Estimating the costs and cost-effectiveness of HIV self-testing among men who have sex with men, United States.

INTRODUCTION: HIV testing is an essential prerequisite for accessing treatment with antiretroviral therapy or prevention using pre-exposure prophylaxis. Internet distribution of HIV self-tests is a novel approach, and data on the programmatic cost of this approach are limited. We analyse the costs and cost-effectiveness of a self-testing programme. METHODS: Men who have sex with men (MSM) reporting unknown or negative HIV status were enrolled from March to August 2015 into a 12-month trial of HIV self-testing in the United States. Participants were randomly assigned either to the self-testing arm or the control arm. All participants received information on HIV testing services and locations in their community. Self-testing participants received up to four self-tests each quarter, which they could use themselves or distribute to their social network associates. Quarterly follow-up surveys collected testing outcomes, including number of tests used and new HIV diagnoses. Using trial expenditure data, we estimated the cost of implementing a self-testing programme. Primary outcomes of this analysis included total programme implementation costs, cost per self-test completed, cost per person tested, cost per new HIV diagnosis among those self-tested and cost per quality adjusted life year (QALY) saved. RESULTS: A total of 2665 men were assigned either to the self-testing arm (n = 1325) or the control arm (n = 1340). HIV testing was reported by 971 self-testing participants who completed a total of 5368 tests. In the control arm, 619 participants completed 1463 HIV tests. The self-testing participants additionally distributed 2864 self-tests to 2152 social network associates. Testing during the trial identified 59 participants and social network associates with newly diagnosed HIV infection in the self-testing arm; 11 control participants were newly diagnosed with HIV. The implementation cost of the HIV self-testing programme was $449,510. The cost per self-test completed, cost per person tested at least once, and incremental cost per new HIV diagnosis was $61, $145 and $9365 respectively. We estimated that self-testing programme potentially averted 3.34 transmissions, saved 14.86 QALYs and nearly $1.6 million lifetime HIV treatment costs. CONCLUSIONS: The HIV self-testing programme identified persons with newly diagnosed HIV infection at low cost, and the programme is cost saving.

HIV Testing Among Internet-Using MSM in the United States: Systematic Review.

Regular HIV testing enables early identification and treatment of HIV among at-risk men who have sex with men (MSM). Characterizing HIV testing needs for Internet-using MSM informs development of Internet-facilitated testing interventions. In this systematic review we analyze HIV testing patterns among Internet-using MSM in the United States who report, through participation in an online study or survey, their HIV status as negative or unknown and identify demographic or behavioral risk factors associated with testing. We systematically searched multiple electronic databases for relevant English-language articles published between January 1, 2005 and December 16, 2014. Using meta-analysis, we summarized the proportion of Internet-using MSM who had ever tested for HIV and the proportion who tested in the 12 months preceding participation in the online study or survey. We also identified factors predictive of these outcomes using meta-regression and narrative synthesis. Thirty-two studies that enrolled 83,186 MSM met our inclusion criteria. Among the studies reporting data for each outcome, 85 % (95 % CI 82-87 %) of participants had ever tested, and 58 % (95 % CI 53-63 %) had tested in the year preceding enrollment in the study, among those for whom those data were reported. Age over 30 years, at least a college education, use of drugs, and self-identification as being homosexual or gay were associated with ever having tested for HIV. A large majority of Internet-using MSM indicated they had been tested for HIV at some point in the past. A smaller proportion-but still a majority-reported they had been tested within the year preceding study or survey participation. MSM who self-identify as heterosexual or bisexual, are younger, or who use drugs (including non-injection drugs) may be less likely to have ever tested for HIV. The overall findings of our systematic review are encouraging; however, a subpopulation of MSM may benefit from targeted outreach. These findings indicate unmet needs for HIV testing among Internet-using MSM and identify subpopulations that might benefit from targeted outreach, such as provision of HIV self-testing kits.

Prevalence of HIV Among U.S. Female Sex Workers: Systematic Review and Meta-analysis.

