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IntroductionUnhealthy alcohol use significantly contributes to viral non-suppression among persons with HIV (PWH). It is unknown whether brief behavioural interventions to reduce alcohol use can improve viral suppression among PWH with unhealthy alcohol use in sub-Saharan Africa (SSA).MethodsAs part of the SEARCH study (NCT04810650), we conducted an individually randomized trial in Kenya and Uganda of a brief, skills-based alcohol intervention among PWH with self-reported unhealthy alcohol use (Alcohol Use Disorders Identification Test-Consumption [AUDIT-C], prior 3 months, ≥3/female; ≥4/male) and at risk of viral non-suppression, defined as either recent HIV viral non-suppression (≥400 copies/ml), missed visits, out of care or new diagnosis. The intervention included baseline and 3-month in-person counselling sessions with interim booster phone calls every 3 weeks. The primary outcome was HIV viral suppression (200 ng/ml (RR 0.97, 95% CI: 0.92-1.02).ConclusionsIn a randomized trial of 401 PWH with unhealthy alcohol use and risk for viral non-suppression, a brief alcohol intervention reduced unhealthy alcohol use but did not affect viral suppression at 24 weeks. Brief alcohol interventions have the potential to improve the health of PWH in SSA by reducing alcohol use, a significant driver of HIV-associated co-morbidities.

IntroductionHIV pre-exposure prophylaxis (PrEP) is an essential prevention strategy being scaled up for priority populations in Kenya, including for HIV serodiscordant couples. The COVID-19 pandemic posed challenges to PrEP rollout. We conducted a qualitative study of PrEP providers to understand how clinics adjusted PrEP delivery during the COVID-19 pandemic.MethodsSince 2017, the Partners Scale-Up Project has integrated PrEP into 25 HIV clinics in Central and Western Kenya. We conducted qualitative interviews with 40 purposively sampled clinic personnel. We interviewed personnel once during the first pandemic wave (May-Aug 2020) and again after some decline in COVID-19 rates (Nov-Jan 2021). We analysed data using inductive memo-writing and summarized data by themes along the PrEP delivery cascade, guided by the Framework for Reporting Adaptation and Modifications (FRAME).ResultsWe interviewed 27 clinical officers, five nurses, four health records and information officers, and four counsellors from Central (n = 20) and Western (n = 20) Kenya. About half (n = 19) were female, with a median age of 32 (IQR: 29-34) and 2.3 years of experience delivering PrEP (IQR: 2-3). All participants reported clinic changes in PrEP demand creation and service delivery during the pandemic. Modifications occurred during PrEP implementation and sustainment phases, were partly reactive to the pandemic and also facilitated by interim Ministry of Health guidance on PrEP delivery during COVID, and were made by PrEP delivery teams, clients and clinic managers. Commonly reported modifications included dispensing multiple-month PrEP refills, intensifying phone-based client engagement and collaborating with other HIV clinics to ensure that clients with prolonged stays in other regions could continue to access PrEP. Some clinics also adopted practices to streamline visits, such as within clinical-room PrEP dispensing, pre-packing PrEP and task-shifting. Most providers liked these changes and hoped they would continue after the pandemic subsides.ConclusionsCOVID-19 served as a catalyst for PrEP delivery innovations in Kenya. HIV clinics successfully and rapidly adapted their PrEP demand creation, refill and retention strategies to promote PrEP uptake and effective use. These modified implementation strategies highlight opportunities to streamline the delivery of PrEP, as well as other HIV and chronic care services, and strengthen engagement with populations post-pandemic.

