Extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV-negative women: study protocol for the randomised, placebo-controlled double-blinded, phase 2 CAPRISA 012C trial.

INTRODUCTION: Women-controlled HIV prevention technologies that overcome adherence challenges of available daily oral pre-exposure prophylaxis and give women a choice of options are urgently needed. Broadly neutralising monoclonal antibodies (bnAbs) administered passively may offer a valuable non-antiretroviral biological intervention for HIV prevention. Animal and human studies have demonstrated that bnAbs which neutralise HIV can prevent infection. The optimal plasma antibody concentrations to confer protection against HIV infection in humans is under intense study. The Centre for the AIDS Programme of Research in South Africa (CAPRISA) 012C trial will evaluate extended safety and pharmacokinetics of CAP256V2LS and VRC07-523LS among young HIV-negative South African and Zambian women. The study design also allows for an evaluation of a signal of HIV prevention efficacy. METHODS AND ANALYSIS: CAPRISA 012 is a series of trials with three distinct protocols. The completed CAPRISA 012A and 012B phase 1 trials provided critical data for the CAPRISA 012C trial, which is divided into parts A and B. In part A, 90 participants were randomised to receive both CAP256V2LS and VRC07-523LS at 20 mg/kg or placebo, subcutaneously every 16 or 24 weeks. Part B will enrol 900 participants in South Africa and Zambia who will be randomised in a 1:1 ratio and receive an initial loading dose of 1.2 g of CAP256V2LS and VRC07-523LS or placebo followed by 600 mg of CAP256V2LS and 1.2 g of VRC07-523LS or placebo subcutaneously every 6 months. Safety will be assessed by frequency and severity of reactogenicity and other related adverse events. Pharmacokinetics of both antibodies will be measured in systemic and mucosal compartments over time, while participants will be monitored for breakthrough HIV infections. ETHICS AND DISSEMINATION OF STUDY FINDINGS: The University of KwaZulu-Natal Biomedical Research Ethics Committee and South African Health Products Regulatory Authority have approved the trial (BREC/00002492/2021, SAHPRA20210317). Results will be disseminated through conference presentations, peer-reviewed publications and the clinical trial registry. TRIAL REGISTRATION NUMBER: PACTR202112683307570.

Canadian SARS-CoV-2 serological survey using antenatal serum samples: a retrospective seroprevalence study.

BACKGROUND: Insufficient data on the rate and distribution of SARS-CoV-2 infection in Canada has presented a substantial challenge to the public health response to the COVID-19 pandemic. Our objective was to assess SARS-CoV-2 seroprevalence in a representative sample of pregnant people throughout Canada, across multiple time points over 2 years of the pandemic, to describe the seroprevalence and show the ability of this process to provide prevalence estimates. METHODS: This Canadian retrospective serological surveillance study used existing serological prenatal samples across 10 provinces over multiple time periods: Feb. 3-21, 2020; Aug. 24-Sept. 11, 2020; Nov. 16-Dec. 4, 2020; Nov. 15-Dec. 3, 2021; and results from the province of British Columbia during a period in which the SARS-CoV-2 B.1.1.529 (Omicron) variant was predominant, from Nov. 15, 2021, to June 11, 2022. Age and postal code administrative data allowed for comparison with concurrent polymerase chain reactivity (PCR)-positive results collected by Statistics Canada and the Canadian Surveillance of COVID-19 in Pregnancy (CANCOVID-Preg) project. RESULTS: Seropositivity in antenatal serum as early as February 2020 indicates SARS-CoV-2 transmission before the World Health Organization's declaration of the pandemic. Seroprevalence in our sample of pregnant people was 1.84 to 8.90 times higher than the recorded concurrent PCR-positive prevalence recorded among females aged 20-49 years in November-December 2020. Overall seropositivity in our sample of pregnant people was low at the end of 2020, increasing to 15% in 1 province by the end of 2021. Seroprevalence among pregnant people in BC during the Omicron period increased from 5.8% to 43% from November 2021 to June 2022. INTERPRETATION: These results indicate widespread vulnerability to SARS-CoV-2 infection before vaccine availability in Canada. During the time periods sampled, public health tracking systems were under-reporting infections, and seroprevalence results during the Omicron period indicate extensive community spread of SARS-CoV-2 infection.

Comparative performance data for multiplex SARS-CoV-2 serological assays from a large panel of dried blood spot specimens.

