Articles tagged as "Health care delivery"

Real-world barriers to active TB case detection in HIV clinics

Implementation and operational research: use of symptom screening and sputum microscopy testing for active tuberculosis case detection among HIV-infected patients in real-world clinical practice in Uganda.

Roy M, Muyindike W, Vijayan T, Kanyesigye M, Bwana M, Wenger M, Martin J, Geng E. J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):e86-91. doi: 10.1097/QAI.0000000000001067.

Background: The uptake of intensified active TB case-finding among HIV-infected patients using symptom screening is not well understood. We evaluated the rate and completeness of each interim step in the TB pulmonary "diagnostic cascade" to understand real-world barriers to active TB case detection.

Methods: We conducted a cohort analysis of new, antiretroviral therapy-naive, HIV-infected patients who attended a large HIV clinic in Mbarara, Uganda (March 1, 2012-September 30, 2013). We used medical records to extract date of completion of each step in the diagnostic cascade: symptom screen, order, collection, processing, and result. Factors associated with lack of sputum order were evaluated using multivariate Poisson regression and chart review of 50 screen-positive patients.

Results: Of 2613 patients, 2439 (93%) were screened for TB and 682 (28%) screened positive. Only 90 (13.2%) had a sputum order. Of this group, 83% completed the diagnostic cascade, 13% were diagnosed with TB, and 50% had a sputum result within 1 day of their visit. Sputum ordering was associated with WHO stage 3 or 4 HIV disease and greater number of symptoms. The main identifiable reasons for lack of sputum order in chart review were treatment of presumed malaria (51%) or bacterial infection (43%).

Conclusions: The majority of newly enrolled HIV-infected patients who screened positive for suspected TB did not have a sputum order, and those who did were more likely to have more symptoms and advanced HIV disease. Further evaluation of provider behavior in the management of screen-positive patients could improve active TB case detection rates.

Abstract access  

Editor’s notes: This cohort analysis of people enrolling for HIV care at a President’s Emergency Plan for AIDS Relief (PEPFAR) clinic in Uganda used medical record review to identify barriers to active TB case finding in a programmatic setting. This study is unique in evaluating each step along the entire TB diagnostic cascade, from the WHO screening tool, which asks about four symptoms, through to sputum result, in a setting where TB diagnosis was based on sputum microscopy, prior to availability of Xpert ® MTB/RIF.

The authors found high uptake of TB symptom screening at enrolment to HIV care, with cough being the most commonly reported symptom. However, most people with symptoms suggestive of TB were not documented to have had sputum investigation ordered, this being the major point of loss from the TB diagnostic pathway. Given that the prevalence of active TB among people newly testing HIV positive is consistently high in African countries, this represents a substantial missed opportunity for prompt identification and treatment of TB. The study design did not allow in-depth evaluation of the reasons for lack of sputum order since this may not be clearly documented in medical records. Factors such as a person’s inability to produce sputum should also be considered. Ultimately, a high sensitivity, affordable, non-sputum based, point-of-care diagnostic test for TB is necessary to overcome the barriers inherent in the current complex TB diagnostic pathway.

Africa
Uganda
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Antiretroviral therapy dramatically reduces transmission of HIV to sexual partners

Antiretroviral therapy for the prevention of HIV-1 transmission.

Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR. N Engl J Med. 2016 Jul 18. [Epub ahead of print]

Background: An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission.

Methods: We randomly assigned 1763 index participants to receive either early or delayed ART. In the early-ART group, 886 participants started therapy at enrollment (CD4+ count, 350 to 550 cells per cubic millimeter). In the delayed-ART group, 877 participants started therapy after two consecutive CD4+ counts fell below 250 cells per cubic millimeter or if an illness indicative of the acquired immunodeficiency syndrome (i.e., an AIDS-defining illness) developed. The primary study end point was the diagnosis of genetically linked HIV-1 infection in the previously HIV-1-negative partner in an intention-to-treat analysis.