IntroductionMaternal antiretroviral therapy (ART) with viral suppression prior to conception, during pregnancy and throughout the breastfeeding period accompanied by infant postnatal prophylaxis (PNP) forms the foundation of current approaches to preventing vertical HIV transmission. Unfortunately, infants continue to acquire HIV infections, with half of these infections occurring during breastfeeding. A consultative meeting of stakeholders was held to review the current state of PNP globally, including the implementation of WHO PNP guidelines in different settings and identifying the key factors affecting PNP uptake and impact, with an aim to optimize future innovative strategies.DiscussionWHO PNP guidelines have been widely implemented with adaptations to the programme context. Some programmes with low rates of antenatal care attendance, maternal HIV testing, maternal ART coverage and viral load testing capacity have opted against risk-stratification and provide an enhanced PNP regimen for all infants exposed to HIV, while other programmes provide infant daily nevirapine antiretroviral (ARV) prophylaxis for an extended duration to cover transmission risk throughout the breastfeeding period. A simplified risk stratification approach may be more relevant for high-performing vertical transmission prevention programmes, while a simplified non-risk stratified approach may be more appropriate for sub-optimally performing programmes given implementation challenges. In settings with concentrated epidemics, where the epidemic is often driven by key populations, infants who are found to be exposed to HIV should be considered at high risk for HIV acquisition. All settings could benefit from newer technologies that promote retention during pregnancy and throughout the breastfeeding period. There are several challenges in enhanced and extended PNP implementation, including ARV stockouts, lack of appropriate formulations, lack of guidance on alternative ARV options for prophylaxis, poor adherence, poor documentation, inconsistent infant feeding practices and in inadequate retention throughout the duration of breastfeeding.ConclusionsTailoring PNP strategies to a programmatic context may improve access, adherence, retention and HIV-free outcomes of infants exposed to HIV. Newer ARV options and technologies that enable simplification of regimens, non-toxic potent agents and convenient administration, including longer-acting formulations, should be prioritized to optimize the effect of PNP in the prevention of vertical HIV transmission.

IntroductionContraceptive implants containing etonogestrel and levonorgestrel have emerged as popular contraceptive options among women in areas of high HIV burden in sub-Saharan Africa. However, recent pharmacokinetic data have shown drug-drug interactions between implants and efavirenz-containing antiretroviral therapy (ART), reducing the effectiveness of the implants. Here, we evaluated pregnancy incidence in 6-month intervals following implant initiation among women using efavirenz and contraceptive implants to assess whether the risk of breakthrough pregnancy is higher after specific periods of implant use.MethodsWe used data from a retrospective longitudinal analysis of women living with HIV ages 18-45 years in western Kenya who attended HIV-care facilities between 2011 and 2015. We used Cox proportional hazard models to compute hazard ratios (HRs) for breakthrough pregnancy by implant type and ART regimen. Depending on the model, we adjusted for socio-demographic and clinical factors, programme, site and interaction between calendar time and ART regimen. We utilized inverse probability weights (IPWs) to account for three sampling phases (electronic medical record [EMR], chart review and phone interview) and calculated overall parameter estimates.ResultsWomen contributed 14,768 woman-years from the largest sampling phase (EMR). The median age was 31 years. Women used etonogestrel implants for 26-69% of the time and levonorgestrel implants for 7-31% of the time, depending on the sampling phase. Women used efavirenz, nevirapine or no ART for 27-33%, 40-46% and 15-26% of follow-ups, respectively. When combining sampling phases, there was little evidence to suggest that the relative hazard of pregnancy among efavirenz-containing ART users relative to nevirapine-containing ART changed with length of time on implants: IPW-adjusted HR of 3.1 (CI: [1.5; 6.4]) at 12 months, 3.4 (CI: [1.8; 6.3]) at 24 months, 3.8 (CI: [1.9; 7.7]) at 36 months and 4.2 (CI: [1.6; 11.1]) at 48 months (interaction p-value = 0.88). Similarly, no significant change in HRs over time was found when comparing women not using ART to nevirapine-containing ART users (interaction p-value = 0.49).ConclusionsWe did not find evidence to suggest implants being more fallible from drug-drug interactions with efavirenz at later time intervals of implant use. Thus, we would not recommend shortening the duration of implant use or replacing implants sooner when concomitantly used with efavirenz.

