Periodic Presumptive Treatment Research Articles

Lessons from Suppressive Therapy and Periodic Presumptive Treatment for Bacterial Vaginosis.

Suppressive therapy and periodic presumptive treatment (PPT) are distinct but related strategies that have been used to reduce the incidence of bacterial vaginosis (BV). Here, we review clinical trial evidence of the effectiveness of suppressive therapy and PPT to reduce BV, and discuss their roles for women who frequently experience symptomatic or asymptomatic BV. Among women who were recently and successfully treated for symptomatic BV, suppressive therapy with twice-weekly metronidazole gel for 16weeks reduces the likelihood of recurrent symptomatic BV and is currently recommended by the Centers for Disease Control and Prevention for prevention of recurrent BV. The premise of PPT is to provide regimens used to treat BV at regular intervals to reduce the overall frequency of BV, regardless of symptoms. Three PPT trials were conducted using different routes (oral or intravaginal), doses, and frequencies of administration. Each trial demonstrated a significant reduction in BV over the course 12months, ranging from a 10 to 45% decrease. PPT regimens that substantially reduce the frequency of BV over time could be evaluated in clinical trials to assess whether a reduced frequency of BV leads to subsequent reductions in BV-associated sequelae. While both suppressive therapy and PPT reduce BV, their impact wanes following cessation of the regimen. Given the high prevalence of BV globally and burden of adverse reproductive health outcomes among women with BV, there is a critical need for more effective treatments that produce durable shifts in the microbiota towards vaginal health.

Impact of baseline vaginal bacterial colonization on subsequent development of bacterial vaginosis among women receiving periodic presumptive treatment for vaginal infections

Impact of baseline vaginal bacterial colonization on subsequent development of bacterial vaginosis among women receiving periodic presumptive treatment for vaginal infections

Impact of Periodic Presumptive Treatment for Bacterial Vaginosis on the Vaginal Microbiome among Women Participating in the Preventing Vaginal Infections Trial.

Evidence suggests that specific vaginal bacteria associated with bacterial vaginosis (BV) may increase the risk of adverse health outcomes in women. Among women participating in a randomized, double-blinded trial, we assessed the effect of periodic presumptive treatment (PPT) on detection of select vaginal bacteria. High-risk women from the United States and Kenya with a recent vaginal infection received intravaginal metronidazole 750 mg plus miconazole 200 mg or placebo for 5 consecutive nights each month for 12 months. Vaginal fluid specimens were collected via polyester/polyethylene terephthalate swabs every other month and tested for bacteria, using quantitative polymerase chain reaction (PCR) assays targeting the 16S ribosomal RNA gene. The effect of PPT on bacterium detection was assessed among all participants and stratified by country. Of 234 women enrolled, 221 had specimens available for analysis. The proportion of follow-up visits with detectable quantities was lower in the PPT arm versus the placebo arm for the following bacteria: BVAB1, BVAB2, Atopobium vaginae, Leptotrichia/Sneathia, and Megasphaera. The magnitude of reductions was greater among Kenyan participants as compared to US participants. Use of monthly PPT for 1 year reduced colonization with several bacteria strongly associated with BV. The role of PPT to improve vaginal health should be considered, and efforts to improve the impact of PPT regimens are warranted.

Association between treatment for gonorrhoea and chlamydia and lower condom use in a cross-sectional study of female sex workers in southern India

ObjectivesTo assess whether having received grey packets containing treatment for gonorrhoea and chlamydia was associated with condom use among female sex workers (FSWs) in 5 districts of southern India covered...

Periodic Presumptive Treatment for Vaginal Infections May Reduce the Incidence of Sexually Transmitted Bacterial Infections.