The extent of the COVID-19 pandemic will be better understood through serosurveys and SARS-CoV-2 antibody testing. Dried blood spot (DBS) samples will play a central role in large scale serosurveillance by simplifying biological specimen collection and transportation, especially in Canada. Direct comparative performance data on multiplex SARS-CoV-2 assays resulting from identical DBS samples are currently lacking. In our study, we aimed to provide performance data for the BioPlex 2200 SARS-CoV-2 IgG (Bio-Rad), V-PLEX SARS-CoV-2 Panel 2 IgG (MSD), and Elecsys Anti-SARS-CoV-2 (Roche) commercial assays, as well as for two highly scalable in-house assays (University of Ottawa and Mount Sinai Hospital protocols) to assess their suitability for DBS-based SARS-CoV-2 DBS serosurveillance. These assays were evaluated against identical panels of DBS samples collected from convalescent COVID-19 patients (n = 97) and individuals undergoing routine sexually transmitted and bloodborne infection (STBBI) testing prior to the COVID-19 pandemic (n = 90). Our findings suggest that several assays are suitable for serosurveillance (sensitivity >97% and specificity >98%). In contrast to other reports, we did not observe an improvement in performance using multiple antigen consensus-based rules to establish overall seropositivity. This may be due to our DBS panel which consisted of samples collected from convalescent COVID-19 patients with significant anti-spike, -receptor binding domain (RBD), and -nucleocapsid antibody titers. This study demonstrates that biological specimens collected as DBS coupled with one of several readily available assays are useful for large-scale COVID-19 serosurveillance.

Adapting Serosurveys for the SARS-CoV-2 Vaccine Era.

Population-level immune surveillance, which includes monitoring exposure and assessing vaccine-induced immunity, is a crucial component of public health decision-making during a pandemic. Serosurveys estimating the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in the population played a key role in characterizing SARS-CoV-2 epidemiology during the early phases of the pandemic. Existing serosurveys provide infrastructure to continue immune surveillance but must be adapted to remain relevant in the SARS-CoV-2 vaccine era. Here, we delineate how SARS-CoV-2 serosurveys should be designed to distinguish infection- and vaccine-induced humoral immune responses to efficiently monitor the evolution of the pandemic. We discuss how serosurvey results can inform vaccine distribution to improve allocation efficiency in countries with scarce vaccine supplies and help assess the need for booster doses in countries with substantial vaccine coverage.

Prevalence and correlates of sexual concerns and associated distress among women living with HIV in Canada.

OBJECTIVES: We assessed the prevalence and correlates of sexual concerns and associated distress among women living with HIV in Canada. METHODS: We analyzed cross-sectional survey data from the Canadian HIV Women's Sexual and Reproductive Health Cohort Study (2017-2018). Self-identified women living with HIV were asked about sexual concerns post-HIV diagnosis and associated distress (none, mild, moderate, severe). Five areas of concern were assessed, including difficulties related to sexual self-esteem, sexual function, relationships, and emotional and behavioral aspects of sex. Logistic regression analyses identified correlates of reporting any sexual concerns and severe distress about these concerns. RESULTS: Of 906 participants (median age 48, Q1-Q3 = 41-55), 596 (65.8%) reported sexual concerns post-HIV diagnosis. We found a high prevalence of concerns related to relationships (43.3%), sexual self-esteem (49.4%), and emotional aspects of sex (45.4%), relative to sexual functioning (38.4%) and behavioral aspects (33.7%). Of those with sexual concerns, 36.7% reported severe distress. Reports of severe distress were the highest for relationship difficulties (32.5%), relative to other areas of concern (21.4%-22.8%). In adjusted analyses, women reporting sexual dissatisfaction and high HIV-related stigma had significantly higher odds of reporting sexual concerns. Conversely, those reporting higher resilience, better mental health, African, Caribbean, and Black identity, and sex as somewhat unimportant, not at all important, or neutral to their lives had lower adjusted odds. Factors associated with severe distress about sexual concerns included older age, body dissatisfaction, sexual dissatisfaction, and high HIV-related stigma, while better mental health and getting support from someone living with HIV were protective. While 84.4% of women had discussed with a provider how viral load impacts transmission risk, only 40.6% had conversations about sexual wellbeing. CONCLUSION: More attention to women's sexual wellbeing within social and relational contexts is critical to ensure the sexual rights of women living with HIV are upheld.

