Reproductive Health Technologies Research Articles

Learnings From an Innovative Model to Expand Access to a New and Underutilized Nonhormonal Contraceptive Diaphragm.

We document the effort over the last 30 years to respond to the call by women advocates at the International Conference on Population and Development for more woman-initiated single or dual-purpose contraceptive methods by developing the Caya contoured diaphragm, an innovative diaphragm designed to meet the needs of women and their partners and expand options for nonhormonal barrier contraception. We describe the complex and interrelated set of activities undertaken to develop the product using a human-centered design process and how we are working to create a corollary sustainable market. This review includes the evidence generated around improved acceptability among couples in low- and middle-income countries and depicts challenges and practical actions on how to dispel misconceptions about diaphragm use. Importantly, we share programmatic lessons learned on increasing universal access to this new sexual and reproductive health technology. Following our new model for increasing access to new and underutilized methods, Caya is now registered and being marketed in nearly 40 countries worldwide.

Knowledge and attitude of adolescents towards sexual health and reproductive health technologies.

Reproductive health and reproductive health technologies are one of the challenging health studies in the developing world. The study focuses on the knowledge and attitude of adolescent students towards reproductive health technologies. It is the need and responsibility of all individuals especially adolescents (the future procreators) to know about Assisted Reproductive Technologies (ART) and the sexual health related to it. The objectives are to evaluate the level of knowledge among late adolescents (18-21 years) regarding sexual and reproductive health. To understand the attitudes of late adolescents towards sexual health and reproductive health technologies. To identify gaps in knowledge and misconceptions about sexual and reproductive health among late adolescents. To determine the awareness and perceptions of late adolescents regarding various reproductive health technologies. The study was a mixed method, 46 respondents of age groups between 18-21 years (late adolescents) were selected, using simple random sampling. A self-administered questionnaire was circulated through Google Forms. Data was collected and analysed using SPSS Statistics Data Editor version 22. The level of knowledge the late adolescents have towards sexual health and reproductive technologies is very low and the study should explore all, to know the merits and demerits of Assisted Reproductive Technologies (ART) and the alternative methods for childbirth. The dissemination of information and availability of educational resources on sexual and reproductive health may be resulting in comparable levels of knowledge among individuals of various age cohorts.

Science and Islamic ethics: Navigating artificial womb technology through Quranic principles

This paper explores the complex interplay between scientific innovation and religious ethics, with a specific focus on the ethical implications of Artificial Womb Technology (AWT) as interpreted through the lens of Quranic teachings on the essence of life. The objective is to meld the burgeoning field of reproductive technologies with the foundational principles of Islamic theology through an examination of Islamic jurisprudential rulings, contemporary bioethical discourse and innovations in reproductive technology. In addition to attention given to the compatibility of AWT with Islamic teachings concerning the sanctity of life, there is also a focus on the concept of motherhood and the preservation of family structure. This study undertakes an extensive exploration of both historical and contemporary interpretations of Islamic precepts, culminating in the establishment of an ethical framework. This framework is designed to harmonise religious doctrines with the exigencies of reproductive science by proposing normative guidelines for the ethical implementation of AWT and similar technologies. This paper makes a substantial contribution to academic discourse on science and religion by integrating advancements in reproductive health technology with moral principles intrinsic to the Islamic faith.

In vitro fertilization as an option for couples with genetic disorders

Errors in human DNA may cause genetic disorders. Technological developments have raised hopes for reducing the risks of genetic inheritance among married couples who have a history of such disorders. Among the developments in reproductive health technology that reduce those risks is the in vitro fertilization (IVF) process. This review aimed to describe the current strategies using IVF and preimplantation genetic testing (PGT), which would be effective for couples with genetic disorders to have healthy offspring. The literature review included full-text, open-access research articles from ScienceDirect, PubMed, and Google Scholar that were published between 2013 and 2023, with 65 articles obtained from various journals. The keywords were “in vitro fertilization,” “reproductive genetic disorders,” “PGT-A,” “PGT-M,” “PGT-SR,” and “oocyte donor.” A total of 46 articles were selected as the most relevant to the review topic, and the results show that the IVF process can be an option for couples with a history of genetic disorders. Several additional procedures can be performed following IVF, such as oocyte donation and PGT, to help couples who want to have offspring without transmitting their genetic disorders. IVF can be an option for couples who have or carry genetic disorders. With IVF, couples can undertake several procedures such as oocyte donation and PGT for aneuploidy, monogenic disorders, or structural rearrangement.

