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Introduction: A number of antiretroviral HIV prevention products are efficacious in preventing HIV infection. However, the sexual and reproductive health needs of many women extend beyond HIV prevention, and research is ongoing to develop multi-purpose prevention technologies (MPTs) that offer dual HIV and pregnancy protection. We do not yet know if these products will be an efficient use of constrained health resources. In this paper, we estimate the cost-effectiveness of combinations of candidate multi-purpose prevention technologies (MPTs), in South Africa among general population women and female sex workers (FSWs). Methods: We combined a cost model with a static model of product impact based on incidence data in South Africa to estimate the cost-effectiveness of five candidate co-formulated or co-provided MPTs: oral PrEP, intravaginal ring, injectable ARV, microbicide gel and SILCS diaphragm used in concert with gel. We accounted for the preferences of end-users by predicting uptake using a discrete choice experiment (DCE). Product availability and protection were systematically varied in five potential rollout scenarios. The impact model estimated the number of infections averted through decreased incidence due to product use over one year. The comparator for each scenario was current levels of male condom use, while a health system perspective was used to estimate discounted lifetime treatment costs averted per HIV infection. Product benefit was estimated in disability-adjusted life years (DALYs) averted. Benefits from contraception were incorporated through adjusting the uptake of these products based on the DCE and through estimating the costs averted from avoiding unwanted pregnancies. We explore the additional impact of STI protection through increased uptake in a sensitivity analysis. Results: At central incidence rates, all single- and multi-purpose scenarios modelled were cost-effective among FSWs and women aged 16 24, at a governmental willingness-to-pay threshold of $1175/DALY averted (range: $214 $810/DALY averted among non-dominant scenarios), however, none were cost-effective among women aged 25 49 (minimum $1706/DALY averted). The cost-effectiveness of products improved with additional protection from pregnancy. Estimates were sensitive to variation in incidence assumptions, but robust to other parameters. Conclusions: To the best of our knowledge, this is the first study to estimate the cost-effectiveness of a range of potential MPTs; suggesting that MPTs will be cost-effective among higher incidence FSWs or young women, but not among lower incidence older women. More work is needed to make attractive MPTs available to potential users who could use them effectively. Keywords: discrete choice experiments; HIV prevention; key populations; multi-purpose prevention; pre-exposure prophylaxis; South Africa, 1 | INTRODUCTION Over the past six years, clinical trials have shown that antiretroviral (ARV)-based pre-exposure prophylaxis (PrEP) can be efficacious in preventing the transmission of human immunodeficiency virus (HIV) [...]

Introduction: Female sex workers (FSWs) are at high-risk for HIV acquisition in South Africa, where the advent of new HIV prevention and treatment interventions represent the potentialto significantly impact the epidemic. This paper focuses on aspects of PrEP acceptability as a new intervention within the context of a larger service delivery programme including the simultaneous rollout of early ART. This paper explores PrEP acceptability among the FGD participants as future potential users. Methods: FGDs were conducted in two clinic-based sites in Johannesburg and Pretoria. They aimed to explore community-level, multi-dimensional acceptability of PrEP within the context of imminent implementation alongside early ART in the TAPS Demonstration Project. Sex worker peer educators recruited participants from varying sex work locales. Facilitation was in English with adaptation by facilitators into local languages as needed. Transcripts were translated and transcribed into English. Thematic analysis was used to analyse the data. Results: Four FGDs were conducted in each site for a total of eight FDGs and 69 participants. Demographics were largely similar across the sites. Overall, there was strong acceptability of PrEP among participants and positive anticipation for the imminent delivery of PrEP in the localsex worker clinics. Themes arising from the discussions exploring aspects of PrEP acceptability included: awareness and understanding of PrEP; PrEP motivations including choice, control, and vulnerability, managing PrEP risks and worries; and, de-stigmatizing and empowering PrEP delivery. Participant discussions and recommendations highlighted the importance of developing clear education and messaging to accurately convey the concept of PrEP, and intervention integration into supportive and tailored services. Conclusions: Through the course of these FGDs, PrEP became a positive and highly anticipated prevention option among the FSWs participants who endorsed implementation in their communities. Effective integration of PrEP into existing services will include comprehensive health programming where ART is also available, appropriate messaging, and support. Keywords: HIV prevention; biomedical prevention products; pre-exposure prophylaxis (PrEP); sex work; qualitative research, 1 | INTRODUCTION Female sex workers (FSWs) are at high-risk for HIV acquisition in South Africa, with a recent study reporting a prevalence of 72% in the greater Johannesburg area, [...]