CAPRISA 018: a phase I/II clinical trial study protocol to assess the safety, acceptability, tolerability and pharmacokinetics of a sustained-release tenofovir alafenamide subdermal implant for HIV prevention in women.

INTRODUCTION: Young African women bear a disproportionately high risk for HIV acquisition. HIV technologies that empower women to protect themselves are needed. Safe, potent antiretroviral agents such as tenofovir alafenamide (TAF), formulated as long-acting subdermal implants, offer an innovative solution. METHODS AND ANALYSIS: CAPRISA 018 is a phase I/II trial to evaluate the safety, acceptability, tolerability and pharmacokinetics (PKs) of a TAF free base subdermal silicone implant containing 110 mg of TAF with an anticipated 0.25 mg/day release rate.The phase I trial (n=60) will assess the safety of one implant inserted in six participants (Group 1), followed by dose escalation components (Groups 2 and 3) assessing the safety, tolerability and PK of one to four TAF 110 mg implants releasing between 0.25 mg and 1 mg daily in 54 healthy women at low risk for HIV infection. Data from this phase I trial will be used to determine the dosing, implant location and implant replacement interval for the phase II trial.The phase II component (Group 4) will assess extended safety, PK, tolerability and acceptability of the implant in 490 at risk women, randomised in a 1:1 ratio to the TAF implant and placebo tablet or to the placebo implant and an oral pre-exposure prophylaxis tablet. Safety will be assessed by calculating the percentage change in creatinine clearance from baseline at weeks 4, 12, 24, 36, 72, 96 and 120, compared with the percentage change in the control group. ETHICS AND DISSEMINATION: The South African Health Products Regulatory Authority and the University of KwaZulu-Natal's Biomedical Research Ethics Committee have approved the trial. Results will be disseminated through open access peer reviewed publications, conference presentations, public stakeholder engagement and upload of data into the clinical trials registry. TRIAL REGISTRATION NUMBER: PACTR201809520959443.

Dried blood spot specimens for SARS-CoV-2 antibody testing: A multi-site, multi-assay comparison.

The true severity of infection due to COVID-19 is under-represented because it is based on only those who are tested. Although nucleic acid amplifications tests (NAAT) are the gold standard for COVID-19 diagnostic testing, serological assays provide better population-level SARS-CoV-2 prevalence estimates. Implementing large sero-surveys present several logistical challenges within Canada due its unique geography including rural and remote communities. Dried blood spot (DBS) sampling is a practical solution but comparative performance data on SARS-CoV-2 serological tests using DBS is currently lacking. Here we present test performance data from a well-characterized SARS-CoV-2 DBS panel sent to laboratories across Canada representing 10 commercial and 2 in-house developed tests for SARS-CoV-2 antibodies. Three commercial assays identified all positive and negative DBS correctly corresponding to a sensitivity, specificity, positive predictive value, and negative predictive value of 100% (95% CI = 72.2, 100). Two in-house assays also performed equally well. In contrast, several commercial assays could not achieve a sensitivity greater than 40% or a negative predictive value greater than 60%. Our findings represent the foundation for future validation studies on DBS specimens that will play a central role in strengthening Canada's public health policy in response to COVID-19.

Strengthening capacity for clinical research in sub-Saharan Africa: partnerships and networks.

Global research collaboration, through partnerships and networks, is an effective way to deliver highly impactful and sustainable research that is collectively owned and promoted for the global good. Many models exist for effective North-South collaborations that are built on trust and balanced benefits. The European & Developing Countries Clinical Trials Partnership (EDCTP) model emphasises capacity development in clinical trials and product-focused implementation research. To ensure effectiveness and sustainability, capacity development requires a long-term perspective, an integrated system-wide approach, and local ownership and leadership from countries experiencing high disease burdens. Guided by these principles, the EDCTP2 programme, established in 2014, has developed and strengthened human capital and institutional capacities in 39 countries in sub-Saharan Africa to undertake high-quality clinical research guided by good clinical and regulatory practices. Projects in these countries have involved 238 African and 163 European institutions. To date, EDCTP has supported 171 Fellows and 232 postgraduate trainees. EDCTP-short-term training activities have equipped 9628 researchers and medical personnel. The EDCTP capacity-building described here includes its Regional Networks of Excellence and its Consortia for public health emergencies which provide the foundation for sustained efforts against emerging and re-emerging global health threats.

