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1.  STI Screening Uptake and Knowledge of STI Symptoms among Female Sex Workers Participating in a Community Randomized Trial in Peru 
This study aims to evaluate condom use, STI screening, and knowledge of STI symptoms among female sex workers (FSW) in Peru associated with sex work venue and a community randomized trial of STI control. One component of the Peru PREVEN intervention conducted mobile-team outreach to FSW to reduce STIs and increase condom use and access to government clinics for STI screening and evaluation. Prevalence ratios were calculated using multivariate Poisson regression models with robust standard errors, clustering by city. As-treated analyses were conducted to assess outcomes associated with reported exposure to the intervention. Care-seeking was more frequent in intervention communities, but differences were not statistically significant. FSW reporting exposure to the intervention had significantly higher likelihood of condom use, STI screening at public health clinics, and symptom recognition compared to those not exposed. Compared with street or bar-based FSW, brothel-based FSW reported significantly higher rates of condom use with last client, recent screening exams for STIs and HIV testing. Brothel-based FSW also more often reported knowledge of STIs and recognition of STI symptoms in women and in men. Interventions to promote STI-detection and prevention among FSW in Peru should consider structural or regulatory factors related to sex work venue.
doi:10.1177/0956462415584488
PMCID: PMC4742423  PMID: 25941053
female sex workers; Peru; sexually transmitted disease; health behavior
2.  Lay health supporters aided by a mobile phone messaging system to improve care of villagers with schizophrenia in Liuyang, China: protocol for a randomised control trial 
BMJ Open  2016;6(1):e010120.
Introduction
Schizophrenia is a severe, chronic and disabling mental illness. Non-adherence to medication and relapse may lead to poorer patient function. This randomised controlled study, under the acronym LEAN (Lay health supporter, e-platform, award, and iNtegration), is designed to improve medication adherence and high relapse among people with schizophrenia in resource poor settings.
Methods/analysis
The community-based LEAN has four parts: (1) Lay health supporters (LHSs), mostly family members who will help supervise patient medication, monitor relapse and side effects, and facilitate access to care, (2) an E-platform to support two-way mobile text and voice messaging to remind patients to take medication; and alert LHSs when patients are non-adherent, (3) an Award system to motivate patients and strengthen LHS support, and (4) iNtegration of the efforts of patients and LHSs with those of village doctors, township mental health administrators and psychiatrists via the e-platform. A random sample of 258 villagers with schizophrenia will be drawn from the schizophrenic ‘686’ Program registry for the 9 Xiang dialect towns of the Liuyang municipality in China. The sample will be further randomised into a control group and a treatment group of equal sizes, and each group will be followed for 6 months after launch of the intervention. The primary outcome will be medication adherence as measured by pill counts and supplemented by pharmacy records. Other outcomes include symptoms and level of function. Outcomes will be assessed primarily when patients present for medication refill visits scheduled every 2 months over the 6-month follow-up period. Data from the study will be analysed using analysis of covariance for the programme effect and an intent-to-treat approach.
Ethics and dissemination
University of Washington: 49464 G; Central South University: CTXY-150002-6. Results will be published in peer-reviewed journals with deidentified data made available on FigShare.
Trial registration number
ChiCTR-ICR-15006053; Pre-results.
doi:10.1136/bmjopen-2015-010120
PMCID: PMC4735204  PMID: 26792221
schizophrenia; medication adherence; mHealth; lay health worker; implementation science; “686” program
3.  Relationship between community-level alcohol outlet accessibility and individual-level HSV-2 infection among young women in South Africa 
Sexually transmitted diseases  2015;42(5):259-265.
Background
Exposure to alcohol outlets may influence sexual health outcomes at the individual- and community-level. Visiting alcohol outlets facilitates alcohol consumption and exposes patrons to a risky environment and network of potential partners, while presence of alcohol outlets in the community may shift social acceptance of riskier behavior. We hypothesize that living in communities with more alcohol outlets is associated with increased sexual risk.
Methods
We performed a cross-sectional analysis in a sample of 2,174 South African schoolgirls (ages 13–21) living across 24 villages in the rural Agincourt sub-district, underpinned by long-term health and socio-demographic surveillance. To examine the association between number of alcohol outlets in village of residence and individual-level prevalent HSV-2 infection, we used generalized estimating equations with logit links, adjusting for individual- and village-level covariates.
Results
The median number of alcohol outlets per village was three (range zero to seven). HSV-2 prevalence increased from villages with no outlets [1.4%, (95% CI: 0.2, 12.1)], to villages with one to four outlets [4.5% (3.7, 5.5)], to villages with more than four outlets [6.3% (5.6, 7.1)]. An increase of one alcohol outlet per village was associated with an 11% increase in odds of HSV-2 infection [adjusted odds ratio (95% CI): 1.11 (0.98, 1.25)].
Conclusions
Living in villages with more alcohol outlets was associated with increased prevalence of HSV-2 infection in young women. Structural interventions and sexual health screenings targeting villages with extensive alcohol outlet environments could help prevent the spread of sexually transmitted infections.
doi:10.1097/OLQ.0000000000000263
PMCID: PMC4436694  PMID: 25868138
4.  Initiation of antiretroviral therapy and viral suppression after home HIV testing and counselling in KwaZulu-Natal, South Africa, and Mbarara district, Uganda: a prospective, observational intervention study 
The lancet. HIV  2014;1(2):e68-e76.
Objective
Antiretroviral therapy (ART) significantly decreases HIV-associated morbidity, mortality, and HIV transmission through HIV viral load suppression. In high HIV prevalence settings, outreach strategies are needed to find asymptomatic HIV positive persons, link them to HIV care and ART, and achieve viral suppression.
Methods
We conducted a prospective intervention study in two rural communities in KwaZulu-Natal, South Africa, and Mbabara district, Uganda. The intervention included home HIV testing and counseling (HTC), point-of-care CD4 count testing for HIV positive persons, referral to care, and one month then quarterly lay counselor follow-up visits. The outcomes at 12 months were linkage to care, and ART initiation and viral suppression among HIV positive persons eligible for ART (CD4≤350 cells/μL).
