A randomized clinical trial of a group cognitive-behavioral therapy to reduce alcohol use among human immunodeficiency virus-infected outpatients in western Kenya.

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.

Implementation of primary care clinical pharmacy services for adults experiencing homelessness.

BACKGROUND: It is estimated that on any given night in the United States, more than half a million individuals experience homelessness. Within the homeless population, chronic conditions such as diabetes, heart disease, and human immunodeficiency virus are found at rates 3-6 times higher than in the general population. Despite this, access to appropriate treatment and preventive care remains difficult for those experiencing homelessness, and many barriers exist to achieving positive health outcomes. OBJECTIVE: The primary objective of this study was to determine the clinical impact and sustainability of implementing clinical pharmacy services in a clinic for adults experiencing homelessness. PRACTICE DESCRIPTION: As a pilot service, a postgraduate year 2 ambulatory care pharmacy resident attended the Pedigo clinic for adults experiencing homelessness 1 half-day per week to provide independent cardiovascular risk reduction (CVRR) disease state management under a collaborative practice agreement. PRACTICE INNOVATION: The existing CVRR model was applied at a clinic location that did not previously have clinical pharmacy services. The provision of these services was adapted to meet the unique health needs of the homeless population. EVALUATION METHODS: The outcomes from having a clinical pharmacist in this clinic setting were retrospectively reviewed from September 2019 to March 2020. RESULTS: During the pilot period, the pharmacist conducted 28 encounters for 14 unique patients and made a mean of 4 clinical interventions per patient encounter. A total of 124 interventions occurred, including comprehensive medication review (n = 23; 82.1%), patient education (n = 21; 75%), medication regimen optimization (n = 18; 64.3%), and tobacco cessation (n = 18; 64.3%), among several others. Clinical outcomes (glycosylated hemoglobin level, blood pressure, and weight) remained stable with pharmacist management throughout the pilot period. CONCLUSION: The addition of a clinical pharmacist to the interdisciplinary care team for patients experiencing homelessness addresses a health care disparity and enhances the care provided to this vulnerable population.

Computer-Based Counseling Program (CARE+ Kenya) to Promote Prevention and HIV Health for People Living With HIV/AIDS: A Randomized Controlled Trial.

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.

Associations with Unprotected Sexual Behavior Among HIV-Infected Drinkers in Western Kenya.

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.

Task-shifting alcohol interventions for HIV+ persons in Kenya: a cost-benefit analysis.

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).

Rates and Covariates of Recent Sexual and Physical Violence Against HIV-Infected Outpatient Drinkers in Western Kenya.

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.

Factors associated with HIV testing among men who have sex with men in Western Kenya: a cross-sectional study.

HIV diagnosis is an important step in the HIV cascade of prevention and treatment. However, men who have sex with men in low- and middle-income countries have limited access to HIV care services. We examined factors associated with prior HIV testing among men who have sex with men in western Kenya. We recruited 95 men who have sex with men aged 18 years and older, and who reported at least one sexual contact with a man in the past 6 months; however, this analysis is restricted to 89 participants who completed questions on HIV testing. Logistic regression model was used to determine factors associated with HIV testing in the past one year. Results indicate that 23 (26%) had not been tested in the past 12 months. Bivariate analyses demonstrated that condomless anal sex (odds ratio = 3.29, 95% confidence interval = 1.18-9.17) and comfort with healthcare providers (odds ratio = 1.15, 95 % CI = 1.05-1.26) were associated with higher odds of HIV testing in the past 12 months. Experiencing social stigma was associated with lower odds of HIV testing in the last 12 months (odds ratio = 0.91, 95% confidence interval = 0.84-0.94). In multivariable models, social stigma remained significantly associated with lower odds of HIV testing in the last 12 months odds ratio = 0.90, 95% confidence interval = 0.82-0.99) after inclusion of sexual risk and individual level variables. Development of men who have sex with men-sensitive HIV-testing services, addressing stigma, and training healthcare workers to provide culturally sensitive services may assist in effectively engaging men who have sex with men in the HIV treatment cascade.

