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Background and Aims: Culturally relevant and feasible interventions are needed to address limited professional resources in sub-Saharan Africa for behaviorally treating the dual epidemics of HIV and alcohol use disorder. This study tested the efficacy of a cognitive-behavioral therapy (CBT) intervention to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya., Design: Randomized clinical trial., Setting: A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration., Participants: A total of 614 HIV-infected outpatients [312 CBT; 302 healthy life-styles (HL); 48.5% male; mean age: 38.9 years; mean education 7.7 years] who reported a minimum of hazardous or binge drinking., Intervention and Comparator: A culturally adapted six-session gender-stratified group CBT intervention compared with HL education, each delivered by paraprofessionals over six weekly 90-minute sessions with a 9-month follow-up., Measurements: Primary outcome measures were percentage of drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the time-line follow-back from baseline to 9 months post-intervention. Exploratory analyses examined unprotected sex and number of partners., Findings: Median attendance was six sessions across condition. Retention at 9 months post-intervention was high and similar by condition: CBT 86% and HL 83%. PDD and DDD marginal means were significantly lower in CBT than HL at all three study phases. Maintenance period, PDD - CBT = 3.64 (0.696), HL = 5.72 (0.71), mean difference 2.08, 95% confidence interval (CI) = 0.13 - 4.04; DDD - CBT = 0.66 (0.96), HL = 0.98 (0.098), mean difference = 0.31, 95% CI = 0.05 - 0.58. Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1-month follow-up., Conclusions: A cognitive-behavioral therapy intervention was more efficacious than healthy lifestyles education in reducing alcohol use among HIV-infected Kenyan outpatient drinkers., (© 2020 Society for the Study of Addiction.)

In countries experiencing the dual burden of HIV disease and health care worker shortages, information and communication technology tools offer the potential to help support HIV treatment adherence and secondary HIV transmission risk reduction for people living with HIV/AIDS. We conducted a randomized controlled trial (September 1, 2011-July 12, 2012) with follow-up through April 2013. Participants were recruited from two clinics affiliated with the Academic Model Providing Access to Healthcare program in western Kenya. A total of 236 participants were enrolled, randomly assigned to intervention ( n = 118) or risk-assessment only control ( n = 118) and followed up for 9 months. Both arms had > 0.5 log10 reduction in viral load over time ( p = .0007), a clinically relevant finding. A computer-based counseling tool is feasible and acceptable in a high-volume East African HIV setting and provides evidence-based ART adherence and risk reduction support that may extend health workforce deficits.

Approximately 71% of HIV-infected individuals live in sub-Saharan Africa. Alcohol use increases unprotected sex, which can lead to HIV transmission. Little research examines risky sex among HIV-infected individuals in East Africa who are not sex workers. The study purpose was to examine associations with unprotected sex in a high-risk sample of 507 HIV-infected sexually active drinkers in western Kenya. They were enrolled in a trial to reduce alcohol use. Past-month baseline alcohol use and sexual behavior were assessed using the Timeline Followback. A zero-inflated negative binomial model examined associations with occurrence and frequency of unprotected sex. Results showed heavy drinking days were significantly associated with unprotected sex occurrence across gender, and with unprotected sex frequency among women. Among women, transactional sex, alcohol-related sexual expectations, condom use self-efficacy, drinking-and-protected-sex days and age were associated with unprotected sex occurrence while alcohol-related sexual expectations, depressive symptoms and condom use self-efficacy were associated with unprotected sex frequency. Among men, alcohol-related sexual expectations, condom use self-efficacy, and age were associated with unprotected sex occurrence, while drinking-and-protected-sex days were associated with unprotected sex occurrence and frequency. Findings suggest robust relationships between heavy drinking and unprotected sex. Further research is needed elucidating the temporal relationships between drinking and unprotected sex in this population.

Victimization from physical and sexual violence presents global health challenges. Partner violence is higher in Kenya than Africa. Violence against drinkers and HIV-infected individuals is typically elevated, so dual vulnerabilities may further augment risk. Understanding violence risks can improve interventions. Participants were 614 HIV-infected outpatient drinkers in western Kenya enrolled in a randomized trial to reduce alcohol use. At baseline, past 90-day partner physical and sexual violence were examined descriptively and in gender-stratified regression models. We hypothesized higher reported violence against women than men, and positive violence association with HIV stigma and alcohol use across gender. Women reported significantly more current sexual (26.3 vs. 5.7%) and physical (38.9 vs. 24.8%) victimization than men. Rates were generally higher than Kenyan lifetime national averages. In both regression models, HIV stigma and alcohol-related sexual expectations were significantly associated with violence while alcohol use was not. For women, higher violence risk was also conferred by childhood violence, past-year transactional sex, and younger age. HIV-infected Kenyan drinkers, particularly women, endorse high current violence due to multiple risk factors. Findings have implications for HIV interventions. Longitudinal research is needed to understand development of risk.

