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.

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.

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.

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.

Treatment outcomes of a stage 1 cognitive-behavioral trial to reduce alcohol use among human immunodeficiency virus-infected out-patients in western Kenya.

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.

Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya.

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.

Estimating alcohol content of traditional brew in Western Kenya using culturally relevant methods: the case for cost over volume.

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.

The association of sexual trauma with persistent pain in a sample of women veterans receiving primary care.

BACKGROUND: Women veterans report high rates of persistent pain and high rates of sexual trauma. We sought to determine whether the presence and intensity of persistent pain, as well as level of pain-related interference, in the VA Connecticut Women's Clinic population was positively associated with reports of sexual trauma. METHODS: Women presenting for routine appointments at the VA Connecticut Women's Health Center were recruited for study. Participants (N = 213) provided detailed information about their demographic, psychosocial, clinical, pain, and sexual trauma status. Bivariate and multivariate analyses were conducted to determine whether a report of sexual trauma was independently associated with the presence of pain, and levels of pain intensity and pain-related interference. RESULTS: A substantial majority (78%) reported an ongoing pain problem, whereas the prevalence of any reported sexual trauma was 36%. In bivariate analysis, persistent pain was associated with a greater number of chronic conditions (P < 0.01), depression symptom severity (P < 0.05), a history of military sexual harassment (P < 0.05), and military forced sex (P < 0.05). In a multivariate logistic regression analysis, persistent pain was independently associated with having at least two (OR 3.32, 95% CI 1.11, 9.90), or three or more chronic conditions (OR 7.56, 95% CI 2.34, 24.4) and depressive symptom severity score (OR 1.10, 95% CI 1.02, 1.19), but was not associated with sexual trauma (OR 1.70, 95% CI 0.66, 4.42). In multivariate linear regression analyses that included only those who reported pain at the time of the assessment, white race (P < 0.05) and sexual trauma histories (P < 0.05) were significantly associated with level of pain intensity, whereas being married (P < 0.01) was negatively associated with pain intensity. Depressive symptom score (P < 0.001) and sexual trauma (P < 0.05) were also significantly associated with level of pain interference. CONCLUSIONS: Reported sexual trauma is prevalent and while not independently associated with the presence of pain among women veterans in our study, for those who have pain, it is associated with greater pain intensity and pain-related interference.

Meta-analysis of psychological interventions for chronic low back pain.

The purpose of this meta-analysis of randomized controlled trials was to evaluate the efficacy of psychological interventions for adults with noncancerous chronic low back pain (CLBP). The authors updated and expanded upon prior meta-analyses by using broad definitions of CLBP and psychological intervention, a broad data search strategy, and state-of-the-art data analysis techniques. All relevant controlled clinical trials meeting the inclusion criteria were identified primarily through a computer-aided literature search. Two independent reviewers screened abstracts and articles for inclusion criteria and extracted relevant data. Cohen's d effect sizes were calculated by using a random effects model. Outcomes included pain intensity, emotional functioning, physical functioning (pain interference or pain-specific disability, health-related quality of life), participant ratings of global improvement, health care utilization, health care provider visits, pain medications, and employment/disability compensation status. A total of 205 effect sizes from 22 studies were pooled in 34 analyses. Positive effects of psychological interventions, contrasted with various control groups, were noted for pain intensity, pain-related interference, health-related quality of life, and depression. Cognitive-behavioral and self-regulatory treatments were specifically found to be efficacious. Multidisciplinary approaches that included a psychological component, when compared with active control conditions, were also noted to have positive short-term effects on pain interference and positive long-term effects on return to work. The results demonstrated positive effects of psychological interventions for CLBP. The rigor of the methods used, as well as the results that reflect mild to moderate heterogeneity and minimal publication bias, suggest confidence in the conclusions of this review.

The prevalence and age-related characteristics of pain in a sample of women veterans receiving primary care.

BACKGROUND: Women veterans are a growing but understudied population believed to be at increased risk for pain problems. Because of risk factors and clinical observations, we hypothesized that women veterans might have a high prevalence of pain and, thus, sought to determine the prevalence of (and age-related variations in) pain and to characterize several key pain dimensions in a sample of women veterans. METHODS: Women with routine appointments at the VA Connecticut Women's Health Center were recruited for study. Participants completed a 59-item questionnaire that provided information about their demographic, clinical, and pain status, as well as use of health services. RESULTS: Of 236 women approached, 213 (89%) completed the questionnaire. The mean age was 52 years, and most (78%) reported an ongoing pain problem. For those reporting pain, the mean duration of pain was 6 years, average pain intensity was 6.3 (range 1-10), and commonly endorsed pain sites included lower extremity (68%), low back (63%), and shoulder (48%). The most frequently endorsed treatment (by 80%) was analgesic medication use. Across the four age categories (20-35, 36-50, 51-65, and > or =66 years), pain prevalences were 64%, 89%, 83%, and 69%, respectively. Although pain intensity levels did not vary across age groups, older women (> or =66) reported using fewer pain treatments, including analgesic medications. Finally, those with (vs. those without) pain reported a greater number of medical and mental health visits in the preceding year. CONCLUSIONS: This study documented a significantly high prevalence of pain among a sample of women veterans receiving primary care in a VA women's health clinic.

Effectiveness of a community-based oral cancer awareness campaign (United States).

OBJECTIVE: The purpose of this study was to provide the first systematic evaluation in the United States of a community-based oral cancer awareness campaign. METHODS: We used a non-equivalent control group design and random-digit-dialing methods to examine billboard effectiveness and pre- and post-billboard impact between intervention and control counties in adult probability samples in Florida, USA. RESULTS: Respondents in the intervention county were more likely than controls to correctly identify the billboard message to get tested for oral cancer, and less likely than controls to report ever having an oral cancer examination, or to have heard of oral cancer. Results of pre-post analyses within each county showed that oral cancer examinations were significantly more frequent in both counties after the campaign. There were no significant differences between counties on the proportion of individuals who reported having seen the campaign or on any other item measuring billboard awareness or impact. CONCLUSIONS: Results suggest the Florida billboard campaign had limited success in increasing public awareness. Future cancer awareness campaigns should incorporate theoretical models, target high-risk groups and the broader community and provide culturally relevant messages as part of a multi-media campaign.

Racial/ethnic differences in the experience of chronic pain.

The purpose of this study was to examine racial/ethnic-related differences in a four-stage model of the processing of chronic pain. The subjects were 1557 chronic pain patients (White=1084, African American=473) evaluated at a pain management clinic at a large southeastern university medical center. Using an analysis of covariance controlling for pain duration and education, African American patients reported significantly higher levels of pain unpleasantness, emotional response to pain, and pain behavior, but not pain intensity than Whites. Differences were largest for the unpleasantness and emotion measures, particularly depression and fear. The groups differed by approximately 1.0 visual analogue scale unit, a magnitude that may be clinically significant. Racial/ethnic differences in the linear relationship between stages were also tested using structural equation modeling and LISREL-8. The results indicate differences in linear associations between pain measures with African Americans showing a stronger link between emotions and pain behavior than Whites.