trials for these problems, but the ethical issues involved in these trials have not been fully examined. In this paper, we discuss ethical issues that emerged during the conduct of a behavioral intervention adaptation and trial using cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. The study was performed within our multinational collaboration, the USAID-Academic Model Providing Access to Healthcare Partnership. We discuss relevant ethical considerations and how we addressed them.

BackgroundIn resource‐poor settings, mortality is at its highest during the first 3 months after combination antiretroviral treatment (cART) initiation. A clear predictor of mortality during this period is having a low CD4 count at the time of treatment initiation. The objective of this study was to evaluate the effect on survival and clinic retention of a nurse‐based rapid assessment clinic for high‐risk individuals initiating cART in a resource‐constrained setting.MethodsThe USAID‐AMPATH Partnership has enrolled more than 140,000 patients at 25 clinics throughout western Kenya. High Risk Express Care (HREC) provides weekly or bi‐weekly rapid contacts with nurses for individuals initiating cART with CD4 counts of ≤100 cells/mm3. All HIV‐infected individuals aged 14 years or older initiating cART with CD4 counts of ≤100 cells/mm3 were eligible for enrolment into HREC and for analysis. Adjusted hazard ratios (AHRs) control for potential confounding using propensity score methods.ResultsBetween March 2007 and March 2009, 4,958 patients initiated cART with CD4 counts of ≤100 cells/mm3. After adjusting for age, sex, CD4 count, use of cotrimoxazole, treatment for tuberculosis, travel time to clinic and type of clinic, individuals in HREC had reduced mortality (AHR: 0.59; 95% confidence interval: 0.45‐0.77), and reduced loss to follow up (AHR: 0.62; 95% CI: 0.55‐0.70) compared with individuals in routine care. Overall, patients in HREC were much more likely to be alive and in care after a median of nearly 11 months of follow up (AHR: 0.62; 95% CI: 0.57‐0.67).ConclusionsFrequent monitoring by dedicated nurses in the early months of cART can significantly reduce mortality and loss to follow up among high‐risk patients initiating treatment in resource‐constrained settings.

BackgroundA major obstacle facing many lower‐income countries in establishing and maintaining HIV treatment programmes is the scarcity of trained health care providers. To address this shortage, the World Health Organization has recommend task shifting to HIV‐infected peers.MethodsWe designed a model of HIV care that utilizes HIV‐infected patients, community care coordinators (CCCs), to care for their clinically stable peers with the assistance of preprogrammed personal digital assistants (PDAs). Rather than presenting for the standard of care, monthly clinic visits, in this model, patients were seen every three months in clinics and monthly by their CCCs in the community during the interim two months. This study was conducted in Kosirai Division, western Kenya, where eight of the 24 sub‐locations (defined geographic areas) within the division were randomly assigned to the intervention with the remainder used as controls.Prior to entering the field, CCCs underwent intensive didactic training and mentoring related to the assessment and support of HIV patients, as well as the use of PDAs. PDAs were programmed with specific questions and to issue alerts if responses fell outside of pre‐established parameters. CCCs were regularly evaluated in six performance areas. An impressionistic analysis on the transcripts from the monthly group meetings that formed the basis of the continuous feedback and quality improvement programme was used to assess this model.ResultsAll eight of the assigned CCCs successfully passed their training and mentoring, entered the field and remained active for the two years of the study. On evaluation of the CCCs, 89% of their summary scores were documented as superior during Year 1 and 94% as superior during Year 2. Six themes emerged from the impressionistic analysis in Year 1: confidentiality and "community" disclosure; roles and responsibilities; logistics; clinical care partnership; antiretroviral adherence; and PDA issues. At the end of the trial, of those patients not lost to follow up, 64% (56 of 87) in the intervention and 52% (58 of 103) in the control group were willing to continue in the programme (p = 0.26).ConclusionWe found that an antiretroviral treatment delivery model that shifted patient monitoring and antiretroviral dispensing tasks into the community by HIV‐infected patients was both acceptable and feasible.Trial registrationClinicalTrials.gov ID NCT00371540