Although female sex workers are known to be vulnerable to HIV infection, little is known about the epidemiology of HIV infection among this high-risk population in the United States. We systematically identified and critically assessed published studies reporting HIV prevalence among female sex workers in the United States. We searched for and included original English-language articles reporting data on the prevalence of HIV as determined by testing at least 50 females who exchanged sexual practices for money or drugs. We did not apply any restrictions on date of publication. We included 14 studies from 1987 to 2013 that reported HIV prevalence for a total of 3975 adult female sex workers. Only two of the 14 studies were conducted in the last 10 years. The pooled estimate of HIV prevalence was 17.3 % (95 % CI 13.5-21.9 %); however, the prevalence of HIV across individual studies varied considerably (ranging from 0.3 to 32 %) and statistical heterogeneity was substantial (I(2) = 0.89, Q = 123; p < 0.001). Although the variance across the 14 studies was high, prevalence was generally high (10 % or greater in 11 of the 14 included studies). Very few studies have documented the prevalence of HIV among female sex workers in the United States; however, the available evidence does suggest that HIV prevalence among this vulnerable population is high.

Opioid pharmacotherapy for chronic non-cancer pain in the United States: a research guideline for developing an evidence-base.

UNLABELLED: This document reports the consensus of an interdisciplinary panel of research and clinical experts charged with reviewing the use of opioids for chronic noncancer pain (CNCP) and formulating guidelines for future research. Prescribing opioids for chronic noncancer pain has recently escalated in the United States. Contrasting with increasing opioid use are: 1) The lack of evidence supporting long-term effectiveness; 2) Escalating misuse of prescription opioids including abuse and diversion; and 3) Uncertainty about the incidence and clinical salience of multiple, poorly characterized adverse drug events (ADEs) including endocrine dysfunction, immunosuppression and infectious disease, opioid-induced hyperalgesia and xerostomia, overdose, falls and fractures, and psychosocial complications. Chief among the limitations of current evidence are: 1) Sparse evidence on long-term opioid effectiveness in chronic pain patients due to the short-term time frame of clinical trials; 2) Insufficiently comprehensive outcome assessment; and 3) Incomplete identification and quantification of ADEs. The panel called for a strategic interdisciplinary approach to the problem domain in which basic scientists and clinicians cooperate to resolve urgent issues and generate a comprehensive evidence base. It offered 4 recommendations in 3 areas: 1) A research strategy for studying the effectiveness of long-term opioid pharmacotherapy; 2) Improvements in evidence-generation methodology; and 3) Potential research topics for generating new evidence. PERSPECTIVE: Prescribing opioids for CNCP has outpaced the growth of scientific evidence bearing on the benefits and harms of these interventions. The need for a strong evidence base is urgent. This guideline offers a strategic approach to creating a comprehensive evidence base to guide safe and effective management of CNCP.

Long-term opioid management for chronic noncancer pain.

BACKGROUND: Opioid therapy for chronic noncancer pain (CNCP) is controversial due to concerns regarding long-term effectiveness and safety, particularly the risk of tolerance, dependence, or abuse. OBJECTIVES: To assess safety, efficacy, and effectiveness of opioids taken long-term for CNCP. SEARCH STRATEGY: We searched 10 bibliographic databases up to May 2009. SELECTION CRITERIA: We searched for studies that: collected efficacy data on participants after at least 6 months of treatment; were full-text articles; did not include redundant data; were prospective; enrolled at least 10 participants; reported data of participants who had CNCP. Randomized controlled trials (RCTs) and pre-post case-series studies were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted safety and effectiveness data and settled discrepancies by consensus. We used random-effects meta-analysis' to summarize data where appropriate, used the I(2) statistic to quantify heterogeneity, and, where appropriate, explored heterogeneity using meta-regression. Several sensitivity analyses were performed to test the robustness of the results. MAIN RESULTS: We reviewed 26 studies with 27 treatment groups that enrolled a total of 4893 participants. Twenty five of the studies were case series or uncontrolled long-term trial continuations, the other was an RCT comparing two opioids. Opioids were administered orally (number of study treatments groups [abbreviated as "k"] = 12, n = 3040), transdermally (k = 5, n = 1628), or intrathecally (k = 10, n = 231). Many participants discontinued due to adverse effects (oral: 22.9% [95% confidence interval (CI): 15.3% to 32.8%]; transdermal: 12.1% [95% CI: 4.9% to 27.0%]; intrathecal: 8.9% [95% CI: 4.0% to 26.1%]); or insufficient pain relief (oral: 10.3% [95% CI: 7.6% to 13.9%]; intrathecal: 7.6% [95% CI: 3.7% to 14.8%]; transdermal: 5.8% [95% CI: 4.2% to 7.9%]). Signs of opioid addiction were reported in 0.27% of participants in the studies that reported that outcome. All three modes of administration were associated with clinically significant reductions in pain, but the amount of pain relief varied among studies. Findings regarding quality of life and functional status were inconclusive due to an insufficient quantity of evidence for oral administration studies and inconclusive statistical findings for transdermal and intrathecal administration studies. AUTHORS' CONCLUSIONS: Many patients discontinue long-term opioid therapy (especially oral opioids) due to adverse events or insufficient pain relief; however, weak evidence suggests that patients who are able to continue opioids long-term experience clinically significant pain relief. Whether quality of life or functioning improves is inconclusive. Many minor adverse events (like nausea and headache) occurred, but serious adverse events, including iatrogenic opioid addiction, were rare.