Bacterial vaginosis (BV) may increase women's susceptibility to sexually transmitted infections (STIs). In a randomized trial of periodic presumptive treatment (PPT) to reduce vaginal infections, we observed a significant reduction in BV. We further assessed the intervention effect on incident Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium infection. Nonpregnant, human immunodeficiency virus-uninfected women from the United States and Kenya received intravaginal metronidazole (750 mg) plus miconazole (200 mg) or placebo for 5 consecutive nights each month for 12 months. Genital fluid specimens were collected every other month. Poisson regression models were used to assess the intervention effect on STI acquisition. Of 234 women enrolled, 221 had specimens available for analysis. Incidence of any bacterial STI (C. trachomatis, N. gonorrhoeae, or M. genitalium infection) was lower in the intervention arm, compared with the placebo arm (incidence rate ratio [IRR], 0.54; 95% confidence interval [CI], .32-.91). When assessed individually, reductions in STI incidences were similar but not statistically significant (IRRs, 0.50 [95% confidence interval {CI}, .20-1.23] for C. trachomatis infection, 0.56 [95% CI, .19-1.67] for N. gonorrhoeae infection, and 0.66 [95% CI, .38-1.15] for M. genitalium infection). In addition to reducing BV, this PPT intervention may also reduce the risk of bacterial STI among women. Because BV is highly prevalent, often persists, and frequently recurs after treatment, interventions that reduce BV over extended periods could play a role in decreasing STI incidence globally.

P06.11 The impact of periodic presumptive treatment for vaginal infections on the vaginal microbiome among women participating in the preventing vaginal infections trial

Background A randomised trial of monthly periodic presumptive treatment (PPT) with intravaginal metronidazole 750 mg plus miconazole 200 mg reduced bacterial vaginosis (BV) by 35% compared to placebo. We further assessed the effect of the intervention on detection of select bacterial species in the vaginal microbiome. Methods HIV-uninfected, non-pregnant women aged 18–45 years from the US and Kenya were randomised to receive PPT or matching placebo for 5 consecutive nights each month for 12 months. Vaginal fluid specimens were collected every other month using Dacron swabs and tested using species-specific quantitative PCR assays that target the 16S rRNA gene. Relative risks [RR] were generated using generalised estimating equations with a log link and exchangeable correlation structure to separately assess the effect of the intervention on species detection. Results Of 234 women enrolled, 221 (94%) had specimens for analysis (PPT n = 110; placebo n = 111). The proportion of follow-up visits with individual species detected was lower in the PPT arm versus placebo for: BVAB1 (13.8% vs. 23.7%; RR = 0.60, 95% CI 0.39–0.93), BVAB2 (30.7% vs. 42.5%; RR = 0.72; 95% CI 0.55–0.95), BVAB3 (22.9% vs. 31.0%; RR = 0.75, 95% CI 0.54–1.03), Atopobium vaginae (59.7% vs. 72.7%; RR = 0.82, 95% CI 0.71–0.94), Leptotrichia/Sneathia (49.4% vs. 60.6%; RR = 0.81, 95% CI 0.68–0.97), and Megasphaera species (26.8% vs. 43.8%; RR = 0.61, 95% CI 0.46–0.82). Lactobactillus crispatus and L. jensenii were more frequently detected in the PPT arm (L. crispatus: 31.8% vs. 26.7%, p = 0.19; L. jensenii: 31.8% vs. 25.1%; p = 0.07). However, these increases were not statistically significant. The prevalence of Gardnerella vaginalis and L. iners during follow-up was high (90% and 91%, respectively) and did not differ by arm. Conclusions Use of monthly PPT for one year significantly reduced BV prevalence as well as colonisation with a number of bacterial species strongly associated with BV. The role of PPT to improve vaginal health should be considered. Disclosure of interest statement R. S. M. has received honoraria for invited lectures and consulting as well as donated study product for this trial from Embil Pharmaceutical Company. R. S. M. currently receives research funding from Hologic/Gen-Probe. J. E. B. received honoraria from Symbiomix, Inc for consulting and donated reagents from Hologic/Gen-Probe. J. S. has received consultancy payments from Akesis, Hologic, Symbiomix, and Starpharma, and has grants/pending grants from Akesis, BD Diagnostic, Hologic, Cepheid, Quidel, Symbiomix, Starpharma, and Viamet. All other authors declare that they do not have a commercial or other association that might pose a conflict of interest.

006.5 Periodic presumptive treatment for vaginal infections may reduce chlamydia and gonorrhoea incidence: a secondary analysis from the preventing vaginal infections trial