Results: Index participants were followed for 10,031 person-years; partners were followed for 8509 person-years. Among partners, 78 HIV-1 infections were observed during the trial (annual incidence, 0.9%; 95% confidence interval [CI], 0.7 to 1.1). Viral-linkage status was determined for 72 (92%) of the partner infections. Of these infections, 46 were linked (3 in the early-ART group and 43 in the delayed-ART group; incidence, 0.5%; 95% CI, 0.4 to 0.7) and 26 were unlinked (14 in the early-ART group and 12 in the delayed-ART group; incidence, 0.3%; 95% CI, 0.2 to 0.4). Early ART was associated with a 93% lower risk of linked partner infection than was delayed ART (hazard ratio, 0.07; 95% CI, 0.02 to 0.22). No linked infections were observed when HIV-1 infection was stably suppressed by ART in the index participant.

Conclusions: The early initiation of ART led to a sustained decrease in genetically linked HIV-1 infections in sexual partners. (Funded by the National Institute of Allergy and Infectious Diseases; HPTN 052 ClinicalTrials.gov number, NCT00074581.).

Abstract access

Editor’s notes: The HPTN 052 trial has been a landmark study in establishing antiretroviral therapy as a strategy for preventing onward transmission of HIV. It was a study of more than 800 couples. More than half of the couples were in African countries. In each couple, one sexual partner was HIV positive and the other HIV negative.  The participants living with HIV were randomised either to receive immediate antiretroviral therapy or to delay until their CD4 count fell to 350, an approved approach at that time. The HIV negative partners were then monitored for acquisition of HIV.  When new HIV infections occurred, the virus was studied for genetic similarity to the virus of the known positive partner. The interim analysis was published in 2011.  It illustrated the programme to be so effective that the randomisation was ended and all the participants living with HIV were offered antiretroviral therapy. 

This article presents data after five years of follow-up, and if anything the results are even more remarkable. In more than 10 000 person-years of follow up, there were only eight transmissions of genetically linked virus from participants receiving antiretroviral therapy. Of these transmissions, four occurred early in treatment when the viral load would not be expected to be suppressed.  The other four occurred after treatment failure. In this enormous study, there were therefore no linked transmissions from participants who were stable on treatment without detectable viraemia. The study provides powerful support for the UNAIDS 90-90-90 treatment target.  The widest possible effective use of antiretroviral therapy will not only improve the health of people treated but could have a dramatic effect on new HIV infections.

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Getting to 90-90-90 in China: where are the gaps?

Disparities in HIV care along the path from infection to viral suppression: a cross-sectional study of HIV/AIDS patient records in 2013, Shandong province, China.

Zhang N, Bussell S, Wang G, Zhu X, Yang X, Huang T, Qian Y, Tao X, Kang D, Wang N. Clin Infect Dis. 2016 Jul 1;63(1):115-21. doi: 10.1093/cid/ciw190. Epub 2016 Mar 29.

Background: The 90-90-90 targets recommended by the Joint United Nations Programme on HIV/AIDS require strengthening human immunodeficiency virus (HIV) care, which includes diagnosis, linkage to and retention in care, assessment for treatment suitability, and optimization of HIV treatment. We sought to quantify patient engagement along the continuum, 10 years after introduction of Chinese HIV care policies.

Methods: We included patients from Shandong, China, who were diagnosed with HIV from 1992 to 2013. Records were obtained from the HIV/AIDS Comprehensive Response Information Management System to populate a 7-step HIV care continuum. Pearson chi2 test and multivariate logistic regression were used for analysis.

