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Contraceptive method considerations for clients with HIV including those on ART: provider reference tool.
[Washington, D.C.], FHI 360, 2017 Nov. 2 p.This is an at-a-glance resource for clinical providers to determine whether clients with HIV, including those on antiretroviral therapy (ART), may initiate or continue using common contraceptive methods. This chart is based on the World Health Organization's Medical Eligibility Criteria for Contraceptive Use (2016). The tool provides foundational information for clinical providers on how the effectiveness of different types of hormonal contraceptive methods is affected by interaction with antiretroviral drugs. It also provides guidance on how to promote informed decision-making and help women with HIV who are taking antiretroviral drugs use their chosen hormonal contraceptive method successfully.
Has the phasing out of stavudine in accordance with changes in WHO guidelines led to a decrease in single-drug substitutions in first-line antiretroviral therapy for HIV in sub-Saharan Africa?
AIDS. 2017 Jan 2; 31(1):147-157.OBJECTIVE: We assessed the relationship between phasing out stavudine in first-line antiretroviral therapy (ART) in accordance with WHO 2010 policy and single-drug substitutions (SDS) (substituting the nucleoside reverse transcriptase inhibitor in first-line ART) in sub-Saharan Africa. DESIGN: Prospective cohort analysis (International epidemiological Databases to Evaluate AIDS-Multiregional) including ART-naive, HIV-infected patients aged at least 16 years, initiating ART between January 2005 and December 2012. Before April 2010 (July 2007 in Zambia) national guidelines called for patients to initiate stavudine-based or zidovudine-based regimen, whereas thereafter tenofovir or zidovudine replaced stavudine in first-line ART. METHODS: We evaluated the frequency of stavudine use and SDS by calendar year 2004-2014. Competing risk regression was used to assess the association between nucleoside reverse transcriptase inhibitor use and SDS in the first 24 months on ART. RESULTS: In all, 33 441 (8.9%; 95% confience interval 8.7-8.9%) SDS occurred among 377 656 patients in the first 24 months on ART, close to 40% of which were amongst patients on stavudine. The decrease in SDS corresponded with the phasing out of stavudine. Competing risks regression models showed that patients on tenofovir were 20-95% less likely to require a SDS than patients on stavudine, whereas patients on zidovudine had a 75-85% decrease in the hazards of SDS when compared to stavudine. CONCLUSION: The decline in SDS in the first 24 months on treatment appears to be associated with phasing out stavudine for zidovudine or tenofovir in first-line ART in our study. Further efforts to decrease the cost of tenofovir and zidovudine for use in this setting is warranted to substitute all patients still receiving stavudine.
Allocation of antiretroviral drugs to HIV-infected patients in Togo: Perspectives of people living with HIV and healthcare providers.
Journal of Medical Ethics. 2017 Dec; 43(12):845-851.Aim To explore the way people living with HIV and healthcare providers in Togo judge the priority of HIV-infected patients regarding the allocation of antiretroviral drugs. Method From June to September 2015, 200 adults living with HIV and 121 healthcare providers living in Togo were recruited for the study. They were presented with stories of a few lines depicting the situation of an HIV-infected patient and were instructed to judge the extent to which the patient should be given priority for antiretroviral drugs. The stories were composed by systematically varying the levels of four factors: (a) the severity of HIV infection, (b) the financial situation of the patient, (c) the patient's family responsibilities and (d) the time elapsed since the first consultation. Results Five clusters were identified: 65% of the participants expressed the view that patients who are poor and severely sick should be treated as a priority, 13% prioritised treatment of patients who are poor and parents of small children, 12% expressed the view that the poor should be treated as a priority, 4% preferred that the sickest be treated as a priority and 6% wanted all patients to get treatment. Conclusions WHO's guideline regarding antiretroviral therapy allocation (the sickest first as the sole criterion) currently in use in many African countries does not reflect the preferences of Togolese people living with HIV. For most HIV-infected patients in Togo, patients who cannot get treatment on their own should be treated as a priority.