A practical clinical guide to counselling on and managing contraception, pre-conception planning, and menopause for women living with HIV.

Background: Women represent one quarter of the population living with HIV in Canada and are an increasingly important sector of the HIV community. While some women's health issues such as cervical cancer screening and management are well addressed in HIV management guidelines, others are not. These include sexual and reproductive health factors such as contraception, pre-conception planning, and menopause. Existing literature has shown that while women living with HIV in Canada receive good HIV care based on HIV care cascade indicators, their women's health and sexual and reproductive health care needs are not being met. Methods: In this article, we present a clinical guide for clinicians providing care for women living with HIV on three key women's health topics that are under-discussed during HIV care visits: (1) contraception, (2) pre-conception planning, and (3) menopause. Results: We have summarized the most pertinent clinical factors on each topic to support straightforward counselling and present important considerations in the context of HIV-related diseases and treatment. Finally, when relevant, we have provided practical stepwise approaches for addressing each of these women's health care topics when seeing a patient during a visit. Conclusions: It is important that HIV specialists stay well-versed in the complex clinical interactions between HIV treatment and management of women's health issues.

Historique: Les femmes forment le quart de la population qui vit avec le VIH au Canada et un segment croissant de la communauté du VIH. Certains problèmes de santé des femmes, comme le dépistage et la prise en charge du cancer du col de l'utérus, sont bien couverts dans les directives sur la prise en charge du VIH, mais d'autres non. Des facteurs liés à la santé sexuelle et reproductive, tels que la contraception, la planification avant la conception et la ménopause, en font partie. Les publications scientifiques ont démontré que les femmes qui vivent avec le VIH au Canada reçoivent de bons soins du VIH en fonction des indicateurs de soins du VIH ventilés en cascade, mais que leurs besoins en matière de santé des femmes, de santé sexuelle et de santé reproductive ne sont pas respectés. Méthodologie: Dans le présent article, les auteurs proposent un guide clinique à l'intention des cliniciens qui soignent des femmes atteintes du VIH, à l'égard de trois sujets en santé des femmes qui ne sont pas assez abordés pendant les rendez-vous sur les soins du VIH : 1) la contraception, 2) la planification avant la conception et 3) la ménopause. Résultats: Les auteurs ont résumé les facteurs cliniques les plus appropriés relatifs à chaque sujet pour favoriser un counseling franc et présentent des points de vue importants dans le contexte des maladies et des traitements liés au VIH. Enfin, lorsque c'est approprié, ils ont fourni une démarche pratique graduelle pour aborder chacun de ces sujets en santé des femmes lors d'un rendez-vous. Conclusions: Il est important que les spécialistes du VIH demeurent bien informés des interactions cliniques complexes entre le traitement du VIH et la prise en charge des problèmes de santé des femmes.

Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial.

INTRODUCTION: New HIV prevention strategies are urgently required. The discovery of broadly neutralising antibodies (bNAbs) has provided the opportunity to evaluate passive immunisation as a potential prevention strategy and facilitate vaccine development. Since 2014, several bNAbs have been isolated from a clade C-infected South African donor, CAPRISA 256. One particular bNAb, CAP256-VRC26.25, was found to be extremely potent, with good coverage against clade C viruses, the dominant HIV clade in sub-Saharan Africa. Challenge studies in non-human primates demonstrated that this antibody was fully protective even at extremely low doses. This bNAb was subsequently structurally engineered and the clinical variant is now referred to as CAP256V2LS. METHODS AND ANALYSIS: CAPRISA 012B is the second of three trials in the CAPRISA 012 bNAb trial programme. It is a first-in-human, phase I study to assess the safety and pharmacokinetics of CAP256V2LS. The study is divided into four groups. Group 1 is a dose escalation of CAP256V2LS administered intravenously to HIV-negative and HIV-positive women. Group 2 is a dose escalation of CAP256V2LS administered subcutaneously (SC), with and without the dispersing agent recombinant human hyaluronidase (rHuPH20) as single or repeat doses in HIV-negative women. Groups 3 and 4 are randomised placebo controlled to assess two (CAP256V2LS+VRC07-523LS; CAP256V2LS+PGT121) and three (CAP256V2LS+VRC07-523LS+PGT121) bNAb combinations administered SC to HIV-negative women. Safety will be assessed by the frequency of reactogenicity and adverse events related to the study product. Pharmacokinetic disposition of CAP256V2LS alone and in combination with VRC07-523LS and PGT121 will be assessed via dose subgroups and route of administration. ETHICS AND DISSEMINATION: The University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC) and the South African Health Products Regulatory Authority (SAHPRA) have granted regulatory approval (trial reference numbers: BREC00000857/2019 and SAHPRA 20200123). Trial results will be disseminated through conference presentations, peer-reviewed publications and the clinical trial registry. TRIAL REGISTRATION NUMBER: PACTR202003767867253; Pre-results.