Results: Of 6500 estimated HIV-infected persons, 60.1% were diagnosed, of whom 41.9% received highly active antiretroviral therapy (HAART). Only 59.6% of patients on HAART and 15% of all infected persons achieved viral suppression. Children infected by mother-to-child transmission (MTCT) and persons infected by intravenous drug use were less likely to be linked to and retained in care (odds ratio [OR], 0.33 [95% confidence interval {CI}, .14-.80] and OR, 0.58 [95% CI, .40-.90], respectively). Persons tested in custodial institutions were substantially less likely to be on HAART (OR, 0.22 [95% CI, .09-.59]) compared with those tested in medical facilities. Patients on HAART infected by homosexual or heterosexual transmission and those infected by MTCT were less likely to achieve viral suppression (OR, 0.18 [95% CI, .09-.34]; OR, 0.12 [95% CI, .06-.22]; OR, 0.07 [95% CI, .02-.20], respectively).

Conclusions: Our report suggests, at the current rate, Shandong Province has to accelerate HIV care efforts to close disparities in HIV care and achieve the 90-90-90 goals equitably.

Abstract access

Editor’s notes: The UNAIDS treatment target set for 2020 aim for at least 90 percent of all people living with HIV to be diagnosed, at least 90 percent of people diagnosed to receive antiretroviral therapy, and for treatment to be effective and consistent enough in at least 90 percent of those people on treatment to suppress the virus. This would result in about 73% of all people living with HIV being virally suppressed.

This study estimated coverage of HIV diagnosis, antiretroviral treatment and viral suppression in Shandong Province in 2013, 10 years after the introduction of a Chinese HIV care policy.

The authors found that overall, only about 60% of people on ART and 15% of all people living with HIV achieved viral suppression (defined in this analysis as having a viral load of less than HIV RNA 50 copies per mL). This is in sharp contrast with recently published figures from Botswana where 97% of people on ART, and about 70% of persons living with HIV were virally suppressed (there defined as having a viral load of less than 400 copies per mL).

With only 15% of persons with HIV being virally suppressed in Shandong Province, a big gap remains for reaching the UNAIDS target of 73%. The authors demonstrate that despite a free, inclusive, nationwide HIV care policy, significant inequalities in HIV testing and treatment exist in Shandong Province. For example people who inject drugs and people in custodial institutions were much less likely to be initiated on ART.

The authors conclude that to achieve the 90-90-90 UNAIDS treatment target, Shandong Province needs to close these disparities in HIV care. 

Asia
China
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Showing they care: lay-counsellors, home-based testing and the value of follow-up support

How home HIV testing and counselling with follow-up support achieves high testing coverage and linkage to treatment and prevention: a qualitative analysis from Uganda.

Ware NC, Wyatt MA, Asiimwe S, Turyamureeba B, Tumwesigye E, van Rooyen H, Barnabas RV, Celum CL. J Int AIDS Soc. 2016 Jun 28;19(1):20929. doi: 10.7448/IAS.19.1.20929. eCollection 2016.

Introduction: The successes of HIV treatment scale-up and the availability of new prevention tools have raised hopes that the epidemic can finally be controlled and ended. Reduction in HIV incidence and control of the epidemic requires high testing rates at population levels, followed by linkage to treatment or prevention. As effective linkage strategies are identified, it becomes important to understand how these strategies work. We use qualitative data from The Linkages Study, a recent community intervention trial of community-based testing with linkage interventions in sub-Saharan Africa, to show how lay counsellor home HIV testing and counselling (home HTC) with follow-up support leads to linkage to clinic-based HIV treatment and medical male circumcision services.

Methods: We conducted 99 semi-structured individual interviews with study participants and three focus groups with 16 lay counsellors in Kabwohe, Sheema District, Uganda. The participant sample included both HIV+ men and women (N=47) and HIV-uncircumcised men (N=52). Interview and focus group audio-recordings were translated and transcribed. Each transcript was summarized. The summaries were analyzed inductively to identify emergent themes. Thematic concepts were grouped to develop general constructs and framing propositional statements.

