Sexual Health for Transgender and Gender Diverse Individuals: Routine Examination, Sexually-Transmitted Infection Screening, and Prevention.

Gynecologists play a critical role in the office evaluation of transgender and gender diverse individuals. This includes the provision of essential healthcare services including the treatment and prevention of human immunodeficiency virus and sexually-transmitted infections and screening for human papillomavirus infection-related diseases and cancers. Caring for patients who identify as transgender or gender diverse (TGD) and who have undergone gender-affirming surgical treatments is challenging due in part to clinical gaps in knowledge resulting from insufficient training and educational resources. A patient-centered approach to the care of TGD individuals requires knowledge of the general principles of affirming, holistic care with attention to the risk factors, and anatomic considerations unique to this population. This review aims to provide basic knowledge needed for the successful gynecologic evaluation of a gender diverse patient.

Factors potentially contributing to the decline of the mpox outbreak in the Netherlands, 2022 and 2023.

BackgroundIn 2022 and 2023, a global outbreak of mpox affected mostly gay, bisexual and other men having sex with men (GBMSM). Outbreak control in the Netherlands included isolation, quarantine, post-exposure prophylaxis vaccination and primary preventive vaccination (PPV).AimWe describe the course of the outbreak, the vaccination programme, vaccine effectiveness (VE) of full vaccination against symptomatic disease, and trends in behaviour to generate hypotheses about factors that influenced the outbreak's decline.MethodsIn this observational study, we collected data from public health services on notified cases, number of PPV invitations and PPV doses administered. We calculated PPV uptake and coverage. Trends in behavioural data of GBMSM visiting sexual health centres were analysed for all consultations in 2022. We estimated VE using the screening method.ResultsUntil 31 December 2023, 1,294 mpox cases were reported. The outbreak peaked in early July 2022 and then declined sharply. PPV started on 25 July 2022; in total 29,851 doses were administered, 45.8% received at least one dose, 35.4% were fully vaccinated. The estimated VE was 68.2% (95% CI 4.3-89.5%). We did not observe an evident decrease in high-risk behaviour.DiscussionIt is unlikely that PPV was a driver of the outbreak's decline, as incidence started to decline well before the start of the PPV programme. The possible impact of behavioural change could not be demonstrated with the available indicators, however, the data had limitations, hampering interpretation. We hypothesise that infection-induced immunity in high-risk groups was an important factor explaining the decline.

Intentions of healthcare seeking and self-isolation for MPOX among men who have sex with men in China: a national cross-sectional study.

Linking identified MPOX cases to care is essential for MPOX control. This study aims to investigate the intentions of healthcare seeking and self-isolation for MPOX among men who have sex with men (MSM) in China. A cross-sectional online survey was conducted in early August 2023 in China. Respondents were recruited by community-based organizations (CBOs), collecting information on demographics, health status, behavioural and psychological characteristics. Univariate and multivariate logistic regression analyses were performed to examine the predictors of intentions to seek healthcare and self-isolate for MPOX within the MSM population. A total of 7725 participants were recruited, with a median age of 30 years. 92.21% of the participants would seek healthcare for MPOX-like symptoms, but only 52.50% intended to self-isolate if diagnosed. Intentions to seek healthcare were lower among those with MPOX-like symptoms in the past 3 months (standardized prevalence ratio (SPRs) = 0.82, 95% CI: 0.74-0.89) and the willingness to self-isolate was reduced among those diagnosed with MPOX in the past 3 months (SPRs = 0.65, 95% CI: 0.48-0.87). Participants free of sexually transmitted infections (STIs) and those aware of their HIV status were more likely to seek healthcare and self-isolate than those with STIs or unaware of their HIV status. Regular followers of MPOX information and those perceiving a low risk of infection were more inclined to take preventive measures. These findings highlight the need for targeted MPOX prevention strategies for high-risk groups and the importance of addressing barriers in infectious disease prevention response.

Sexual behaviour and incidence of sexually transmitted infections among men who have sex with men (MSM) using daily and event-driven pre-exposure prophylaxis (PrEP): Four-year follow-up of the Amsterdam PrEP (AMPrEP) demonstration project cohort.