Innovative Approaches to Menstruation and Fertility Tracking Using Wearable Reproductive Health Technology: Systematic Review.

Emerging digital health technology has moved into the reproductive health market for female individuals. In the past, mobile health apps have been used to monitor the menstrual cycle using manual entry. New technological trends involve the use of wearable devices to track fertility by assessing physiological changes such as temperature, heart rate, and respiratory rate. The primary aims of this study are to review the types of wearables that have been developed and evaluated for menstrual cycle tracking and to examine whether they may detect changes in the menstrual cycle in female individuals. Another aim is to review whether these devices are effective for tracking various stages in the menstrual cycle including ovulation and menstruation. Finally, the secondary aim is to assess whether the studies have validated their findings by reporting accuracy and sensitivity. A review of PubMed or MEDLINE was undertaken to evaluate wearable devices for their effectiveness in predicting fertility and differentiating between the different stages of the menstrual cycle. Fertility cycle-tracking wearables include devices that can be worn on the wrists, on the fingers, intravaginally, and inside the ear. Wearable devices hold promise for predicting different stages of the menstrual cycle including the fertile window and may be used by female individuals as part of their reproductive health. Most devices had high accuracy for detecting fertility and were able to differentiate between the luteal phase (early and late), fertile window, and menstruation by assessing changes in heart rate, heart rate variability, temperature, and respiratory rate. More research is needed to evaluate consumer perspectives on reproductive technology for monitoring fertility, and ethical issues around the privacy of digital data need to be addressed. Additionally, there is also a need for more studies to validate and confirm this research, given its scarcity, especially in relation to changes in respiratory rate as a proxy for reproductive cycle staging.

Application value of tumor necrosis factor inhibitors in in vitro fertilization-embryo transfer in infertile women with polycystic ovary syndrome

BackgroundClinical value of tumor necrosis factor (TNF) inhibitors in in vitro fertilization-embryo transfer (IVF-ET) in infertile women with polycystic ovary syndrome (PCOS) was investigated in this study.MethodsA retrospective analysis was performed on the clinical data of 100 PCOS patients who received IVF-ET for the first time at Hebei Institute of reproductive health science and technology from January 2010 to June 2020. The patients were divided into Inhibitor group and Control group according to whether they were treated with or without TNF inhibitors. Next, the two groups were subject to comparison in terms of the days of gonadotropin (Gn) use, total dosage of Gn, trigger time, hormone level and endometrial condition on the day of human chorionic gonadotropin (HCG) injection, the effects of two different regimens on controlled ovarian hyperstimulation (COH) and pregnancy outcomes.ResultsThere were no significant differences in baseline characteristics between the two groups, including age, duration of infertility, body mass index (BMI), ovarian volume, antral follicle count, and basal hormone levels. Compared with the Control group, the days of Gn use and trigger time of patients in the Inhibitor group were significantly shortened, and the total Gn dosage was notably reduced. In terms of sex hormone levels on the HCG injection, the Inhibitor group displayed much lower serum estradiol levels while higher serum luteinizing hormone and progesterone (P) levels than the Control group. Notably, the high-quality embryo rate was also significantly increased with the use of TNF inhibitors. However, significant differences were not observed in endometrial thickness (on the day of HCG injection), proportion of endometrial A, B and C morphology (on the day of HCG injection), cycle cancellation rate, number of oocytes retrieved, fertilization rate, and cleavage rate between the two groups. Importantly, the clinical pregnancy rate in the Inhibitor group was significantly higher than that in the Control group, but there was no significant difference in the biochemical pregnancy rate, early abortion rate, multiple birth rate, ectopic pregnancy rate and number of live births between the two groups.ConclusionCollectively, after application of TNF-α inhibitor regimen, superior overall treatment effect can be observed in infertile PCOS patients receiving IVF-ET. Therefore, TNF inhibitors have certain application value in IVF-ET in infertile women with PCOS.