National HIV testing and diagnosis coverage in sub-Saharan Africa: a new modeling tool for estimating the 'first 90' from program and survey data.

OBJECTIVE: HIV testing services (HTS) are a crucial component of national HIV responses. Learning one's HIV diagnosis is the entry point to accessing life-saving antiretroviral treatment and care. Recognizing the critical role of HTS, the Joint United Nations Programme on HIV/AIDS (UNAIDS) launched the 90-90-90 targets stipulating that by 2020, 90% of people living with HIV know their status, 90% of those who know their status receive antiretroviral therapy, and 90% of those on treatment have a suppressed viral load. Countries will need to regularly monitor progress on these three indicators. Estimating the proportion of people living with HIV who know their status (i.e. the 'first 90'), however, is difficult. METHODS: We developed a mathematical model (henceforth referred to as 'Shiny90') that formally synthesizes population-based survey and HTS program data to estimate HIV status awareness over time. The proposed model uses country-specific HIV epidemic parameters from the standard UNAIDS Spectrum model to produce outputs that are consistent with other national HIV estimates. Shiny90 provides estimates of HIV testing history, diagnosis rates, and knowledge of HIV status by age and sex. We validate Shiny90 using both in-sample comparisons and out-of-sample predictions using data from three countries: Côte d'Ivoire, Malawi, and Mozambique. RESULTS: In-sample comparisons suggest that Shiny90 can accurately reproduce longitudinal sex-specific trends in HIV testing. Out-of-sample predictions of the fraction of people living with HIV ever tested over a 4-to-6-year time horizon are also in good agreement with empirical survey estimates. Importantly, out-of-sample predictions of HIV knowledge of status are consistent (i.e. within 4% points) with those of the fully calibrated model in the three countries when HTS program data are included. The model's predictions of knowledge of status are higher than available self-reported HIV awareness estimates, however, suggesting - in line with previous studies - that these self-reports could be affected by nondisclosure of HIV status awareness. CONCLUSION: Knowledge of HIV status is a key indicator to monitor progress, identify bottlenecks, and target HIV responses. Shiny90 can help countries track progress towards their 'first 90' by leveraging surveys of HIV testing behaviors and annual HTS program data.

Cross-sectional study of the health of southern African truck drivers.

OBJECTIVES: Lifestyle and working conditions of truck drivers predisposes them to risk-factors associated with communicable and non-communicable diseases, but little is known about the health status of African truck driver. This study aims to assess a cross-section of truckers in South Africa to describe their health information. SETTING: The study took place across three truck-stop rest areas in the South African provinces of Free State and Gauteng. PARTICIPANTS: Eligibility criteria included being males aged 18 years and older, full-time employment as a long-distance truck driver. A total of 614 male truck drivers participated; 384 (63%) were Zimbabwean and 325 (55%) completed high-school. PRIMARY AND SECONDARY OUTCOME MEASURES: The trucker survey explored demographics; working conditions; sexual, eating and sleeping behaviours; mental health status, medical history and cardiac risk-factors. Medical assessments included physical measurements, glucose and lipid measurements, ECG, carotid intima-media thickness (CIMT) and cardiac ultrasound. RESULTS: In the previous month, 554 (91%) participants were sexually active; 522 (86%) had sex with a regular partner; 174 (27%) with a casual partner; 87 (14%) with a sex worker. Average time driving was 10 hours/day, 20 days/month, 302 (50%) never worked night shifts and 74 (12%) worked nights approximately four times per week. 112 (18%) experienced daytime sleepiness and 59 (10%) were ever hospitalised from an accident. Forty-seven (8%, 95% CI 5.3 to 9.5) were HIV-positive, with half taking antiretrovirals. Forty-eight (8%) truckers had some moderate depression, while 21 (4%) suffered from post-traumatic stress disorder. Reported tuberculosis, myocardial infarction, and diabetes were <3%. Prominent cardiac risk-factors included smoking (n=63, 11%), consuming alcohol (>15 drinks/week) (n=54, 9%), overweight/obesity (n=417, 69%), and hypertension (n=220, 36%,95% CI 32.1 to 39.7). ECG results showed 23 (4.9%) and 29 (5.3%) drivers had left ventricular hypertrophy using the Cornell criterion and product, respectively. CIMT measurements indicated nine (4.2%) drivers had a carotid atherosclerotic plaque. CONCLUSION: This first holistic assessment of health among southern African male truck drivers demonstrates substantial addressable cardiovascular risk factors, mental health issues and sexual risk behaviours.