BACKGROUND: An increasing number of countries are currently implementing or scaling-up HIV pre-exposure prophylaxis (PrEP) care. With the introduction of PrEP, there was apprehension that condom use would decline and sexually transmitted infections (STIs) would increase. To inform sexual health counselling and STI screening programmes, we aimed to study sexual behaviour and STI incidence among men who have sex with men (MSM) and transgender women who use long-term daily or event-driven PrEP. METHODS AND FINDINGS: The Amsterdam PrEP demonstration project (AMPrEP) was a prospective, closed cohort study, providing oral daily PrEP and event-driven PrEP to MSM and transgender women from 2015 to 2020. Participants could choose their PrEP regimen and could switch at each three-monthly visit. STI testing occurred at and, upon request, in-between 3-monthly study visits. We assessed changes in numbers of sex partners and condomless anal sex (CAS) acts with casual partners over time using negative binomial regression, adjusted for age. We assessed HIV incidence and changes in incidence rates (IRs) of any STI (i.e., chlamydia, gonorrhoea, or infectious syphilis) and individual STIs over time using Poisson regression, adjusted for age and testing frequency. A total of 367 participants (365 MSM) commenced PrEP and were followed for a median 3.9 years (interquartile range [IQR] = 3.4-4.0). Median age was 40 years (IQR = 32-48), 315 participants (85.8%) self-declared ethnicity as white and 280 (76.3%) had a university or university of applied sciences degree. Overall median number of sex partners (past 3 months) was 13 (IQR = 6-26) and decreased per additional year on PrEP (adjusted rate ratio [aRR] = 0.86/year, 95% confidence interval [CI] = 0.83-0.88). Overall median number of CAS acts with casual partners (past 3 months) was 10 (IQR = 3-20.5) and also decreased (aRR = 0.92/year, 95% CI = 0.88-0.97). We diagnosed any STI in 1,092 consultations during 1,258 person years, resulting in an IR of 87/100 person years (95% CI = 82-92). IRs of any STI did not increase over time for daily PrEP or event-driven PrEP users. Two daily PrEP users, and no event-driven PrEP users, were diagnosed with HIV during their first year on PrEP. Study limitations include censoring follow-up due to COVID-19 measures and an underrepresentation of younger, non-white, practically educated, and transgender individuals. CONCLUSIONS: In this prospective cohort with a comparatively long follow-up period of 4 years, we observed very low HIV incidence and decreases in the numbers of casual sex partners and CAS acts over time. Although the STI incidence was high, it did not increase over time. TRIAL REGISTRATION: The study was registered at the Netherlands Trial Register (NL5413) https://www.onderzoekmetmensen.nl/en/trial/22706.

Perceptions about doxycycline post-exposure prophylaxis (Doxy-PEP) as an STI-prevention strategy among gay and bisexual men (GBM) in the United States: Results from a qualitative study.

OBJECTIVE: To leverage qualitative data to explore gay and bisexual men's (GBM) perceptions about doxycycline post-exposure prophylaxis (Doxy-PEP). Doxy-PEP is a novel biomedical STI-prevention strategy that helps reduce the risk of acquiring bacterial STIs. Little is known about Doxy-PEP's acceptability in the U.S., nor how best to engage those most vulnerable to STIs in taking up this nascent prevention strategy. METHOD: Between July and September of 2023, 24 GBM from across the U.S. completed qualitative interviews about their perceptions regarding Doxy-PEP. Interviews were analyzed using a codebook approach to thematic analysis. RESULTS: Participants were generally interested in using Doxy-PEP, but were concerned about the potential for antibiotic resistance, side-effects, medication interactions to occur, along with stigmatizing discourse around its use. Meanwhile, participants were motivated by the simplicity of Doxy-PEP and the protection it could confer on both an individual and community-level- as well as its potential to reduce STI-related anxiety. Finally, participants desired additional information on Doxy-PEP to address their concerns. CONCLUSIONS: There is a need for clear guidelines and expanded public health messaging on Doxy-PEP in the U.S.

Barriers to sexual health care for sexually diverse Muslim men: a scoping review.

Sexually diverse Muslim men (SDMM) are seen to present later and with more advanced symptoms of HIV and other sexually transmitted infections (STIs). The limited access to sexual healthcare services is attributed to the stigma associated with their multiple intersecting identities. We conducted a scoping review to synthesise research on barriers impeding SDMM's access to sexual health care. We used Arksey and O'Malley's five-stage framework as the methodology for the review. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses' extension for scoping reviews, was used as a guide for the presentation of the results. Searches conducted in EBSCOhost, Scopus, MEDLINE, Embase, CINAHL, Global Health, and Google Scholar yielded 1382 results, of which 18 studies were deemed eligible for this review. Bronfenbrenner's socioecological model was employed as a framework to analyse the studies. Through analysing the eligible studies, we identified factors operating at three different levels that can impede SDMM's access to sexual health care. Limited awareness and low-perceived risk of HIV/STIs, coupled with the fear of sexual identity disclosure might act as individual-level barriers to sexually diverse Muslim men's access to sexual health care. The experiences of discrimination within clinical settings were presented as a healthcare system-related issue discouraging SDMM from revisiting those services. Heteronormative and religious ideologies, homophobic government programs, and poverty might manifest in the more intimate domains of healthcare delivery, creating hostile spaces for SDMM. Intensive research and advocacy efforts are required to improve SDMM's access to sexual health care, which can reduce their risk of HIV/STIs.