Introduction: Oral pre-exposure prophylaxis (PrEP) is a promising new prevention approach for those most at risk of HIV infection. However, there are concerns that behavioural disinhibition, specifically reductions in condom use, might limit PrEP's protective effect. This study uses the case of female sex workers (FSWs) in Johannesburg, South Africa, to assess whether decreased levels of condom use following the introduction of PrEP may limit HIV risk reduction. Methods: We developed a static model of HIV risk and compared HIV-risk estimates before and after the introduction of PrEP to determine the maximum tolerated reductions in condom use with regular partners and clients for HIV risk not to change. The model incorporated the effects of increased STI exposure owing to decreased condom use. Noting that condom use with regular partners is generally low, we also estimated the change in condom use tolerated with clients only, to still achieve 50 and 90% risk reduction on PrEP. The model was parameterized using data from Hillbrow, Johannesburg. Sensitivity analyses were performed to ascertain the robustness of our results. Results: Reductions in condom use could be tolerated by FSWs with lower baseline condom use (65%). For scenarios where 75% PrEP effectiveness is attained, 50% HIV-risk reduction on PrEP would be possible even with 100% reduction in condom use from consistent condom use as high as 70% with clients. Increased exposure to STIs through reductions in condom use had limited effect on the reductions in condom use tolerated for HIV risk not to increase on PrEP. Conclusions: PrEP is likely to be of benefit in reducing HIV risk, even if reductions in condom use do occur. Efforts to promote consistent condom use will be critical for FSWs with high initial levels of condom use, but with challenges in adhering to PrEP. Keywords: HIV; pre-exposure prophylaxis; sexually transmitted infections; mathematical models; behaviour change; risk compensation; condom migration To access the supplementary material to this article please see Supplementary Files under Article Tools online., Introduction Oral pre-exposure prophylaxis (PrEP) is a promising approach to HIV prevention. It is hoped that PrEP might become an effective addition to combined HIV prevention and help to significantly [...]

: Introduction: Oral pre‐exposure prophylaxis (PrEP) for HIV prevention has been proven to significantly reduce new HIV infections yet scale‐up has been slow. As contexts continue to adjust to make space for PrEP, it is crucial to understand the perspectives and experiences of potential end‐users. In order to inform PrEP and demand creation interventions, this paper examines personal perspectives on adopting and using PrEP among HIV at‐risk populations in sub‐Saharan Africa. Methods: Using the principles of a scoping review in July 2018, we explored the extent, range, and nature of published literature regarding PrEP uptake and use among; men who have sex with men, HIV serodiscordant couples, adolescent girls and young women, pregnant and breastfeeding women, women partners of migrant workers; and people who use drugs. Steps included: identification of the research question; identification of relevant studies; study selection; charting the data; and collation – summarizing and reporting results. PubMed and PsycInfo were searched for papers relating to PrEP uptake and use in sub‐Saharan Africa. Resulting papers were reviewed with data extracted and compiled in Excel for analysis. A broad content analysis was conducted and organized into high‐level themes. Results and discussion: Thirty‐five papers were included in this review. There was little opposition in general to oral PrEP; however, there were significant nuances in its broader acceptability, applicability, and usability. We identified five themes within which these are discussed. These relate to balancing complexities of personal empowerment and stigma; navigating complex risk environments; influences of relationships and partners; efficacy and side effects; and practicalities of use. This body of research suggests that while product attributes and the logistics of PrEP delivery and use are important topics, it is vital to consider stigma, the interactions of PrEP use with relationships, and the need for broader understanding of ARVs for prevention versus treatment. Conclusions: Planning for, programming and promoting the adoption of oral PrEP necessitates a deeper understanding of end‐user priorities in order to ensure successful interventions. This review illustrates the nuances facilitating or deterring PrEP use that may affect the larger effort of PrEP scale‐up., Introduction Oral pre‐exposure prophylaxis (PrEP) for HIV prevention has been proven to significantly reduce new HIV infections in efficacy trials, yet introduction has been slow. PrEP is being implemented in [...]