Results: Trial participants expressed interest in linking to clinic-based services at testing, but faced obstacles that eroded their initial enthusiasm. Follow-up support by lay counsellors intervened to restore interest and inspire action. Together, home HTC and follow-up support improved morale, created a desire to reciprocate, and provided reassurance that services were trustworthy. In different ways, these functions built links to the health service system. They worked to strengthen individuals' general sense of capability, while making the idea of accessing services more manageable and familiar, thus reducing linkage barriers.

Conclusions: Home HTC with follow-up support leads to linkage by building "social bridges," interpersonal connections established and developed through repeated face-to-face contact between counsellors and prospective users of HIV treatment and male circumcision services. Social bridges link communities to the service system, inspiring individuals to overcome obstacles and access care.

Abstract  Full-text [free] access 

Editor’s notes: How can people be encouraged once they have received a positive HIV-test result to link and stay in treatment? This is a crucial question as the momentum for everyone living with HIV to be on antiretroviral therapy grows.  The authors of this paper demonstrate clearly and succinctly the value of personal contact in supporting people to test and the link to care. Lay-counsellors paying visits to people’s homes provided the encouragement to help some people to link to care. The home visits were seen by people visited as a sign that ‘someone cared’.  The personal attention and information provided promoted trust. The visits also created a sense of obligation: the person visited felt they should do something in return to please the counsellor.

Increasing numbers of people living with HIV does not necessarily mean that it is easier for someone coping with a positive-test result to link to care. We should not underestimate the continued burden that an HIV-positive test result places on individuals.  Many barriers remain both to testing and sustaining a link to care. The authors of this paper provide examples of how to overcome some of those barriers. However, while this paper provides encouraging findings on the value of the home-based activity, the findings also pose a challenge. Can such follow-up support services, which demand more than a single visit, be provided widely enough to benefit all people who need such attention and support? 

Africa
Uganda
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Patient navigators and financial incentives have no effect on HIV viral suppression in people with substance use disorders

Effect of patient navigation with or without financial incentives on viral suppression among hospitalized patients with HIV infection and substance use: a randomized clinical trial.  

Metsch LR, Feaster DJ, Gooden L, Matheson T, Stitzer M, Das M, Jain MK, Rodriguez AE, Armstrong WS, Lucas GM, Nijhawan AE, Drainoni ML, Herrera P, Vergara-Rodriguez P, Jacobson JM, Mugavero MJ, Sullivan M, Daar ES, McMahon DK, Ferris DC, Lindblad R, VanVeldhuisen P, Oden N, Castellon PC, Tross S, Haynes LF, Douaihy A, Sorensen JL, Metzger DS, Mandler RN, Colfax GN, del Rio C. JAMA. 2016 Jul 12;316(2):156-70. doi: 10.1001/jama.2016.8914.

Importance: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates.

Objective: To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients.

Design, setting, and participants: From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months.

Interventions: Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment.

Main outcomes and measures: The primary outcome was HIV viral suppression (200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up.

Results: Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68).

Conclusions and relevance: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01612169.

Abstract access

Editor’s notes: Substance use in people living with HIV has consistently been shown to be associated with poor clinical outcomes. Within this population, management often requires a combination of treatment for both HIV and substance use disorders. It is evident that it is the poor engagement in one or both of these treatment approaches that contributes significantly to poor clinical outcomes. The author’s group aimed to fill a gap in current evidence and explore whether two activities, patient navigation and financial incentives, could potentially motivate engagement with both treatment approaches and ultimately improve HIV viral suppression.

This study tested, among people living with HIV in hospital,  with substance use disorders, six months of patient navigation alone (care co-ordination and case management), or six months of patient navigation alongside a financial incentive plan. While overall uptake and retention to the programme schedules were high, no differences in HIV-1 viral suppression rates (which were generally poor) or death by 12 months were noted.