Background: Among HIV+ patients, alcohol use is a highly prevalent risk factor for both HIV transmission and poor adherence to HIV treatment. The large-scale implementation of effective interventions for treating alcohol problems remains a challenge in low-income countries with generalized HIV epidemics. It is essential to consider an intervention's cost-effectiveness in dollars-per-health-outcome, and the long-term economic impact -or "return on investment" in monetary terms., Methods: We conducted a cost-benefit analysis, measuring economic return on investment, of a task-shifted cognitive-behavioral therapy (CBT) intervention delivered by paraprofessionals to reduce alcohol use in a modeled cohort of 13,440 outpatients in Kenya. In our base-case, we estimated the costs and economic benefits from a societal perspective across a six-year time horizon, with a 3% annual discount rate. Costs included all costs associated with training and administering task-shifted CBT therapy. Benefits included the economic impact of lowered HIV incidence as well as the improvements in household and labor-force productivity. We conducted univariate and multivariate probabilistic sensitivity analyses to test the robustness of our results., Results: Under the base case, total costs for CBT rollout was $554,000, the value of benefits were $628,000, and the benefit-to-cost ratio was 1.13. Sensitivity analyses showed that under most assumptions, the benefit-to-cost ratio remained above unity indicating that the intervention was cost-saving (i.e., had positive return on investment). The duration of the treatment effect most effected the results in sensitivity analyses., Conclusions: CBT can be effectively and economically task-shifted to paraprofessionals in Kenya. The intervention can generate not only reductions in morbidity and mortality, but also economic savings for the health system in the medium and long term. The findings have implications for other countries with generalized HIV epidemics, high prevalence of alcohol consumption, and shortages of mental health professionals., Trial Registration: This paper uses data derived from "Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans (KHBS)" with ClinicalTrials.gov registration NCT00792519 on 11/17/2008; and preliminary data from "A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention" ( NCT01503255 , registered on 12/16/2011).

Background: To counteract the syndemics of HIV and alcohol in Sub-Saharan Africa, international collaborations have developed interventions to reduce alcohol consumption. Reliable and accurate methods are needed to estimate alcohol use outcomes. A direct alcohol biomarker called phosphatidylethanol (PEth) has been shown to validate heavy, daily drinking, but the literature indicates mixed results for moderate and nondaily drinkers, including among HIV-infected populations. This study examined the associations of the PEth biomarker with self-report alcohol use at 2 time points in 127 HIV-infected outpatient drinkers in western Kenya., Methods: Participants were consecutively enrolled in a randomized clinical trial to test the efficacy of a behavioral intervention to reduce alcohol use in Eldoret, Kenya. They endorsed current alcohol use, and a minimum score of 3 on the Alcohol Use Disorders Identification Test-Consumption or consuming ≥6 drinks per occasion at least monthly in the past year. Study interviews and blood draws were conducted at baseline and at 3 months post treatment from July 2012 through September 2013. Alcohol use was assessed using the Timeline Followback questionnaire. Blood samples were analyzed for the presence of the PEth biomarker and were compared to self-reported alcohol use. We also conducted semistructured interviews with 14 study completers in February through March 2014., Results: Baseline data indicated an average of moderate-heavy alcohol use: 50% drinking days and a median of 4.5 drinks per drinking day. At baseline, 46% of women (31 of 67) and 8% of men (5 of 60) tested negative for PEth (p < 0.001). At the 3-month follow-up, 93% of women (25 of 27) and 97% of men (30 of 31) who reported drinking tested positive, while 70% of women (28 of 40) and 35% of men (10 of 29) who denied drinking tested negative for PEth. Interviews were consistent with self-reported alcohol use among 13 individuals with negative baseline results., Conclusions: These results add to the growing literature showing lack of agreement between self-report and PEth results among unhealthy and nondaily drinkers, particularly women. More research is needed to determine at what level of consumption over what period of time PEth becomes a reliable and accurate indicator of alcohol use., (Copyright © 2016 by the Research Society on Alcoholism.)