Background Women with bacterial vaginosis (BV) are at increased risk for sexually transmitted infections (STI), including Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Among women participating in a randomised trial of periodic presumptive treatment to reduce vaginal infections, we assessed the intervention effect on incident CT and GC infections. Methods Non pregnant, HIV-uninfected women aged 18–45 from the US and Kenya were randomised to receive intravaginal metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months. Genital specimens were collected every other month. Baseline specimens were tested for CT/GC during the trial and follow-up specimens were tested after trial completion using the Aptima Combo-2 assay. Baseline STIs were treated according to local guidelines. Poisson regression models were used to assess the intervention effect on the outcomes separately and as a combined endpoint. Results Of 234 women enrolled, 221 (94%) had specimens available for analysis (intervention n = 110; placebo n = 111). Baseline CT and GC prevalence was 7% (n = 16) and 1% (n = 3), respectively, and similar by arm. Among 205 CT- participants, there were 21 incident CT infections during 179.6 person-years (CT incidence = 11.7/100 person-years), with lower CT incidence in the intervention arm versus placebo (7.8/100 person-years versus 15.6/100 person-years; incidence rate ratio [IRR] = 0.50, 95% CI 0.20–1.23). Among 218 GC- participants, GC incidence was 7.2/100 person-years (14 infections during 93.3 person-years) and also lower in the intervention arm (5.2/100 person-years versus 9.3/100 person-years; IRR = 0.56, 95% CI 0.19–1.67). Results were consistent when CT/GC was assessed as combined endpoint (IRR = 0.57; 95% CI 0.27–1.19). Conclusions This intervention, which significantly reduced BV over 12 months, may also reduce women’s STI acquisition risk. The small sample size in this secondary analysis precluded detection of significant associations, but generated point estimates for reductions in STIs that could inform the planning of future STI prevention trials Disclosure of interest statement R. S. M. has received honoraria for invited lectures and consulting as well as donated study product for this trial from Embil Pharmaceutical Company. R. S. M. currently receives research funding from Hologic/Gen-Probe. J. E. B. received honoraria from Symbiomix, Inc for consulting and donated reagents from Hologic/Gen-Probe. J. S. has received consultancy payments from Akesis, Hologic, Symbiomix, and Starpharma, and has grants/pending grants from Akesis, BD Diagnostic, Hologic, Cepheid, Quidel, Symbiomix, Starpharma, and Viamet. All other authors declare that they do not have a commercial or other association that might pose a conflict of interest.

P12.08 Sti management is hiv prevention: improving access to a comprehensive package of stigma-free srh and hiv services for key populations by implementing the latest who guidelines

Introduction “Shadows and Light” is a three-year project implemented by four IPPF Member Associations and funded by the German BACKUP Initiative. The project developed service capacity that addressed the linked sexual and reproductive health (SRH) and HIV needs of four key populations: transgender people (India); sex workers (Uganda); people who use drugs (Kenya); and men who have sex with men (Cameroon). Often at increased risk of STIs, screening, diagnosis and treatment of STIs are crucial parts of a comprehensive response to HIV. Methods The initial activities focused on preparing clinic sites, including training of service providers to provide stigma-free services. This involved consultations with key population networks and peer educators to inform development of a full continuum of HIV services, including other STIs, as part of SRH services. Recommended interventions were guided by available WHO guidelines for key populations, and included an assessment of implementation in line with current recommendations. Results The project contributed to the development of stigma-free SRH services that offered safe access for key populations in each clinic site. The assessment of available STI services found that while syndromic management for all key populations was available, there was limited availability of targeted screening for asymptomatic STIs. While serological testing for syphilis infection was available in some sites, none were screening for gonorrhoeal or chlamydial infections. No periodic presumptive treatment for asymptomatic STIs was undertaken. Conclusion The inclusion of SRH-related recommendations in the WHO consolidated HIV guidelines for key populations were a critical advancement. By creating a strong link that STI management is HIV prevention enables a greater possibility of addressing within programmes funded by the Global Fund to fight AIDS, Tuberculosis and Malaria. However, additional implementation tools are required to support strengthening of STI-specific services for key populations. Disclosure of interest statement Nothing to declare.

Randomized Trial of Periodic Presumptive Treatment With High-Dose Intravaginal Metronidazole and Miconazole to Prevent Vaginal Infections in HIV-negative Women.