Geneva, Switzerland, WHO, 2015 Nov. 2 p. (Pre-Exposure Prophylaxis (PrEP); Policy Brief)This policy brief defines PrEP, presents the World Health Organization's current recommendations for PrEP use and the evidence for it, discusses PrEP's expected cost-effectiveness, and lists considerations for PrEP implementation.
[HIV-1 resistance to antiretroviral drugs in pregnant women from Buenos Aires metropolitan area] Resistencia de HIV-1 a drogas antirretrovirales en gestantes del area Metropolitana de Buenos Aires.
Medicina. 2016; 76(6):349-354.The study aimed to determine the prevalence of antiretroviral resistance associated mutations in HIV-1 infected pregnant woman treated in Buenos Aires metropolitan area (period 2008-2014). A total of 136 women with viral load = 500 copies/ml were included: 77 (56.6%) were treatment-naive and 59 (43.4%) were antiretroviral-experienced patients either with current (n: 24) or previous (n = 35) antiretroviral therapy. Genotypic baseline resistance was investigated in plasma of antiretroviral-naive patients and antiretroviral-experienced patients. The resistance mutations were identified according to the lists of the World Health Organization and the International Antiviral Society, respectively. Frequencies of resistance associated mutations detected in 2008-2011 and 2012-2014 were compared. A total of 37 (27.2%) women presented at least one resistance associated mutation: 25/94 (26.5%) in 2008-2011 and 12/42 (28.5%) in 2012-2014 (p > 0.05). Among naives, 15 (19.5%) had at least one mutation: 10/49 (20.4%) in the period 2008-2011 and 5/28 (17.8%) in 2012-2014 (p > 0.05). The resistance mutations detected in naives were associated with non nucleoside reverse transcriptase inhibitors, being K103N the most common mutation in both periods. In antiretroviral experienced patients, 22/59 (37.3%) had at least one resistance mutation. This study demonstrates a high frequency of resistance associated mutations which remained stable in the period analyzed. These levels suggest an increased circulation of HIV-1 antiretroviral resistant strains in our setting compared to previous reports from Argentina.
Projected Uptake of New Antiretroviral (ARV) Medicines in Adults in Low- and Middle-Income Countries: A Forecast Analysis 2015-2025.
PloS One. 2016; 11(10):e0164619.With anti-retroviral treatment (ART) scale-up set to continue over the next few years it is of key importance that manufacturers and planners in low- and middle-income countries (LMICs) hardest hit by the HIV/AIDS pandemic are able to anticipate and respond to future changes to treatment regimens, generics pipeline and demand, in order to secure continued access to all ARV medicines required. We did a forecast analysis, using secondary WHO and UNAIDS data sources, to estimate the number of people living with HIV (PLHIV) and the market share and demand for a range of new and existing ARV drugs in LMICs up to 2025. UNAIDS estimates 24.7 million person-years of ART in 2020 and 28.5 million person-years of ART in 2025 (24.3 million on first-line treatment, 3.5 million on second-line treatment, and 0.6 million on third-line treatment). Our analysis showed that TAF and DTG will be major players in the ART regimen by 2025, with 8 million and 15 million patients using these ARVs respectively. However, as safety and efficacy of dolutegravir (DTG) and tenofovir alafenamide (TAF) during pregnancy and among TB/HIV co-infected patients using rifampicin is still under debate, and ART scale-up is predicted to increase considerably, there also remains a clear need for continuous supplies of existing ARVs including TDF and EFV, which 16 million and 10 million patients-respectively-are predicted to be using in 2025. It will be important to ensure that the existing capacities of generics manufacturers, which are geared towards ARVs of higher doses (such as TDF 300mg and EFV 600mg), will not be adversely impacted due to the introduction of lower dose ARVs such as TAF 25mg and DTG 50mg. With increased access to viral load testing, more patients would be using protease inhibitors containing regimens in second-line, with 1 million patients on LPV/r and 2.3 million on ATV/r by 2025. However, it will remain important to continue monitoring the evolution of ARV market in LMICs to guarantee the availability of these medicines.