Computer-aided detection mammography for breast cancer screening: systematic review and meta-analysis.

CONTEXT: Mammography is generally accepted as the best available breast cancer screening method; however, some cancers detectable on mammography images are missed. Computer-aided detection (CAD) systems for mammography are intended to reduce false negatives by marking suspicious areas of the mammograms for reviewers to consider. Although the prospect of improving the sensitivity of screening mammograms has led to the diffusion of CAD for mammography, little is known about its diagnostic accuracy. OBJECTIVE: To assess the diagnostic performance of CAD for screening mammography in terms of sensitivity and specificity and incremental recall, biopsy, and cancer diagnosis rates. DATA SOURCES: Published literature identified by systematic literature searches of 17 databases, including MEDLINE, EMBASE, and the Cochrane Library, searched through 25 September 2008. STUDY SELECTION: A reviewer and an information specialist selected full-length English-language articles that enrolled asymptomatic women for routine breast cancer screening and provided data needed for our analyses using criteria established a priori. We identified 75 potentially relevant publications, of which 7 (9%) were included. DATA EXTRACTION: Data were extracted and internal validity was assessed by a single review author, and forms were approved by the co-authors. RESULTS: Three studies (n = 347,324) reported sensitivity and specificity, or data to calculate them, and five studies (n = 51,162) reported data to calculate incremental rates of cancer diagnoses and recall and biopsy of women who did not have breast cancer. The pooled sensitivity was 86.0% (95% CI 84.2-87.6%) and specificity was 88.2% (95% CI 88.1-88.3%). Of the 100,000 women screened, CAD yielded an additional 50 (95% CI 30-80) correct breast cancer diagnoses, 1,190 (95% CI 1,090-1,290) recalls of healthy women, and 80 (95% CI 60-100) biopsies of healthy women. A total of 96% (95% CI 93.9-97.3%) of women recalled based upon CAD and 65.1% (95% CI 52.3-76.0%) of women biopsied based upon CAD were healthy. No studies reported patient-oriented clinical outcomes.

Long-term opioid therapy for chronic noncancer pain: a systematic review and meta-analysis of efficacy and safety.

Opioid therapy for chronic noncancer pain (CNCP) is controversial due to concerns regarding long-term efficacy and adverse events (including addiction). We systematically reviewed the clinical evidence on patients treated with opioids for CNCP for at least six months. Of 115 studies identified by our search of eleven databases (through April 7, 2007), 17 studies (patients [n]=3,079) met inclusion criteria. Studies evaluated oral (studies [k]=7; n=1,504), transdermal (k=3; n=1, 993), and/or intrathecal (k=8; n=177) opioids. Many patients withdrew from the clinical trials due to adverse effects (oral: 32.5% [95% confidence interval (CI), 26.1%-39.6%]; intrathecal: 6.3% [95% CI, 2.9%-13.1%]; transdermal: 17.5% [95% CI, 6.5%-39.0%]), or due to insufficient pain relief (oral: 11.9% [95% CI, 7.8%-17.7%]; intrathecal: 10.5% [95% CI, 3.5%-27.4%]; transdermal: 5.8% [95% CI, 4.2%-7.3%]). Signs of opioid addiction were reported in only 0.05% (1/2,042) of patients and abuse in only 0.43% (3/685). There was an insufficient amount of data on transdermal opioids to quantify pain relief. For patients able to remain on oral or intrathecal opioids for at least six months, pain scores were reduced long-term (oral: standardized mean difference [SMD] 1.99, 95% CI, 1.17-2.80; intrathecal: SMD 1.33, 95% CI, 0.97-1.69). We conclude that many patients discontinue long-term opioid therapy due to adverse events or insufficient pain relief; however, weak evidence suggests that oral and intrathecal opioids reduce pain long-term in the relatively small proportion of individuals with CNCP who continue treatment.