Objective: Efficient, effective health care requires rapid availability of patient information. We designed, implemented, and assessed the impact of a primary care electronic medical record (EMR) in three rural Kenyan health centers., Method: Local clinicians identified data required for primary care and public health reporting. We designed paper encounter forms to capture these data in adult medicine, pediatric, and antenatal clinics. Encounter form data were hand-entered into a new primary care module in an existing EMR serving onsite clinics serving patients infected with the human immunodeficiency virus (HIV). Before subsequent visits, Summary Reports were printed containing selected patient data with reminders for needed HIV care. We assessed effects on patient flow and provider work with time-motion studies before implementation and two years later, and we surveyed providers' satisfaction with the EMR., Results: Between September 2008 and December 2011, 72 635 primary care patients were registered and 114 480 encounter forms were completed. During 2011, 32 193 unique patients visited primary care clinics, and encounter forms were completed for all visits. Of 1031 (3.2%) who were HIV-infected, 85% received HIV care. Patient clinic time increased from 37 to 81 min/visit after EMR implementation in one health center and 56 to 106 min/visit in the other. However, outpatient visits to both health centers increased by 85%. Three-quarters of increased time was spent waiting. Despite nearly doubling visits, there was no change in clinical officers' work patterns, but the nurses' and the clerks' patient care time decreased after EMR implementation. Providers were generally satisfied with the EMR but desired additional training., Conclusions: We successfully implemented a primary care EMR in three rural Kenyan health centers. Patient waiting time was dramatically lengthened while the nurses' and the clerks' patient care time decreased. Long-term use of EMRs in such settings will require changes in culture and workflow., (© The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

We evaluated performance, accuracy, and acceptability parameters of unsupervised oral fluid (OF) HIV self-testing (HIVST) in a general population in western Kenya. In a prospective validation design, we enrolled 240 adults to perform rapid OF HIVST and compared results to staff administered OF and rapid fingerstick tests. All reactive, discrepant, and a proportion of negative results were confirmed with lab ELISA. Twenty participants were video-recorded conducting self-testing. All participants completed a staff administered survey before and after HIVST to assess attitudes towards OF HIVST acceptability. HIV prevalence was 14.6 %. Thirty-six of the 239 HIVSTs were invalid (15.1 %; 95 % CI 11.1-20.1 %), with males twice as likely to have invalid results as females. HIVST sensitivity was 89.7 % (95 % CI 73-98 %) and specificity was 98 % (95 % CI 89-99 %). Although sensitivity was somewhat lower than expected, there is clear interest in, and high acceptability (94 %) of OF HIV self-testing.

Background: Widespread violence followed the 2007 presidential elections in Kenya resulting in the deaths of a reported 1,133 people and the displacement of approximately 660,000 others. At the time of the crisis the United States Agency for International Development-Academic Model Providing Access to Healthcare (USAID-AMPATH) Partnership was operating 17 primary HIV clinics in western Kenya and treating 59,437 HIV positive patients (23,437 on antiretroviral therapy (ART))., Methods: This case study examines AMPATH's provision of care and maintenance of patients on ART throughout the period of disruption. This was accomplished by implementing immediate interventions including rapid information dissemination through the media, emergency hotlines and community liaisons; organization of a Crisis Response leadership team; the prompt assembly of multidisciplinary teams to address patient care, including psychological support staff (in clinics and in camps for internally displaced persons (IDP)); and the use of the AMPATH Medical Records System to identify patients on ART who had missed clinic appointments., Results: These interventions resulted in the opening of all AMPATH clinics within five days of their scheduled post-holiday opening dates, 23,949 patient visits in January 2008 (23,259 previously scheduled), uninterrupted availability of antiretrovirals at all clinics, treatment of 1,420 HIV patients in IDP camps, distribution of basic provisions, mobilization of outreach services to locate missing AMPATH patients and delivery of psychosocial support to 300 staff members and 632 patients in IDP camps., Conclusion: Key lessons learned in maintaining the delivery of HIV care in a crisis situation include the importance of advance planning to develop programs that can function during a crisis, an emphasis on a rapid programmatic response, the ability of clinics to function autonomously, patient knowledge of their disease, the use of community and patient networks, addressing staff needs and developing effective patient tracking systems.