Findings
3,393 adults were tested for HIV (96% coverage), of whom 635 (19%) were HIV positive. At baseline, 36% of HIV positive persons were newly identified (64% were previously known to be HIV positive) and 40% were taking ART. By month 12, 619 (97%) of HIV positive persons visited an HIV clinic, and of 123 ART eligible participants, 94 (76%) initiated ART by 12 months. Of the 77 participants on ART by month 9, 59 (77%) achieved viral suppression by month 12. Among all HIV positive persons, the proportion with viral suppression (<1,000 copies/mL) increased from 50% to 65% (p=<0.001) at 12 months.
Interpretation
Community-based HTC in rural South Africa and Uganda achieved high testing coverage and linkage to care. Among those eligible for ART, a high proportion initiated ART and achieved viral suppression, indicating high adherence. Implementation of this HTC approach by existing community health workers in Africa should be evaluated to determine effectiveness and costs.
doi:10.1016/S2352-3018(14)70024-4
PMCID: PMC4292844  PMID: 25601912
Community-based HIV testing and counseling (HTC); home HTC; point-of-care CD4; linkage to care; HIV prevention and care; HIV infectiousness; community viral load
5.  Antiretroviral Drug Use in a Cohort of HIV-Uninfected Women in the United States: HIV Prevention Trials Network 064 
PLoS ONE  2015;10(10):e0140074.
Antiretroviral (ARV) drug use was analyzed in HIV-uninfected women in an observational cohort study conducted in 10 urban and periurban communities in the United States with high rates of poverty and HIV infection. Plasma samples collected in 2009–2010 were tested for the presence of 16 ARV drugs. ARV drugs were detected in samples from 39 (2%) of 1,806 participants: 27/181 (15%) in Baltimore, MD and 12/179 (7%) in Bronx, NY. The ARV drugs detected included different combinations of non-nucleoside reverse transcriptase inhibitors and protease inhibitors (1–4 drugs/sample). These data were analyzed in the context of self-reported data on ARV drug use. None of the 39 women who had ARV drugs detected reported ARV drug use at any study visit. Further research is needed to evaluate ARV drug use by HIV-uninfected individuals.
doi:10.1371/journal.pone.0140074
PMCID: PMC4596522  PMID: 26445283
6.  Lineages of Oncogenic Human Papillomavirus Types Other Than Type 16 and 18 and Risk for Cervical Intraepithelial Neoplasia 
Background
Data on clinical outcomes of infection with variants of oncogenic human papillomavirus (HPV) types other than HPV16 and HPV18 are rare. We investigated intratypic variations in non-HPV16/18 oncogenic types and their corresponding relationships with cervical intraepithelial neoplasia grades 2–3 (CIN2/3).
Methods
Study subjects were women who were positive for one or more of 11 non-HPV16/18 oncogenic types. Subjects were followed every six months for two years for detection of HPV and cervical lesions. Variant lineages were defined by sequencing the 3’ part of the long control region and the entire E6/E7 region of HPV genome. Lineage-associated risk of CIN2/3 was assessed using logistic regression with generalized estimating equations.
Results
A total of 4591 type-specific HPV infections among 2667 women were included in the analysis. The increase in risk of CIN2/3 was statistically significant for women with HPV31 A or B compared with C variants, HPV33 A1 compared with B variants, HPV45 A3 or B2 compared with B1 variants, HPV56 B compared with A2 variants, and HPV58 A1 or A3 compared with C variants. For these five types, the adjusted odds ratio associated with CIN2/3 was 2.0 (95% confidence interval [CI] = 1.5 to 2.6) for infections with single-type high-risk (HR) variants, 1.7 (95% CI = 1.0 to 2.7) for infections with two or more types but only one HR variant, and 5.3 (95% CI = 3.1 to 8.4) for infections with HR variants of two or more types as compared with those with single-type non-HR variants. The likelihood of CIN2/3 was similar for women with HPV16 infection and for those with HPV58 A1 variant infection.
Conclusions
These findings suggest that for a given HPV type, intratypic nucleotide changes may alter phenotypic traits that affect the probability of neoplasia.
doi:10.1093/jnci/dju270
PMCID: PMC4168311  PMID: 25217779
7.  Health facility determinants and trends of ICD-10 outpatient psychiatric consultations across Sofala, Mozambique: time-series analyses from 2012 to 2014 
BMC Psychiatry  2015;15:227.
Background
Few peer-reviewed publications have taken a longitudinal or systems approach to mental healthcare (MH) utilization in low- and middle-income countries. We analyzed: (1) outpatient ICD-10 diagnoses over time and by gender; and (2) health facility determinants of MH service utilization.
Methods
We reviewed a census of 15,856 outpatient psychiatric consultations conducted at Ministry clinics in Sofala province, Mozambique from January 2012-June 2014. Generalized estimating equations were used to model facility determinants of ICD-10 diagnoses.
Results
Across the period, 48.9 % of consults were for epilepsy, 22.4 % for schizophrenia/delusional disorders, and 8.8 % for neurotic/stress-related disorders. The proportion of schizophrenia/delusional disorders has decreased over time (32 % in 2012; 13 % in 2014, p = 0.003), in favor of greater diversity of diagnoses. Epilepsy has increased significantly in absolute and proportional terms. Women are more likely to present for neurotic/stress-related conditions (12.8 % of consults for women, 5.7 % for men, p < 0.001), while men are more likely to present for substance use (1.9 % for women, 6.4 % for men, p < 0.001). Clinics with more psychiatric technicians have a 2.1-fold (CI: 1.2, 3.6) increased rate of schizophrenia/delusional disorder diagnoses. Rural clinics saw a higher proportion of epilepsy cases and a lower proportion of organic, substance use, schizophrenia, and mood disorder cases.