One factor that must be highlighted is that the participation in actual substance use treatment programmes post hospital discharge was low across all groups (average 24.8%), primarily due to a lack of available services in the regions. It may be that the programme may have been more effective in a different population of people already established in substance use treatment programmes, or if treatment had been more easily accessible.

The study serves as a reminder that such key populations are extremely vulnerable with a number of comorbidities and competing priorities. While not supporting health care navigation or financial incentives in their defined setting, the study findings emphasise a need to develop and tailor, cost-effective activities to improve health outcomes in this group.

Northern America
United States of America
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The HIV prevention cascade – a new approach to guide HIV prevention programmes

Providing a conceptual framework for HIV prevention cascades and assessing feasibility of empirical measurement with data from east Zimbabwe: a case study.

Garnett GP, Hallett TB, Takaruza A, Hargreaves J, Rhead R, Warren M, Nyamukapa C, Gregson S. Lancet HIV. 2016 Jul;3(7):e297-306. doi: 10.1016/S2352-3018(16)30039-X.

Background: The HIV treatment cascade illustrates the steps required for successful treatment and is a powerful advocacy and monitoring tool. Similar cascades for people susceptible to infection could improve HIV prevention programming. We aim to show the feasibility of using cascade models to monitor prevention programmes.

Methods: Conceptual prevention cascades are described taking intervention-centric and client-centric perspectives to look at supply, demand, and efficacy of interventions. Data from two rounds of a population-based study in east Zimbabwe are used to derive the values of steps for cascades for voluntary medical male circumcision (VMMC) and for partner reduction or condom use driven by HIV testing and counselling (HTC).

Findings: In 2009 to 2011 the availability of circumcision services was negligible, but by 2012 to 2013 about a third of the population had access. However, where it was available only 12% of eligible men sought to be circumcised leading to an increase in circumcision prevalence from 3.1% to 6.9%. Of uninfected men, 85.3% did not perceive themselves to be at risk of acquiring HIV. The proportions of men and women tested for HIV increased from 27.5% to 56.6% and from 61.1% to 79.6%, respectively, with 30.4% of men tested self-reporting reduced sexual partner numbers and 12.8% reporting increased condom use.

Interpretation: Prevention cascades can be populated to inform HIV prevention programmes. In eastern Zimbabwe programmes need to provide greater access to circumcision services and the design and implementation of associated demand creation activities. Whereas, HTC services need to consider how to increase reductions in partner numbers or increased condom use or should not be considered as contributing to prevention services for the HIV-negative adults.

Abstract  Full-text [free] access 

Editor’s notes: UNAIDS has set an ambitious goal of reducing new adult HIV infections below 500 000 per year by 2020. Achieving this goal relies on increased coverage of primary HIV prevention programmes, including pre-exposure prophylaxis and voluntary medical male circumcision (VMMC). The HIV treatment cascade is a well known tool to monitor the performance of services for people living with HIV, and to identify gaps in care. An HIV prevention cascade could provide a similarly useful tool to inform prevention programmes. The tool would define the steps necessary for an effective HIV prevention programme, estimating the proportion of people lost at each step, and hence identifying the barriers to effective HIV prevention in populations. The authors propose a framework for HIV prevention cascades, differentiating between availability, uptake, adherence, and efficacy.  The framework would estimate the proportion of the population protected by a given strategy or combination of strategies. Population survey data from rural Zimbabwe are used to illustrate the prevention cascade for VMMC and behaviour change driven by HIV testing and counselling (HTC). These data are used to highlight the barriers impacting on reducing HIV incidence. As the authors acknowledge, there are limitations to the cascade approach for HIV prevention. The cascade is more difficult to define and to estimate for HIV prevention than for HIV treatment. In order for the cascade to be useful, it is necessary to have a good understanding of who is at risk of acquiring HIV.  However, the prevention needs of HIV negative adults change over time as people move in and out of risk. Although the authors illustrate the use of the cascade for an individual programme, it is more difficult to assess the combined effect of several prevention strategies. Still, the cascade approach may provide a useful tool to help guide HIV prevention efforts, by identifying gaps and prioritising areas for action.