IntroductionAdolescents and young adults living with HIV (AYAH) have the lowest rates of retention in HIV care and antiretroviral therapy (ART) adherence, partly due to the demands of school associated with this life stage, to HIV-related stigma and to fears of serostatus disclosure. We explore the implications of school-based stigma and disclosure on the development of agency during a critical life stage in rural Kenya and Uganda.MethodsWe conducted a qualitative study in the baseline year of the SEARCH Youth study, a combination intervention using a life-stage approach among youth (15-24 years old) living with HIV in western Kenya and southwestern Uganda to improve viral load suppression and health outcomes. We conducted in-depth, semi-structured interviews in 2019 with three cohorts of purposively selected study participants (youth [n = 83], balanced for sex, life stage and HIV care status; recommended family members of youth [n = 33]; and providers [n = 20]). Inductive analysis exploring contextual factors affecting HIV care engagement revealed the high salience of schooling environments.ResultsStigma within school settings, elicited by non-consensual serostatus disclosure, medication schedules and clinic appointments, exerts a constraining factor around which AYAH must navigate to identify and pursue opportunities available to them as young people. HIV status can affect cross-generational support and cohort formation, as AYAH differ from non-AYAH peers because of care-related demands affecting schooling, exams and graduation. However, adolescents demonstrate a capacity to overcome anticipated stigma and protect themselves by selectively disclosing HIV status to trusted peers and caregivers, as they develop a sense of agency concomitant with this life stage. Older adolescents showed greater ability to seek out supportive relationships than younger ones who relied on adult caregivers to facilitate this support.ConclusionsSchool is a potential site of HIV stigma and also a setting for learning how to resist such stigma. School-going adolescents should be supported to identify helpful peers and selectively disclose serostatus as they master decision making about when and where to take medications, and who should know. Stigma is avoided by fewer visits to the clinic; providers should consider longer refills, discreet packaging and long-acting, injectable ART for students.

IntroductionCOVID-19 parallels HIV in many ways. Socio-behavioural science has been critical in elucidating the context and factors surrounding individual levels of engagement with known effective prevention and treatment tools for HIV, thus offering important lessons for ongoing efforts to combat the COVID-19 pandemic.DiscussionNon-adherence to effective disease mitigation strategies (e.g. condoms for HIV and masks for COVID-19) can be attributed in part to prioritizing comfort, convenience and individual autonomy over public health. Importantly, misinformation can fuel denialism and conspiracies that discredit scientific knowledge and motivate nonadherence. These preferences and the extent to which individuals can act on their preferences may be constrained by the structures and culture in which they live. Both HIV and COVID-19 have been politicized and influenced by evolving recommendations from scientists, clinicians, policymakers and politically motivated organizations. While vaccines are vital for ending both pandemics, their impact will depend on availability and uptake. Four decades of experience with the HIV epidemic have shown that information alone is insufficient to overcome these challenges; interventions must address the underlying, often complex factors that influence human behaviour. This article builds from socio-behavioural science theory and describes practical and successful approaches to enable and support adherence to prevention and treatment strategies, including vaccine adoption. Key methods include reframing tools to enhance motivation, promoting centralized sources of trusted information, strategic development and messaging with and within key populations (e.g. through social media) and appealing to self-empowerment, altruism and informed decision making. Orchestrated evidence-based activism is needed to overcome manipulative politicization, while consistent transparent messaging around scientific discoveries and clinical recommendations are critical for public acceptance and support. Ultimately, the effectiveness of COVID-19 vaccines will depend on our ability to engender trust in the communities most affected.ConclusionsMany lessons learned from socio-behavioural science in the HIV pandemic are applicable to the COVID-19 pandemic. Individual behaviour must be understood within its interpersonal and societal context to address the current barriers to adherence to disease-mitigating strategies and promote an effective response to the COVID-19 pandemic, which is likely to be endured for the foreseeable future.

IntroductionLong-term mortality among TB survivors appears to be higher than control populations without TB in many settings. However, data are limited among persons with HIV (PWH). We assessed the association between cured TB and long-term mortality among persons with PWH in Haiti.MethodsA prospective cohort of PWH from the CIPRA HT-001 trial was followed from study enrolment (August 2005 to July 2008) to study closure (December 2018) to compare mortality between participants with and without TB. The index date for the survival analysis was defined as 240 days after TB diagnosis or randomization date. Time to death was described using Kaplan-Meier curves, and log-rank tests were used to compare time to death between the TB and no-TB cohorts. The association between TB and long-term mortality was estimated with multivariable Cox models.ResultsOf the 816 participants in the CIPRA HT-001 trial, 77 were excluded for a history of TB prior to study enrolment and 31 were excluded due to death or attrition prior to the index date, leaving 574 in the no-TB and 134 in the TB cohort. Twenty-four (17.9%) participants in the TB and 48 (8.4%) in the no-TB cohort died during follow-up. Five and 10-year mortality rates were 14.2% and 17.9% respectively, in the TB cohort, and 6.1% and 8.4% in the no-TB cohort. In Kaplan-Meier analysis, participants in the TB cohort had a significantly shorter time to death (log-rank p