Surrogacy in Indonesia: The comparative legality and Islamic perspective

Reproductive health technology allows married couples who experience infertility to have a child through assisted reproductive technology (ART), such as the in vitro fertilisation (IVF) process. The transfer of the extracted embryo to the woman’s womb is called surrogacy technology (gestational surrogacy). The legality of the practice of surrogacy is still questionable, both on a national and international level. This research discussed the legality of surrogacy in some religious countries, focusing on Indonesia. This research used normative juridical research methods or literature review through a comparative religion-legal approach. This study indicated that most do not have a specific legal instrument regarding surrogacy practice. International law also does not have a standard legal instrument regarding the legality of surrogacy. Legality is determined by each religious country’s national laws and customs. For example, Indonesian law prohibits this practice implicitly under Law No. 36 of 2009 concerning health. The United Kingdom legalised surrogacy through the Surrogacy Agreement Act 1985, which was amended to the Human Fertilization and Embryology Act 2008, Greece through the Greek Legislation Law 3089/2002 and Law 3305/2005, and India through the 2019 Surrogacy Regulation Bill. Those countries have their limitations and characteristics that rule surrogacy. Surrogacy is indeed a technological advancement in the health sector. However, for countries that are influenced much by religion, technological advances sometimes conflict with the culture and the belief that has long been followed by most of the population. For Indonesia, the largest of Sunni Islam ruled surrogacy against the law. Next, Iran, as a Shia Islam country, ruled that surrogacy is a legal action.Contribution: The research provided information and knowledge regarding the different settings of surrogacy practice. Most religious countries bravely rejected or put strict limits on the practice of surrogacy.

Patient perspectives on noninvasive prenatal testing among black women in the United States: a scoping review

Advances in reproductive health technologies such as noninvasive prenatal testing (NIPT) are changing the landscape of prenatal care and maternal health. NIPT, made clinically available in the United States (US) in 2011, is a screening test that utilizes cell-free DNA (cfDNA) to detect for aneuploidies and genetic characteristics in fetal DNA. In September 2020, the American College of Obstetricians and Gynecologists (ACOG) recommended NIPT for all pregnant patients regardless of age or risk factors. We examined peer-reviewed, empirical studies published from January 2011 to February 2022, assessing NIPT studies with patient perspectives in the US and what is known about how empirical studies include Black women. Our scoping review draws from PubMed (with advanced MeSH search options) and Scopus databases for advanced scoping review, with 33 articles meeting our criteria. Empirical studies on NIPT show patient perceptions range across five themes: 1) accuracy / safety, 2) return of results, 3) patient knowledge, 4) informed consent, and 5) perceptions among minoritized groups (with perceptions of race and gender as a social demographic intersection). Additionally, among the 15 studies that included that Black woman in their study sample, none measured the perceptions of Black women with genetic conditions. Bridging this knowledge gap is critical because NIPT is becoming increasingly accessible across the nation and is being developed to screen for additional genetic conditions, such as sickle cell disease. Ultimately, NIPT researchers need to go to greater lengths to examine the patient perspectives of Black women with and without genetic conditions.

Like mother, like daughter, like granddaughter… Transgenerational ignorance engendered by a defective reproductive health technology.

From 1941, the synthetic oestrogen diethylstilbestrol (DES) was administered to millions of women around the world to prevent miscarriages. In 1971, a clear and direct link was shown between taking DES during pregnancy and its subsequent long-term morbid effects on offspring. In the last 50 years, the list of side effects of in-utero exposure to DES has grown to include cancer, infertility, significant prematurity and urogenital malformation, amongst others. Based on qualitative sociological research conducted between 2010 and 2013, compiling archives, judicial documents and 108 interviews, this article illustrates a continuous production of ignorance in France. By focusing on DES as a reproductive health technology, three aspects are stressed. First, in terms of recognition of adverse effects, despite DES being identified as a prototype for other technologies such as the contraceptive pill or hormone replacement therapy, there remained a strong reluctance to import knowledge from the USA on its dangers and risks. Second, there was indifference to transgenerational side effects: even when the most visible effects of DES were finally acknowledged, there was a lack of consideration of the health of descendants; an inability to deem the knowledge of these repercussions as emancipatory or potentially empowering for the offspring. Third, regarding the health care of DES daughters, an important propensity to undone science is highlighted, with notable indifference to the risks of hormonalization of the female body, even on the part of activists. Thus, decades after it was last given to pregnant women, the shadow of DES still lingers as a failed reproductive health technology.