Sexually transmitted infections and the HPV-related burden: evolution of Italian epidemiology and policy.

Sexually transmitted infections (STIs) are a major public health problem worldwide, with a high prevalence between the ages of 15 and 25 in most Western countries. High notification rates of chlamydia, gonorrhea, and syphilis are reported in the WHO European Region, with differences between countries. In Italy, the total number of STIs alerts increased by 18% from 2020 to 2021. HPV is the most common sexually transmitted infection; globally one in seven women is infected by this virus, and certain sexual behaviors are important risk factors for HPV-related cancers, particularly cervical cancer (CC), anogenital cancers and cancers of the head and neck. The burden of CC is relevant worldwide, in particular in Europe CC is the third leading cause of cancer-related deaths in women aged 15-44. This HPV-related tumor is preventable through a combined strategy of vaccination and screening for precursor lesions. In Italy, the coverage of organized screening varies from region to region and the average HPV vaccination rate is still far from the expected optimal threshold of 95% at the age of 12. To address the challenges of health promotion and HPV prevention, priority actions are needed such as: promoting education and information at every level, from schools to healthcare professionals. In Italy, education of adolescents on sexual and reproductive health, still remains critical, regionally inhomogeneous and much lower than in other European countries. Equitable measures need to be taken, and schools are an important place for health promotion activities.

A cinenurducation activity using Call the Midwife to teach about sexually transmitted infections and preeclampsia: design, implementation, and assessment.

BACKGROUND: Nursing students need to learn about sexually transmitted infections and preeclampsia. Cinenureducation is a rigorous method that uses materials from commercial movies or television series to teach health sciences students. OBJECTIVES: Using content analysis of the television series Call the Midwife, design a cinenureducation activity teaching nursing students about sexually transmitted infections and preeclampsia. Evaluate its effectiveness in knowledge acquisition. DESIGN, IMPLEMENTATION, AND PRE-POST ASSESSMENT OF KNOWLEDGE GAIN FOR TEACHING ACTIVITIES: The study comprised three main steps: designing the teaching activity, implementing it, and analyzing its pedagogical effectiveness through a pre-and-post study to assess knowledge acquisition resulting from the teaching activity. PARTICIPANTS: A six-member panel assessed the suitability of materials for the teaching goals. All second-year undergraduate nursing students in the course "Nursing management and leadership" at a nursing school in the 2022-2023 academic year were invited to participate (N = 160). METHODS: The panel conducted a content analysis of the first two seasons of the series to determine the usefulness of each episode for teaching the chosen topics. Students were randomly assigned to groups watching episodes emphasizing either sexually transmitted infections or preeclampsia, followed by discussion. Learning was gauged through a pre-post viewing 20-question multiple-choice test. Additionally, students' satisfaction was evaluated. RESULTS: A total of 142 nursing students participated. Significant differences between mean scores before and after intervention were found [6.90 vs. 6.42 on the preintervention assessment, p < 0.05; mean gain, 0.49 (95 % CI: 0.22-0.76)]. Most students were satisfied with the activity. CONCLUSIONS: The activity was useful for teaching about sexually transmitted infections and preeclampsia. The use of a television series portraying nurses enables the exploration of these critical topics. This has potential implications for integrating similar methods into nurse education curricula, emphasizing the broader impact of the research on pedagogical practices in healthcare education.

Understanding effective post-test linkage strategies for HIV prevention and care: a scoping review.

