bluuebunny/crossref_metadata_2025 huggingface dataset:
O06.5 An Exploratory Evaluation of Universal Opt-Out Chlamydia Testing During Clinical Encounters For Young Women in the United States
Authors: Owusu-Edusei K , Hoover K W , Hart-Cooper G D , Gift T L
Published: July 2013

Background

Chlamydia testing rates are low, with only about a third of sexually active young women tested at clinical encounters. Even fewer sexually active female adolescents are tested. Interventions to increase testing coverage have been moderately successful. In this study, we assessed the relative health and economic outcomes of patient-directed, universal, opt-out testing for women aged 15–24 years in the United States who have at least one clinical encounter each year when compared with current testing (30% coverage).

Methods

We used a basic dynamic compartmental model that included two groups based on their self-reported sexual activity in the past 12 months, with 72% being sexually active and 28% inactive. For our base case analysis, we assumed a 75% uptake of the intervention by sexually active women and 5% by sexually inactive women. All model parameters were obtained from the literature. The model was calibrated to produce a pre-intervention prevalence close to the national burden for those aged 15–24 years in the United States (≈2.5%). Health outcomes were measured in quality-adjusted life years (QALYs).

Results

Based on our model (including health insurance coverage and utilisation rates), the estimated effective annual testing rate increased to approximately 52%, and overall chlamydia prevalence decreased by 60% to ≈1% over a three-year period. The estimated cost per QALY gained was $1372. When we assumed an uptake rate ≥ 85%, the overall prevalence decreased to zero.

Conclusion

The universal, opt-out testing intervention was cost-effective because it did not require additional costs over and above testing and treatment. Our exploratory analyses suggest that implementation of opt-out testing of young women during clinical encounters might substantially increase testing coverage of sexually active young women. However, even with a higher uptake, testing gaps would remain because many women might not have health insurance coverage, or not utilise healthcare.
O06.6 A Randomised, Double-Blind, Controlled Study to Assess the Efficacy and Safety of Nifuratel in the Treatment of Trichomoniasis
Authors: Mendling W , Caserini M , Palmieri R
Published: July 2013

Background

Trichomoniasis is the most prevalent non-viral sexually transmitted disease and there is a clear need for identifying oral therapies that are effective against 5-nitroimidazole-resistantT. vaginalis(TV) infections. A randomised, double-blind, double-dummy, parallel group pivotal study was carried out to assess the efficacy and safety of a 7-day oral treatment course with nifuratel in comparison with metronidazole in women with trichomoniasis infection.

Methods

Four-hundred-thirty-one patients, aged ≥ 18 years, were enrolled after providing their written informed consent. Women with a positive TV wet-mount microscopy were randomised and the diagnosis was confirmed by the InPouchTMTV culture method 3 days after. They received one tablet of nifuratel 200mg or metronidazole 250mg and one tablet of the corresponding placebo of the comparator three times daily after meals for 7 days. The TV eradication rate was assessed on day 21 ± 3 after the first drug intake. The concomitant infection by candidosis and the vulvovaginal signs and symptoms were also evaluated.

The non-inferiority of nifuratel compared to metronidazole at the pre-specified margin of Δ-10% was defined as the clinically acceptable difference between the two active treatments.

Results

The TV eradication was achieved by the 95.9% of patients in the per protocol data set: 95.2% and 96.5% in the nifuratel and metronidazole group, respectively (p = 0.0062). The eradication rate of vulvovaginal candidosis after treatment with nifuratel or metronidazole was 53.6% vs. 45.8%. A similar decrease in vaginal signs and symptoms, such as edoema, erythema, colpitis, cervicitis, itching, burning and dysuria, was detected in both groups. The treatments were also well tolerated with a comparable safety profile.