COVID-19 Vaccine Hesitancy and the Rural-Urban Divide: A Preliminary Analysis

The purpose of the systematic review of strategies for addressing vaccine hesitancy is to identify strategies that have been implemented and evaluated across diverse global contexts in an effort to respond to, and manage, issues of vaccine hesitancy. This is to fulfil the requirements of the SAGE working group (WG) dealing with vaccine hesitancy in respect to: a) identifying existing and new activities and strategies relating to vaccines or from other areas that could successfully address vaccine hesitancy; b) identifying strategies that do not work well, and; c) prioritising activities and strategies based on an assessment of their potential impact. These requirements were translated into the following specific objectives: 1. Identify published strategies related to vaccine hesitancy and hesitancy of other health technologies (reproductive health technologies (RHT) were chosen as the additional focus) and provide a descriptive analysis of the findings; 2. Map all evaluated strategi...

Virtually girlfriends: ‘emergent femininity’ and the women who buy virtual loving services in China

ABSTRACT Beginning in 2014, Chinese Internet-users can purchase care and concern online. Customers can hire both male and female virtual lovers (xuni lianren) to talk to them while the lovers perform character roles of their choice. By examining why female customers consume virtual loving services, we argue that women hire male virtual lovers to assuage the frustrations that they accrue in their daily lives, and not to look for offline romantic partners. Inspired by the concept of ‘emergent masculinity’ (Inhorn & Wentzell, 2011. Embodying emergent masculinities: Men engaging with reproductive and sexual health technologies in the Middle East and Mexico. American Ethnologist, 38(4), 801–815), we coin the term emergent femininity. This term describes how, after a century-long process where the individual breaks free from familial and societal strictures, present-day young and urban Chinese women now exhibit a novel mode of womanhood characterized by historically unprecedented self-confidence, a willingness to openly articulate and purchase what they want, and a high degree of mediatization. Hence, this paper illuminates the appearance of ‘new women’ in China.

US Women's Perceptions and Acceptance of New Reproductive Health Technologies.

Background: Women have faced persistent problems accessing reproductive health care. New applications of health technologies to reproductive health, specifically online fertility specialist consultations and reproductive hormone self-collection tests (SCTs), present unique opportunities to overcome these issues. This article uses the technology acceptance model to examine factors that influence women's intentions to use these new reproductive health technologies.Materials and Methods: Participants (n = 327 US women) completed an online survey assessing perceptions related to both of these reproductive health technologies, including usefulness, ease of use, risk, trust, subjective norms, and personal responsibility, to learn about fertility.Results: Participants indicated high perceptions of usefulness, ease of use, and trust, as well as low perceptions of risk and subjective norms for both online fertility consultations (OFCs) and reproductive hormone SCTs. Women indicated low perceptions of responsibility to use OFCs, but high perceptions of responsibility to use reproductive hormone SCTs. Structural equation modeling indicated that intentions to use OFCs were predicted by usefulness, subjective norms, and responsibility; intentions to use reproductive hormone SCTs were predicted by usefulness, ease of use, subjective norms, and responsibility.Conclusions: Fertility specialist consultations and reproductive hormone testing can provide women with essential fertility information that facilitates informed reproductive decisions; however, these services have historically been difficult to access. Widespread uptake of new reproductive health technologies could promote positive advances in women's reproductive health outcomes.

Accessibility and availability of assisted reproductive technology for people living with HIV in Europe: a thematic literature review

ABSTRACT As antiretroviral therapies have transformed HIV into a manageable chronic disease, many individuals have or will choose to have children, and the use of assisted reproductive technology can serve as an effective risk-reducing strategy. In this thematic literature review, we examine the state of research on access to and availability of assisted reproductive health technologies for people living with HIV in Europe, with the aim of identifying gaps for further research. We find that the existing literature is focused on serodiscordant couples consisting of an HIV-positive man and an HIV-negative women. This is in part because more treatment options are available for men living with HIV than women, reflecting underlying gender discrimination in treatment. The existing scholarship largely ignores reproductive options for seroconcordant couples or single individuals, or for men and women with underlying infertility. Finally, very little research addresses the question of financial affordability, which is a known barrier to infertility treatment.