INTRODUCTION: Following HIV testing services (HTS), the World Health Organization recommends prompt linkage to prevention and treatment. Scale-up of effective linkage strategies is essential to achieving the global 95-95-95 goals for maintaining low HIV incidence by 2030 and reducing HIV-related morbidity and mortality. Whereas linkage to care including same-day antiretroviral therapy (ART) initiation for all people with HIV is now routinely implemented in testing programmes, linkage to HIV prevention interventions including behavioural or biomedical strategies, for HIV-negative individuals remains sub-optimal. This review aims to evaluate effective post-HTS linkage strategies for HIV overall, and highlight gaps specifically in linkage to prevention. METHODS: Using the five-step Arksey and O'Malley framework, we conducted a scoping review searching existing published and grey literature. We searched PubMed, Cochrane Library, CINAHL, Web of Science and EMBASE databases for English-language studies published between 1 January 2010 and 30 November 2023. Linkage interventions included as streamlined interventions-involving same-day HIV testing, ART initiation and point-of-care CD4 cell count/viral load, case management-involving linkage coordinators developing personalized HIV care and risk reduction plans, incentives-financial and non-financial, partner services-including contact tracing, virtual-like social media, quality improvement-like use of score cards, and peer-based interventions. Outcomes of interest were linkage to any form of HIV prevention and/or care including ART initiation. RESULTS: Of 2358 articles screened, 66 research studies met the inclusion criteria. Only nine linkage to prevention studies were identified (n = 9/66, 14%)-involving pre-exposure prophylaxis, voluntary medical male circumcision, sexually transmitted infection and cervical cancer screening. Linkage to care studies (n = 57/66, 86%) focused on streamlined interventions in the general population and on case management among key populations. DISCUSSION: Despite a wide range of HIV prevention interventions available, there was a dearth of literature on HIV prevention programmes and on the use of messaging on treatment as prevention strategy. Linkage to care studies were comparatively numerous except those evaluating virtual interventions, incentives and quality improvement. CONCLUSIONS: The findings give insights into linkage strategies but more understanding of how to provide these effectively for maximum prevention impact is needed.

Sexual and reproductive health among forcibly displaced persons in urban environments in low and middle-income countries: scoping review findings.

BACKGROUND: Most forcibly displaced persons are hosted in low- and middle-income countries (LMIC). There is a growing urbanization of forcibly displaced persons, whereby most refugees and nearly half of internally displaced persons live in urban areas. This scoping review assesses the sexual and reproductive health (SRH) needs, outcomes, and priorities among forcibly displaced persons living in urban LMIC. METHODS: Following The Joanna Briggs Institute scoping review methodology we searched eight databases for literature published between 1998 and 2023 on SRH needs among urban refugees in LMIC. SHR was operationalized as any dimension of sexual health (comprehensive sexuality education [CSE]; sexual and gender based violence [GBV]; HIV and STI prevention and control; sexual function and psychosexual counseling) and/or reproductive health (antental, intrapartum, and postnatal care; contraception; fertility care; safe abortion care). Searches included peer-reviewed and grey literature studies across quantitative, qualitative, or mixed-methods designs. FINDINGS: The review included 92 studies spanning 100 countries: 55 peer-reviewed publications and 37 grey literature reports. Most peer-reviewed articles (n = 38) discussed sexual health domains including: GBV (n = 23); HIV/STI (n = 19); and CSE (n = 12). Over one-third (n = 20) discussed reproductive health, including: antenatal, intrapartum and postnatal care (n = 13); contraception (n = 13); fertility (n = 1); and safe abortion (n = 1). Eight included both reproductive and sexual health. Most grey literature (n = 29) examined GBV vulnerabilities. Themes across studies revealed social-ecological barriers to realizing optimal SRH and accessing SRH services, including factors spanning structural (e.g., livelihood loss), health institution (e.g., lack of health insurance), community (e.g., reduced social support), interpersonal (e.g., gender inequitable relationships), and intrapersonal (e.g., low literacy) levels. CONCLUSIONS: This review identified displacement processes, resource insecurities, and multiple forms of stigma as factors contributing to poor SRH outcomes, as well as producing SRH access barriers for forcibly displaced individuals in urban LMIC. Findings have implications for mobilizing innovative approaches such as self-care strategies for SRH (e.g., HIV self-testing) to address these gaps. Regions such as Africa, Latin America, and the Caribbean are underrepresented in research in this review. Our findings can guide SRH providers, policymakers, and researchers to develop programming to address the diverse SRH needs of urban forcibly displaced persons in LMIC. Most forcibly displaced individuals live in low- and middle-income countries (LMICs), with a significant number residing in urban areas. This scoping review examines the sexual and reproductive health (SRH) outcomes of forcibly displaced individuals in urban LMICs. We searched eight databases for relevant literature published between 1998 and 2023. Inclusion criteria encompassed peer-reviewed articles and grey literature. SRH was defined to include various dimensions of sexual health (comprehensive sexuality education; sexual and gender-based violence; HIV/ STI prevention; sexual function, and psychosexual counseling) and reproductive health (antenatal, intrapartum, and postnatal care; contraception; fertility care; and safe abortion care). We included 90 documents (53 peer-reviewed articles, 37 grey literature reports) spanning 100 countries. Most peer-reviewed articles addressed sexual health and approximately one-third centered reproductive health. The grey literature primarily explored sexual and gender-based violence vulnerabilities. Identified SRH barriers encompassed challenges across structural (livelihood loss), health institution (lack of insurance), community (reduced social support), interpersonal (gender inequities), and individual (low literacy) levels. Findings underscore gaps in addressing SRH needs among urban refugees in LMICs specifically regarding sexual function, fertility care, and safe abortion, as well as regional knowledge gaps regarding urban refugees in Africa, Latin America, and the Caribbean. Self-care strategies for SRH (e.g., HIV self-testing, long-acting self-injectable contraception, abortion self-management) hold significant promise to address SRH barriers experienced by urban refugees and warrant further exploration with this population. Urgent research efforts are necessary to bridge these knowledge gaps and develop tailored interventions aimed at supporting urban refugees in LMICs.