Conclusion

The trial proved that nifuratel 600 mg/day, minimum recommended daily dosage, is effective as metronidazole 750mg/day, average dosage recommended, in the treatment of trichomoniasis infection and suggests that nifuratel could still be an efficient alternative to metronidazole as first-line treatment.
O07.2 The Changing Relationship Between Migration and HIV Over the Life Course of Affected Households in North India
Authors: Rai T , Lambert H S , Piot P , Agarwal K S , Ward H
Published: July 2013

Background

Much research explores the relationship between migration and HIV risk; elsewhere the focus is on how HIV affects household structure and viability. In India, rural-to-urban, circular migrants are targeted with prevention campaigns but little is known about the impact of HIV on livelihoods.

Aim

To explore the structural and contextual influences on the life course of HIV-affected circular migrant families, focussing on long-term prognosis, and consider implications for programmes.

Methods

In-depth interviews with HIV-positive patients at an antiretroviral therapy (ART) centre in northern India. Data were analysed using framework and thematic analysis.

Results

20 men and 13 women were interviewed. Short-term migration to urban areas secured an improved economic livelihood, but HIV diagnosis was often late following a prolonged period of privately-obtained symptomatic treatments. At eventual HIV diagnosis, most participants faced serious debt and physical degradation. They felt conflicted about future migration – their economic liabilities pushed them towards migrant work, but their poor health and strict treatment regime made them reluctant to leave home. Insecure job markets and discriminatory policies attenuated their employment choices while the opportunity costs of monthly ART centre visits and related medical care mounted up. The role reversal from primary earners and carers to needing care and financial support changed household organisation. Temporary care arrangements gave way to shifts in household composition, with gendered effects. Long term adherence to daily antiretroviral medication and the recommended healthy, regular meals could be compromised by the social and economic consequences of becoming positive.

Discussion

Migration may increase HIV risk but following infection, HIV regulates future migration. It often increased the need to migrate again and forced some people to make choices that compromised their long-term health. Targeting migrants with prevention, testing and treatment programmes may fail to achieve desired outcomes without the simultaneous implementation of structural interventions.
O07.3 A Psychological Experiment to Examine the Global Impact of Stigma on Individuals Diagnosed with Type 1 Herpes Simplex Virus (HSV-1)
Authors: Whale J , Clarke E , Patel N , Graham C , Ingham R , Patel R
Published: July 2013

Background

HSV-1 causes at least 50% of primary genital herpes infections in Europe, Canada, Australia and the USA. In the UK, rates may be even higher, as the level 3 STI clinic in Southampton observes approximately 80% of primary genital herpes infections in young women are due to HSV-1. Regardless of location, individuals disclosing genital herpes infection may experience enacted stigma associated with negative stereotypes of sexual immorality. Patients may often fear rejection and conceal their HSV status, deleteriously affecting social relationships and self-identity. Our study aimed to assess whether a relationship could be established between female HSV-1 infected status and sexual attractiveness to males, and whether a significant difference existed between male responses to HSV-1 orolabial and genital herpes infection disclosures by females.

Methods

The study was a randomised controlled trial of 111 male participants, recruited from university undergraduate students. Participants were randomly allocated to 1 of 3 groups and shown discrete video scenarios of a female actress disclosing HSV-1 infection. Group-specific questionnaires yielded quantitative data from visual analogue scales measuring attractiveness and truthfulness regarding disclosure.

Results

Pilot data showed that there may be a significant reduction in female attractiveness to males, associated with HSV-1 genital herpes disclosure, but not following HSV-1 orolabial herpes disclosure. Pilot data showed there may be a significant reduction in male’s perceived truthfulness of HSV-1 orolabial herpes disclosure by females, in place of HSV-1 genital herpes. A full complement of results will be available by the ISSTDR/IUSTI conference.