Sex and Male Circumcision: Women's Preferences Across Different Cultures and Countries: A Systematic Review.

INTRODUCTION: Women's choices for a sexual partner are influenced by numerous personal, cultural, social, political and religious factors, and may also include aspects of penile anatomy such as male circumcision (MC) status. AIM: To perform a systematic review examining (i) whether MC status influences women's preference for sexual activity and the reasons for this, and (ii) whether women prefer MC for their sons. METHODS: PRISMA-compliant searches were conducted of PubMed, Google Scholar, Embase, and the Cochrane Database of Systematic Reviews. Articles that met the inclusion criteria were rated for quality using the SIGN system. RESULTS: Database searches identified 29 publications with original data for inclusion, including 22 for aim (i) and 4 of these and 7 others pertaining to aim (ii). In the overwhelming majority of studies, women expressed a preference for the circumcised penis. The main reasons given for this preference were better appearance, better hygiene, reduced risk of infection, and enhanced sexual activity, including vaginal intercourse, manual stimulation, and fellatio. In studies that assessed mothers' preference for MC of sons, health, disease prevention, and hygiene were cited as major reasons for this preference. Cultural differences in preference were evident among some of the studies examined. Nevertheless, a preference for a circumcised penis was seen in most populations regardless of the frequency of MC in the study setting. CONCLUSION: Women's preferences generally favor the circumcised penis for sexual activity, hygiene, and lower risk of infection. The findings add to the already well-established health benefits favoring MC and provide important sociosexual information on an issue of widespread interest. Morris BJ, Hankins CA, Lumbers ER, et al. Sex and Male Circumcision: Women's Preferences Across Different Cultures and Countries: A Systematic Review. Sex Med 2019;7:145-161.

Love with HIV: A Latent Class Analysis of Sexual and Intimate Relationship Experiences Among Women Living with HIV in Canada.

Love remains hidden in HIV research in favor of a focus on risk. Among 1424 women living with HIV in Canada, we explored (1) whether eight facets of sex and intimacy (marital status, sexual activity, physical intimacy, emotional closeness, power equity, sexual exclusivity, relationship duration, and couple HIV serostatus) may coalesce into distinct relationship types, and (2) how these relationship types may be linked to love as well as various social, psychological, and structural factors. Five latent classes were identified: no relationship (46.5%), relationships without sex (8.6%), and three types of sexual relationships-short term (15.4%), long term/unhappy (6.4%), and long term/happy (23.2%, characterized by equitable power, high levels of physical and emotional closeness, and mainly HIV-negative partners). While women in long-term/happy relationships were most likely to report feeling love for and wanted by someone "all of the time," love was not exclusive to sexual or romantic partners and a sizeable proportion of women reported affection across latent classes. Factors independently associated with latent class membership included age, children living at home, sexism/genderism, income, sex work, violence, trauma, depression, HIV treatment, awareness of treatment's prevention benefits, and HIV-related stigma. Findings reveal the diversity of women's experiences with respect to love, sex, and relationships and draw attention to the sociostructural factors shaping intimate partnering in the context of HIV. A nuanced focus on promoting healthy relationships and supportive social environments may offer a more comprehensive approach to supporting women's overall sexual health and well-being than programs focused solely on sexual risk reduction.

Using mathematical modeling to inform health policy: A case study from voluntary medical male circumcision scale-up in eastern and southern Africa and proposed framework for success.

