bluuebunny/crossref_metadata_2025_split huggingface dataset:
O08.4 Online Access to Home STI Specimen Collection and E-Prescriptions Linked to Public Health - is a Comparative Effectiveness Trial Feasible?
Authors: Spielberg F , Levy V , Kapur I , Lensing S , Acevedo N , Venkatasubramanian L , Leivermann C , Philip S , Padian N , Gaydos C 
Published: July 2013

BackgroundOnline STI testing and treatment may improve access at lower cost and with higher acceptability than clinic-based services.MethodsWe conducted a demonstration (non-significant-risk medical device) study of an online system for STI education, vaginal specimen collection for chlamydia, gonorrhoea, and trichomonas testing, treatment, and partner notification, in collaboration with 4 San Francisco Bay area health departments. English and Spanish speaking women (18–30 yr) were recruited over 3 months through various methods.ResultsThe website had 6,855 hits with a click through rate of 6.6%(450). Of 256 deemed eligible, 85%(217) enrolled. Among these, 54% (117) had not seen a clinician in the past year and 87%(142) had not had an STI test since last unprotected sex. Among those mailed a kit (213), 67% (143) returned the kit. Of these, 80% (115) of participants accessed test results online the same day results were posted, within 2 days (86%, 122) or by study end (92%, 131). STI prevalence was 5.6% (chlamydia and trichomonas). All STI infected participants received treatment either the same day (75%,6/8) at a pharmacy or within 7 days at a clinic (25%, 2/8). Internet recruitment reached the highest number of participants (100/217, 46%), while advertising on subways reached the highest number of positives (5/8, 63%). Of 106 participants completing follow-up surveys, 98% (104) indicated the site was easy to use and 98% (104) would recommend the project to a friend. No negative outcomes were reported. If participating in a future trial, 94% (100) would prefer an online system over clinic-based care.ConclusionsAn online system for STI testing and treatment appears feasible, and highly acceptable to participants. We recommend a future comparative effectiveness trial to determine whether an online system can increase testing and treatment of STI infections at lower cost and with higher acceptability than clinic-based care.
O08.5 Should All Pregnant Women Be Screened For Chlamydial Infection as Recommended by CDC, or Only Those Younger Than 25 Years as Recommended by USPSTF?
Authors: Tao G , Hoover K 
Published: July 2013

BackgroundIn the United States, chlamydia screening has been recommended for pregnant women of all ages by CDC, and for pregnant women younger than 25 years by USPSTF. The benefits of chlamydia screening are highly dependent on chlamydia prevalence. Very limited evidence, such as age-specific positivity in pregnant women, has been available to support these recommendations. We analysed data from a large commercial laboratory corporation with a substantial share of the U.S. market, with testing in all 50 states, to estimate the positivity of chlamydia among pregnant women.MethodsAmong all chlamydia tests performed at a woman’s first pregnancy-related visit between June 2008 and July 2010, we estimated chlamydia positivity by age, then further stratified by insurance coverage and geographic region.ResultsOf 600,990 pregnant women aged 15–44 years, 61.9% had private insurance and 34.1% had Medicaid coverage; 60.8% resided in the South region; 43.4% were aged 15–24 years, 26.7% 25–29 years, and 19.1% 30–34 years. Chlamydia positivity significantly decreased by age (15–19 years: 10.3%; 20–24 years: 5.6%; 25–29 years: 1.9%; 30–34 years: 0.9%; and 35–44 years: 0.6%). The pattern of decreased age-specific positivity was similar among insurance and region subgroups.ConclusionsOur findings of age-specific positivity, derived from a very large number of tests among pregnant women in the United States, suggest that it is more effective to screen younger pregnant women than older ones. Harmonizing CDC and USPSTF recommendations for pregnant women could be explored by review of age-specific positivity data and estimates of prenatal adverse health outcomes caused by chlamydia (miscarriage, preterm birth, and infant mortality) in order to develop consensus regarding quantitative thresholds of these health outcomes.
O08.6 Do You Have an STI? Findings from a Dedicated Men’s Sexual Health Clinic in Alexandra Township, South Africa
Authors: Lewis D A , Ricketts C , Vezi A , Maseko V 
Published: July 2013

