Faculty Bibliography

BACKGROUND:Unhealthy alcohol consumption exacerbates the HIV epidemic in East Africa. Potential benefits of new trials that test the effectiveness of alcohol interventions could not be evaluated by traditional sampling methods. Given the competition for health care resources in East Africa, this study aims to determine the optimal sample size given the opportunity cost of potentially re-allocating trial funds towards cost-effective alcohol treatments. METHODS:We used value of information methods to determine the optimal sample size by maximizing the expected net benefit of sampling for a hypothetical 2-arm intervention vs. control randomized trial, across ranges of policymaker's willingness-to-pay for the health benefit of an intervention. Probability distributions describing the relative likelihood of alternative trial results were imputed based on prior studies. In the base case, policymaker's willingness-to-pay was based on a simultaneously resource-constrained priority (routine HIV virological testing). Sensitivity analysis was performed for various willingness-to-pay thresholds and intervention durations. RESULTS:A new effectiveness trial accounting for the benefit of more precise decision-making on alcohol intervention implementation would benefit East Africa $67,000 with the optimal sample size of 100 persons per arm under the base case willingness-to-pay threshold and intervention duration of 20 years. At both a conservative willingness-to-pay of 1 x GDP/capita and a high willingness-to-pay of 3 x GDP/capita for an additional health gain added by an alcohol intervention, a new trial was not recommended due to limited decision uncertainty. When intervention duration was 10 or 5 years, there was no return on investment across suggested willingness-to-pay thresholds. CONCLUSIONS:Value of information methods could be used as an alternative approach to assist the efficient design of alcohol trials. If reducing unhealthy alcohol use is a long-term goal for HIV programs in East Africa, additional new trials with optimal sample sizes ranging from 100 to 250 persons per arm could save the opportunity cost of implementing less cost-effective alcohol strategies in HIV prevention. Otherwise, conducting a new trial is not recommended.

Herpes zoster ophthalmicus (HZO) is a common, vision and potentially life-threatening disease caused by the reactivation of the varicella-zoster virus (VZV) in the distribution of the first division of cranial nerve V. Although the rate of herpes zoster increases with age, over half of the people with zoster in general, including HZO, are under age 60. In addition, over 90% of people with zoster are immunocompetent, even though the disease is more common and severe in immunocompromised patients. The incidence of zoster is increasing worldwide for unknown reasons. The epidemiology has not yet been impacted by the zoster vaccine (ZV). The lack of a strong recommendation by physicians for this vaccine is a major barrier to its use. An unresolved dilemma regards the optimum timing for this vaccine. In the USA, the current recommendation by the Centers for Disease Control and Prevention (CDC) is for eligible people age 60 and older, despite its greater efficacy in reducing the incidence of disease and Food and Drug Administration (FDA) approval for age 50-59. Although there is a consensus regarding use of acute high-dose oral antiviral treatment to reduce ocular complications, there is limited evidence for prolonged treatment. The rationale for a proposed randomised controlled trial (RCT) of suppressive antiviral treatment to reduce chronic eye disease and postherpetic neuralgia (PHN) includes evidence that zoster is followed by chronic active VZV infection and similarities between HZO and herpes simplex virus (HSV) eye infection, where this treatment is effective and is the standard of care.

OBJECTIVES: Attrition from care among HIV infected patients can lead to poor clinical outcomes. Our objective was to evaluate hypothetical interventions seeking to improve retention-in-care (RIC) for HIV-infected patients in East Africa, asking whether they could offer favorable value compared to earlier ART initiation. METHODS: We used a micro-simulation model to analyze two RIC focused strategies within an East African HIV treatment program--"risk reduction," defined as intervention(s) that decrease the risk of attrition from care; and "outreach," defined as interventions that find patients and relink them with care. We compared this to earlier ART treatment as a measure of the potential health benefits forgone (e.g., opportunity cost). RESULTS: Reducing attrition by 40% at an average cost of $10 per person remains a less efficient use of resources compared to ensuring full access to ART (cost- effectiveness ratio $1300 vs $3700) for ART eligible patients. An outreach intervention had limited clinical benefit in our simulation. If intervention costs are <$10 per person, however, an intervention able to achieve a 40% (or greater) reduction in attrition may be a cost-effective next implementation option following implementation of earlier ART treatment. CONCLUSIONS: Our results suggest that programs should consider retention focused programs once they have already achieved high degrees of ART coverage among eligible patients. It is important that decision makers understand the epidemiology and associated outcomes of those patients who are classified as lost to follow up in their systems prior to implementation in order to achieve the highest value.