Lancet. 2016 Nov 26; 388(10060):2579.Add to my documents.
Expert Review of Clinical Pharmacology. 2016 Aug 22; 9(11):1493-1503.Introduction: WHO recommends tenofovir, efavirenz, and lamivudine or emtricitabine for first-line antiretroviral therapy (ART) in adults, which replaced more toxic regimens using stavudine, zidovudine or nevirapine. Areas covered: We searched Pubmed to identify observational studies and randomized controlled trials reporting toxicity of these antiretrovirals published between 2011 and 2016, and hand-searched abstracts presented at major HIV conferences in 2015 and 2016, focusing on data from sub-Saharan Africa. Tenofovir’s nephrotoxicity manifests as mild renal tubular dysfunction (common and of uncertain clinical significance), acute kidney injury (rare), and chronic declining glomerular filtration rate (common). African studies, which include high proportions of patients with renal dysfunction from opportunistic diseases, report population improvement in renal function after starting tenofovir-based ART. Tenofovir modestly decreases bone mineral density, and there is emerging data that this increases fracture risk. Efavirenz commonly causes early self-limiting neuropsychiatric toxicity and hypersensitivity rashes. Recent studies have highlighted its long-term neuropsychiatric effects, notably suicidality and neurocognitive impairment, and metabolic toxicities (dyslipidemia, dysglycemia, and lipoatrophy). We point out the challenges clinicians face in the recognition and attribution of adverse drug reactions. Expert commentary: Tenofovir and efavirenz are generally well tolerated, but both are associated with potentially serious toxicities. Pharmacovigilance systems in resource-limited settings with high HIV burden should be strengthened.
Short Communication: Population-Based Surveillance of HIV-1 Drug Resistance in Cameroonian Adults Initiating Antiretroviral Therapy According to the World Health Organization Guidelines.
AIDS Research and Human Retroviruses. 2016 Apr; 32(4):329-33.With ongoing earlier enrollment on and rapid scale-up of antiretroviral therapy (ART) in Cameroon, there are increasing risks of transmitted HIV drug resistance (HIVDR) at population levels. We, therefore, evaluated the threshold of HIVDR in a population initiating ART, to inform on the effectiveness of first-line regimens, considering HIV-1 diversity, plasma viral load (PVL), and CD4-based disease progression. A total of 53 adults [median (interquartile range, IQR) CD4: 162 cell/mm(3) (48-284); median (IQR) PVL: 5.34 log10 RNA (4.17-6.42) copies/ml] initiating ART in 2014 at the Yaounde Central Hospital were enrolled for HIV-1 protease-reverse transcriptase sequencing. Drug resistance mutations (DRMs) were interpreted using the 2009 World Health Organization (WHO) list versus the Stanford HIVdb algorithm version 7.0. Level of DRMs was low (3.77%) versus moderate (7.55%), respectively, following the WHO list (T69D, K103N) versus Stanford HIVdb (T69D, A98G, K103N, K238T), respectively. Prevailing clade was CRF02_AG (71.70%). Based on Stanford HIVdb, a slightly higher proportion of patients with DRMs were found among ones infected with CRF02_AG than in those non-CRF02_AG infected (7.89% vs. 6.67%, p = 1.000), with lower PVL (7.69% <5.5 vs. 0% >/=5.5 log10 RNA copies/ml, p = .488) and with higher CD4 counts (9.52% CD4 >/=200 vs. 3.33% CD4 <200 cells/mm(3), p = .749). Thresholds of DRMs suggest that standard first-line regimens currently used in Cameroon may remain effective at population levels, despite scale-up of ART in the country, pending adherence, and closed virological monitoring. With an intent-to-diagnose approach, the discrepant levels of DRMs support using Stanford HIVdb to evaluate initial ART, while revising the WHO list for surveillance.