Introduction: The HIV response has long recognized that certain "key populations" such as individuals in detention, adolescent girls and young women, sex workers, people who use drugs, LGBTQ individuals, migrants and others face higher barriers to access to, uptake of, and retention in HIV prevention and treatment services. One approach to addressing these barriers is the training of community paralegals to advocate for the rights of individuals and to address discrimination in health settings. Discussion: Community paralegal programmes have been able to successfully address rights violations that impact access to health services and underlying determinants of health across a range of countries and populations, focusing upon issues such as discrimination and the denial of health services; unlawful detention of outreach workers, sex workers, persons who use drugs and men who have sex with men; and harmful traditional practices and gender‐based violence. In addition to resolving specific cases, evaluations of paralegal programmes have found that these programmes increased legal literacy among key populations at risk of HIV and increased understanding of human rights among healthcare providers, resulting in improved access to HIV services. Some evaluations have noted challenges related to the sustainability of paralegal programmes similar to those raised with community health worker programmes more broadly. Conclusions: To achieve global HIV goals, funding for legal literacy and paralegal programmes should be increased and interventions should be rigorously evaluated. Efforts should target discrimination in access to HIV prevention and treatment and criminalization of key populations, two key barriers to ensuring access to HIV prevention and treatment services. [ABSTRACT FROM AUTHOR]

Introduction: Data from two randomized controlled trials (RCTs) showed that injectable cabotegravir (CAB) for pre-exposure prophylaxis (PrEP) was efficacious in reducing HIV acquisition. The US Food and Drug Administration approved CAB for PrEP in December 2021; Australia in August 2022; Zimbabwe in October 2022; South Africa in November 2022; Malawi in March 2023; and regulatory approvals are being sought in additional countries. The World Health Organization (WHO) recommended CAB be offered to people at substantial risk of HIV in July 2022. However, implementation experience beyond RCTs is limited. As countries consider CAB implementation, questions remain regarding delivery and involvement of populations excluded from the trials. A coordinated approach is needed to ensure these are addressed and CAB can be introduced in low- and middle-income countries in timely, acceptable and effective ways. Discussion: Beginning in 2018, the Biomedical Prevention Implementation Collaborative (BioPIC) convened over 100 global health experts to develop a comprehensive introduction strategy for CAB. Using this roadmap, country landscaping for CAB introduction and lessons from oral PrEP implementation, AVAC and WHO co-convened 50 researchers, donors, implementers and civil society in September 2021 to: (1) identify questions and evidence gaps related to CAB across contexts and partners; (2) define the implementation science agenda; and (3) agree on mechanism(s) for future coordination. As a result, CAB-related questions were identified, including: defining optimal and feasible HIV testing strategies that expand access; delivery models; integration with a range of services, including family planning and antenatal care; and embedding CAB in demand generation for HIV prevention choices. Through convenings and mapping of implementation research, BioPIC identified gaps in populations, geographies and delivery approaches. Conclusions: The introduction strategy refined by BioPIC lays the groundwork for future HIV prevention products. Ongoing policy and implementation dialogue is critical to accelerate the design of CAB implementation studies that adequately address priority knowledge gaps. Additional long-acting HIV prevention products may be available over the next 5 years, increasing choice, but potentially making delivery and stakeholder engagement more complex. Ongoing coordination with WHO will accelerate the adoption of evidence-based policies and wide-scale implementation, and lessons from BioPIC can inform introduction processes for long-acting HIV prevention products. [ABSTRACT FROM AUTHOR]