Associations Between the Phosphatidylethanol Alcohol Biomarker and Self-Reported Alcohol Use in a Sample of HIV-Infected Outpatient Drinkers in Western Kenya.

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.

Assessing the impact of a primary care electronic medical record system in three Kenyan rural health centers.

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.

Accuracy and Acceptability of Oral Fluid HIV Self-Testing in a General Adult Population in Kenya.

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.

Implementation and Operational Research: A Time-Motion Analysis of HIV Transmission Prevention Counseling and Antiretroviral Adherence Messages in Western Kenya.

BACKGROUND: Shortages of health workers and large number of HIV-infected persons in Africa mean that time to provide antiretroviral therapy (ART) adherence and other messages to patients is limited. METHODS: Using time-motion methodology, we documented the intensity and nature of counseling delivered to patients. The study was conducted at a rural and an urban HIV clinic in western Kenya. We recorded all activities of 190 adult patients on ART during their return clinic visits to assess type, frequency, and duration of counseling messages. RESULTS: Mean visit length for patients at the rural clinic was 44.5 (SD = 27.9) minutes and at urban clinic was 78.2 (SD = 42.1) minutes. Median time spent receiving any counseling during a visit was 4.07 minutes [interquartile range (IQR), 1.57-7.33] at rural and 3.99 (IQR, 2.87-6.25) minutes at urban, representing 11% and 8% of total mean visit time, respectively. Median time patients received ART adherence counseling was 1.29 (IQR, 0.77-2.83) minutes at rural and 1.76 (IQR, 1.23-2.83) minutes at urban (P = 0.001 for difference). Patients received a median time of 0.18 (0-0.72) minutes at rural and 0.28 (IQR, 0-0.67) minutes at urban clinic of counseling regarding contraception and pregnancy. Most patients in the study did not receive any counseling regarding alcohol/substance use, emerging risks for ongoing HIV transmission. CONCLUSIONS: Although ART adherence was discussed with most patients, time was limited. Reproductive counseling was provided to only half of the patients, and "positive prevention" messaging was minimal. There are strategic opportunities to enhance counseling and information received by clients within HIV programs in resource-limited settings.

Reprint of: "This is the medicine:" a Kenyan community responds to a sexual concurrency reduction intervention.

We report the results of the first study designed to evaluate the feasibility and acceptability of an HIV prevention intervention focused on concurrent sexual partnerships. Mathematical models and longitudinal studies of stable couples indicate concurrency plays a critical role in sustaining generalized HIV epidemics in heterosexual populations, and East and Southern African nations identified concurrency reduction as a priority for HIV prevention. "Know Your Network" (KYN) is a single-session community-level concurrency awareness intervention designed to address this need. It is rooted in traditional social network research, but takes advantage of new network methodology and years of participatory action research with communities living in a region of Kenya with the highest HIV prevalence nationally. KYN combines didactic presentation, interactive exercises, high-impact graphics, and a network survey with immediate visualization of the results, to prompt a community conversation about sexual norms. We combined focus group discussions and the traditional east African baraza to evaluate the feasibility and acceptability of KYN for use with adults living in rural Nyanza Province, Kenya. We were able to implement KYN with fidelity to its components. Participants understood the intervention's messages about concurrency and its role in HIV transmission through sexual networks. They agreed to provide anonymous egocentric data on their sexual partnerships, and in return we successfully simulated a representation of their local network for them to view and discuss. This launched a dynamic conversation about concurrency and sexual norms that persisted after the intervention. The concurrency message was novel, but resonant to participants, who reported sharing it with their children, friends, and sexual partners. With clear evidence of KYN's feasibility and acceptability, it would be appropriate to evaluate the effectiveness of the intervention using a community-randomized trial. If effective, KYN would offer an inexpensive complement to ongoing comprehensive HIV prevention efforts in generalized epidemic settings.

"This is the medicine:" A Kenyan community responds to a sexual concurrency reduction intervention.