Lancet. 2016 Aug 20; 388(10046):743-4.Add to my documents.
Performance of Risk Charts to Guide Targeted HIV Viral Load Monitoring of ART: Applying the Method on the Data From a Multicenter Study in Rural Lesotho.
Journal of Acquired Immune Deficiency Syndromes. 2016 May 1; 72(1):e22-5.Add to my documents.
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2nd ed.
Geneva, Switzerland, WHO, 2016.  p.These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structured along the continuum of HIV testing, prevention, treatment and care. This edition updates the 2013 consolidated guidelines on the use of antiretroviral drugs following an extensive review of evidence and consultations in mid-2015, shared at the end of 2015, and now published in full in 2016. It is being published in a changing global context for HIV and for health more broadly.
Guideline: Updates on HIV and infant feeding. The duration of breastfeeding and support from health services to improve feeding practices among mothers living with HIV.
Geneva, Switzerland, WHO, 2016.  p.The objective of this guideline is to improve the HIV-free survival of HIV-exposed infants by providing guidance on appropriate infant feeding practices and use of ARV drugs for mothers living with HIV and by updating WHO-related tools and training materials. The guideline is intended mainly for countries with high HIV prevalence and settings in which diarrhoea, pneumonia and undernutrition are common causes of infant and child mortality. However, it may also be relevant to settings with a low prevalence of HIV depending on the background rates and causes of infant and child mortality. This guideline aims to help Member States and their partners in their efforts to make informed decisions on the appropriate nutrition actions to achieve the Sustainable Development Goals, the global targets set in the comprehensive implementation plan on maternal, infant and young child nutrition, the Global Strategy for Women’s, Children’s and Adolescents’ Health (2016-2030) and the Global Health Sector Strategy on Sexually Transmitted Infections 2016-2021. The target audience for this guideline includes: (1) national policy-makers in health ministries; (2) programme managers working in child health, essential drugs and health worker training; (3) health-care providers, researchers and clinicians providing services to pregnant women and mothers living with HIV at various levels of health care; and (4) development partners providing financial and/or technical support for child health programmes, including those in conflict and emergency settings. (Excerpt)
Research gaps identified during the 2014 update of the WHO medical eligibility criteria for contraceptive use and selected practice recommendations for contraceptive use.
Contraception. 2016 Sep; 94(3):195-201.Universal access to safe and effective contraception is an important public health goal. Family planning and prevention of unintended pregnancy are essential to securing the well-being and autonomy of individuals, while supporting the health and development of communities. The World Health Organization (WHO) recently undertook a process to update its global guidance on “who” can use contraception safely and “how” to use contraception safely and effectively to generate the fifth edition of the WHO Medical Eligibility Criteria for Contraceptive Use (MEC) and the third edition of the WHO Selected Practice Recommendations for Contraceptive Use (SPR). Overall, the MEC demonstrates that contraception is remarkably safe for most people; at least one highly effective contraceptive method is assigned a category “1” or “2” across the majority of conditions in the guidance, indicating no restrictions on use or that the advantages of using a particular method generally outweigh the theoretical or proven risks of use. Once a medically appropriate method is identified, the SPR offers critical guidance on safe and effective use, important for contraceptive management and service delivery. The major goal for producing these evidence-based recommendations is to help improve access to and strengthen the quality of family planning services worldwide. While these recommendations reflect a rigorous synthesis and interpretation of the best evidence to date and contribute significantly to medical and public health knowledge around the world, a number of recommendations in both the MEC and SPR are grounded in limited to no direct evidence. In the absence of direct evidence, indirect evidence and expert opinion inform assessments. Each revision of the MEC and SPR offers an opportunity to identify current knowledge gaps and promote research necessary to continually strengthen the guidelines. As part of the most recent revision of these guidelines, a Guideline Development Group convened in March and September 2014 to generate updated recommendations. During these meetings, we identified a number of key research questions for a variety of topics discussed during the technical consultations. The full list of research gaps is included in Table 1, not further prioritized. However, we present three important topics of global relevance to national programs and policies in greater detail: (a) intrauterine device (IUD) initiation among women at high risk for sexually transmitted infections (STIs); (b) bidirectional drug-drug interactions with use of hormonal contraception (HC) and antiretroviral therapy (ART); and (c) initiation of progestogen-containing contraception following use of ulipristal acetate (UPA) emergency contraception. Each section presents some background on the public health importance of the topic and discusses the limitations of existing data and considerations for future rigorous research. [Excerpts].