Discussion and Conclusions
Outpatient MH service provision is increasing in Mozambique, although currently focuses on epilepsy and schizophrenia/delusional disorders. Mid-level psychiatric providers appear to be associated with a higher proportion of schizophrenia/delusional disorder diagnoses. Due to diagnostic or utilization differences, rural clinics may be missing important cases of organic, substance use, schizophrenia, and mood disorders. Models and decision-support tools for mental healthcare integration with primary care practice are needed in Mozambique to allow further scale-up of mental health services.
doi:10.1186/s12888-015-0609-4
PMCID: PMC4581480  PMID: 26399237
Mental health services; Outpatient psychiatry; Health facility determinants; Time-trends; Gender differences; Mozambique
8.  Patient Volume, Human Resource Levels and Attrition from HIV Treatment Programs in Central Mozambique 
Introduction
Human resource shortages are viewed as one of the primary obstacles to provide effective services to growing patient populations receiving antiretroviral therapy (ART) and to expand ART access further. We examined the relationship of patient volume, human resource levels and patient characteristics with attrition from HIV treatment programs in central Mozambique.
Methods
We conducted a retrospective cohort study of adult, ART-naïve, non-pregnant patients who initiated ART between January 2006 and June 2008 in the national HIV care program. Cox proportional hazards models were used to assess the association of patient volume, clinical staff burden, and pharmacy staff burden with attrition, while adjusting for patient characteristics.
Results
A total of 11,793 patients from 18 clinics were studied. After adjusting for patient characteristics, patients attending clinics with medium pharmacy staff burden (HR= 1.39 [95% CI: 1.07–1.80]) and high pharmacy staff burden (HR = 2.09 [95% CI: 1.50–2.91]) tended to have a higher risk of attrition (p-value for trend: <0.001). Patients attending clinics with higher clinical staff burden did not have a statistically higher risk of attrition. Patients attending clinics with medium patient volume levels (HR= 1.45 [95% CI: 1.04–2.04]) and high patient volume levels (HR = 1.41 [95% CI: 1.04–2.92]) had a higher risk of attrition, but the trend test was not significant (p=0.198).
Discussion
Patients attending clinics with higher pharmacy staff burden had a higher risk of attrition. These results highlight a potential area within the health system where interventions could be applied to improve the retention of these patient populations.
doi:10.1097/QAI.0b013e3182167e90
PMCID: PMC4551473  PMID: 21372723
Mozambique; antiretroviral therapy; health system; patient volume; human resources; attrition
9.  Host Genetic and Viral Determinants of HIV-1 RNA Set Point among HIV-1 Seroconverters from Sub-Saharan Africa 
Journal of Virology  2014;89(4):2104-2111.
ABSTRACT
We quantified the collective impact of source partner HIV-1 RNA levels, human leukocyte antigen (HLA) alleles, and innate responses through Toll-like receptor (TLR) alleles on the HIV-1 set point. Data came from HIV-1 seroconverters in African HIV-1 serodiscordant couple cohorts. Linear regression was used to determine associations with set point and R2 to estimate variation explained by covariates. The strongest predictors of set point were HLA alleles (B*53:01, B*14:01, and B*27:03) and plasma HIV-1 levels of the transmitting partner, which explained 13% and 10% of variation in set point, respectively. HLA-A concordance between partners and TLR polymorphisms (TLR2 rs3804100 and TLR7 rs179012) also were associated with set point, explaining 6% and 5% of the variation, respectively. Overall, these factors and genital factors of the transmitter (i.e., male circumcision, bacterial vaginosis, and use of acyclovir) explained 46% of variation in set point. We found that both innate and adaptive immune responses, together with plasma HIV-1 levels of the transmitting partner, explain almost half of the variation in viral load set point.
IMPORTANCE After HIV-1 infection, uncontrolled virus replication leads to a rapid increase in HIV-1 concentrations. Once host immune responses develop, however, HIV-1 levels reach a peak and subsequently decline until they reach a stable level that may persist for years. This stable HIV-1 set point represents an equilibrium between the virus and host responses and is predictive of later disease progression and transmission potential. Understanding how host and virus factors interact to determine HIV-1 set point may elucidate novel mechanisms or biological pathways for treating HIV-1 infection. We identified host and virus factors that predict HIV-1 set point in people who recently acquired HIV-1, finding that both innate and adaptive immune responses, along with factors that likely influence HIV-1 virulence and inoculum, explain ∼46% of the variation in HIV-1 set point.
doi:10.1128/JVI.01573-14
PMCID: PMC4338863  PMID: 25473042
10.  Choosing a metric for measurement of pre-exposure prophylaxis 
The Lancet. Infectious diseases  2014;14(12):1177-1178.
doi:10.1016/S1473-3099(14)70989-2
PMCID: PMC4507263  PMID: 25455980
11.  Venue-Based Recruitment of Women at Elevated Risk for HIV: An HIV Prevention Trials Network Study 
Journal of Women's Health  2014;23(6):541-551.
Abstract
Background: The challenge of identifying and recruiting U.S. women at elevated risk for HIV acquisition impedes prevention studies and services. HIV Prevention Trials Network (HPTN) 064 was a U.S. multisite, longitudinal cohort study designed to estimate HIV incidence among women living in communities with prevalent HIV and poverty. Venue-based sampling (VBS) methodologies and participant and venue characteristics are described.
Methods: Eligible women were recruited from 10 U.S. communities with prevalent HIV and poverty using VBS. Participant eligibility criteria included age 18–44 years, residing in a designated census tract/zip code, and self-report of at least one high-risk personal and/or male sexual partner characteristic associated with HIV acquisition (e.g., incarceration history). Ethnography was conducted to finalize recruitment areas and venues.
Results: Eight thousand twenty-nine women were screened and 2,099 women were enrolled (88% black, median age 29 years) over 14 months. The majority of participants were recruited from outdoor venues (58%), retail spaces (18%), and social service organizations (13%). The proportion of women recruited per venue category varied by site. Most participants (73%) had both individual and partner characteristics that qualified them for the study; 14% were eligible based on partner risk only.