In the context of a long-term institutional 'twinning' partnership initiated by Indiana and Moi Universities more than 22 years ago, a vibrant program of research has arisen and grown in size and stature. The history of the AMPATH (Academic Model Providing Access to Healthcare) Research Program is described, with its distinctive attention to Kenyan-North American equity, mutual benefit, policies that support research best practices, peer review within research working groups/cores, contributions to clinical care, use of healthcare informatics, development of research infrastructure and commitment to research workforce capacity. In the development and management of research within our partnership, we describe a number of significant challenges we have encountered that require ongoing attention, many of which are "good problems" occasioned by the program's success and growth. Finally, we assess the special value a partnership program like ours has created and end by affirming the importance of organizational diversity, solidarity of purpose, and resilience in the 'research enterprise.'

Background: Measurement of adherence to antiretroviral therapy (ART) by patient self-report is common in resource-limited settings but widely believed to overstate actual adherence. The extent to which these measures overstate adherence has not been examined among a large patient population., Methods: HIV-infected adult patients in Kenya who initiated ART within the past 3 months were followed for 6 months. Adherence was measured by participants' self-reports of doses missed in the past 7 days during monthly clinic visits and by continuous Medication Event Monitoring System (MEMS) in participants' pill bottles. Seven-day self-reported adherence was compared to 7-day MEMS adherence, 30-day MEMS adherence, and adherence more than 90% during each of the first 6 months., Results: Self-reported and MEMS adherence measures were linked for 669 participants. Mean 7-day self-reported adherence was 98.7% and mean 7-day MEMS adherence was 86.0%, a difference of 12.7% (P < 0.01). The difference between the two adherence measures increased over time due to a decline in 7-day MEMS adherence. However, patients with lower MEMS adherence were in fact more likely to self-report missed doses and the difference between self-reported and MEMS adherence was similar for each number of self-reported missed doses. When analysis was limited to patients who reported rarely or never removing multiple doses at the same time, mean difference was 10.5% (P < 0.01)., Conclusion: There is a sizable and significant difference between self-reported and MEMS adherence. However, a strong relationship between the measures suggests that self-reported adherence is informative for clinical monitoring and program evaluation.

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.

Background. There was a 6-month shortage of antiretrovirals (cART) in Kenya. Methods. We assessed morbidity, mortality, and loss to follow-up (LTFU) in this retrospective analysis of adults who were enrolled during the six-month period with restricted cART (cap) or the six months prior (pre-cap) and eligible for cART at enrollment by the pre-cap standard. Cox models were used to adjust for potential confounders. Results. 9009 adults were eligible for analysis: 4,714 pre-cap and 4,295 during the cap. Median number of days from enrollment to cART initiation was 42 pre-cap and 56 for the cap (P < 0.001). After adjustment, individuals in the cap were at higher risk of mortality (HR = 1.21; 95% CI : 1.06-1.39) and LTFU (HR = 1.12; 95% CI : 1.04-1.22). There was no difference between the groups in their risk of developing a new AIDS-defining illness (HR = 0.92 95% CI 0.82-1.03). Conclusions. Rationing of cART, even for a relatively short period of six months, led to clinically adverse outcomes.

Aims: Dual epidemics of human immunodeficiency virus (HIV) and alcohol use disorders, and a dearth of professional resources for behavioral treatment in sub-Saharan Africa, suggest the need for development of culturally relevant and feasible interventions. The purpose of this study was to test the preliminary efficacy of a culturally adapted six-session gender-stratified group cognitive-behavioral therapy (CBT) intervention delivered by paraprofessionals to reduce alcohol use among HIV-infected out-patients in Eldoret, Kenya., Design: Randomized clinical trial comparing CBT against a usual care assessment-only control., Setting: A large HIV out-patient clinic in Eldoret, Kenya, part of the Academic Model for Providing Access to Healthcare collaboration., Participants: Seventy-five HIV-infected out-patients who were antiretroviral (ARV)-initiated or ARV-eligible and who reported hazardous or binge drinking., Measurements: Percentage of drinking days (PDD) and mean drinks per drinking days (DDD) measured continuously using the Time line Follow back method., Findings: There were 299 ineligible and 102 eligible out-patients with 12 refusals. Effect sizes of the change in alcohol use since baseline between the two conditions at the 30-day follow-up were large [d=0.95, P=0.0002, mean difference=24.93, 95% confidence interval (CI): 12.43, 37.43 PDD; d=0.76, P=0.002, mean difference=2.88, 95% CI: 1.05, 4.70 DDD]. Randomized participants attended 93% of the six CBT sessions offered. Reported alcohol abstinence at the 90-day follow-up was 69% (CBT) and 38% (usual care). Paraprofessional counselors achieved independent ratings of adherence and competence equivalent to college-educated therapists in the United States. Treatment effect sizes were comparable to alcohol intervention studies conducted in the United States., Conclusions: Cognitive-behavioral therapy can be adapted successfully to group paraprofessional delivery in Kenya and may be effective in reducing alcohol use among HIV-infected Kenyan out-patients., (© 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.)