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: What’s new. Policy brief.
Geneva, Switzerland, WHO, 2015 Nov.  p. (Policy Brief)The 2015 guidelines includes 10 new recommendations to improve the quality and efficiency of services to people living with HIV. Implementation of the recommendations in these guidelines on universal eligibility for ART will mean that more people will start ART earlier. The updated guidelines present both new recommendations and previous WHO guidance. They include clinical recommendations (“the what” of using ARVs for treatment and prevention) and service delivery recommendations to support implementation (“the how” of providing ARVs), organized according to the continuum of HIV testing, prevention, treatment and care. For the first time the guideline includes “good practice statements” on interventions whose benefits substantially outweigh the potential harms.
Geneva, Switzerland, WHO, 2015 Sep.  p. (Guidelines)This early-release guideline makes available two key recommendations that were developed during the revision process in 2015. First, antiretroviral therapy (ART) should be initiated in everyone living with HIV at any CD4 cell count. Second, the use of daily oral pre-exposure prophylaxis (PrEP) is recommended as a prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches. The first of these recommendations is based on evidence from clinical trials and observational studies released since 2013 showing that earlier use of ART results in better clinical outcomes for people living with HIV compared with delayed treatment. The second recommendation is based on clinical trial results confirming the efficacy of the ARV drug tenofovir for use as PrEP to prevent people from acquiring HIV in a wide variety of settings and populations. The recommendations in this guideline will form part of the revised consolidated guidelines on the use of ARV drugs for treating and preventing HIV infection to be published by WHO in 2016. The full update of the guidelines will consist of comprehensive clinical recommendations together with revised operational and service delivery guidance to support implementation.
Geneva, Switzerland, UNAIDS, 2015  p. (UNAIDS 2015 - Reference; UNAIDS / JC2765)Implementing PrEP poses new challenges in planning, managing and funding combination prevention. Realizing the promise of PrEP will require governments, funders, civil society and other stakeholders to join forces to systematically address them–licensing antiretroviral medicines for PrEP use, setting priorities for locations and populations for implementation, making services user-friendly and ensuring adherence. These efforts are worthwhile based on their contribution to achieving the global targets of less than 500 000 people annually acquiring HIV in 2020 and the end of AIDS as a public health threat by 2030.
Antiviral therapy. 2014; 19 Suppl 3:1.Add to my documents.
Simplification of antiretroviral therapy: a necessary step in the public health response to HIV/AIDS in resource-limited settings.
Antiviral therapy. 2014; 19 Suppl 3:31-7.The global scale-up of antiretroviral therapy (ART) over the past decade represents one of the great public health and human rights achievements of recent times. Moving from an individualized treatment approach to a simplified and standardized public health approach has been critical to ART scale-up, simplifying both prescribing practices and supply chain management. In terms of the latter, the risk of stock-outs can be reduced and simplified prescribing practices support task shifting of care to nursing and other non-physician clinicians; this strategy is critical to increase access to ART care in settings where physicians are limited in number. In order to support such simplification, successive World Health Organization guidelines for ART in resource-limited settings have aimed to reduce the number of recommended options for first-line ART in such settings. Future drug and regimen choices for resource-limited settings will likely be guided by the same principles that have led to the recommendation of a single preferred regimen and will favour drugs that have the following characteristics: minimal risk of failure, efficacy and tolerability, robustness and forgiveness, no overlapping resistance in treatment sequencing, convenience, affordability, and compatibility with anti-TB and anti-hepatitis treatments.