Vaginal infections are common, frequently recur, and may increase women's risk for sexually transmitted infections (STIs). We tested the efficacy of a novel regimen to prevent recurrent vaginal infections. Human immunodeficiency virus (HIV)-negative women 18-45 years old with 1 or more vaginal infections, including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or Trichomonas vaginalis (TV), were randomly assigned to receive vaginal suppositories containing metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months. Primary endpoints, evaluated every 2 months, were BV (Gram stain) and VVC (positive wet mount and culture). Participants (N = 234) were randomly assigned to the intervention (N = 118) or placebo (N = 116) arm. Two hundred seventeen (93%) women completed an end-of-study evaluation. The intervention reduced the proportion of visits with BV compared to placebo (21.2% vs 32.5%; relative risk [RR] 0.65, 95% confidence interval [CI] .48-.87). In contrast, the proportion of visits with VVC was similar in the intervention (10.4%) versus placebo (11.3%) arms (RR 0.92, 95% CI .62-1.37). Monthly treatment with intravaginal metronidazole plus miconazole reduced the proportion of visits with BV during 12 months of follow-up. Further study will be important to determine whether this intervention can reduce women's risk of STIs.

Systematic review of facility-based sexual and reproductive health services for female sex workers in Africa.

BackgroundSeveral biological, behavioural, and structural risk factors place female sex workers (FSWs) at heightened risk of HIV, sexually transmitted infections (STIs), and other adverse sexual and reproductive health (SRH) outcomes. FSW projects in many settings have demonstrated effective ways of altering this risk, improving the health and wellbeing of these women. Yet the optimum delivery model of FSW projects in Africa is unclear. This systematic review describes intervention packages, service-delivery models, and extent of government involvement in these services in Africa.MethodsOn 22 November 2012, we searched Web of Science and MEDLINE, without date restrictions, for studies describing clinical and non-clinical facility-based SRH prevention and care services for FSWs in low- and middle-income countries in Africa. We also identified articles in key non-indexed journals and on websites of international organizations. A single reviewer screened titles and abstracts, and extracted data from articles using standardised tools.ResultsWe located 149 articles, which described 54 projects. Most were localised and small-scale; focused on research activities (rather than on large-scale service delivery); operated with little coordination, either nationally or regionally; and had scanty government support (instead a range of international donors generally funded services). Almost all sites only addressed HIV prevention and STIs. Most services distributed male condoms, but only 10% provided female condoms. HIV services mainly encompassed HIV counselling and testing; few offered HIV care and treatment such as CD4 testing or antiretroviral therapy (ART). While STI services were more comprehensive, periodic presumptive treatment was only provided in 11 instances. Services often ignored broader SRH needs such as family planning, cervical cancer screening, and gender-based violence services.ConclusionsSex work programmes in Africa have limited coverage and a narrow scope of services and are poorly coordinated with broader HIV and SRH services. To improve FSWs’ health and reduce onward HIV transmission, access to ART needs to be addressed urgently. Nevertheless, HIV prevention should remain the mainstay of services. Service delivery models that integrate broader SRH services and address structural risk factors are much needed. Government-led FSW services of high quality and scale would markedly reduce SRH vulnerabilities of FSWs in Africa.

Chlamydia prevalence and associated behaviours among female sex workers in Vanuatu: results from an integrated bio-behavioural survey, 2011.

There is insufficient data on sexually transmitted infections (STI) and related behaviours among key populations, including female sex workers (FSW), in the Pacific region. Using respondent driven sampling, we conducted an integrated bio-behavioural survey with FSW in Vanuatu (aged ≥18 years) to investigate risk behaviours associations with Chlamydia trachomatis (CT). Weighted population estimates and correlates of CT infection were calculated. Among 149 FSW, prevalence of CT was 36 % (95 % CI 26-48 %). Few FSW reported consistent condom use with recent transactional sex partners (TSP) (8 %; 95 % CI 2-13 %). CT infection was positively associated with increasing number of TSP (adjusted odds ratio [AOR] 1.1; 95 % CI 1.0-1.2) and group sex (AOR 2.9; 95 % CI 1.1-8.2). CT was negatively associated with increasing age of first sex (AOR 0.6; 95 % CI 0.5-0.9) and previous STI treatment (AOR 0.1; 95 % CI 0.0-0.4). A comprehensive public health strategy for prevention and treatment of STI among FSW, incorporating community empowerment strategies, FSW-targeted health services and periodic presumptive treatment, is urgently needed in Vanuatu.