The ultimate gatekeepers: A qualitative exploration of pharmacists’ contraceptive service delivery practices in Albania

ObjectivesPharmacists play a key role in contraceptive service delivery in Albania. This qualitative study explores the availability and accessibility of different contraceptive methods in Tirana, Albania, as well as the knowledge, opinions, and provision practices of retail pharmacists in the county. MethodsIn 2016, we conducted 16 in-person interviews with retail pharmacists in Tirana county, Albania. We also observed practices and dynamics in the pharmacies. We analyzed our data using descriptive statistics and for content and themes using inductive and deductive techniques. ResultsOur findings suggest that although a number of contraceptive methods are available in pharmacies, there are numerous barriers to access. Pharmacists were both uninformed and misinformed about reproductive health technologies, in general, and hormonal contraceptives, in particular. Pharmacists reported that the lack of awareness, fear of judgment, and embarrassment among women are some of the biggest obstacles for women seeking contraceptives from pharmacies. Yet few pharmacists reflected on their own lack of knowledge and the role that health service provider misinformation and judgment plays in contraceptive service delivery. ConclusionSupporting continuing education efforts for pharmacists and pharmacists in training in Albania appears warranted. Improving pharmacists’ knowledge of reproductive health technologies and fostering values clarification and transformation could address current barriers to access. ImplicationsOur findings shed light on the barriers to contraceptive access in Albanian pharmacies. Developing strategies to raise awareness about contraception, training pharmacists to provide medically accurate counselling, and improving knowledge within the community through culturally and linguistically resonant education campaigns appear warranted.

How can HIV/STI testing services be more accessible and acceptable for gender and sexually diverse young people? A brief report exploring young people's perspectives in Queensland.

Gender and sexually diverse young people (GSDYP) are an important target group for HIV/sexually transmitted infection (STI) prevention and there is an immediate need to explore ways to make testing interventions accessible and appropriate for this group. We used a modified World Café workshop with 14 GSDYP in Brisbane Australia, to inform the development of a pilot community-based testing intervention. The workshop identified the key features of an ideal service, which would include multiple, accessible sites that offer holistic, affordable services and confidential care by respectful and knowledgeable providers. The service would allow young people to engage in decision-making processes, have a culturally inclusive, comfortable and friendly atmosphere, and provide free sexual and reproductive health technologies. When designing HIV/STI testing interventions for key groups, health promotion practitioners need to be cognisant of localised and nuanced expectations and ensure that services are tailored to the needs and experiences of the local population. SO WHAT?: This study provides insights into the needs and expectations of HIV/STI testing interventions for GSDYP in Australia, a key at-risk group whose perspectives are not adequately voiced in sexual health research and intervention design. This study explores facilitators and current barriers to HIV/STI testing with a group of gender and sexually diverse young people in Brisbane, Australia. Outcomes provide insights into the needs and expectations of HIV/STI testing services for this group.

Muftis in the Matrix

Abstract English- and Arabic-language cyberfatwas on emergency contraception (EC) illuminate current debates around sexuality in the global Muslim community. In websites with fatwas about EC, there are significant differences in the way that English- and Arabic-language fatwa websites discuss this reproductive health technology. During the study period of 2016–17, English-language sites were more likely to rule that EC was not religiously acceptable, whereas no Arabic-language online fatwas declared the technology forbidden to Muslims. In contrast, Arabic questions to online fatwa sites were more concerned about whether EC would facilitate illicit sex and the health risks of contraceptives. Only English-language sites discussed the morality of pharmacists providing EC. These websites and fatwas reveal different visions of Muslims’ relationships with technology, science, and scientific experts. They also suggest the influence of non-Islamic religious constituencies on Muslim interpretations of reproductive health technologies.

Isolated follicle stimulated hormone deficiency in male: case report

BackgroundRecent rapid advances in assisted reproductive health technologies enables couples with subfertility to conceive through various intervention. Majority of treatment modalities target the female partner. However it is important to identify and treat male factor subfertility right at the outset. We report a case of isolated follicle stimulating hormone deficiency resulting in azoospermia and primary subfertility.Case presentationA 28 year otherwise healthy male presented with primary subfertility with a healthy female counterpart. He was found to have non obstructive azoospermia with low seminal fluid volume. He had normal external genitalia and potency with increased libido. Further evaluation revealed an isolated deficiency of follicle stimulating hormone with elevated testosterone levels. His luteinizing hormone and prolactin levels were normal. Contrast enhanced CT scan of chest, abdomen and pelvis and MRI scan of the pituitary fossa were normal too.ConclusionIn the era of modern reproductive technology it is important to further evaluate males with non-obstructive azoospermia to detect underlying gonadotropin deficiency.

Engaging Human Rights in the Response to the Evolving Zika Virus Epidemic.