Conclusion

Female patients diagnosed with HSV-1 genital herpes are often advised by clinicians that strategic disclosure of orolabial herpes will maintain role relationships with male partners. However, our findings show that orolabial herpes disclosure may negatively affect relationships, as male partners may perceive such disclosure to be significantly less truthful than genital herpes disclosure.
O07.4 The Price of Sex: Insights into the Determinants of the Price of Commercial Sex Among Female Sex Workers in Rural Zimbabwe
Authors: Elmes J , Nhongo K , Hallett T , White P , Ward H , Garnett G , Nyamukapa C , Gregson S
Published: July 2013

Background

Amid overall reduced demand for paid sex it is unclear how the economic organisation of sex work is affected. We explore factors associated with the price of paid sex in rural Eastern Zimbabwe.

Methods

We collected and analysed cross-sectional data on 161 women who reported receiving either cash or commodities at their most recent commercial sexual encounter and who were recruited using snowball and location-based methods in October-December 2010. We used linear modelling to assess the impact of social and behavioural variables on payments for sex.

Results

Eighty percent of sex workers (SW) were paid in cash; the mean payment was US$11 (95% CI:$9-$13) and amount did not vary by payment type (p > 0.2). All acts were penile-vaginal. When clients requested condoms, consistent condom use was more prevalent than in encounters where they did not (82% vs. 38%,p < 0.01). Mean payment in 100% protected encounters was $3 lower than when condom use was inconsistent (at least one unprotected act) (p = 0.03). Mean payment was higher when encounters were initiated in private locations (SW or client’s house) than in bars and public places (e.g. markets): $13, $11 and $8, respectively (trend: p = 0.003). Independent factors positively associated with payment were secondary education (vs. no or primary education, p = 0.013), a night-long encounter (vs. one act, p = 0.03), higher numbers of acts (p < 0.01), clients not requesting condoms (vs. requesting condoms, p < 0.05); encounters initiated in public (vs. private locations p < 0.01) were negatively associated with payment.

Conclusion

Clients who did not request protected sex paid more than clients who did, and more educated SW were able to negotiate higher prices. Under extreme macroeconomic pressures SW may be less financially able to refuse unprotected sex. We need to understand better the importance of economics of sex work for HIV/STI epidemics.
O07.5 Unprotected Sex Among High-Risk Partners: Associations Between Relational Characteristics of Last Sexual Partner and Unprotected Anal Intercourse (UAI) Among Men Who Have Sex with Men (MSM) and Transgender Women (TGW) in Lima, Peru
Authors: Cambou M C , Perez-Brumer A , Segura E R , Salvatierra J , Peinado J , Lama J R , Sanchez J , Clark J L
Published: July 2013

Background

Factors influencing condom use among MSM/TW may include partner type and recent STI diagnosis. We examined the association of partner type with UAI among MSM/TW in urban Lima, Peru, recently diagnosed with HIV or STI.

Methods

We surveyed MSM/TW in Lima diagnosed with HIV/STI within the last month regarding their sexual practises with the most recent partner according to partner type (stable, casual, anonymous, commercial sex client or sex worker). We used a multivariate regression analysis to estimate prevalence ratios (PR) with UAI as the main outcome.

Results

Among 340 participants (mean age: 30.9, range: 18 – 60), 62.5% self-identified as homosexual, 5.7% heterosexual, 17.6% bisexual, and 14.3% TW. Participants classified their last partners as 44.5% stable, 34.0% casual, 10.2% anonymous, 9.9% commercial sex client and 1.5% sex worker. Overall, 72.3% of participants reported UAI with their last partner. Using stable partners as the reference category, UAI was positively associated with all other partner types: PR: 1.5 (95% CI: 1.1 – 1.9, p < 0.05) for casual partners, PR: 1.5 (95% CI: 1.0 – 2.0, p < 0.05) for anonymous partners, PR: 1.6 (95% CI: 1.2 – 2.0, p < 0.05) for commercial sex clients and PR: 2.3 (95% CI: 1.7 – 3.0, p < 0.05) for sex workers.