Africa
Zimbabwe
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Research on intimate partner violence prevention - complex ethical issues

Ethical challenges of randomized violence intervention trials: examining the SHARE intervention in Rakai, Uganda.

Wagman JA, Paul A, Namatovu F, Ssekubugu R, Nalugoda F. Psychol Violence. 2016 Jul;6(3):442-451.

Objective: We identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda.

Methods: Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs.

Results: Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial.

Conclusion: Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.

Abstract access

Editor’s notes: Data from 81 countries indicate that 30% of women aged 15 and above have experienced physical and/or sexual intimate partner violence in their lifetime. Settings with the highest intimate partner violence prevalence were found to be in sub-Saharan Africa, the region most affected by HIV.  Intimate partner violence is now widely accepted to be both a precursor to and sequelae of HIV infection. In response, a growing number of combination intimate partner violence and HIV prevention programmes have been implemented and systematically evaluated through randomised trials. The authors of this paper discuss some of the practical, ethical and safety challenges introduced by randomised trials on violence prevention, drawing on experience from a project in rural Uganda.

International guidelines have been established for the ethical conduct of biomedical research involving human subjects. The subject of violence against women and the method of randomised controlled trials are not easily resolved with these standard guidelines. In response, specialised recommendations for conducting safe and ethical population-based survey research on violence against women have been developed. These guidelines are an important development, but randomised trials to evaluate intimate partner violence prevention programmes face practical challenges in responding to common research ethics and safety considerations. These include: what to offer control communities in a trial investigating the optimal delivery approach for an activity likely to be effective in a setting with no standard of care. This needs to be done while maintaining the integrity of the study.

Drawing from their experience of the SHARE trial in the Rakai District in Uganda, the authors offer three reflections from lessons learned. (1) Ongoing need to formally update programmes that address multiple and overlapping vulnerabilities of individuals experiencing intimate partner violence and at risk of, or living with, HIV. (2) Cluster-randomised trials are a promising approach for programme evaluation but introduce numerous challenges with practical and ethical implications. (3) Given widespread underreporting of intimate partner violence, evaluation of violence programmes may have particularly high levels of unanticipated demand. The authors advocate for a framework of relevant considerations to be developed to guide researchers working on activities to reduce intimate partner violence. These guidelines should address potentially common challenges. They also encourage researchers to share field lessons arising from their studies in order to a) contribute to the development of this framework b) for revising and improving guidelines for the ethical conduct of intimate partner violence programmes in low resource settings.

Africa
Uganda
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Viral load testing is more cost-effective than CD4 testing

Laboratory monitoring of antiretroviral therapy for HIV infection: cost-effectiveness and budget impact of current and novel strategies.

Ouattara EN, Robine M, Eholie SP, MacLean RL, Moh R, Losina E, Gabillard D, Paltiel AD, Danel C, Walensky RP, Anglaret X, Freedberg KA. Clin Infect Dis. 2016 Jun 1;62(11):1454-62. doi: 10.1093/cid/ciw117. Epub 2016 Mar 1.

Background: Optimal laboratory monitoring of antiretroviral therapy (ART) for human immunodeficiency virus (HIV) remains controversial. We evaluated current and novel monitoring strategies in Cote d'Ivoire, West Africa.

Methods: We used the Cost-Effectiveness of Preventing AIDS Complications -International model to compare clinical outcomes, cost-effectiveness, and budget impact of 11 ART monitoring strategies varying by type (CD4 and/or viral load [VL]) and frequency. We included "adaptive" strategies (biannual then annual monitoring for patients on ART/suppressed). Mean CD4 count at ART initiation was 154/µL. Laboratory test costs were CD4=$11 and VL=$33. The standard of care (SOC; biannual CD4) was the comparator. We assessed cost-effectiveness relative to Cote d'Ivoire's 2013 per capita GDP ($1500).