The baraza is a customary form of community assembly in East Africa. We examined the use of the health baraza as a process that can improve data collection and deepen community understanding of sociocultural issues surrounding HIV/AIDS. In the evaluation of the United States Agency for International Development (USAID)-Academic Model for Prevention and Treatment of HIV/AIDS Partnership (USAID-AMPATH) in Kenya, investigators facilitated mabaraza (the plural of baraza) to gather information of relevance to program success, improvement, and community collaboration. Seven mabaraza were held at local health facilities. Mabaraza rapidly evoked essential information for the USAID-AMPATH program and facilitated vibrant discussion of themes that were of interest to local communities. Mabaraza combined individual and community outlooks, producing emic understanding of the program's meaning to local populations. The baraza assemblage is a promising technique for applied sociology, participatory research, and program evaluation.

Objectives: To assess whether community-based care delivered by people living with HIV/AIDS (PLWAs) could replace clinic-based HIV care., Design: Prospective cluster randomized controlled clinical trial., Setting: Villages surrounding 1 rural clinic in western Kenya., Subjects: HIV-infected adults clinically stable on antiretroviral therapy (ART)., Intervention: The intervention group received monthly Personal Digital Assistant supported home assessments by PLWAs with clinic appointments every 3 months. The control group received standard of care monthly clinic visits., Main Outcomes Measured: Viral load, CD4 count, Karnofsky score, stability of ART regimen, opportunistic infections, pregnancies, and number of clinic visits., Results: After 1 year, there were no significant intervention-control differences with regard to detectable viral load, mean CD4 count, decline in Karnofsky score, change in ART regimen, new opportunistic infection, or pregnancy rate. Intervention patients made half as many clinic visits as did controls (P < 0.001)., Conclusions: Community-based care by PLWAs resulted in similar clinical outcomes as usual care but with half the number of clinic visits. This pilot study suggests that task-shifting and mobile technologies can deliver safe and effective community-based care to PLWAs, expediting ART rollout and increasing access to treatment while expanding the capacity of health care institutions in resource-constrained environments.

Objective: To determine risk factors for death in HIV-infected African patients on anti-retroviral therapy (ART)., Design: Retrospective Case-control study., Setting: The MOH-USAID-AMPATH Partnership ambulatory HIV-care clinics in western Kenya., Results: Between November 2001 and December 2005 demographic, clinical and laboratory data from 527 deceased and 1054 living patients receiving ART were compared to determine independent risk factors for death. Median age at ART initiation was 38 versus 36 years for the deceased and living patients respectively (p<0.0148). Median time from enrollment at AMPATH to initiation of ART was two weeks for both groups while median time on ART was eight weeks for the deceased and fourty two weeks for the living (p<0.0001). Patients with CD4 cell counts <100/mm3 were more likely to die than those with counts >100/mm3 (HR=1.553. 95% CI (1.156, 2.087), p<0.003). Patients attending rural clinics had threefold higher risk of dying compared to patients attending clinic at a tertiary referral hospital (p<0.0001). Two years after initiating treatment fifty percent of non-adherent patients were alive compared to 75% of adherent patients. Male gender, WHO Stage and haemoglobin level <10 grams% were associated with time to death while age, marital status, educational level, employment status and weight were not., Conclusion: Profoundly immunosuppressed patients were more likely to die early in the course of treatment. Also, patients receiving care in rural clinics were at greater risk of dying than those receiving care in the tertiary referral hospital.