Reaching the Unreachable: Providing STI Control Services to Female Sex Workers via Mobile Team Outreach

BackgroundAs part of a community-randomized trial of a multicomponent intervention to prevent sexually transmitted infections, we created Mobile Teams (MTs) in ten intervention cities across Peru to improve outreach to female sex workers (FSW) for strengthened STI prevention services. MethodsThroughout 20 two-month cycles, MTs provided counseling; condoms; screening and specific treatment for Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), and vaginal Trichomonas vaginalis (TV) infections; and periodic presumptive metronidazole treatment for vaginal infections. ResultsMTs had 48,207 separate encounters with 24,814 FSW; numbers of sex work venues and of FSW reached increased steadily over several cycles. Approximately 50% of FSW reached per cycle were new. Reported condom use with last client increased from 73% to 93%. Presumptive metronidazole treatment was accepted 83% of times offered. Over 38 months, CT prevalence declined from 15·4% to 8·2%, and TV prevalence from 7·3% to 2·6%. Among participants in ≥9 cycles, CT prevalence decreased from 12·9% to 6·0% (p <0·001); TV from 4·6% to 1·5% (p <0·001); and NG from 0·8% to 0·4% (p =0·07). ConclusionsMobile outreach to FSW reached many FSW not utilizing government clinics. Self-reported condom use substantially increased; CT and TV prevalences declined significantly. The community-randomized trial, reported separately, demonstrated significantly greater reductions in composite prevalence of CT, NG, TV, or high-titer syphilis serology in FSW in these ten intervention cities than in ten matched control cities.

Prevention and control of sexually transmissible infections among hotel-based female sex workers in Dhaka, Bangladesh

Hotel-based sex workers in Bangladesh have high rates of sexually transmissible infections (STIs), high client turnover and low condom use. Two monthly clinic-based strategies were compared: periodic presumptive treatment (PPT) and enhanced syndromic management (ESM) - one round of presumptive treatment followed by treatment based on assessment and laboratory tests. A randomised controlled trial compared PPT and ESM by prevalence and incidence, behaviour, retention, cost and STI incidence and prevalence. Demographic, behavioural and clinical data were collected from women at two clinics in Dhaka. All women received presumptive treatment and were randomised to receive PPT or ESM at nine monthly visits. In total, 549 women (median age: <20 years) were enrolled. At baseline, the prevalence of chlamydia (Chlamydia trachomatis) and gonorrhoea (Neisseria gonorrhoeae) was 41% (ESM: 41%; PPT: 42%). After 9 months, chlamydia and gonorrhoea decreased to 7% overall, (ESM: 7.4%; PPT: 6.8%). At each visit, 98% of women receiving ESM met the therapy criteria and were treated. Retention was low (50%). Total costs were 50% lower per visit for each woman for PPT (ESM: $11.62 v. PPT: $5.80). The number of sex work sessions was reduced from 3.3 to 2.5 (P<0.001), but income did not change. Coercion was reduced but condom use at last sex did not change significantly. Monthly PPT and ESM were effective approaches for STI control. PPT offered a feasible, low-cost alternative to ESM. Educational aspects led to a reduction in coercion and fewer sessions. Implementation studies are needed to improve condom use and retention.

Priority interventions to reduce HIV transmission in sex work settings in sub‐Saharan Africa and delivery of these services

IntroductionVirtually no African country provides HIV prevention services in sex work settings with an adequate scale and intensity. Uncertainty remains about the optimal set of interventions and mode of delivery.MethodsWe systematically reviewed studies reporting interventions for reducing HIV transmission among female sex workers in sub-Saharan Africa between January 2000 and July 2011. Medline (PubMed) and non-indexed journals were searched for studies with quantitative study outcomes.ResultsWe located 26 studies, including seven randomized trials. Evidence supports implementation of the following interventions to reduce unprotected sex among female sex workers: peer-mediated condom promotion, risk-reduction counselling and skills-building for safer sex. One study found that interventions to counter hazardous alcohol-use lowered unprotected sex. Data also show effectiveness of screening for sexually transmitted infections (STIs) and syndromic STI treatment, but experience with periodic presumptive treatment is limited. HIV testing and counselling is essential for facilitating sex workers’ access to care and antiretroviral treatment (ART), but testing models for sex workers and indeed for ART access are little studied, as are structural interventions, which create conditions conducive for risk reduction. With the exception of Senegal, persistent criminalization of sex work across Africa reduces sex workers’ control over working conditions and impedes their access to health services. It also obstructs health-service provision and legal protection.ConclusionsThere is sufficient evidence of effectiveness of targeted interventions with female sex workers in Africa to inform delivery of services for this population. With improved planning and political will, services – including peer interventions, condom promotion and STI screening – would act at multiple levels to reduce HIV exposure and transmission efficiency among sex workers. Initiatives are required to enhance access to HIV testing and ART for sex workers, using current CD4 thresholds, or possibly earlier for prevention. Services implemented at sufficient scale and intensity also serve as a platform for subsequent community mobilization and sex worker empowerment, and alleviate a major source of incident infection sustaining even generalized HIV epidemics. Ultimately, structural and legal changes that align public health and human rights are needed to ensure that sex workers on the continent are adequately protected from HIV.