BackgroundA walk-in weekly men’s sexual health clinical service, provided by a male clinical team, was established in 2006.MethodsWe analysed new patient episodes at a dedicated men’s sexual health clinic in Alexandra Township, South Africa over 6 years (2007–2012). STI syndromes were treated immediately and all men were offered urine-based molecular screening forNeisseria gonorrhoeae(NG),Chlamydia trachomatis(CT),Trichomonas vaginalis(TV) andMycoplasma genitalium(MG) infections and serological screening for syphilis. Clinical and laboratory data were analysed using STATATMversion 10.ResultsAmong the 876 new clinical episodes, the most common presentations were genital warts (432, 49.5%), male urethritis syndrome (188, 21.6%) and genital ulceration (82, 9.4%). The proportion of patients attending for genital wart treatment increased over time. Few men (51, 5.9%) presented as sexual contacts. The patients’ peak age range was 25–29 years; only 40 (4.6%) men were < 20 years old. HIV testing history was provided by 871 men: 156/430 (36.3%) men who knew their serostatus were HIV positive but 441 (50.6%) had never tested. Laboratory testing of 822 urine specimens detected 108 (13.1%) NG, 100 (12.2%) CT, 51 (6.2%) TV and 68 (8.3%) MG infections. The syndromic approach alone would not have treated 16 (14.8%) NG, 57 (57.0%) CT, 46 (90.2%) TV and 49 (72.1%) MG infections. NG/CT infections were most prevalent among those aged 18–19 years old (34.5% and 17.2%, respectively); in contrast, TV/MG infections were most prevalent in the 35–39 year old age group (1.7% and 11.8%, respectively). The prevalence of rapid plasma reagin seroreactivity was 2.2%. Overall condom use was 16.9% with regular partners and 52.5% with non-regular partners.ConclusionAsymptomatic STIs, poor clinic attendance by youth, poor uptake of HIV testing by men and low rates of condom use with partners remain challenges for STI management in South Africa.
O09.2 Financing Free and Universal Access to Antiretroviral Drugs in the Long-Run: ART Cost Evolution in Brazil
Authors: Meiners-Chabin C 
Published: July 2013

BackgroundFollowing the international aid crisis, developing country governments have assumed greater financial responsibility in the fight against HIV/AIDS. First-line antiretroviral drugs (ARVs) have become more affordable, yet, assuring lifetime treatment requires the provision of expensive second and third-line therapy. Considering the longterm perspective, this analysis examines ARV mean cost evolution in Brazil and highlights main factors influencing its behaviour.MethodsTransactional data for ARV procurement made by the Brazilian Ministry of Health (BMoH) between 1998 and 2011 were used to calculate mean annual ARV cost, adjusted to 2011 US$. Literature review on ARV price determinants and interviews with BMoH representatives have complemented the analysis.ResultsFrom 1999 to 2003, thanks to local generic production and repeated compulsory licencing threats, total ARV expenditure fell by 56%, despite patient increase of 72%, which led to a 74% decrease in the cost per patient per year. Following the inclusion of third-line ARVs, in 2005, total expenditure peaked at about US$ 460 million (2011 US$) for the treatment of nearly 160,000 patients. Although the compulsory licencing of Efavirenz, in 2007, together with assertive price negotiations on patented drugs led to a significant drop in costs, most recently, as the number of patients continues to increase, local production remains highly uncompetitive, and, new-generation patented drugs are further being incorporated, mean annual cost has recovered speed, reaching values 35% higher than 2003.ConclusionThe downward trend in mean ARV costs reached an inflexion point in 2003, after when limited savings from generic production and originator firm discounts were no longer able to compensate for the incorporation of highly expensive second and third-line ARVs. This finding reinforces patent protection being a major barrier to quality and longterm treatment in developing countries. In the case of Brazil, it further calls for higher efficiency on local production capacity.
O09.3 A Successful Model in Reaching Out Mobile Population to Control the Spread of STI/HIV/AIDS: Experience from Link Worker Scheme Implemented in 200 Villages Mostly Inhibited by Mobile Population in West Bengal, India
Authors: Panda B , Ghosh D , Ishlam A , Kundu R , Mahato M 
Published: July 2013