Conclusion

UAI with the last partner was more commonly reported for non-stable partners. These unexpected results warrant further investigation into the influence of partner type on high-risk sexual behaviour among HIV/STI infected MSM/TGW. A better understanding of relational partner-level factors is critical for improving HIV/STI prevention and partner notification efforts for Peruvian MSM/TGW.
O07.6 Age Related Differences in Contraceptive Prevalence and Preference Among Harder-To-Reach Women on Antiretroviral Therapy (ART) Living with HIV in British Columbia (BC), Canada
Authors: Patterson S , Salters K , Zhang W , Chen Y , Hogg B , Ogilvie G , Kaida A
Published: July 2013

Background

Contraceptive use among HIV-positive women prevents unwanted pregnancy and reduces STI and HIV transmission. Recent studies link the use of hormonal contraceptive methods to increased risk of HIV transmission, consequently WHO guidelines recommend dual protection for HIV-positive women. Little is known about the uptake of dual contraceptive methods among women living with HIV. This study sought to measure differences in contraceptive prevalence and preference among HIV-positive women of different ages.

Methods

The Longitudinal Investigation into Supportive and Ancillary health services (LISA) cohort is a prospective study of harder-to-reach HIV-positive individuals accessing ART in BC. Interviewer-administered surveys collected information on socio-demographic, behavioural and structural factors while clinical variables were linked through the Drug Treatment Program at BC Centre for Excellence in HIV/AIDS. This analysis included non-pregnant women aged 18–49 years. The outcome variable of interest was self-reported current contraceptive use.

Results

Of the 166 women in this analysis, the median age was 38 years (IQR 33–43. In the six months before interview, 57% demonstrated viral suppression (VL < 50 copies) and median CD4 count was 280 (IQR 170–490). Contraceptive use was reported by 109 women (66%). Of the 104 women reporting vaginal sexual intercourse ≤ 6 months before interview, contraceptive methods included: barrier methods (condoms) (30%); dual methods (barrier method plus hormonal/permanent method) (27%); no method (24%), permanent methods (tubal ligation/hysterectomy) (10%); and hormonal methods (nuvaring/intrauterine device/oral/injectable) (9%). A significant difference was observed in contraceptive preference between sexually active women aged ≤ 35 years (n = 42) and > 35 years (n = 62), with older women choosing permanent or dual methods and younger women selecting hormonal, barrier or no contraceptive method (p = < 0.001).

Conclusion

Younger women demonstrate poor uptake of dual contraceptives, electing to use individual hormonal or barrier methods, or engage in unprotected intercourse. This demographic are at most risk of HIV transmission, potentially exacerbated by hormonal contraceptives.
O08.2 Use and Effectiveness of an Online Partner Notification Tool For STI, Called Suggest-A-Test
Authors: Gõtz H M , Rooijen M S van , Vriens P , Coul E Op de , Hamers M , Heijman T , Heuvel F van den , Koekenbier R , Leeuwen P van , Voeten H
Published: July 2013

Background

Partner notification (PN) is crucial for STI control. We developed SuggestATest.nl (SAT), an internet-based notification system for verified diagnoses of STI/HIV, that uses an index-chosen method per partner (email, text messaging, postal letter or a gay dating site; anonymous or non-anonymous). SAT was piloted at the Public Health STI clinics in Amsterdam and Rotterdam, the Netherlands. It was offered additional to counselling by the nurse.

Method

We evaluated SAT use and effectiveness from March-July 2012. Numbers/method of sent SAT notifications were extracted from the SAT database, and epidemiological data from electronic patient records. Determinants for SAT use (age, sex, ethnicity, partners, STI) were assessed using logistic regression analysis.

Results

Of 1184 index-clients receiving a SAT code, 160 (14%) notified through SAT. They sent 588 notifications (median 2), 82% by text messaging and 16% by email; 86% was non-anonymous. Univariate analysis of SAT use in heterosexuals showed that people with only 1 partner used SAT less often than others; this was the only significant predictor. In MSM, the STI diagnosed was the only significant univariate factor, with MSM with syphilis using SAT more often than MSM having other STI. Among all 67 SAT users in Rotterdam, 56% (225/402) of their eligible partners were notifiable, and 95% (213/225) of those were notified using SAT. In 17 MSM, 36% (87/239) of eligible partners were notifiable, and 97 (111% of 87) were notified in SAT. Of all notified partners, 56% entered SAT to see the STI they were notified for, and 20% visited the STI clinic in Amsterdam/Rotterdam. STI positivity in partners was lower in those notified by SAT (28%, n = 116) than in those with contact cards (45%, n = 152; p < 0.001).