In late 2015, an increase in the number of infants born with microcephaly in poor communities in northeast Brazil prompted investigation of antenatal Zika infection as the cause. Zika now circulates in 69 countries, and has affected pregnancies of women in 29 countries. Public health officials, policymakers, and international organizations are considering interventions to address health consequences of the Zika epidemic. To date, public health responses have focused on mosquito vector eradication, sexual and reproductive health services, knowledge and technology including diagnostic test and vaccine development, and health system preparedness. We summarize responses to date and apply human rights and related principles including nondiscrimination, participation, the legal and policy context, and accountability to identify shortcomings and to offer suggestions for more equitable, effective, and sustainable Zika responses.

Cyborg witches: class composition and social reproduction in the GynePunk collective

This paper takes Haraway’s techno-scientific concept of the cyborg as the basis for understanding a feminist theory of class that is rooted in socially reproductive labour. Arguing that the Operaismo notion of class composition ignored reproductive labour as either a technical or political component of proletarian composition, this article claims that social reproduction in fact provides the foundation for both. Through the notion of the cyborg, this article situates class as a human and machinic con, which is at once conquered by capital’s technological methods of accumulation but also finds its modes of resistance within these same convergences. Using the GynePunk collective’s DIY reproductive health technologies as an example of class composition through cyborgic social reproduction, this article aims to develop a techno-feminist concept of class suitable to the prevailing technological conditions of our time.

P06.13 Inflammatory cytokine biomarkers identify women with asymptomatic genital infections that increase the risk of hiv infection

Introduction Untreated sexually transmitted infections (STIs) and bacterial vaginosis (BV) cause genital inflammation and increased risk of HIV infection. WHO-recommended syndromic STI and BV management is limited as large numbers of women with asymptomatic infections go untreated. The purpose of this study was to evaluate genital cytokine profiles as a biomarker to identify women with asymptomatic, treatable infections. Methods Luminex was used to measure the concentrations of 42 cytokines in cervicovaginal lavages (CVL) from 227 HIV-uninfected women from Durban, South Africa, and nine cytokines in endocervical swabs from 264 women from Bondo, Kenya and Pretoria, South Africa. Women were screened for BV and treatable STIs ( Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis , Mycoplasma genitalium ) using microscopy and molecular assays. Nonparametric receiver operating characteristic curves and logistic regression were used to identify cytokine profiles associated with STIs/BV. Results In women from Durban, concomitant increased IL-1α and IL-1β and decreased IP-10 concentrations in CVLs predicted the presence of a treatable genital condition, correctly classifying 76% of women (sensitivity 72%, specificity 81%, PPV 86% and NPV 64%). In a separate validation cohort of women from Bondo and Pretoria, IL-1α, IL-1β and IP-10 concentrations in endocervical swabs correctly classified 72% of the participants according to STI/BV status. This approach performed substantially better than clinical signs in both cohorts from Durban (sensitivity 19%, specificity 92%, PPV 79% and NPV 40%) and Pretoria and Bondo (sensitivity 29%, specificity 78%, PPV 68%, NPV 39%). Conclusion Across two cohorts of women residing in different regions in sub-Saharan Africa, genital IL-1α, IL-1β and IP-10 together was the best immunological predictor of the presence of an STI or BV. Supplementing syndromic management with point-of-care assessment of biomarkers of genital inflammation may improve STI/BV management for women, enabling more effective treatment of asymptomatic infections and potentially reducing their risk of HIV infection. Disclosure of interest statement This work was supported by a Strategic Health Innovation Partnerships (SHIP) grant from the South African Medical Research Council and grants from the Poliomyelitis Research Foundation (PRF) of South Africa and European and Developing Countries Clinical Trials Partnership (EDCTP). The cohorts were supported by grants from the Comprehensive International Program of Research on AIDS (CIPRA) of the Division of AIDS (DAIDS); National Institute of Allergy and infectious Disease (NIAID); National Institutes of Health (NIH) and US Department of Health and Human Services (DHHS) [grant number U19 AI51794]. FEM-PrEP was conducted under two grants funded by the United States Agency for International Development (USAID): the Contraceptive and Reproductive Health Technologies and Research Utilisation Program (GPO-A-00–05–00022–00), and the Preventive Technologies Agreement (GHO-A-00–09–00016–00). Early support was also provided by the Bill and Melinda Gates Foundation. Gilead Sciences, Inc. donated Truvada® and placebo. LM was supported by the PRF; South African Medical Research Council (MRC); the Carnegie Corporation; the National Research Foundation (NRF) of South Africa and the UCT Clinical Infectious Diseases Research Initiative/Wellcome Trust. No pharmaceutical grants were received in the development of this study.