The fact is that over 57% of the 2.9 million HIV positive people in India live in rural areas. India still has a rural base with 69% of its population living in rural areas. Young migrant workers and other highly mobile population essentially come from villages. Due to rural-urban continuum, rural population is also not lagging behind its urban counterpart in adopting high-risk behaviours.To face the challenge of HIV/AIDS in rural India is even more difficult due to poor literacy rates resulting in poor awareness, mostly engaged in unorganised sector and stigma associated with it.Link Workers Scheme (LWS) implemented in 100 villages each at Purulia & Murshidabad targeting youth, vulnerable and high risk population for prevention of STI/HIV/AIDS and improve service delivery linkages. Murshidabad & Purulia is a vulnerable district due to high migration, interstate border, trafficking, poverty, illiteracy and poor health care. Link Workers have been accepted as frontline development functionaries and are proving to be successful in reaching out to the target population.LWS successfully reached out 4861 HRGs and 146079 vulnerable young men and women in last two years. Referral services to ICTC, STI and TB have increased significantly and a total of about 18500 cases referred to health facilities for testing of HIV, 79% cases actually turned up for testing; more than 7800 STI cases identified, 64% reported; 2700 TB cases identified, 52% reported and utilised the services. About 3860 pregnant women identified in the project area and referred for HIV testing.The link-worker, through a due diligence process, keeps on motivating the person to access HIV/AIDS related services such as HIV testing, treatment of STIs, ART, treatment of opportunistic infections and minimise the gap between beneficiary and service delivery. This need to scalled up to arrest the spread of STI/HIV/AIDS in rural setting.
O09.5 Optimizing Care Efficiency at the STI Clinic: Using Chlamydia Home Collection Kits
Authors: Koekenbier R , Hendriks A , Veen M van , Leeuwen P van 
Published: July 2013

BackgroundTo study the efficiency of Chlamydia home collection kits for young people, in order to optimise care at the Amsterdam STI clinic.MethodsSince 2012, young people under the age of 25 with a low risk profile for STIs are only tested for Chlamydia. Tests for other STIs are indicated after testing Chlamydia positive. From September-November 2012, young people using the online intake were offered two different ways of Chlamydia testing: receiving a home collection kit, or coming to the clinic. The collection kit is send to the client by mail and is used to collect a swab or urine sample. This sample is send back to the laboratory for testing. The client can retrieve the results online by using the provided login.ResultsIn the study period, 523 online requests were done. Of these, 388 (74%) opted for the home collection kit and 135 (26%) preferred an appointment at the clinic. Of the requested kits, 86% were send back. All clients checked their test result online. Chlamydia was diagnosed in 5.5% of the clients receiving a home kit and in 2.9% of those tested at the clinic. Women were more likely to request a home collection kit (77% versus 60% of men, p < 0.001) as were young people aged 20–24 years (76% versus 64% aged < 20 years, p < 0.05). None of the Chlamydia-positive clients tested positive on the subsequent STI tests. Testing at the clinic takes three times more time of the nurse.ConclusionsYoung people prefer a home collection kit to a test at the clinic. Furthermore, offering home collection kits is time and cost saving. Because clients who test negative are not seen at the clinic, more time is left for high-risk groups. In conclusion, Chlamydia home collection kits optimise care efficiency at the STI clinic.
O09.6 CD4 Below 500: Increase of ART Patients and the Financial Impact in Brazil
Authors: Silva F Viegas Neves da , Guimarães A , Hallal R , Greco D 
Published: July 2013

BackgroundIn 2012 the Brazilian Ministry of Health began discussing early treatment for patients with CD4 from 350 to 500. This recommendation aimed to increase the quality of life for PLVIH in Brazil. One of the concerns was the financial impact and the increased number of patients that would access the health system.MethodsTo identify the number of PLVIH eligible we extracted from SISCEL’s (a Brazilian centralised Laboratory Exams Control System) databank data of the patients with at least one CD4 test (in 2010, 2011 and 2012) between 350 and 500. SISCEL only includes patients on follow up within the public network of laboratories (currently 100 CD4 Laboratories). Around 75% of patients are on follow up in SISCEL. Additionally, to remove patients already on ART we crossed 2 databanks - the SISCEL with the SICLOM (a Brazilian centralised Drugs Control Logistic System). On the other hand, to identify the cost of initial ART, from the total of 1.395 currently dispensed, we selected the seven most used(AZT/3TC+EFV; AZT/3TC+LPV/r; TDF+3TC+EFV; AZT/3TC+ATV+RTV; AZT/3TC+NVP; TDF+3TC+ATV+RTV; TDF+3TC+LPV/r) that represent 91.5% of the initial treatment regimens.ResultsThere is a cumulative number of approximately 35.221 patients that are eligible for the new recommendation that are being monitored with a potential increase of up to 25% of the patients that are not in SISCEL. The proportional increase in the annual expenditure of ARVs would be of around 43 million dollars (10% increase in the total annual budget for ARVs of around 415 million dollars).ConclusionFrom the data above we can conclude that a 10% increase in budget is a small expenditure in comparison to the potential benefits of early ART such as avoiding opportunistic infections, improving quality of life, diminishing costs of hospitalisation, increasing survival rate and diminishing risk of transmission.
O10.1 Age Specific Round 1 Results of a Cervical Cancer Screening Trial: HPV FOCAL
Authors: Ogilvie G , Krajden M , Ehlen T , Martin R , Smith L , Peacock S , Stuart G C E , Franco E L , Coldman A J 
Published: July 2013