The Posttrial Effect of Oral Periodic Presumptive Treatment for Vaginal Infections on the Incidence of Bacterial Vaginosis and Lactobacillus Colonization

We previously demonstrated a decrease in bacterial vaginosis (BV) and an increase in Lactobacillus colonization among randomized controlled trial (RCT) participants who received monthly oral periodic presumptive treatment (PPT; 2 g metronidazole + 150 mg fluconazole). Posttrial data were analyzed to test the hypothesis that the treatment effect would persist after completion of 1 year of PPT. Data were obtained from women who completed all 12 RCT visits and attended ≥ 1 posttrial visit within 120 days after completion of the RCT. We used Andersen-Gill proportional hazards models to estimate the posttrial effect of the intervention on the incidence of BV by Gram stain and detection of Lactobacillus species by culture. The analysis included 165 subjects (83 active and 82 placebo). The posttrial incidence of BV was 260 per 100 person-years in the intervention arm versus 358 per 100 person-years in the placebo arm (hazard ratio = 0.76; 95% confidence interval, 0.51-1.12). The posttrial incidence of Lactobacillus colonization was 180 per 100 person-years in the intervention arm versus 127 per 100 person-years in the placebo arm (hazard ratio = 1.42; 95% confidence interval, 0.85-2.71). Despite a decrease in BV and an increase in Lactobacillus colonization during the RCT, the effect of PPT was not sustained at the same level after cessation of the intervention. New interventions that reduce BV recurrence and promote Lactobacillus colonization without the need for ongoing treatment are needed.

Periodic presumptive treatment of curable sexually transmitted infections among sex workers

Unprotected sex work remains a major driver of HIV/sexually transmitted infection (STI) epidemics in many countries. STI treatment can lower disease burden, complications and prevalence of HIV cofactors. Periodic presumptive treatment (PPT) has been used with sex workers to reduce their high burden of largely asymptomatic STIs. The objective of this review is to assess benefits and harms of PPT among female sex workers. We searched MEDLINE for studies related to sex work and STIs during 1990-2010, extracted data from eligible studies in duplicate and conducted meta-analysis by study design using random effects models. Two thousand, three hundred and fifteen articles were screened, 18 studies met inclusion criteria and 14 were included in meta-analyses. One published randomized controlled trial (RCT) reported significant reductions of gonorrhoea (Neisseria gonorrhoeae) [rate ratio (RR) 0.46, 95% confidence interval (CI) 0.31-0.68] and chlamydia (Chlamydia trachomatis) (RR 0.38, 95%CI 0.26-0.57), but no effect on serologic syphilis (RR 1.02, 95%CI 0.54-1.95). Similar results were seen for N. gonorrhoeae and C. trachomatis in pooled analyses, including data from one unpublished RCT and across study designs, and correlated with initial prevalence (R(2) = 0.155). One observational study reported genital ulcer disease (GUD) declines in sex workers, and two reported impact among male client populations for N. gonorrhoeae [odds ratio (OR) 0.60, 95% CI 0.38-0.94], C. trachomatis (OR 0.47, 95% CI 0.31-0.71) and GUD (OR 0.21, 95% CI 0.11-0.42). No studies reported evidence of risk compensation or antibiotic resistance. PPT can reduce prevalence of gonorrhoea, chlamydia and ulcerative STIs among sex workers in whom prevalence is high. Sustained STI reductions can be achieved when PPT is implemented together with peer interventions and condom promotion. Additional benefits may include impact on STI and HIV transmission at population level.