Background Operational research is required to design delivery of pre-exposure prophylaxis (PrEP) and early antiretroviral treatment (ART). This paper presents the primary analysis of programmatic data, as well as demographic, behavioural, and clinical data, from the TAPS Demonstration Project, which offered both interventions to female sex workers (FSWs) at 2 urban clinic sites in South Africa. Methods and findings The TAPS study was conducted between 30 March 2015 and 30 June 2017, with the enrolment period ending on 31 July 2016. TAPS was a prospective observational cohort study with 2 groups receiving interventions delivered in existing service settings: (1) PrEP as part of combination prevention for HIV-negative FSWs and (2) early ART for HIV-positive FSWs. The main outcome was programme retention at 12 months of follow-up. Of the 947 FSWs initially seen in clinic, 692 were HIV tested. HIV prevalence was 49%. Among those returning to clinic after HIV testing and clinical screening, 93% of the women who were HIV-negative were confirmed as clinically eligible for PrEP (n = 224/241), and 41% (n = 110/270) of the women who were HIV-positive had CD4 counts within National Department of Health ART initiation guidelines at assessment. Of the remaining women who were HIV-positive, 93% were eligible for early ART (n = 148/160). From those eligible, 98% (n = 219/224) and 94% (n = 139/148) took up PrEP and early ART, respectively. At baseline, a substantial fraction of women had a steady partner, worked in brothels, and were born in Zimbabwe. Of those enrolled, 22% on PrEP (n = 49/219) and 60% on early ART (n = 83/139) were seen at 12 months; we observed high rates of loss to follow-up: 71% (n = 156/219) and 30% (n = 42/139) in the PrEP and early ART groups, respectively. Little change over time was reported in consistent condom use or the number of sexual partners in the last 7 days, with high levels of consistent condom use with clients and low use with steady partners in both study groups. There were no seroconversions on PrEP and 7 virological failures on early ART among women remaining in the study. Reported adherence to PrEP varied over time between 70% and 85%, whereas over 90% of participants reported taking pills daily while on early ART. Data on provider-side costs were also collected and analysed. The total cost of service delivery was approximately US$126 for PrEP and US$406 for early ART per person-year. The main limitations of this study include the lack of a control group, which was not included due to ethical considerations; clinical study requirements imposed when PrEP was not approved through the regulatory system, which could have affected uptake; and the timing of the implementation of a national sex worker HIV programme, which could have also affected uptake and retention. Conclusions PrEP and early ART services can be implemented within FSW routine services in high prevalence, urban settings. We observed good uptake for both PrEP and early ART; however, retention rates for PrEP were low. Retention rates for early ART were similar to retention rates for the current standard of care. While the cost of the interventions was higher than previously published, there is potential for cost reduction at scale. The TAPS Demonstration Project results provided the basis for the first government PrEP and early ART guidelines and the rollout of the national sex worker HIV programme in South Africa., Author(s): Robyn Eakle 1,2,3, Gabriela B. Gomez 1,2,4,*, Niven Naicker 1, Rutendo Bothma 1, Judie Mbogua 1, Maria A. Cabrera Escobar 1, Elaine Saayman 5, Michelle Moorhouse 1, W. D. [...]

Background: Mitigation measures for the first wave of the COVID-19 pandemic and burden on health systems created challenges for pre-exposure prophylaxis (PrEP) service delivery. We examined PrEP uptake in PEPFAR programs before and after the start of the COVID-19 pandemic. Methods: We studied two PEPFAR program monitoring indicators, using routine Monitoring, Evaluation, Reporting (MER) indicators capturing uptake of PrEP (PrEP_NEW) and overall use of PrEP (PrEP_CURR). We also analyzed descriptive program narratives to understand successes and challenges field teams encountered after the start of the COVID-19 pandemic. To assess changes in coverage of PrEP across 21 countries, we calculated the "PrEP to need ratio" (PnR) using a published methodology. We defined the pre-COVID time period as April 1, 2019 –March 31, 2020 and the COVID time period as April 1, 2020 –March 31, 2021. Findings: The total number of persons who initiated PrEP increased by 157% from 233,250 in the pre-COVID-19 period compared with 599,935 in the COVID-19 period. All countries, except five, noted significant increases in PrEP uptake. PrEP uptake among adolescent girls and young women (AGYW) increased by 159% from 80,452 AGYW in the pre-COVID-19 period to 208,607 AGYW in the COVID-19 period. There were 77,430 key populations (KP) initiated on PrEP in the pre-COVID-19 period and 209,114 KP initiated in the COVID-19 period (a 170% increase). The PnR increased 214% in the COVID-19 period across all PEPFAR-supported countries. Adaptations, such as multi-month dispensing (MMD) of PrEP; virtual demand creation activities; decentralized, community-based and virtual service delivery, were implemented to maintain PrEP services. Conclusions: PEPFAR programs continued to maintain and initiate new clients on PrEP despite the challenges posed by the COVID-19 pandemic. Adaptations such as MMD of PrEP and use of technology were vital in expanding service delivery and increasing PrEP coverage. Funding: This project has been supported by the U.S. President's Emergency Plan for AIDS Relief. [ABSTRACT FROM AUTHOR]