Objective: To determine the incidence of loss to follow-up in a treatment programme for people living with human immunodeficiency virus (HIV) infection in Kenya and to investigate how loss to follow-up is affected by gender., Methods: Between November 2001 and November 2007, 50 275 HIV-positive individuals aged ≥ 14 years (69% female; median age: 36.2 years) were enrolled in the study. An individual was lost to follow-up when absent from the HIV treatment clinic for > 3 months if on combination antiretroviral therapy (cART) or for > 6 months if not. The incidence of loss to follow-up was calculated using Kaplan-Meier methods and factors associated with loss to follow-up were identified by logistic and Cox multivariate regression analysis., Findings: Overall, 8% of individuals attended no follow-up visits, and 54% of them were lost to follow-up. The overall incidence of loss to follow-up was 25.1 per 100 person-years. Among the 92% who attended at least one follow-up visit, the incidence of loss to follow-up before and after starting cART was 27.2 and 14.0 per 100 person-years, respectively. Baseline factors associated with loss to follow-up included younger age, a long travel time to the clinic, patient disclosure of positive HIV status, high CD4+ lymphocyte count, advanced-stage HIV disease, and rural clinic location. Men were at an increased risk overall and before and after starting cART., Conclusion: The risk of being lost to follow-up was high, particularly before starting cART. Men were more likely to become lost to follow-up, even after adjusting for baseline sociodemographic and clinical characteristics. Interventions designed for men and women separately could improve retention.

Traditional homemade brew is believed to represent the highest proportion of alcohol use in sub-Saharan Africa. In Eldoret, Kenya, two types of brew are common: chang'aa, spirits, and busaa, maize beer. Local residents refer to the amount of brew consumed by the amount of money spent, suggesting a culturally relevant estimation method. The purposes of this study were to analyze ethanol content of chang'aa and busaa; and to compare two methods of alcohol estimation: use by cost, and use by volume, the latter the current international standard. Laboratory results showed mean ethanol content was 34% (SD = 14%) for chang'aa and 4% (SD = 1%) for busaa. Standard drink unit equivalents for chang'aa and busaa, respectively, were 2 and 1.3 (US) and 3.5 and 2.3 (Great Britain). Using a computational approach, both methods demonstrated comparable results. We conclude that cost estimation of alcohol content is more culturally relevant and does not differ in accuracy from the international standard.

Background: United states Agency for International development-Academic Model for Providing Accesses to Healthcare (USAID-AMPATH) cares for over 80,000 HIV-infected patients. Express care (EC) model addresses challenges of: clinically stable patient's adherent to combined-antiretroviral-therapy with minimal need for clinician intervention and high risk patients newly initiated on cART with CD4 counts < or = 100 cells/mm3 with frequent need for clinician intervention., Objective: To improve patient outcomes without increasing clinic resources., Design: A descriptive study of a clinician supervised shared nurse model., Setting: USAID-AMPATH clinics, Western Kenya., Results: Four thousand eight hundred and twenty four patients were seen during the pilot period, 90.4% were eligible for EC of whom 34.6% were enrolled. Nurses performed all traditional roles and attended to two thirds and three quarters of stable and high risk patient visits respectively. Clinicians attended to one third and one quarter of stable and high risk patient visits respectively and all visits ineligible for express care., Conclusion: The EC model is feasible. Task shifting allowed stable patients to receive visits with nurses, while clinicians had more time to concentrate on patients that were new as well as more acutely ill patients.

Two-thirds of those with HIV worldwide live in sub-Saharan Africa. Alcohol use is associated with the HIV epidemic through risky sex and suboptimal ARV adherence. In western Kenya, hazardous drinking was reported by HIV (53%) and general medicine (68%) outpatients. Cognitive behavioral treatment (CBT) has demonstrated strong efficacy to reduce alcohol use. This article reports on a systematic cultural adaptation and pilot feasibility study of group paraprofessional-delivered CBT to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. Following adaptation and counselor training, five pilot groups were run (n = 27). Overall attendance was 77%. Percent days abstinent from alcohol (PDA) before session 1 was 52-100% (women) and 21-36% (men), and by session 6 was 96-100% (women) and 89-100% (men). PDA effect sizes (Cohen's d) between first and last CBT session were 2.32 (women) and 2.64 (men). Participants reported treatment satisfaction. Results indicate feasibility, acceptability and preliminary efficacy for CBT in Kenya.