Conclusion: VBS is a feasible and effective approach to rapidly recruit a population of women at enhanced risk for HIV in the United States. Such a recruitment approach is needed in order to engage women most at risk and requires strong community engagement.
doi:10.1089/jwh.2013.4654
PMCID: PMC4046355  PMID: 24742266
12.  The Relationship between Alcohol Outlets, HIV Risk Behavior, and HSV-2 Infection among South African Young Women: A Cross-Sectional Study 
PLoS ONE  2015;10(5):e0125510.
Background
Alcohol consumption has a disinhibiting effect that may make sexual risk behaviors and disease transmission more likely. The characteristics of alcohol-serving outlets (e.g. music, dim lights, lack of condoms) may further encourage risky sexual activity. We hypothesize that frequenting alcohol outlets will be associated with HIV risk.
Methods
In a sample of 2,533 school-attending young women in rural South Africa, we performed a cross-sectional analysis to examine the association between frequency of alcohol outlet visits in the last six months and four outcomes related to HIV risk: number of sex partners in the last three months, unprotected sex acts in the last three months, transactional sex with most recent partner, and HSV-2 infection. We also tested for interaction by alcohol consumption.
Results
Visiting alcohol outlets was associated with having more sex partners [adjusted odds ratio (aOR), one versus zero partners (95% confidence interval (CI)): 1.51 (1.21, 1.88)], more unprotected sex acts [aOR, one versus zero acts (95% CI): 2.28 (1.52, 3.42)], higher levels of transactional sex [aOR (95% CI): 1.63 (1.03, 2.59)], and HSV-2 infection [aOR (95% CI): 1.30 (0.88, 1.91)]. In combination with exposure to alcohol consumption, visits to alcohol outlets were more strongly associated with all four outcomes than with either risk factor alone. Statistical evidence of interaction between alcohol outlet visits and alcohol consumption was observed for all outcomes except transactional sex.
Conclusions
Frequenting alcohol outlets was associated with increased sexual risk in rural South African young women, especially when they consumed alcohol. Sexual health interventions targeted at alcohol outlets may effectively reach adolescents at high risk for sexually transmitted infections like HIV and HSV-2.
Trial Registration
HIV Prevention Trials Network HPTN 068
doi:10.1371/journal.pone.0125510
PMCID: PMC4425652  PMID: 25954812
13.  VIRAL LOAD AND SHORT-TERM NATURAL HISTORY OF TYPE-SPECIFIC ONCOGENIC HUMAN PAPILLOMAVIRUS INFECTIONS IN A HIGH-RISK COHORT OF MID-ADULT WOMEN 
Oncogenic human papillomavirus (HPV) viral load may inform the origin of newly detected infections and characterize oncogenic HPV natural history in mid-adult women. From 2007–2011, we enrolled 521 25–65 year old female online daters and followed them triannually with mailed health and sexual behavior questionnaires and kits for self-sampling for PCR-based HPV DNA testing. Samples from oncogenic HPV positive women were selected for type-specific DNA load testing by real-time PCR with adjustment for cellularity. Linear or logistic regression models were used to evaluate relationships between viral levels, health and sexual behavior, and longitudinal oncogenic HPV detection. Type-specific viral levels were borderline significantly higher in oncogenic HPV infections that were prevalent versus newly detected (p=0.092), but levels in newly detected infections were higher than in infections re-detected after intercurrent negativity (p<.001). Recent sex partners were not significantly associated with viral levels. Compared to prevalent infections detected intermittently, the likelihood of persistent (OR=4.31,95%CI:2.20–8.45) or single-time (OR=1.32,95%CI:1.03–1.71) detection increased per 1-unit increase in baseline log10 viral load. Viral load differences between re-detected and newly detected infections suggest a portion of new detections were due to new acquisition, although report of recent new sex partners (a potential marker of new infection) was not predictive of viral load; oncogenic HPV infections in mid-adult women with new partners likely represent a mix of new acquisition and reactivation or intermittent detection of previous infection. Intermittent detection was characterized by low viral levels, suggesting that intermittent detection of persisting oncogenic HPV infection may be of limited clinical significance
doi:10.1002/ijc.28509
PMCID: PMC3947429  PMID: 24136492
human papillomavirus; viral load; persistence; women; epidemiology
14.  Retention Strategies and Factors Associated with Missed Visits Among Low Income Women at Increased Risk of HIV Acquisition in the US (HPTN 064) 
AIDS Patient Care and STDs  2014;28(4):206-217.
Abstract
Women at high-risk for HIV acquisition often face challenges that hinder their retention in HIV prevention trials. These same challenges may contribute to missed clinical care visits among HIV-infected women. This article, informed by the Gelberg-Andersen Behavioral Model for Vulnerable Populations, identifies factors associated with missed study visits and describes the multifaceted retention strategies used by study sites. HPTN 064 was a multisite, longitudinal HIV seroincidence study in 10 US communities. Eligible women were aged 18–44 years, resided in a census tract/zipcode with high poverty and HIV prevalence, and self-reported ≥1 personal or sex partner behavior related to HIV acquisition. Multivariate analyses of predisposing (e.g., substance use) and enabling (e.g., unmet health care needs) characteristics, and study attributes (i.e., recruitment venue, time of enrollment) identified factors associated with missed study visits. Retention strategies included: community engagement; interpersonal relationship building; reduction of external barriers; staff capacity building; and external tracing. Visit completion was 93% and 94% at 6 and 12 months. Unstable housing and later date of enrollment were associated with increased likelihood of missed study visits. Black race, recruitment from an outdoor venue, and financial responsibility for children were associated with greater likelihood of attendance. Multifaceted retention strategies may reduce missed study visits. Knowledge of factors associated with missed visits may help to focus efforts.
doi:10.1089/apc.2013.0366
PMCID: PMC3985524  PMID: 24697160
15.  Rates and Determinants of Oral Human Papillomavirus (HPV) Infection in Young Men 
Sexually transmitted diseases  2012;39(11):860-867.
Background
Little is known about rates and determinants of oral human papillomavirus (HPV) infection, an infection that is etiologically linked with oropharyngeal cancers.