Management of acute sexual assault presenting to a large Australian sexual health clinic in 2012-2021: a retrospective clinical audit.

Background The incidence of sexual assault continues to rise in Australia. This study aimed to describe the nature of assault, HIV/STI positivity, and its management at a sexual health clinic. Methods We performed a chart review of 516 sexual assault cases presenting to Melbourne Sexual Health Centre between 2012 and 2021, collecting data on victim demographics, details of assault, HIV/STI testing and positivity, police involvement, and offer of counselling. Results We included 516 cases: 124 males (24.0%); 384 females (74.4%); and eight transgender (1.6%) victims. The proportion of assault cases presenting to Melbourne Sexual Health Centre increased from 0.1% (37/37,070) in 2012 to 0.2% (56/36,514) in 2021 (P trend =0.006). HIV post-exposure prophylaxis was prescribed for 64.5% (80/124) of males and 12.5% (48/384) of females. Among victims, 69.4% (358/516) were tested for HIV and no one tested positive, while 71.9% (371/516) were tested for syphilis, with 1.6% (6/371) positive. Gonorrhoea and chlamydia were tested at the oropharynx (44.8% [231/516] vs 28.7% [148/516]), genitals (83.7% [432/516] vs 92.4% [477/516]) and anorectum (35.3% [182/516] vs 35.3% [182/516]). Positivity for gonorrhoea and chlamydia were: 2.6% (6/231) vs 2.0% (3/148) at oropharynx, 1.4% (6/432) vs 2.9% (14/477) at genitals, and 5.5% (10/182) vs 7.1% (13/182) at anorectum. According to clinical records, 25.2% (130/516) of victims sought police involvement, and 71.7% (370/516) were offered counselling. Conclusions Sexual assault was an uncommon presentation at Melbourne Sexual Health Centre, with diverse circumstances surrounding assault; however, clinical documentation varied, indicating a need for a standard primary care protocol for clients presenting with acute sexual assault.

Doxycycline as Postsexual Exposure Prophylaxis: Use, Acceptability, and Associated Sexual Health Behaviors Among a Multi-Site Sample of Clinical Trial Participants.

Doxycycline postexposure prophylaxis (doxy-PEP) reduces sexually transmitted infections (STIs) in men who have sex with men (MSM) and transgender women (TGW). In a clinical trial of doxy-PEP, we sought to assess acceptability, impact, and meaning of doxy-PEP use among MSM/TGW. We conducted semistructured, in-depth 1:1 interviews with MSM and TGW enrolled in the intervention arm of the Doxy-PEP study. We queried motivations for and meaning of use, attitudes, beliefs, adherence, effect on sexual behaviors, and partner, community, and structural factors related to use. We coded interview transcripts into content areas, followed by thematic analysis. We interviewed 44 participants (median age 38), 2% were TGW, 17% Black, 61% White, 30% Hispanic, and 45% persons with HIV. We identified three overarching themes. First, participants found doxy-PEP acceptable, and believed it was effective based on their history of STIs, easy to adhere to, and acceptable to sex partners. Second, doxy-PEP benefited their quality of life and mental health, offering "peace of mind" by reducing their anxiety about acquisition or unwitting transmission of STIs. Participants reported feeling more "in control" of preventing STIs, and positive about supporting their personal, partner, and community health. Third, impact on sexual behavior was variable, with most reporting no change or a brief initial change. Participants in a multi-site clinical trial of doxycycline for STI prevention perceived it to be efficacious, and that it provided quality-of-life benefits, including reduced anxiety and sense of control over sexual health. Doxy-PEP had limited impact on sexual behavior. Clinicaltrials.gov: NCT03980223.