IntroductionFrailty is frequently observed among people with HIV, and food insecurity is associated with frailty in the general population. Evidence is scarce on the associations between food insecurity and frailty among women with HIV who may be particularly vulnerable to the impacts of food insecurity. The goal of this study was to assess associations between food insecurity and frailty among women with and without HIV.MethodsThere were 1265 participants from the Women's Interagency HIV Study who participated in frailty assessments in 2017. Frailty was measured using the Fried Frailty Phenotype, and women were subsequently categorized as robust, pre-frail or frail. Food insecurity was assessed using the U.S. Household Food Security Survey Module, with women categorized as having high, marginal, low or very low food security. Multinomial logistic regression models were conducted to examine cross-sectional associations between food insecurity and frailty while adjusting for socio-demographic, behavioural and HIV status covariates.Results and discussionApproximately one-third (31.9%) of the women had marginal, low or very low food security, and the proportions of women who met the criteria for frailty or pre-frailty were 55.6% and 12.4% respectively. In the adjusted model, the relative risk ratio (RRR) of frailty for women with very low food security versus women with high food security was 3.37 (95% CI [1.38 to 8.24], p

IntroductionKey populations at elevated risk to contract or transmit HIV may also be at higher risk of COVID-19 complications and adverse outcomes associated with public health prevention measures. However, the conditions faced by specific populations vary according to social, structural and environmental factors, including stigma and discrimination, criminalization, social and economic safety nets and the local epidemiology of HIV and COVID-19, which determine risk of exposure and vulnerability to adverse health outcomes, as well as the ability to comply with measures such as physical distancing. This commentary identifies common vulnerabilities and cross-cutting themes in terms of the impacts of COVID-19 on key populations before addressing issues and concerns specific to particular populations.DiscussionCross-cutting themes include direct impacts such as disrupted access to essential medicines, commodities and services such as anti-retroviral treatment, HIV pre-exposure prophylaxis, opioid agonist treatment, viral load monitoring, HIV and sexually transmitted infections testing, condoms and syringes. Indirect impacts include significant collateral damage arising from prevention measures which restrict human rights, increase or impose criminal penalties, and expand police powers to target vulnerable and criminalized populations. Significant heterogeneity in the COVID-19 pandemic, the underlying HIV epidemic and the ability of key populations to protect themselves means that people who inject drugs and sex workers face particular challenges, including indirect impacts as a result of police targeting, loss of income and sometimes both. Geographical variations mean that transgender people and men who have sex with men in regions like Africa and the middle east remain criminalized, as well as stigmatized and discriminated against, increasing their vulnerability to adverse outcomes in relation to COVID-19.ConclusionsDisruptions to both licit and illicit supply chains, loss of income and livelihoods and changes in behaviour as a result of lockdowns and physical distancing have the potential to exacerbate the impacts of the COVID-19 pandemic on key populations. While these impacts will vary significantly, human-rights approaches to COVID-19 emergency laws and public health prevention measures that are population-specific and sensitive, will be key to reducing adverse health outcomes and ensuring that no one is left behind.

IntroductionThe majority of new HIV infections occur through mucosal transmission. The availability of readily applicable and accessible platforms for anti-retroviral (ARV) delivery is critical for the prevention of HIV acquisition through sexual transmission in both women and men. There is a compelling need for developing new topical delivery systems that have advantages over the pills, gels and rings, which currently fail to guarantee protection against mucosal viral transmission in vulnerable populations due to lack of user compliance. The silk fibroin (SF) platform offers another option that may be better suited to individual circumstances and preferences to increase efficacy through user compliance. The objective of this study was to test safety and efficacy of SF for anti-HIV drug delivery to mucosal sites and for viral prevention.MethodsWe formulated a potent HIV inhibitor Griffithsin (Grft) in a mucoadhesive silk fibroin (SF) drug delivery platform and tested the application in a non-human primate model in vivo and a pre-clinical human cervical and colorectal tissue explant model. Both vaginal and rectal compartments were assessed in rhesus macaques (Mucaca mulatta) that received SF (n = 4), no SF (n = 7) and SF-Grft (n = 11). In this study, we evaluated the composition of local microbiota, inflammatory cytokine production, histopathological changes in the vaginal and rectal compartments and mucosal protection after ex vivo SHIV challenge.ResultsEffective Grft release and retention in mucosal tissues from the SF-Grft platform resulted in protection against HIV in human cervical and colorectal tissue as well as against SHIV challenge in both rhesus macaque vaginal and rectal tissues. Mucoadhesion of SF-Grft inserts did not cause any inflammatory responses or changes in local microbiota.ConclusionsWe demonstrated that in vivo delivery of SF-Grft in rhesus macaques fully protects against SHIV challenge ex vivo after two hours of application and is safe to use in both the vaginal and rectal compartments. Our study provides support for the development of silk fibroin as a highly promising, user-friendly HIV prevention modality to address the global disparity in HIV infection.