BACKGROUND: In the current report, we ask if targeting a cognitive behavioral therapy (CBT)-based intervention aimed at reducing hazardous alcohol consumption to HIV-infected persons in East Africa would have a favorable value at costs that are feasible for scale-up. METHODS: Using a computer simulation to inform HIV prevention decisions in East Africa, we compared 4 different strategies for targeting a CBT intervention-(i) all HIV-infected persons attending clinic; (ii) only those patients in the pre-antiretroviral therapy (ART) stages of care; (iii) only those patients receiving ART; and (iv) only those patients with detectable viral loads (VLs) regardless of disease stage. We define targeting as screening for hazardous alcohol consumption (e.g., using the Alcohol Use Disorders Identification Test and offering the CBT intervention to those who screen positive). We compared these targeting strategies to a null strategy (no intervention) or a hypothetical scenario where an alcohol intervention was delivered to all adults regardless of HIV status. RESULTS: An intervention targeted to HIV-infected patients could prevent 18,000 new infections, add 46,000 quality-adjusted life years (QALYs), and yield an incremental cost-effectiveness ratio of $600/QALY compared to the null scenario. Narrowing the prioritized population to only HIV-infected patients in pre-ART phases of care results in 15,000 infections averted, the addition of 21,000 QALYs and would be cost-saving, while prioritizing based on an unsuppressed HIV-1 VL test results in 8,300 new infections averted, adds 6,000 additional QALYs, and would be cost-saving as well. CONCLUSIONS: Our results suggest that targeting a cognitive-based treatment aimed at reducing hazardous alcohol consumption to subgroups of HIV-infected patients provides favorable value in comparison with other beneficial strategies for HIV prevention and control in this region. It may even be cost-saving under certain circumstances.

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.

BACKGROUND: Use of the tuberculin skin test (TST) for diagnosis of latent tuberculosis infection (LTBI) among individuals who received the Bacille Calmette-Guerin (BCG) vaccine is complicated by its potential cross-reaction with TST antigens which may cause false-positive results and lead to patient and physician reluctance to initiate LTBI treatment. QuantiFERON(R)-TB Gold (QFT-G) lacks this cross-reaction. We sought to study the impact of implementing QFT-G testing in 2006 on LTBI treatment initiation and completion at NYC chest clinics. METHODS: QFT-G results from 10/2006-12/2008 in NYC Department of Health and Mental Hygiene chest clinics were obtained from the electronic medical record system. The proportions of patients who initiated and completed treatment among patients tested with QFT-G were compared to those tested with TST from 10/2004-9/2006. RESULTS: Among 36,167 patients tested with QFT-G, 2,300 (6%) tested positive, 33,327 (93%) tested negative, and 540 (1%) had an indeterminate result. Among those who had a positive QFT-G test and deemed eligible, 985 (80%) initiated LTBI treatment and 490 (40%) completed treatment. Historically, among patients tested with TST, 7,073 (19%) tested positive (p<0.0001 compared to QFT-G); 3,182 (79%) of those eligible initiated LTBI treatment and 1,210 (30%) completed treatment (p<0.0001 compared to QFT-G). CONCLUSIONS: QFT-G implementation increased the proportion of patients completing LTBI treatment. Additional studies are needed in more settings to determine whether using QFT-G leads to a sustained increase in treatment completion.