BackgroundHPV FOCAL Study is a randomised trial evaluating the efficacy of high risk-HPV DNA (hr-HPV) testing, with Liquid Based Cytology (LBC) triage testing of hr-HPV positives, compared to LBC testing alone (with triage hr-HPV testing for ASCUS positives) in an organised screening programme. Round 1 age specific results comparing differences in screen detection rates between women < 35 yrs vs ≥ 35 yrs are presented.MethodsBetween January 2008 and May 2012, 25,243 consented women aged 25 to 65 were randomised to receive either: primary hr-HPV testing (HPV arms) or primary LBC testing (Control arm). Samples obtained with ThinPrep®LBC. HPV testing performed with Qiagen Hybrid Capture 2®High-Risk HPV DNA Test.ResultsData is presented for 21,985 participants enrolled as of July 1, 2011 who had completed Round 1 follow-up procedures by February 20, 2012. Overall, detection rates for CIN3+ were not statistically different between the HPV arm (7.8/1000; 95% CI: 6.1, 9.6) and the control arm (4.9/1000; 95% CI: 3.3, 6.5) when women of all ages were evaluated. In women ≥ 35yrs, the overall detection rate for CIN2+ and CIN3+ were both significantly higher in the HPV arm compared to the control arm (CIN2+: 9.9/1000 vs. 5.1/1000 respectively)(CIN3+: 4.4/1000 vs. 2.0/1000 respectively). For women < 35 yrs, HPV testing detected more CIN2+ and CIN3+ than LBC, but this did not achieve statistical significance. Overall, colposcopy referrals were higher in the HPV testing arm vs. control arm (59.1/1000, vs. 31.5/1000). HPV testing in < 35 yrs referred significantly more women to colposcopy than cytology (153.2/1000 vs. 73.3/1000).ConclusionHPV screening with cytology triage detects significantly more CIN2+ lesions in women ≥ 35 years than LBC alone in the first round of screening. In women < 35, there was no difference in detection rates, but overall, HPV primary screening resulted in higher colposcopy rates.
O10.4 Efficacy and Safety of Intralesional (IL) Injection of Mycobacterium W Vaccine Vs. Imiquimod Cream in the Treatment of Anogenital Warts: A Double Blind Randomised Trial
Authors: Gupta S , Dar L , Kumar P , Sharma V , Verma K , Dwivedi S N 
Published: July 2013

IntroductionExternal Anogenital warts (EGW) are associated with poor response to treatment and high recurrence rates. There is a need for development of immunotherapeutic agents for treatment of AGW.ObjectivesTo compare efficiency and safety of IL injection of killed Mycobacterium w (Mw) Vaccine and Imiquimod cream in complete resolution of EGWs, recurrence rates, and reduction in HPV viral load.Method89 patients (71 male and 18 female) with EGW were recruited over a period of 3 years. Patients were randomised in to two Group: Group A Patients (Male 34, Female 10) received Imiquimod cream and IL placebo injection; Group B patients (Male 37 and female 8) received Placebo cream and IL Mw injections. HPV Genotyping was done by reverse line blot hybridization by the Linear Array (Roche) and viral load was done by Real Time quantitative PCR.ResultsMean percentage reduction in Imiquimod and Mw groups were 84.7% and 83.2%, respectively (P > 0.05). Overall, 59% and 66.7% of patients in Imiquimod and Mw groups respectively showed complete clearance. There was no significant difference in adverse events and recurrence rates. HPV DNA was detected in anogenital warts samples in 84 (94.38%) of 89 patients. The predominant types were HPV-6(55%), 11(41.5%) followed by HPV 16(5.6%), 18(4.4%), and others(27.5%). 22(24.7%) showed infection by multiple HPV types. Baseline HPV 6 and 11 DNA load ranges were 1.4 × 102–2.1 × 108 and 2.6 × 102–2.1 × 108 copies/mg, respectively (P value < 0.001). After treatment, there was a significant decline in viral load of HPV 6 in both the groups, but of HPV 11 only in Mw group.ConclusionsThere was no significant difference in efficacy and adverse events in both the treatments. HPV viral load declined significantly and correlated with clinical resolution. Further studies are needed to explore whether injection Mw works for patients who do not respond to topical imiquimod.
O10.5 Human Papillomavirus (HPV) Genotypes Associated with Persistent HSIL Isolated by Laser Capture Microdissection
Authors: Cornall A M , Roberts J , Garland S M , Hillman R J , Poyten M , Jin F , Grulich A E , Tabrizi S N 
Published: July 2013