Abstract Introduction The HIV response has long recognized that certain “key populations” such as individuals in detention, adolescent girls and young women, sex workers, people who use drugs, LGBTQ individuals, migrants and others face higher barriers to access to, uptake of, and retention in HIV prevention and treatment services. One approach to addressing these barriers is the training of community paralegals to advocate for the rights of individuals and to address discrimination in health settings. Discussion Community paralegal programmes have been able to successfully address rights violations that impact access to health services and underlying determinants of health across a range of countries and populations, focusing upon issues such as discrimination and the denial of health services; unlawful detention of outreach workers, sex workers, persons who use drugs and men who have sex with men; and harmful traditional practices and gender‐based violence. In addition to resolving specific cases, evaluations of paralegal programmes have found that these programmes increased legal literacy among key populations at risk of HIV and increased understanding of human rights among healthcare providers, resulting in improved access to HIV services. Some evaluations have noted challenges related to the sustainability of paralegal programmes similar to those raised with community health worker programmes more broadly. Conclusions To achieve global HIV goals, funding for legal literacy and paralegal programmes should be increased and interventions should be rigorously evaluated. Efforts should target discrimination in access to HIV prevention and treatment and criminalization of key populations, two key barriers to ensuring access to HIV prevention and treatment services.

Abstract Introduction Data from two randomized controlled trials (RCTs) showed that injectable cabotegravir (CAB) for pre‐exposure prophylaxis (PrEP) was efficacious in reducing HIV acquisition. The US Food and Drug Administration approved CAB for PrEP in December 2021; Australia in August 2022; Zimbabwe in October 2022; South Africa in November 2022; Malawi in March 2023; and regulatory approvals are being sought in additional countries. The World Health Organization (WHO) recommended CAB be offered to people at substantial risk of HIV in July 2022. However, implementation experience beyond RCTs is limited. As countries consider CAB implementation, questions remain regarding delivery and involvement of populations excluded from the trials. A coordinated approach is needed to ensure these are addressed and CAB can be introduced in low‐ and middle‐income countries in timely, acceptable and effective ways. Discussion Beginning in 2018, the Biomedical Prevention Implementation Collaborative (BioPIC) convened over 100 global health experts to develop a comprehensive introduction strategy for CAB. Using this roadmap, country landscaping for CAB introduction and lessons from oral PrEP implementation, AVAC and WHO co‐convened 50 researchers, donors, implementers and civil society in September 2021 to: (1) identify questions and evidence gaps related to CAB across contexts and partners; (2) define the implementation science agenda; and (3) agree on mechanism(s) for future coordination. As a result, CAB‐related questions were identified, including: defining optimal and feasible HIV testing strategies that expand access; delivery models; integration with a range of services, including family planning and antenatal care; and embedding CAB in demand generation for HIV prevention choices. Through convenings and mapping of implementation research, BioPIC identified gaps in populations, geographies and delivery approaches. Conclusions The introduction strategy refined by BioPIC lays the groundwork for future HIV prevention products. Ongoing policy and implementation dialogue is critical to accelerate the design of CAB implementation studies that adequately address priority knowledge gaps. Additional long‐acting HIV prevention products may be available over the next 5 years, increasing choice, but potentially making delivery and stakeholder engagement more complex. Ongoing coordination with WHO will accelerate the adoption of evidence‐based policies and wide‐scale implementation, and lessons from BioPIC can inform introduction processes for long‐acting HIV prevention products.