Methods
A cohort of male university students (18–24 years of age) was examined every 4 months (212 men; 704 visits). Oral specimens were collected via gargle/rinse and swabbing of the oropharynx. Genotyping for HPV type 16 (HPV-16) and 36 other alpha-genus types was performed by PCR-based assay. Data on potential determinants was gathered via clinical examination, in-person questionnaire, and biweekly online diary. Hazard ratios (HR) were used to measure associations with incident infection.
Results
Prevalence of oral HPV infection at enrollment was 7.5% and 12-month cumulative incidence was 12.3% (95% confidence interval (CI): 7.0, 21.3). Prevalence of oral HPV-16 was 2.8% and 12-month cumulative incidence was 0.8% (CI: 0.1, 5.7). 28.6% of prevalent and none of incident oral HPV infections were detected more than once. In a multivariate model, incident oral HPV infection was associated with recent frequency of performing oral sex (≥1 per week: HR=3.7; CI: 1.4, 9.8), recent anal sex with men (HR=42.9; CI: 8.8, 205.5), current infection with the same HPV type in the genitals (HR=6.2; CI: 2.4, 16.4) and hyponychium (HR=11.8, CI: 4.1; 34.2).
Conclusions
Although nearly 20% of sexually active male university students had evidence of oral HPV infection within 12 months, most infections were transient. HPV-16 was not common. Sexual contact and autoinoculation appeared to play independent roles in the transmission of alpha-genus HPV to the oral cavity of young men.
doi:10.1097/OLQ.0b013e318269d098
PMCID: PMC4375438  PMID: 23064535
HPV; oral HPV; young men; epidemiology
16.  Uptake and Population-Level Impact of Expedited Partner Therapy (EPT) on Chlamydia trachomatis and Neisseria gonorrhoeae: The Washington State Community-Level Randomized Trial of EPT 
PLoS Medicine  2015;12(1):e1001777.
Background
Expedited partner therapy (EPT), the practice of treating the sex partners of persons with sexually transmitted infections without their medical evaluation, increases partner treatment and decreases gonorrhea and chlamydia reinfection rates. We conducted a stepped-wedge, community-level randomized trial to determine whether a public health intervention promoting EPT could increase its use and decrease chlamydia test positivity and gonorrhea incidence in women.
Methods and Findings
The trial randomly assigned local health jurisdictions (LHJs) in Washington State, US, into four study waves. Waves instituted the intervention in randomly assigned order at intervals of 6–8 mo. Of the state’s 25 LHJs, 24 were eligible and 23 participated. Heterosexual individuals with gonorrhea or chlamydial infection were eligible for the intervention. The study made free patient-delivered partner therapy (PDPT) available to clinicians, and provided public health partner services based on clinician referral. The main study outcomes were chlamydia test positivity among women ages 14–25 y in 219 sentinel clinics, and incidence of reported gonorrhea in women, both measured at the community level. Receipt of PDPT from clinicians was evaluated among randomly selected patients. 23 and 22 LHJs provided data on gonorrhea and chlamydia outcomes, respectively. The intervention increased the percentage of persons receiving PDPT from clinicians (from 18% to 34%, p < 0.001) and the percentage receiving partner services (from 25% to 45%, p < 0.001). Chlamydia test positivity and gonorrhea incidence in women decreased over the study period, from 8.2% to 6.5% and from 59.6 to 26.4 per 100,000, respectively. After adjusting for temporal trends, the intervention was associated with an approximately 10% reduction in both chlamydia positivity and gonorrhea incidence, though the confidence bounds on these outcomes both crossed one (chlamydia positivity prevalence ratio = 0.89, 95% CI 0.77–1.04, p = 0.15; gonorrhea incidence rate ratio = 0.91, 95% CI .71–1.16, p = 0.45). Study findings were potentially limited by inadequate statistical power, by the institution of some aspects of the study intervention outside of the research randomization sequence, and by the fact that LHJs did not constitute truly isolated sexual networks.
Conclusions
A public health intervention promoting the use of free PDPT substantially increased its use and may have resulted in decreased chlamydial and gonococcal infections at the population level.
Trial Registration
ClinicalTrials.gov NCT01665690
Editors’ Summary
Background
Every day, more than 1 million people worldwide acquire a sexually transmitted infection (STI). STIs are viral, bacterial, or parasitic infections that pass between people during sexual activity (through semen, vaginal fluids, blood, or skin-to-skin contact). Two of the most common STIs—chlamydia and gonorrhea—are caused by bacteria (Chlamydia trachomatis and Neisseria gonorrhoeae, respectively). Chlamydia rarely has any symptoms, especially in women, although some infected individuals experience pain when urinating or a discharge from the penis or vagina. The typical symptoms of gonorrhea (“the clap”) include a thick green or yellow discharge from the vagina or penis and pain when urinating, but about 10% of infected men and half of infected women have no symptoms. Both these STIs are diagnosed by testing a urine sample or a genital swab and can be treated with antibiotics. If left untreated, both infections can spread to other parts of the body and cause serious health problems including pelvic inflammatory disease (infection of the internal reproductive organs) and infertility in women.
Why Was This Study Done?
Condom use during sex reduces the risk of getting or passing on chlamydia or gonorrhea, but additional approaches are needed to reduce the incidence (the number of new cases in a population in a year) of these STIs. One promising approach is expedited partner therapy (EPT)—treating the sex partners of people with a curable STI without requiring the partners to undergo a medical evaluation. EPT usually involves clinicians giving their patients antibiotics to give to their sex partners (patient-delivered partner therapy, or PDPT). Although clinical trials of EPT have shown that the approach increases partner treatment and decreases gonorrhea and chlamydia reinfection rates, EPT has not been widely adopted in the US. In this stepped-wedge, community-level randomized trial, the researchers test whether a public health program can increase the population-level use of EPT and decrease the prevalence of chlamydial infection (the proportion of a population that has chlamydia) and the incidence of gonorrhea in women. A stepped-wedge randomized trial sequentially and randomly rolls out an intervention to groups (clusters) of people and compares outcomes both between groups and within groups before and after the intervention.