Health care for patients with HIV infection in developing countries has increased substantially in response to major international funding. Scaling up treatment programs requires timely data on the type, quantity, and quality of care being provided. Increasingly, such programs are turning to electronic health records (EHRs) to provide these data. We describe how a medical school in the United States and another in Kenya collaborated to develop and implement an EHR in a large HIV/AIDS care program in western Kenya. These data were used to manage patients, providers, and the program itself as it grew to encompass 18 sites serving more than 90,000 patients. Lessons learned have been applicable beyond HIV/AIDS to include primary care, chronic disease management, and community-based health screening and disease prevention programs. EHRs will be key to providing the highest possible quality of care for the funds developing countries can commit to health care. Public, private, and academic partnerships can facilitate the development and implementation of EHRs in resource-constrained settings.

Clinical programmes are typically evaluated on operational performance metrics of cost, quality and outcomes. Measures of patient satisfaction are used to assess the experience of receiving care, but other perspectives, including those of staff and communities, are not often sought or used to assess and improve programmes. For strategic planning, the Kenyan HIV/AIDS programme AMPATH (Academic Model Providing Access to Healthcare) sought to evaluate its performance in 2006. The method used for this evaluation was termed 'triangulation', because it used information from three different sources--patients, communities, and programme staff. From January to August 2006, Indiana University external evaluators and AMPATH staff gathered information on strengths, weaknesses and suggestions for improvement of AMPATH. Activities included in-depth key-informant semi-structured interviews of 26 AMPATH clinical and support staff, 56 patients at eight clinic sites, and seven village health dialogues (mabaraza) at five sublocations within the AMPATH catchment area. Data sources included field notes and transcripts of translated audio recordings, which were subjected to qualitative content analysis. Eighteen recommendations for programme improvement emerged, including ten from all three respondent perspectives. Three recommendations were cited by patients and in mabaraza, but not by staff. Triangulation uncovered improvement emphases that an internal assessment would miss. AMPATH and Kenyan Ministry of Health leadership have deliberated these recommendations and accelerated strategic change actions, including rural satellite programmes, collaboration with village-based workers, and door-to-door village-based screening and counselling.

Background: A 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., Methods: We 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., Results: All 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)., Conclusion: We 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 Registration: ClinicalTrials.gov ID NCT00371540.

Background: In 2001, HIV postexposure prophylaxis (PEP) was initiated in western Kenya., Methods: Design, implementation, and evolution of the PEP program are described. Patient data were analyzed for reasons, time to initiation, and PEP outcome., Results: Occupational PEP was initiated first followed by nonoccupational PEP (nPEP). Antiretroviral regimens were based upon national PEP guidelines, affordability and availability, and prevailing HIV prevalence. Emerging side effects data and cost improvements influenced regimen changes. Between November 2001 and December 2006, 446 patients sought PEP. Occupational exposure: 91 patients: 51 males; 72 accepted HIV testing; 48 of 52 source patients were HIV infected; median exposure-PEP time 3 hours (range: 0.3-96 hours). Of 72 HIV-negative patients receiving PEP, 3 discontinued, 69 completed, and 23 performed post-PEP HIV RNA polymerase chain reaction (all negative). Eleven follow-up HIV enzyme-linked immunosorbent assay tests have all turned negative. Nonoccupational exposure: 355 patients; 285 females; 90 children; 300 accepted HIV testing; median exposure-nPEP time 19 hours (range: 1-672 hours). Of 296 HIV-negative patients on nPEP, 1 died, 15 discontinued, 104 are on record having completed PEP, and 129 returned for 6-week HIV RNA polymerase chain reaction (1 patient tested positive). Eighty-seven follow-up HIV enzyme-linked immunosorbent assay tests have all turned negative., Conclusions: It is feasible to provide PEP and nPEP in resource-constrained settings.

Background and Objective: The HIV/AIDS epidemic in sub-Saharan Africa is decimating populations, deteriorating economies, deepening poverty, and destabilizing traditional social orders. The advent of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) made significant supplemental resources available to sub-Saharan national programs for the prevention and treatment of HIV/AIDS, but few programs have demonstrated the capacity to use these resources to increase rapidly in size. In this context, AMPATH, a collaboration of Indiana University School of Medicine, the Moi University School of Medicine, and the Moi Teaching and Referral Hospital in Eldoret, Kenya, is a stunning exception. This report summarizes findings from an assessment of AMPATH staff perceptions of how and why this has happened. PARTICIPANTS AND APPROACH: Semistructured, in-depth, individual interviews of 26 AMPATH workers were conducted and recorded. Field notes from these interviews were generated by independent reviewers and subjected to close-reading qualitative analysis for themes., Results: The themes identified were as follows: creating effectively, connecting with others, making a difference, serving those in great need, providing comprehensive care to restore healthy lives, and growing as a person and a professional., Conclusion: Inspired personnel are among the critical assets of an effective program. Among the reasons for success of this HIV/AIDS program are a set of work values and motivations that would be helpful in any setting, but perhaps nowhere more critical than in the grueling work of making a complex program work spectacularly well in the challenging setting of a resource-poor country. Sometimes, even in the face of long odds, the human spirit prevails.