Background. The development of antiretroviral (ARV)-based prevention products has the potential to substantially change the HIV prevention landscape; yet, little is known about how appealing these products will be outside of clinical trials, as compared with the existing options. Methods. We conducted a discrete choice experiment (DCE) to measure preferences for 5 new products among 4 important populations in the HIV response: adult men and women in the general population (aged 18 to 49 y), adolescent girls (aged 16 to 17 y), and self-identifying female sex workers (aged 18 to 49 y). We interviewed 661 self-reported HIV-negative participants in peri-urban South Africa, who were asked to choose between 3 unique, hypothetical products over 10 choice sets. Data were analyzed using multinomial, latent class and mixed multinomial logit models. Results. HIV protection was the most important attribute to respondents; however, results indicate significant demand among all groups for multipurpose prevention products that offer protection from HIV infection, other STIs, and unwanted pregnancy. All groups demonstrated a strong preference for long-lasting injectable products. There was substantial heterogeneity in preferences within and across population groups. Limitations. Hypothetical DCE data may not mirror real-world choices, and products will have more attributes in reality than represented in choice tasks. Background data on participants, including sensitive areas of HIV status and condom use, was self-reported. Conclusions. These results suggest that stimulating demand for new HIV prevention products may require a more a nuanced approach than simply developing highly effective products. No single product is likely to be equally attractive or acceptable across different groups. This study strengthens the call for effective and attractive multipurpose prevention products to be deployed as part of a comprehensive combination prevention strategy. [ABSTRACT FROM AUTHOR]

An abstract of the article "Conceptualizations of Uncertainty and Risk and Implications for Biomedical HIV Prevention Technologies in Sub-Saharan Africa: A Systematic Review" by Emily Warren, Pauline Paterson, Shelley Lees, Robyn Eakle, Jonathan Stadler, and Heidi Larson is presented.

Objectives: The objective of this research was to design relevant, tailored oral pre-exposure prophylaxis (PrEP) and early antiretroviral (ART) interventions for female sex workers (FSWs) in South Africa. This paper examines the methods, process and outcomes of employing an inductive approach to formative research exploring intervention feasibility and acceptability., Setting: Research was conducted in several sex work-related settings including five sites in and around clinics and stakeholder offices., Participants: Participants in this research included stakeholders, experts in the field and FSWs. This included at least 25 separate engagements, 14 local organisations and 8 focus group discussions (FGDs) with 69 participants, in addition to ad hoc meetings., Results: The first set of outcomes consisted of five selected methods: (1) stakeholder consultations; (2) site assessments and selection; (3) field observations and mapping; (4) development of supportive structures to encourage retention and intervention adherence; (5) FGDs conducted with FSWs to explore specifics of acceptability. In terms of feasibility, two sites were selected in central Johannesburg and Pretoria out of five considered. The urban site contexts varied, necessitating adjustments to intervention implementation. There was overall support for PrEP and early ART from stakeholders and FSWs. Concerns included potential issues with adherence to PrEP (and early ART), possible reduction in condom use, resistance to antiretrovirals and burden on scarce resources. These concerns indicated where special attention should be focused on education, messaging and programming as well as development of supportive structures., Conclusions: The inductive approach allowed for a wide range of perspectives, defining population needs and accessibility. This research illustrated how similar sex work environments can vary and how implementation of interventions may not be uniform across contexts. Lessons learnt in details could assist in future project designs and implementation of new interventions where feasibility, social and cultural factors affecting acceptability must be considered., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Updated guidelines from the WHO recommend antiretroviral treatment for adults with HIV at any CD4 count and daily oral pre-exposure prophylaxis (PrEP) for people at substantial risk of HIV infection. However, implementation challenges may hinder the ability of programmes to translate these recommendations into successful practice. This demonstration project is the first to integrate PrEP and immediate treatment (ITx) for female sex workers (FSWs) in South Africa to answer operational research questions., Methods and Analysis: This is a prospective cohort study where the main outcome is retention at 12 months. The study population is recruited into two arms across two urban sites: (1) PrEP for HIV-negative FSWs (n=400) and (2) ITx for HIV-positive FSWs with CD4 greater than national guidelines (n=300). We investigate process and other health indicators, uptake and use of PrEP and ITx through qualitative research, and evaluate cost-effectiveness analysis combined with estimates of impact through epidemiological modelling., Ethics and Dissemination: The Treatment And Prevention for female Sex workers in South Africa (TAPS) Project was designed as an implementation study before emtricitabine/tenofovir disoproxil fumarate was licenced as an indication for PrEP in South Africa. Therefore, clinical trial requirements for ethical and South African Medicines Control Council approvals were followed. Results will be disseminated to participants, local health officials and other stakeholders, as well as in peer-reviewed journals and at conferences., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)