What Did the Researchers Do and Find?
The researchers randomly assigned local health jurisdictions in Washington State, US, to one of four study groups. The intervention, which was instituted sequentially by the groups at intervals of 6–8 months, included the provision of free PDPT packs for clinicians to hand to their patients and the provision of partner services—public health department staff offered patients free PDPT to treat up to three partners and offered to contact the partners of patients who did not want to notify their partners personally about their STI. During the 22-month trial, the intervention increased the proportion of patients receiving PDPT from clinicians from 18% to 34% and the proportion of patients receiving partner services from 25% to 45%. Chlamydia test positivity among young women attending clinics established to screen for chlamydia and gonorrhea as part of US infertility prevention efforts (sentinel clinics) decreased from 8.2% to 6.5%. The incidence of reported gonorrhea among women in the state (gonorrhea infrequently infects women in Washington State, so the researchers needed to look at a larger population than women attending sentinel clinics to get reliable figures for their analysis) decreased from 59.6 per 100,000 to 26.4 per 100,000. After adjusting for temporal trends (changes in the incidence of STIs over time unrelated to the intervention) and running appropriate statistical models, the researchers estimated that the intervention was associated with an approximately 10% reduction in chlamydia positivity and gonorrhea incidence, although these results were statistically insignificant and may therefore be chance findings.
What Do These Findings Mean?
Some aspects of this trial may limit the accuracy and robustness of its findings. For example, during the study period, there was an increase in partner services outside the trial that might have contributed to the observed decreases in STIs and decreased the study’s ability to find an effect associated with the study intervention. Nevertheless, these findings show that the implementation of a public health program promoting the provision of free PDPT substantially increased PDPT use by clinicians in Washington State. Moreover, although the trial did not definitively show that EPT decreased chlamydia test positivity or the incidence of gonorrhea, substantial population-level declines in both STIs occurred concurrently with the introduction of the intervention. The researchers conclude that the continued use and expansion of EPT as a way to reduce the incidence of chlamydia and gonorrhea is warranted, and suggest that the public health intervention used in this trial provides a model for health departments seeking to increase EPT use.
Additional Information.
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001777.
The World Health Organization provides a fact sheet about sexually transmitted infections (in several languages)
The US Centers for Disease Control and Prevention provides detailed information about sexually transmitted diseases, chlamydia, gonorrhea, and expedited partner therapy (some information available in several languages)
The UK National Health Service Choices website provides information about chlamydia (including some personal stories) and gonorrhea
Healthtalkonline (a not-for-profit organization) provides personal stories about sexually transmitted infections
MedlinePlus provides links to further resources about sexually transmitted infections (in English and Spanish)
More information about this trial is available
The Washington State Department of Health website includes information about Washington State’s EPT program, including EPT guidelines and information related to the legal process for instituting EPT in the state
Matthew Golden and colleagues report on the effects of promoting treatment without testing for sexual partners of patients with chlamydia or gonorrhea.
doi:10.1371/journal.pmed.1001777
PMCID: PMC4295847  PMID: 25590331
17.  CHARACTERISTICS OF MULTIPLE AND CONCURRENT PARTNERSHIPS AMONG WOMEN AT HIGH RISK FOR HIV INFECTION 
Objectives
We examined parameters of sexual partnerships, including respondents’ participation in concurrency, belief that their partner had concurrent partnerships (partners’ concurrency), and partnership intervals, among the 2,099 women in HIV Prevention Trials Network 064, a study of women at high risk for HIV infection, in ten US communities.
Methods
We analyzed baseline survey responses about partnership dates to determine prevalence of participants’ and partners’ concurrency, intervals between partnerships, knowledge of whether recent partner(s) had undergone HIV testing, and intercourse frequency during the preceding 6 months.
Results
Prevalence of participants’ and partners’ concurrency was 40% and 36% respectively; 24% of respondents had both concurrent partnerships and non-monogamous partners. Among women with >1 partner and no concurrent partnerships themselves, the median gap between partners was one month. Multiple episodes of unprotected vaginal intercourse with >2 of their most recent partners was reported by 60% of women who had both concurrent partnerships and non-monogamous partners, 50% with only concurrent partners and no partners’ concurrency, and 33% with only partners’ concurrency versus 14% of women with neither type of concurrency (p<.0001). Women who had any involvement with concurrency were also more likely than women with no concurrency involvement to report lack of awareness of whether recent partners had undergone HIV testing (participants’ concurrency 41%, partners’ concurrency 40%, both participants’ and partners’ concurrency 48%, neither 17%; p<.0001).
Conclusions
These network patterns and short gaps between partnerships may create substantial opportunities for HIV transmission in this sample of women at high risk for HIV infection.
doi:10.1097/QAI.0b013e3182a9c22a
PMCID: PMC4172374  PMID: 24056163
18.  Determinants of Per-Coital-Act HIV-1 Infectivity Among African HIV-1–Serodiscordant Couples 
The Journal of Infectious Diseases  2012;205(3):358-365.
(See the editorial commentary by Gray and Wawer on pages 351–2.)
Background. Knowledge of factors that affect per-act infectivity of human immunodeficiency virus type 1 (HIV-1) is important for designing HIV-1 prevention interventions and for the mathematical modeling of the spread of HIV-1.
Methods. We analyzed data from a prospective study of African HIV-1–serodiscordant couples. We assessed transmissions for linkage within the study partnership, based on HIV-1 sequencing. The primary exposure measure was the HIV-1–seropositive partners’ reports of number of sex acts and condom use with their study partner.
Results. Of 3297 couples experiencing 86 linked HIV-1 transmissions, the unadjusted per-act risks of unprotected male-to-female (MTF) and female-to-male (FTM) transmission were 0.0019 (95% confidence interval [CI], .0010–.0037) and 0.0010 (95% CI, .00060–.0017), respectively. After adjusting for plasma HIV-1 RNA of the HIV-1–infected partner and herpes simplex virus type 2 serostatus and age of the HIV-1–uninfected partner, we calculated the relative risk (RR) for MTF versus FTM transmission to be 1.03 (P = .93). Each log10 increase in plasma HIV-1 RNA increased the per-act risk of transmission by 2.9-fold (95% CI, 2.2–3.8). Self-reported condom use reduced the per-act risk by 78% (RR = 0.22 [95% CI, .11–.42]).