We report the results of the first study designed to evaluate the feasibility and acceptability of an HIV prevention intervention focused on concurrent sexual partnerships. Mathematical models and longitudinal studies of stable couples indicate concurrency plays a critical role in sustaining generalized HIV epidemics in heterosexual populations, and East and Southern African nations identified concurrency reduction as a priority for HIV prevention. "Know Your Network" (KYN) is a single-session community-level concurrency awareness intervention designed to address this need. It is rooted in traditional social network research, but takes advantage of new network methodology and years of participatory action research with communities living in a region of Kenya with the highest HIV prevalence nationally. KYN combines didactic presentation, interactive exercises, high-impact graphics, and a network survey with immediate visualization of the results, to prompt a community conversation about sexual norms. We combined focus group discussions and the traditional east African baraza to evaluate the feasibility and acceptability of KYN for use with adults living in rural Nyanza Province, Kenya. We were able to implement KYN with fidelity to its components. Participants understood the intervention's messages about concurrency and its role in HIV transmission through sexual networks. They agreed to provide anonymous egocentric data on their sexual partnerships, and in return we successfully simulated a representation of their local network for them to view and discuss. This launched a dynamic conversation about concurrency and sexual norms that persisted after the intervention. The concurrency message was novel, but resonant to participants, who reported sharing it with their children, friends, and sexual partners. With clear evidence of KYN's feasibility and acceptability, it would be appropriate to evaluate the effectiveness of the intervention using a community-randomized trial. If effective, KYN would offer an inexpensive complement to ongoing comprehensive HIV prevention efforts in generalized epidemic settings.

Delivery of HIV care during the 2007 post-election crisis in Kenya: a case study analyzing the response of the Academic Model Providing Access to Healthcare (AMPATH) program.

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.

Antiretroviral treatment interruptions induced by the Kenyan postelection crisis are associated with virological failure.

BACKGROUND: Antiretroviral treatment interruptions (TIs) cause suboptimal clinical outcomes. Data on TIs during social disruption are limited. METHODS: We determined effects of unplanned TIs after the 2007-2008 Kenyan postelection violence on virological failure, comparing viral load (VL) outcomes in HIV-infected adults with and without conflict-induced TI. RESULTS: Two hundred and one patients were enrolled, median 2.2 years after conflict and 4.3 years on treatment. Eighty-eight patients experienced conflict-related TIs and 113 received continuous treatment. After adjusting for preconflict CD4, patients with TIs were more likely to have detectable VL, VL >5,000 and VL >10,000. CONCLUSIONS: Unplanned conflict-related TIs are associated with increased likelihood of virological failure.

Experience implementing electronic health records in the antenatal clinic of a teaching and referral hospital in Kenya.

INTRODUCTION: Electronic health records (EHRs) are receiving a lot of attention for their potential to improve care. OBJECTIVE: To develop and implement EHRs in the antenatal clinic (ANC) of a teaching and referral hospital in Western Kenya. RESULTS: A multidisciplinary team developed a phased implementation of EHRs in the ANC as part of a CDC-funded effort to develop and implement primary care EHRs in lower level and referral facilities in Kenya comprising a clinic registration system and initial- and return-visit encounter forms that captured and reported data required for reporting. This was successfully done, the EHR fully implemented in the ANC including a reminder system to enhance adherence to care guidelines. CONCLUSIONS: It is possible to implement EHRs in a referral hospital ANC.

"These are good problems to have ": establishing a collaborative research partnership in East Africa.

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.'

Differences between self-reported and electronically monitored adherence among patients receiving antiretroviral therapy in a resource-limited setting.

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.

Ethical issues in a stage 1 cognitive-behavioral therapy feasibility study and trial to reduce alcohol use among HIV-infected outpatients in western Kenya.

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.

Short-Term Rationing of Combination Antiretroviral Therapy: Impact on Morbidity, Mortality, and Loss to Follow-Up in a Large HIV Treatment Program in Western Kenya.

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.