Prevention of sexually transmitted infections in urban communities (Peru PREVEN): a multicomponent community-randomised controlled trial

SummaryBackgroundPrevious community-randomised trials of interventions to control sexually transmitted infections (STIs) have involved rural settings, were rarely multicomponent, and had varying results. We aimed to assess the effect of a multicomponent intervention on curable STIs in urban young adults and female sex workers (FSWs).MethodsIn this community-randomised trial, baseline STI screening was done between August, and November, 2002, in random household samples of young adults (aged 18–29 years) and in FSWs in Peruvian cities with more than 50 000 inhabitants. Geographically separate cities were selected, matched into pairs, and randomly allocated to intervention or control groups with an S-PLUS program. Follow-up surveys of random samples were done after 2 years and 3 years. The intervention comprised four modalities: strengthened STI syndromic management by pharmacy workers and clinicians; mobile-team outreach to FSWs for STI screening and pathogen-specific treatment; periodic presumptive treatment of FSWs for trichomoniasis; and condom promotion for FSWs and the general population. Individuals in control cities received standard care. The composite primary endpoint was infection of young adults with Chlamydia trachomatis, Trichomonas vaginalis, or Neisseria gonorrhoeae, or syphilis seroreactivity. Laboratory workers and the data analyst were masked, but fieldworkers, the Peruvian study team, and participants in the outcome surveys were not. All analyses were done by intention to treat. This trial is registered, ISRCTN43722548.FindingsWe did baseline surveys of 15 261 young adults in 24 Peruvian cities. Of those, 20 geographically separate cities were matched into pairs, in each of which one city was assigned to intervention and the other to standard of care. In the 2006 follow-up survey, data for the composite primary outcome were available for 12 930 young adults. We report a non-significant reduction in prevalence of STIs in young adults, adjusted for baseline prevalence, in intervention cities compared with control cities (relative risk 0·84, 95% CI 0·69–1·02; p=0·096). In subgroup analyses, significant reductions were noted in intervention cities in young adult women and FSWs.InterpretationSyndromic management of STIs, mobile-team outreach to FSWs, presumptive treatment for trichomoniasis in FSWs, and condom promotion might reduce the composite prevalence of any of the four curable STIs investigated in this trial.FundingWellcome Trust and Burroughs Wellcome Fund, National Institutes of Health, Center for AIDS Research, CIPRA, and USAID-Peru.

Periodic presumptive treatment of curable sexually transmitted infections among sex workers

Curable sexually transmitted infections (STIs) are common occupational hazards for female sex workers in low-income and middle-income countries. Yet, most infections are asymptomatic and sensitive screening tests are rarely affordable or feasible. Periodic presumptive treatment (PPT) has been used as a component of STI control interventions to rapidly reduce STI prevalence. Six recent observational studies confirm earlier randomized controlled trial findings that PPT reduces gonorrhoea and chlamydia prevalence among sex workers. One modeling study estimated effects on Neisseria gonorrhoeae, Chlamydia trachomatis, Haemophilus ducreyi, and HIV prevalence at different levels of PPT coverage and frequency, among sex workers who take PPT and among all sex workers. Important operational issues include use of single-dose combination antibiotics for high cure rates, conditions for introducing PPT, frequency and coverage, and use of PPT together with other intervention components to maximize and sustain STI control and reinforce HIV prevention. PPT is an effective short-term measure to rapidly reduce prevalence of gonorrhoea, chlamydia, and ulcerative chancroid among female sex workers. It should be implemented together with other measures--to increase condom use, reduce risk and vulnerability--in order to maintain low STI prevalence when PPT is phased out.

Establishing and Sustaining a Healthy Vaginal Environment: Analysis of Data From a Randomized Trial of Periodic Presumptive Treatment for Vaginal Infections

Data from a randomized trial of oral periodic presumptive treatment (PPT) to reduce vaginal infections were analyzed to assess the effect of the intervention on a healthy vaginal environment (normal flora confirmed by Gram stain with no candidiasis or trichomoniasis). The incidence of a healthy vaginal environment was 608 cases per 100 person-years in the intervention arm and 454 cases per 100 person-years in the placebo arm (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.17-1.58). Sustained vaginal health (healthy vaginal environment for ≥3 consecutive visits) was also more frequent in the intervention arm (HR, 1.69; 95% CI, 1.23-2.33). PPT is effective at establishing and sustaining a healthy vaginal environment.

O3-S5.04 The post-trial effect of periodic presumptive treatment for vaginal infections on the incidence of bacterial vaginosis and Lactobacillus colonisation

BackgroundBacterial vaginosis (BV) is a highly prevalent infection that frequently recurs following standard treatment. In a randomised controlled trial (RCT) of oral periodic presumptive treatment (PPT) to reduce vaginal infections...