Conclusions. Modifiable risk factors for HIV-1 transmission were plasma HIV-1 RNA level and condom use, and, in HIV-1–uninfected partners, herpes simplex virus 2 infection, genital ulcers, Trichomonas vaginalis, vaginitis or cervicitis, and male circumcision.
doi:10.1093/infdis/jir747
PMCID: PMC3256946  PMID: 22241800
19.  Summary measures of adherence using pill counts in two HIV prevention trials: the need for standardisation in reporting 
AIDS and behavior  2013;17(9):10.1007/s10461-013-0542-9.
For trials of user-dependent HIV prevention products, accurate adherence measurements are essential to interpret and compare results across trials. We used pill count data from two recent HIV prevention trials of herpes simplex virus type 2 (HSV-2) suppression, to show that estimates of adherence vary substantially depending on assumptions that are made in analysing pill count data. We associate calculated adherence with biological markers of anti-HSV-2 activity. In both trials, calculated adherence varied considerably, depending on the summary measure used, and the handling of intervals with apparent ‘over-adherence’ (fewer pills returned than expected), and unreturned pills. Intervals of apparent over-adherence were associated with reduced antiviral effects on biological markers of herpes reactivation, indicating these are likely to represent periods of non-adherence. Our results demonstrate the clear need for standardisation in reporting of adherence data that are based on pill counts.
doi:10.1007/s10461-013-0542-9
PMCID: PMC3812335  PMID: 23801018
Adherence; HIV prevention; pill counts
20.  Daily Acyclovir to Decrease Herpes Simplex Virus Type 2 (HSV-2) Transmission from HSV-2/HIV-1 Coinfected Persons: A Randomized Controlled Trial 
The Journal of Infectious Diseases  2013;208(9):1366-1374.
Background. Daily suppressive therapy with valacyclovir reduces risk of sexual transmission of herpes simplex virus type 2 (HSV-2) in HSV-2–serodiscordant heterosexual couples by 48%. Whether suppressive therapy reduces HSV-2 transmission from persons coinfected with HSV-2 and human immunodeficiency virus type 1 (HIV-1) is unknown.
Methods. Within a randomized trial of daily acyclovir 400 mg twice daily in African HIV-1 serodiscordant couples, in which the HIV-1–infected partner was HSV-2 seropositive, we identified partnerships in which HIV-1–susceptible partners were HSV-2 seronegative to estimate the effect of acyclovir on risk of HSV-2 transmission.
Results. We randomly assigned 911 HSV-2/HIV-1–serodiscordant couples to daily receipt of acyclovir or placebo. We observed 68 HSV-2 seroconversions, 40 and 28 in acyclovir and placebo groups, respectively (HSV-2 incidence, 5.1 cases per 100 person-years; hazard ratio [HR], 1.35 [95% confidence interval, .83–2.20]; P = .22). Among HSV-2–susceptible women, vaginal drying practices (adjusted HR, 44.35; P = .004) and unprotected sex (adjusted HR, 9.91; P = .002) were significant risk factors for HSV-2 acquisition; having more children was protective (adjusted HR, 0.47 per additional child; P = .012). Among HSV-2–susceptible men, only age ≤30 years was associated with increased risk of HSV-2 acquisition (P = .016).
Conclusions. Treatment of African HSV-2/HIV-1–infected persons with daily suppressive acyclovir did not decrease risk of HSV-2 transmission to susceptible partners. More-effective prevention strategies to reduce HSV-2 transmission from HIV-1–infected persons are needed.
doi:10.1093/infdis/jit333
PMCID: PMC3789565  PMID: 23901094
HSV-2; HIV-1; acyclovir; transmission; serodiscordant couples; Africa
21.  Integrated Strategies for Combination HIV Prevention: Principles and examples for men who have sex with men in the Americas and heterosexual African populations 
Combination HIV prevention is a high priority for increasing the impact of partially efficacious HIV prevention interventions for specific populations and settings. Developing the package requires critical review of local epidemiology of HIV infection regarding populations most impacted and most at risk, drivers of HIV infection, and available interventions to address these risk factors. Interventions should be considered in terms of the evidence basis for efficacy, potential synergies, feasibility of delivery at scale, which is important in order to achieve high coverage and impact, coupled with high acceptability to populations, which will impact uptake, adherence, and retention. Evaluation requires process measures of uptake, adherence, retention, and outcome measures of reduction in HIV infectiousness and acquisition. Three examples of combination prevention concepts are summarized for men who have sex with men (MSM) in the Americas, young women in sub-Saharan Africa, and HIV-1 serodiscordant couples.
doi:10.1097/QAI.0b013e3182986f3a
PMCID: PMC3708491  PMID: 23764638
Combination HIV prevention; integrated prevention; men who have sex with men; young women in Africa; HIV-1 serodiscordant couples
22.  Study Design Considerations for Evaluating Efficacy of Systemic Pre-Exposure Prophylaxis Interventions 
Background
The development of interventions for systemic Pre-Exposure Prophylaxis (PrEP) faces several significant challenges following the US Food and Drug Administration’s (FDA) approval of Emtricitabine/Tenofovir (FTC/TDF) for HIV prevention. This development is particularly complex because of inconsistency of efficacy results of FTC/TDF PrEP trials for HIV prevention.
Methods
Possible designs for a PrEP Phase 3 efficacy trial are obtained by considering scenarios for potential experimental PrEP and control regimens, including consideration of placebo and active controls, longer acting PrEP and alternate dosing schedules.