Results: Discounted life expectancy was 16.69 years for SOC, 16.97 years with VL confirmation of immunologic failure, and 17.25 years for adaptive VL. Mean time on failed first-line ART was 3.7 years for SOC and <0.9 years for all routine/adaptive VL strategies. VL failure confirmation was cost-saving compared with SOC. Adaptive VL had an incremental cost-effectiveness ratio (ICER) of $4100/year of life saved compared with VL confirmation and increased the 5-year budget by $310/patient compared with SOC. Adaptive VL achieved an ICER <1x GDP if second-line ART and VL costs simultaneously decreased to $156 and $13, respectively.

Conclusions: VL confirmation of immunologic failure is more effective and less costly than CD4 monitoring in Cote d'Ivoire. Adaptive VL monitoring reduces time on failing ART, is cost-effective, and should become standard in Cote d'Ivoire and similar settings.

Abstract access 

Editor’s notes: Monitoring whether or not people are able to effectively use HIV antiretroviral therapy (ART) to supress viral load is important to maintaining individual and population health. There are two ways to monitor whether or not people are able to adhere to ART, assessing CD4 cell count or viral load. These tests require different amounts of expensive laboratory resources. This paper explores 11 ways in which ART regimens can be monitored in Cote d’Ivoire to assess the potential impact and cost-effectiveness of different strategies compared to current care (twice-yearly CD4 tests). The authors estimate that adding viral load failure confirmation to current practice would be cost saving. Adaptive viral load monitoring is found to be cost-effective. This approach involves decreasing monitoring from twice-annually to annually among people who present with suppressed viral loads for one year. In many countries, viral load monitoring is not generally available. This research is important because it illustrates that viral load monitoring strategies can be cost saving compared to CD4 counts, in line with WHO recommendations. 

Africa
Côte d'Ivoire
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Improved survival with lymphoma in the antiretroviral therapy era

Evolution of HIV-associated lymphoma over 3 decades.

Ramaswami R, Chia G, Dalla Pria A, Pinato DJ, Parker K, Nelson M, Bower M. J Acquir Immune Defic Syndr. 2016 Jun 1;72(2):177-83. doi: 10.1097/QAI.0000000000000946.

Introduction: The emergence of combined antiretroviral therapy (cART) and improvements in the management of opportunistic infections have altered the HIV epidemic over the last 30 years. We aimed to assess changes to the biology and outcomes of HIV-associated lymphomas over this period at the national center for HIV oncology in the United Kingdom.

Methods: Clinical characteristics at lymphoma diagnosis have been prospectively collected since 1986, along with details of lymphoma treatment and outcomes. The clinical features and outcomes were compared between 3 decades: pre-cART decade (1986-1995), early-cART decade (1996-2005), and late-cART decade (2006-2015).

Results: A total of 615 patients with HIV-associated lymphoma were included in the study: 158 patients in the pre-cART era, 200 patients in the early-cART era, and 257 patients in the late-cART era. In more recent decades, patients were older (P < 0.0001) and had higher CD4 cell counts (P < 0.0001) at lymphoma diagnosis. Over time, there has also been a shift in lymphoma histological subtypes, with an increase in lymphoma subtypes associated with moderate immunosuppression. The overall survival for patients with HIV-associated lymphoma has dramatically improved over the 3 decades (P < 0.0001).

Conclusion: Over the last 30 years, the clinical demographic of HIV-associated lymphomas has evolved, and the outcomes have improved.

Abstract access

Editor’s notes: Lymphomas are the second most common malignancy after Kaposi’s sarcoma among people living with HIV in Europe, Australia and northern America. This study examined how the biology and rates of survival have changed since combination antiretroviral therapy (cART) became available.