Providing high-quality HIV/AIDS care requires high-quality, accessible data on individual patients and visits. These data can also drive strategic decision-making by health systems, national programs, and funding agencies. One major obstacle to HIV/AIDS care in developing countries is lack of electronic medical record systems (EMRs) to collect, manage, and report clinical data. In 2001, we implemented a simple primary care EMR at a rural health centre in western Kenya. This EMR evolved into a comprehensive, scalable system serving 19 urban and rural health centres. To date, the AMPATH Medical Record System contains 10 million observations from 400,000 visit records on 45,000 patients. Critical components include paper encounter forms for adults and children, technicians entering/managing data, and modules for patient registration, scheduling, encounters, clinical observations, setting user privileges, and a concept dictionary. Key outputs include patient summaries, care reminders, and reports for program management, operating ancillary services (e.g., tracing patients who fail to return for appointments), strategic planning (e.g., hiring health care providers and staff), reports to national AIDS programs and funding agencies, and research.

Objectives: Determine outcome differences between orphaned and non-orphaned children receiving antiretroviral therapy (ART)., Design: Retrospective review of prospectively recorded electronic data., Setting: Nine HIV clinics in western Kenya., Population: 279 children on ART enrolled between August 2002 and February 2005., Main Measures: Orphan status, CD4%, sex- and age-adjusted height (HAZ) and weight (WAZ) z scores, ART adherence, mortality., Results: Median follow-up was 34 months. Cohort included 51% males and 54% orphans. At ART initiation (baseline), 71% of children had CDC clinical stage B or C disease. Median CD4% was 9% and increased dramatically the first 30 weeks of therapy, then leveled off. Parents and guardians reported perfect adherence at every visit for 75% of children. Adherence and orphan status were not significantly associated with CD4% response. Adjusted for baseline age, follow-up was significantly shorter among orphaned children (median 33 vs. 41 weeks, P = 0.096). One-year mortality was 7.1% for orphaned and 6.6% for non-orphaned children (P = 0.836). HAZ and WAZ were significantly below norm in both groups. With ART, HAZ remained stable, while WAZ tended to increase toward the norm, especially among non-orphans. Orphans showed identical weight gains as non-orphans the first 70 weeks after start of ART but experienced reductions afterwards., Conclusions: Good ART adherence is possible in western rural Kenya. ART for HIV-infected children produced substantial and sustainable CD4% improvement. Orphan status was not associated with worse short-term outcomes but may be a factor for long-term therapy response. ART alone may not be sufficient to reverse significant developmental lags in the HIV-positive pediatric population.

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.

Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or "what is fair" for study participants in an HIV/AIDS clinical drug trial., Design: Qualitative study with focus groups., Setting: Teaching and referral hospital and rural health centre in Western Kenya., Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators., Results: Eighty nine individuals participated in a total of 11 focus groups over a four month period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidizing of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants., Conclusions: Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants.

Administering and monitoring therapy is crucial to the battle against HIV/AIDS in sub-Saharan Africa. Electronic medical records (EMRs) can aid in documenting care, monitoring drug adherence and response to therapy, and providing data for quality improvement and research. Faculty at Moi University in Kenya and Indiana and University in the USA opened adult and pediatric HIV clinics in a national referral hospital, a district hospital, and six rural health centers in western Kenya using a newly developed EMR to support comprehensive outpatient HIV/AIDS care. Demographic, clinical, and HIV risk data, diagnostic test results, and treatment information are recorded on paper encounter forms and hand-entered into a central database that prints summary flowsheets and reminders for appropriate testing and treatment. There are separate modules for monitoring the Antenatal Clinic and Pharmacy. The EMR was designed with input from clinicians who understand the local community and constraints of providing care in resource poor settings. To date, the EMR contains more than 30,000 visit records for more than 4000 patients, almost half taking antiretroviral drugs. We describe the development and structure of this EMR and plans for future development that include wireless connections, tablet computers, and migration to a Web-based platform.