Results
Non-inferiority (NI) trials with hazard ratio NI margins ranging from 1.10 to 1.25 can be justified in the contexts of the three PrEP trials demonstrating efficacy of FTC/TDF. However these HIV endpoint trials may require extremely large numbers of participants, particularly in settings where FTC/TDF has been shown to reduce the risk of HIV acquisition. NI trials also are often difficult to interpret because they depend on prior placebo-controlled efficacy results. Superiority trials for PrEP are plausible in settings where FTC/TDF efficacy is not yet established, possibly due to low adherence (i.e. women at risk as in FemPrEP and VOICE): a new product with potential for higher adherence and potency would be a promising candidate in this setting.
Conclusions
Following FDA approval of FTC/TDF for PrEP, trials to establish efficacy of new PrEP regimens require stringent design standards, together with rigorous debate about adherence within study populations and many important ethical issues.
doi:10.1097/QAI.0b013e3182986fac
PMCID: PMC3725298  PMID: 23764624
Pre-exposure Prophylaxis; Non-inferiority; efficacy; phase 3; clinical trials; adherence
23.  Estimating duration in partnership studies: issues, methods and examples 
Background and objectives
Understanding the time course of sexual partnerships is important for understanding sexual behaviour, transmission risks for sexually transmitted infections (STI) and development of mathematical models of disease transmission.
Study design
The authors describe issues and biases relating to censoring, truncation and sampling that arise when estimating partnership duration. Recommendations for study design and analysis methods are presented and illustrated using data from a sexual-behaviour survey that enrolled individuals from an adolescent-health clinic and two STD clinics. Survey participants were queried, for each of (up to) four partnerships in the last 3 months, about the month and year of first sex, the number of days since last sex and whether partnerships were limited to single encounters. Participants were followed every 4 months for up to 1 year.
Results
After adjustment for censoring and truncation, the estimated median duration of sexual partnerships declined from 9 months (unadjusted) to 1.6 months (adjusted). Similarly, adjustment for censoring and truncation reduced the bias in relative risks for the effect of age in a Cox model. Other approaches, such as weighted estimation, also reduced bias in the estimated duration distribution.
Conclusion
Methods are available for estimating partnership duration from censored and truncated samples. Ignoring censoring, truncation and other sampling issues results in biased estimates.
doi:10.1136/sti.2009.037960
PMCID: PMC3050014  PMID: 20332366
24.  HIV Acquisition Among Women From Selected Areas of the United States 
Annals of internal medicine  2013;158(1):10-18.
Background
Women account for 23% of newly diagnosed HIV infections in the United States, but there are few recent, well-characterized cohorts of U.S. women in whom behavior characteristics and HIV acquisition have been well-described.
Objective
To evaluate HIV incidence and describe behaviors among U.S. women residing in areas of high HIV prevalence.
Design
Multisite, longitudinal cohort of women who had HIV rapid testing and audio computer-assisted self-interviews at baseline and every 6 months for up to 12 months. (ClinicalTrials.gov: NCT00995176)
Setting
10 urban and periurban communities with high HIV prevalence and poverty rates, located in the northeastern and southeastern United States.
Patients
Venue-based sampling was used to recruit women aged 18 to 44 years who recently had unprotected sex and had 1 or more additional personal or partner risk factors and no self-reported previous HIV diagnosis.
Measurements
HIV prevalence and incidence, frequency of HIV risk behaviors, and health status perceptions.
Results
Among 2099 high-risk women (85.9% black and 11.7% of Hispanic ethnicity), 32 (1.5%) were diagnosed with HIV infection at enrollment. Annual HIV incidence was 0.32% (95% CI, 0.14% to 0.74%). Older age, substance use, and knowing a partner had HIV were associated with HIV prevalence. Ten women died during the study (0.61% per year).
Limitations
Longitudinal assessment of risk behaviors was limited to a maximum of 12 months. There were few incident HIV infections, precluding identification of characteristics predictive of HIV acquisition.
Conclusion
This study enrolled a cohort of women with HIV incidence substantially higher than the Centers for Disease Control and Prevention national estimate in the general population of U.S. black women. Concerted efforts to improve preventive health care strategies for HIV and overall health status are needed for similar populations.
doi:10.7326/0003-4819-158-1-201301010-00004
PMCID: PMC4033695  PMID: 23277896
25.  QUANTITATIVE HUMAN PAPILLOMAVIRUS 16 AND 18 LEVELS IN INCIDENT INFECTIONS AND CERVICAL LESION DEVELOPMENT 
Journal of medical virology  2009;81(4):713-721.
Human papillomavirus (HPV) RNA levels may be a more sensitive early indicator of predisposition to carcinogenesis than DNA levels. We evaluated whether levels of HPV-16 and HPV-18 DNA and messenger RNA (mRNA) in newly detected infections are associated with cervical lesion development. Female university students were recruited from 1990-2004. Cervical samples for HPV DNA, HPV mRNA, and Papanicolaou testing were collected tri-annually, and women were referred for colposcopically-directed biopsy when indicated. Quantitative real-time polymerase chain reaction of L1 and E7 DNA and E7 mRNA was performed on samples from women with HPV-16 and HPV-18 infections that were incidently detected by consensus PCR. Adjusting for other HPV types, increasing E7 cervical HPV-16 mRNA levels at the time of incident HPV-16 DNA detection were associated with an increased risk of cervical intraepithelial neoplasia grade 2 to 3 (HR per 1 log10 increase in mRNA=6.36,95%CI=2.00-20.23). Increasing HPV-16 mRNA levels were also associated with an increased risk of cervical squamous intraepithelial lesions; the risk was highest at the incident positive visit and decreased over time. Neither HPV-16 E7 DNA levels nor HPV-18 E7 DNA nor mRNA levels were significantly associated with cervical lesion development. Report of >1 new partner in the past 8 months (relative to no new partners) was associated with increased HPV mRNA (viral level ratio [VLR]=10.05,95%CI=1.09-92.56) and increased HPV DNA (VLR=16.80,95%CI=1.46-193.01). In newly detected HPV-16 infections, increasing levels of E7 mRNA appear to be associated with an increased risk of developing cervical pre-cancer.
doi:10.1002/jmv.21450
PMCID: PMC3984467  PMID: 19235870
HPV; viral load; mRNA; cervical pre-cancer

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