People living with HIV and diagnosed with lymphoma over the past thirty years in a specialist oncology centre in the United Kingdom were included in the study. The mean age at diagnosis of lymphoma increased over time, most likely reflecting improvement in life expectancy with cART. As would be expected, the mean CD4 count and the proportion of people with a suppressed viral load at lymphoma diagnosis increased, while proportion with an AIDS-defining illness before lymphoma diagnosis declined significantly.  

This study demonstrated a shift of the histological subtypes of lymphoma that are associated with less severe immunosuppression, for example the proportion of primary CNS lymphoma (PCNSL) and diffuse large B-cell lymphoma (DLBCL), which are associated with severe immunosuppression, declined, while the proportion of Burkitt’s lymphoma and Hodgkin’s lymphoma (associated with less profound immunosuppression) increased.

A key finding of this study was the significantly improved overall survival of people with lymphoma. The improved survival is not explained by changes in histological subtypes of lymphoma over time, as improvement in prognosis was observed for each histological subtype. The substantial improvement in overall survival is attributable to a number of factors. They include the availability of cART, attention to opportunistic infection prophylaxis, improved supportive care for people undergoing lymphoma treatment as well as improved modalities of lymphoma treatment. Such modalities include efficacious drugs that can be safely co-administered with cART, e.g., rituximab, novel agents and use of autologous stem cell transplants.  

Europe
United Kingdom
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Ending deaths in people with TB and HIV – still some way to go

High mortality in tuberculosis patients despite HIV interventions in Swaziland.

Mchunu G, van Griensven J, Hinderaker SG, Kizito W, Sikhondze W, Manzi M, Dlamini T, Harries AD. Public Health Action. 2016 Jun 21;6(2):105-10. doi: 10.5588/pha.15.0081.

Setting: All health facilities providing tuberculosis (TB) care in Swaziland.

Objective: To describe the impact of human immunodeficiency virus (HIV) interventions on the trend of TB treatment outcomes during 2010-2013 in Swaziland; and to describe the evolution in TB case notification, the uptake of HIV testing, antiretroviral therapy (ART) and cotrimoxazole preventive therapy (CPT), and the proportion of TB-HIV co-infected patients with adverse treatment outcomes, including mortality, loss to follow-up and treatment failure.

Design: A retrospective descriptive study using aggregated national TB programme data.

Results: Between 2010 and 2013, TB case notifications in Swaziland decreased by 40%, HIV testing increased from 86% to 96%, CPT uptake increased from 93% to 99% and ART uptake among TB patients increased from 35% to 75%. The TB-HIV co-infection rate remained around 70% and the proportion of TB-HIV cases with adverse outcomes decreased from 36% to 30%. Mortality remained high, at 14-16%, over the study period, and anti-tuberculosis treatment failure rates were stable over time (<5%).

Conclusion: Despite high CPT and ART uptake in TB-HIV patients, mortality remained high. Further studies are required to better define high-risk patient groups, understand the reasons for death and design appropriate interventions.

Abstract  Full-text [free] access 

Editor’s notes: This article adds to the body of evidence describing a reduction in TB case notifications at national level at a time of increasing coverage of antiretroviral therapy. Despite the apparent strengthening of the HIV treatment cascade in people with TB, mortality remained high. Around one in seven people with TB and HIV died during TB treatment, and additional deaths may have occurred in people lost to follow-up or with no outcome evaluation.

This analysis using aggregated data does not allow for detailed understanding of why people with TB and HIV died. The authors raise a number of important questions arising from these results. To achieve World Health Organization End TB target of reducing TB deaths by 90% by 2030, we need to understand where to focus resources for maximum impact.

Although not the focus of this paper, it is notable that there appeared to be a relatively stable TB case notification rate in HIV negative people across the four-year study period. This is a reminder that although TB/HIV programmes may be the key to reducing TB mortality, broader population-level programmes to interrupt TB transmission will be required to drive down TB incidence rates.           

Africa
Swaziland
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