WHO Collaborating Centre for Acquired Immunodeficiency Syndrome for the Eastern Mediterranean Regional Office, Faculty of Medicine, Kuwait University, Kuwait.
Medical Principles and Practice. 2014; 23 Suppl 1:47-51.In the early 1980s, the World Health Organization (WHO) designated the Virology Unit of the Faculty of Medicine, Health Sciences Centre, Kuwait University, Kuwait, a collaborating centre for AIDS for the Eastern Mediterranean Regional Office (EMRO), recognizing it to be in compliance with WHO guidelines. In this centre, research integral to the efforts of WHO to combat AIDS is conducted. In addition to annual workshops and symposia, the centre is constantly updating and renewing its facilities and capabilities in keeping with current and latest advances in virology. As an example of the activities of the centre, the HIV-1 RNA viral load in plasma samples of HIV-1 patients is determined by real-time PCR using the AmpliPrep TaqMan HIV-1 test v2.0. HIV-1 drug resistance is determined by sequencing the reverse transcriptase and protease regions on the HIV-1 pol gene, using the TRUGENE HIV-1 Genotyping Assay on the OpenGene(R) DNA Sequencing System. HIV-1 subtypes are determined by sequencing the reverse transcriptase and protease regions on the HIV-1 pol gene using the genotyping assays described above. A fundamental program of Kuwait's WHO AIDS collaboration centre is the national project on the surveillance of drug resistance in human deficiency virus in Kuwait, which illustrates how the centre and its activities in Kuwait can serve the EMRO region of WHO. (c) 2014 S. Karger AG, Basel.
Adoption of national recommendations related to use of antiretroviral therapy before and shortly following the launch of the 2013 WHO consolidated guidelines.
AIDS. 2014 Mar; 28 Suppl 2:S217-24.OBJECTIVE: To determine the status of key national policies on the use of antiretroviral therapy (ART) at the time of the launch of the 2013 WHO consolidated guidelines as well as to track early progress towards adoption of these recommendations following dissemination. DESIGN: Descriptive analysis of global data on baseline ART policies as of June 2013 and early intentions to adopt the 2013 WHO for use of antiretroviral drugs guidelines as of November 2013. METHODS: Compilation of existing global reports on key HIV policies, review of national guidelines, data collection through annual drug procurement surveys and through guidelines dissemination meetings in each of the six WHO regions. RESULTS: Data were available from 124 low- and middle-income countries, including 97% of the 57 high-priority countries that have been identified by WHO and the Joint United Nations Program on HIV/AIDS (UNAIDS). At baseline, only one country reported recommending antiretroviral therapy (ART) at a CD4 T-cell count 250 cells/mul or less for adults and adolescents in 2013, whereas nine countries already recommended using CD4 T-cell count 500 cells/mul or less. Recommendations for ART initiation regardless of CD4 T-cell count for HIV-infected patients with tuberculosis (86%), hepatitis B (75%), all HIV-infected women who were pregnant or breastfeeding (option B+: 40%) or HIV-infected persons in a serodiscordant relationship (26%) had been nationally adopted as of June 2013. Eight of 67 countries (12%) already recommended treating all children less than 5 years of age. The triple antiretroviral combination of tenofovir + lamivudine (or emtricitabine) + efavirenz was recommended as the preferred first-line option for adults and adolescents more frequently (51%) than for pregnant women (38%), or for both adults/adolescents and pregnant women (28%; P < 0.05). Fewer than half (37%) of all countries reported recommending lopinavir/ritonavir for all HIV-infected children less than 3 years of age; 54% of countries reported recommending routine viral load monitoring, whereas only 41% recommended nurse-initiated ART. CONCLUSIONS: A number of key WHO policy recommendations on antiretroviral drug use were adopted rapidly by countries in advance of or shortly following the launch of the 2013 guidelines. Efforts are needed to support and track ongoing policy adoption and ensure that it is accompanied by the scale-up of evidence-based interventions.
Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial.
Trials. 2013; 14:230.BACKGROUND: Antiretroviral therapy (ART) suppresses HIV viral load in all body compartments and so limits the risk of HIV transmission. It has been suggested that ART not only contributes to preventing transmission at individual but potentially also at population level. This trial aims to evaluate the effect of ART initiated immediately after identification/diagnosis of HIV-infected individuals, regardless of CD4 count, on HIV incidence in the surrounding population. The primary outcome of the overall trial will be HIV incidence over two years. Secondary outcomes will include i) socio-behavioural outcomes (acceptability of repeat HIV counselling and testing, treatment acceptance and linkage to care, sexual partnerships and quality of life); ii) clinical outcomes (mortality and morbidity, retention into care, adherence to ART, virologic failure and acquired HIV drug resistance), iii) cost-effectiveness of the intervention. The first phase will specifically focus on the trial's secondary outcomes. METHODS/DESIGN: A cluster-randomised trial in 34 (2 x 17) clusters within a rural area of northern KwaZulu-Natal (South Africa), covering a total population of 34,000 inhabitants aged 16 years and above, of whom an estimated 27,200 would be HIV-uninfected at start of the trial. The first phase of the trial will include ten (2 x 5) clusters. Consecutive rounds of home-based HIV testing will be carried out. HIV-infected participants will be followed in dedicated trial clinics: in intervention clusters, they will be offered immediate ART initiation regardless of CD4 count and clinical stage; in control clusters they will be offered ART according to national treatment eligibility guidelines (CD4 <350 cells/muL, World Health Organisation stage 3 or 4 disease or multidrug-resistant/extensively drug-resistant tuberculosis). Following proof of acceptability and feasibility from the first phase, the trial will be rolled out to further clusters. DISCUSSION: We aim to provide proof-of-principle evidence regarding the effectiveness of Treatment-as-Prevention in reducing HIV incidence at the population level. Data collected from the participants at home and in the clinics will inform understanding of socio-behavioural, economic and clinical impacts of the intervention as well as feasibility and generalizability. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.
BMJ. 2013; 347:f4172.Add to my documents.
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recommendations for a public health approach.
Geneva, Switzerland, WHO, 2013.  p.The 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection provide new guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the care of people living with HIV and the use of antiretroviral (ARV) drugs for treating and preventing HIV infection.
Efavirenz conceptions and regimen management in a prospective cohort of women on antiretroviral therapy.
Infectious Diseases In Obstetrics and Gynecology. 2012; 2012:723096.Use of the antiretroviral drug efavirenz (EFV) is not recommended by the WHO or South African HIV treatment guidelines during the first trimester of pregnancy due to potential fetal teratogenicity; there is little evidence of how clinicians manage EFV-related fertility concerns. Women on antiretroviral therapy (ART) were enrolled into a prospective cohort in four public clinics in Johannesburg, South Africa. Fertility intentions, ART regimens, and pregnancy testing were routinely assessed during visits. Women reporting that they were trying to conceive while on EFV were referred for regimen changes. Kaplan-Meier estimators were used to assess incidence across ART regimens. From the 822 women with followup visits between August 2009-March 2011, 170 pregnancies were detected during study followup, including 56 EFV conceptions. Pregnancy incidence rates were comparable across EFV, nevirapine, and lopinavir/ritonavir person-years (95% 100/users (P=0.25)); incidence rates on EFV were 18.6 Confidence Interval: 14.2-24.2). Treatment substitution from EFV was made for 57 women, due to pregnancy intentions or actual pregnancy; however, regimen changes were not systematically applied across women. High rates of pregnancy on EFV and inconsistencies in treatment management suggest that clearer guidelines are needed regarding how to manage fertility-related issues in. women on EFV-based regimens.