BACKGROUND: Modeling contributes to health program planning by allowing users to estimate future outcomes that are otherwise difficult to evaluate. However, modeling results are often not easily translated into practical policies. This paper examines the barriers and enabling factors that can allow models to better inform health decision-making. DESCRIPTION: The Decision Makers' Program Planning Tool (DMPPT) and its successor, DMPPT 2, are illustrative examples of modeling tools that have been used to inform health policy. Their use underpinned Voluntary Medical Male Circumcision (VMMC) scale-up for HIV prevention in southern and eastern Africa. Both examine the impact and cost-effectiveness of VMMC scale-up, with DMPPT used initially in global advocacy and DMPPT 2 then providing VMMC coverage estimates by client age and subnational region for use in country-specific program planning. Their application involved three essential steps: identifying and engaging a wide array of stakeholders from the outset, reaching consensus on key assumptions and analysis plans, and convening data validation meetings with critical stakeholders. The subsequent DMPPT 2 Online is a user-friendly tool for in-country modeling analyses and continuous program planning and monitoring. LESSONS LEARNED: Through three iterations of the DMPPT applied to VMMC, a comprehensive framework with six steps was identified: (1) identify a champion, (2) engage stakeholders early and often, (3) encourage consensus, (4) customize analyses, (5), build capacity, and (6) establish a plan for sustainability. This framework could be successfully adapted to other HIV prevention programs to translate modeling results to policy and programming. CONCLUSIONS: Models can be used to mobilize support, strategically plan, and monitor key programmatic elements, but they can also help inform policy environments in which programs are conceptualized and implemented to achieve results. The ways in which modeling has informed VMMC programs and policy may be applicable to an array of other health interventions.

Does Male Circumcision Reduce Women's Risk of Sexually Transmitted Infections, Cervical Cancer, and Associated Conditions?

Background: Male circumcision (MC) is proven to substantially reduce men's risk of a number of sexually transmitted infections (STIs). We conducted a detailed systematic review of the scientific literature to determine the relationship between MC and risk of STIs and associated conditions in women. Methods: Database searches by "circumcision women" and "circumcision female" identified 68 relevant articles for inclusion. Examination of bibliographies of these yielded 14 further publications. Each was rated for quality using a conventional rating system. Results: Evaluation of the data from the studies retrieved showed that MC is associated with a reduced risk in women of being infected by oncogenic human papillomavirus (HPV) genotypes and of contracting cervical cancer. Data from randomized controlled trials and other studies has confirmed that partner MC reduces women's risk not only of oncogenic HPV, but as well Trichomonas vaginalis, bacterial vaginosis and possibly genital ulcer disease. For herpes simplex virus type 2, Chlamydia trachomatis, Treponema pallidum, human immunodeficiency virus and candidiasis, the evidence is mixed. Male partner MC did not reduce risk of gonorrhea, Mycoplasma genitalium, dysuria or vaginal discharge in women. Conclusion: MC reduces risk of oncogenic HPV genotypes, cervical cancer, T. vaginalis, bacterial vaginosis and possibly genital ulcer disease in women. The reduction in risk of these STIs and cervical cancer adds to the data supporting global efforts to deploy MC as a health-promoting and life-saving public health measure and supplements other STI prevention strategies.

Supporting the Sexual Rights of Women Living With HIV: A Critical Analysis of Sexual Satisfaction and Pleasure Across Five Relationship Types.

In the context of human immunodeficiency virus (HIV), a focus on protecting others has overridden concern about women's own sexual well-being. Drawing on feminist theories, we measured sexual satisfaction and pleasure across five relationship types among women living with HIV in Canada. Of the 1,230 women surveyed, 38.1% were completely or very satisfied with their sexual lives, while 31.0% and 30.9% were reasonably or not very/not at all satisfied, respectively. Among those reporting recent sexual experiences (n = 675), 41.3% always felt pleasure, with the rest reporting usually/sometimes (38.7%) or seldom/not at all (20.0%). Sex did not equate with satisfaction or pleasure, as some women were completely satisfied without sex, while others were having sex without reporting pleasure. After adjusting for confounding factors, such as education, violence, depression, sex work, antiretroviral therapy, and provider discussions about transmission risk, women in long-term/happy relationships (characterized by higher levels of love, greater physical and emotional intimacy, more equitable relationship power, and mainly HIV-negative partners) had increased odds of sexual satisfaction and pleasure relative to women in all other relational contexts. Those in relationships without sex also reported higher satisfaction ratings than women in some sexual relationships. Findings put focus on women's rights, which are critical to overall well-being.