Conclusion

SAT is a valuable addition for supporting partner notification and management, although challenges as non-notifiable partners are not solved by SAT.
O08.3 Barriers to Bacterial STI Screening of HIV+ Men Who Have Sex with Men (MSM) in HIV Primary Care Settings
Authors: Barbee L A , Dhanireddy S , Tat S , Radford A , Marrazzo J M
Published: July 2013

Background

In the U.S., bacterial STI disproportionately affect HIV+ MSM. Screening for STI in HIV care settings remains suboptimal, but barriers have not been fully elucidated.

Methods

As part of a CDC initiative to increase STI screening among HIV+ MSM in care, we sought to (1) define current screening coverage, and (2) identify patient and provider related barriers to screening at the largest HIV clinic in the Pacific Northwest. We extracted aggregated testing data from electronic medical records, and created separate anonymous surveys for patients (written) and providers (electronic). All male clinic attendees seen during a 3-week period in 2012 were invited to participate; 110 MSM contributed. Of 33 clinic providers invited, 28 (85%) responded; 82% (23/28) were attending physicians.

Results

From March 2011-September 2012, among 1,379 HIV+ MSM engaged in care, 38% had extragenital testing, 40% urine testing, and 80% syphilis serology at least once. Of patients surveyed, 71% reported having sex in the last 2 months. 31% described seeking STI screening outside of the HIV clinic; of those, reported reasons included: being “easier” (42%), preferring “anonymity” (21%), wanting “more frequent screening” (16%). Providers reported being unfamiliar with current CDC screening guidelines (32%) and uncomfortable with discussing sexual practises and performing a genital exam (21%). Many (68%) stated time was a major barrier. Eleven (40%) providers cited patients’ reluctance as a barrier, reporting common patient excuses including: being unprepared (55%), testing elsewhere (82%) and preferring same-gender provider (27%). Asked about potential solutions, providers chose easier access to electronic-tracking of testing results (82%), access to results from other clinics (71%) and self-collection of specimens (57%).

Conclusion

At a large academic HIV primary care clinic, STI screening was substandard, with providers reporting numerous barriers. Interventions to address these obstacles include implementation of an STI self-testing programme, and enhanced education for providers.
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

Background

Online STI testing and treatment may improve access at lower cost and with higher acceptability than clinic-based services.

Methods

We 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.

Results

The 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.

Conclusions

An 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

Background

In 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.

Methods

Among 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.

Results

Of 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.

Conclusions

Our 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

Background

A walk-in weekly men’s sexual health clinical service, provided by a male clinical team, was established in 2006.

Methods

We 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.

Results

Among 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.

Conclusion

Asymptomatic 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

Background

Following 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.

Methods

Transactional 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.

Results

From 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.

Conclusion

The 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

Background

To study the efficiency of Chlamydia home collection kits for young people, in order to optimise care at the Amsterdam STI clinic.

Methods

Since 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.

Results

In 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.

Conclusions

Young 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

Background

In 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.

Methods

To 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.

Results

There 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).

Conclusion

From 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

Background

HPV 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.

Methods

Between 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.

Results

Data 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).