BackgroundAnal squamous cell carcinoma (ASCC) is preceded by persistent high-grade squamous intraepithelial lesion (HSIL). A small proportion of HSIL will progress to ASCC; estimates in men who have sex with men (MSM) suggest one in 400 per year in HIV-positive men and one in 4,000 per year in HIV-negative men. There are no tests to predict which HSIL are more likely to persist and potentially progress to ASCC. As MSM are often concurrently infected with multiple anal HPV genotypes, the role of each in progression to ASCC is unclear.MethodsBiopsies of suspected HSIL collected during high-resolution anoscopy from participants enrolled in the ongoing SPANC cohort of homosexual men (Sydney, Australia) between November 2010 and December 2011. Samples taken at 0, 6 and 12 months were formalin-fixed, paraffin-embedded then sandwich sectioned. Sections 1 and 5 were stained (haematoxylin and eosin [H&E]) and section 2 placed on a PEN-membrane slide. H&E sections were reviewed and lesions annotated using Aperio ScanScope software. Annotated abnormal tissue was isolated using laser capture microdissection (LCM), DNA was extracted and HPV genotypes present determined by reverse hybridisation assay (HPV SPF10-LiPA25, Labo Bio-medical Products).ResultsFrom a pilot study comprising 16 men diagnosed with HSIL at one or more visits, 94% were positive for at least one HPV type. HPV16 was the most common genotype detected in HSIL (28%), followed by 45, 18 (each 17%), 58 (11%), 56, 31, 52, 34 and 33 (each 6%). Three participants had HSIL that persisted over three consecutive visits: 2 were positive for HPV16 and 1 for HPV18. An additional 28% of HSIL persisted for 2 consecutive visits, and were positive for HPV58 (40%), 16, 18 or 33 (each 20%).ConclusionOverall, 10% of HSIL persisted for longer than 12 months with HPV16 being present in majority of these.
O11.1 Herpes Simplex Virus (HSV) Infection in the VOICE (MTN 003) Study: Pre-Exposure Prophylaxis (PrEP) For HIV with Daily Use of Oral Tenofovir, Oral Tenofovir-Emtricitabine, or Vaginal Tenofovir Gel
Authors: Marrazzo J , Rabe L , Kelly C , Livant T , Chirenje M , Richardson B , Deal C , Piper J , Hillier S 
Published: July 2013

BackgroundIn subSaharan Africa, HSV-2 infection is common, and increases risk of HIV transmission and acquisition. Tenofovir gel applied before and after vaginal intercourse provided partial protection from HSV-2 acquisition in the CAPRISA 004 study. We enrolled women in a 5-arm, randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of daily use of oral tenofovir, oral tenofovir-emtricitabine, and 1% vaginal tenofovir gel as HIV PrEP, and assessed characteristics of women with baseline HSV and risk of HSV seroincidence during the study.MethodsFrom September 2009-June 2011, 12,379 women were screened at 15 sites in South Africa, Uganda, and Zimbabwe. Eligibility criteria included normal renal, hematologic and hepatic function, report of vaginal intercourse in prior 3 months, negative pregnancy test, and willingness to use effective contraception throughout. Testing for HSV-2 type-specific antibody (Focus HerpeSelect EIA) was performed on plasma from enrollment and study exit.ResultsOf 5,029 participants, baseline HSV serology was available for 4996 (99.3%). Most were from Durban (62%), followed by Johannesburg (14%), Zimbabwe (13%), Uganda (6%), and Klerksdorp (5.2%). Mean age was 25.3 years; 79% were unmarried. Over follow-up of 5,511 person years, end-of-study retention was 91%. Using a cutoff index value of > 3.5, 46% of participants were HSV-2 and 95% HSV-1 seropositive at enrollment. Country- and age-specific HSV-2 seroprevalence ranged from 32% (Zimbabwe) to 63% (Uganda). Seroincidence of HSV-2 by arm will be presented.ConclusionsIn this population of women at risk for HIV-1, seroprevalence of HSV-2 was high, with potentially important differences by age and site of enrollment.