Program Director Reports of COVID-19 Lockdown-Driven Service Changes in Community-Based STI Clinics and Syringe Services Programs in the Southeastern U.S.

The COVID-19 pandemic strained the U.S. health care system, posing logistical challenges for community-based programs. This study surveyed 11 program directors in sexually transmitted infection (STI) clinics and syringe services programs (SSPs) that served people who use substances and are at risk for HIV in five southeastern U.S. states. Brief survey questions asked about programs' use of in-person and telehealth services. Results indicated widespread reduction of in-person services and concomitant adoption of telehealth services. In STI clinics, telehealth replaced in-person visits for all but urgent treatment of active symptoms. In SSPs, in-person contact continued or increased from pre-pandemic volumes. In both programs, the most salient telehealth use barrier was limited device or internet access and limited technological ease. Services were sustained through innovative adaptations. This snapshot of response to the early COVID-19 lockdown phase offers actionable guidance about service preparedness for future public health catastrophes in community-based programs serving vulnerable populations.

Preventive Care for Men Who Have Sex With Men.

Men who have sex with men (MSM) is an inclusive term used to refer to phenotypic males who have insertive or receptive sex (penile-anal or penile-oral) with other phenotypic males, including people who are transgender or have other gender identities. MSM may report their sexual orientation as homosexual, bisexual, heterosexual, or something else, but this stated sexual orientation may not align with their sexual attraction or behaviors. Several health conditions disproportionately affect MSM compared with age-matched heterosexual men, including HIV infection, anal cancer, syphilis, and depression. Clinicians should use culturally sensitive questions to obtain a comprehensive sexual history and assess sexual risk. MSM should receive regular screening for HIV, hepatitis B and C, gonorrhea, chlamydia, and syphilis. Vaccinations for hepatitis A and B and human papillomavirus should be offered. MSM may benefit from preexposure prophylaxis to prevent HIV infection, postexposure prophylaxis to reduce the risk of HIV transmission, and counseling on safer sexual practices. Screening for anal cancer associated with human papillomavirus may be performed by digital anal rectal examination, although the optimal screening strategy has yet to be determined. Clinicians should also consider more frequent screenings for mental health issues in the MSM population because the rates of depression, suicide, substance use, and other psychosocial issues are higher than those of the general population.

Associations between intravaginal practices and incidence of sexually transmitted infections and bacterial vaginosis among women enrolled in the dapivirine vaginal ring trial (The Ring Study) in southwestern Uganda: a retrospective secondary analysis.

OBJECTIVES: We assessed associations between intravaginal practices (IVPs) and the incidence of sexually transmitted infections (STIs) and bacterial vaginosis (BV) among women using the dapivirine vaginal ring (DVR) or placebo vaginal ring in southwestern Uganda. METHODS: This was a retrospective secondary analysis of data collected from women at risk of HIV infection recruited into the Ring Study. The latter evaluated the safety and efficacy of the DVR between 2013 and 2016. At baseline, a behavioural questionnaire was administered to obtain information on sexual activity and IVP (exposure) defined as; insertion inside the vagina of any items aimed at cleaning the vagina for any reason before, during or after sex other than practices to manage menses. Each participant self-inserted the DVR/placebo and replaced it every 4 weeks for 2 years. Outcomes were diagnosis of STIs, that is, Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis (TV), HIV and BV. The incidence rate of STI/BV was estimated, overall, by IVP and trial arm in single-event-per-participant and multiple-event-per-participant analyses. RESULTS: Of the 197 women enrolled, 66 (33.5%) were <25 years of age. Overall, 93 (47.2%) practised at least one form of IVP. During the follow-up, 172 (87.3%) women were diagnosed with an STI/BV at least once. The majority had TV (73.6%, n=145). Overall rate of STI/BV was 51.9/100 person-years, 95% CI 44.7 to 60.3 (IVP: yes, 51.0 (40.8-63.8) vs no, 52.6 (43.0-64.4)). IVPs were not statistically significantly associated with rate of individual STIs/BV. Similar results were observed when the analyses were conducted separately for each trial arm. CONCLUSIONS: IVP was not associated with risk of STIs/BV in the Ring Study. TRIAL REGISTRATION NUMBER: NCT01539226.