Conclusion

HPV 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.
O10.2 A Community-Randomised Phase IV Human Papillomavirus (HPV) Vaccination Trial of Vaccination Strategy
Authors: Paavonen J
Published: July 2013

High-risk human papillomavirus (hrHPV) is the 2nd leading cause of cancer in women Bivalent Cervarix™ vaccine is highly efficacious against hrHPVs and associated precancers. Mathematical models disagree about the best vaccination strategy. Thus, we established a community randomised phase IV trial (CRT) to assess effectiveness of different vaccination strategies. During two school years (2007–8 and 2008–9) 80 000 1992–1995 born boys and girls were invited to participate in a CRT in a total of 33 communities in Finland. In 11 arm A communities 90% of girls and boys received HPV16/18 vaccine, in 11 arm B communities 90% of girls received HPV16/18 vaccine and boys received hepatitis B-virus (HBV) vaccine, and in 11 arm C communities both girls and boys received HBV vaccine. Effectiveness of the vaccination strategies in terms of reduction of hrHPV rates was assessed in vaccinated and unvaccinated 18.5 year-old girls. Recruitment resulted in equal enrolment of four birth cohorts (born 1992–95) comprising altogether 32 176 (approximately 40% response) adolescents, including 22 514 girls (> 50% response per birth cohort and arm) and 11 651 boys (20–30% response per birth cohort and arm). Already completed follow-up of 3 614 and 3 256 1992 and 1993 born girls at the age of 18.5 years prove that cervical samples from 350 vaccinated and 85 unvaccinated girls by community will be available. Assuming 80%–95% vaccine efficacy and 30%–50% effectiveness we have 80%–90% power to identify differences between vaccination strategies. In conclusion, this phase IV CRT augments decision making how to implement HPV vaccination programmes.
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

Introduction

External 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.

Objectives

To 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.

Method

89 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.

Results

Mean 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.

Conclusions

There 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

Background

Anal 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.

Methods

Biopsies 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).

Results

From 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%).

Conclusion

Overall, 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

Background

In 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.

Methods

From 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.

Results

Of 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.

Conclusions

In 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.
O11.2 Sexual Behaviour of Heterosexual Men and Women Receiving Antiretroviral Pre-Exposure Prophylaxis For HIV Prevention: Post-Unblinding Analysis of the Partners PrEP Study
Authors: Mugwanya K K , Donnell D , Celum C , Mugo N , Thomas K K , Ngure K , Ndase P , Katabira E , Baeten J M
Published: July 2013

Background

Limited data are available to assess the potential for increased sexual risk-taking by persons using antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention. In July 2011, the Partners PrEP Study, a randomised trial of daily oral tenofovir and emtricitabine/tenofovir PrEP among HIV-uninfected members of African heterosexual HIV serodiscordant couples, demonstrated efficacy of PrEP for HIV prevention and use of placebo was discontinued in the trial. Follow-up of study participants on active PrEP through December 2012 provided an opportunity to evaluate risk behaviour on PrEP after efficacy was announced.

Methods

Among participants assigned to active PrEP pre-unblinding who continued follow-up after the placebo arm was stopped, we used zero-inflated negative binomial regression with robust standard errors and adjusted for baseline sexual behaviour, age, gender, and secular changes to compare the frequency of unprotected sex up to 12 months before versus after knowledge of PrEP efficacy.

Results

We analysed 54,876 person-months (33,254 pre- versus 21,622 post-unblinding) from 3024 HIV-uninfected subjects (64% male). On average, the observed frequency of unprotected sex with the HIV-infected study partner was 58 per 100 person-months pre-unblinding versus 53 per 100 person-months post-unblinding, reflecting no immediate change or change in trend over time following unblinding (p = 0.734 and 0.264, respectively). The annual average total number of unprotected sex post-unblinding was 6 acts versus 5 that would have been expected in the counterfactual situation had unblinding not occurred. There was no significant increase in diagnoses of incident sexually transmitted infections or pregnancy post- versus pre-unblinding (p > 0.05).

Conclusion

The transition from a blinded, placebo-controlled trial to all participants aware they were receiving active PrEP in the Partners PrEP Study provided a “natural experiment” to evaluate behavioural risk compensation. PrEP, provided as part of a comprehensive prevention package, may not result in substantial changes in risk-taking sexual behaviour in HIV serodiscordant couples.