IntroductionMen in sub-Saharan Africa are less likely to use HIV testing services than their female counterparts. Norms of masculinity are frequently cited as the main barrier to men's use of HIV testing services, but very little is known about how health institutions are organized to facilitate or impede men's care. We examined the organization of health institutions in Malawi, and implications for men's use of HIV testing services.MethodsA mixed methods ethnography was conducted in Malawi between October 2013 and September 2014. National Ministry of Health guidelines from 2012 to 2014 were analysed, counting the frequency of recommended preventative services by sex. In-depth interviews were conducted with 18 healthcare workers and 11 national key informants (29 total). Five rural health facilities participated in direct observation and 52 observational journals were completed to document the structure and implementation of HIV services within local facilities. All data were analysed using the theory of gendered organization. Findings were grouped into one of the three theoretical levels of organization: (1) organizational policy; (2) organizational practice; and (3) structure of gendered expectations.ResultsHealth institutions were gendered across three levels. Organizational policy: National guidelines omitted young and adult men's health during reproductive years (176-433 recommended visits for women vs. 32 visits for men). Health education strategies focused on reproductive and child health services, with little education strategies targeting men. Organizational practice: HIV testing was primarily offered during reproductive and child health services and located near female-focused departments within health facilities. As these departments were women's spaces, others could easily tell that men were using HIV services. Structure of gendered expectations: Clients who successfully accessed HIV testing services were perceived as exemplifying characteristics that were traditionally considered feminine: compliance (obeying instructions without explanation); deference (respecting providers regardless of provider behaviour); and patience ("waiting like a woman").ConclusionsHealth institutions in Malawi were organized in ways that created substantial, multilevel barriers to men's HIV testing and reinforced perceptions of absent, difficult men. Future research should prioritize a gendered organization framework to understand and address the complex realities of men's constrained access to HIV services.

IntroductionThe HIV epidemic in Tijuana, Mexico is concentrated in key populations, including people who inject drugs (PWID). However, HIV interventions among PWID are minimal, and federal funding was provided for compulsory abstinence programmes associated with HIV and overdose. Alternatively, opioid agonist therapy reduces overdose, reincarceration, HIV, while improving antiretroviral therapy (ART) outcomes. We assessed potential impact and synergies of scaled-up integrated ART and opioid agonist therapy, compared to scale-up of each separately, and potential harms of compulsory abstinence programmes on HIV and fatal overdose among PWID in Tijuana.MethodsWe developed a dynamic model of HIV transmission and overdose among PWID in Tijuana. We simulated scale-up of opioid agonist therapy from zero to 40% coverage among PWID. We evaluated synergistic benefits of an integrated harm reduction and ART scale-up strategy (40% opioid agonist therapy coverage and 10-fold ART recruitment), compared to scale-up of each intervention alone or no scale-up of low coverage ART and no harm reduction). We additionally simulated compulsory abstinence programmes (associated with 14% higher risk of receptive syringe sharing and 76% higher odds of overdose) among PWID.ResultsWithout intervention, HIV incidence among PWID could increase from 0.72 per 100 person-years (PY) in 2020 to 0.92 per 100 PY in 2030. Over ten years, opioid agonist therapy scale-up could avert 31% (95% uncertainty interval (UI): 18%, 46%) and 22% (95% UI: 10%, 28%) new HIV infections and fatal overdoses, respectively, with the majority of HIV impact from the direct effect on HIV transmission due to low ART coverage. Integrating opioid agonist therapy and ART scale-up provided synergistic benefits, with opioid agonist therapy effects on ART recruitment/retention averting 9% more new infections compared to ART scale-up alone. The intervention strategy could avert 48% (95% UI: 26%, 68%) of new HIV infections and one-fifth of fatal overdoses over ten years. Conversely, compulsory abstinence programmes could increase HIV and overdoses.ConclusionsIntegrating ART with opioid agonist therapy could provide synergistic benefits and prevent HIV and overdoses among PWID in Tijuana, whereas compulsory abstinence programmes could cause harm. Policymakers should consider the benefits of integrating harm reduction and HIV services for PWID.

IntroductionAlthough transgender women (trans women) often are conflated with men who have sex with men  (MSM) in HIV research and services, there are distinct population differences that are important for implementing effective HIV prevention. Our objective was to examine pre-exposure prophylaxis (PrEP) disparities between the two populations and compare individual, social and structural factors that influence differences between MSM and trans women along the PrEP continuum.MethodsWe analysed data from two population-based studies, one with trans women (Trans*National Study, 2016 - 18) and the other with MSM (National HIV Behavioral Surveillance, 2017). Trans women were recruited via respondent-driven sampling and MSM using time location sampling. Key indicators of the PrEP continuum were evaluated, including awareness, health insurance, provider discussions, recent use and adherence. Associations were also examined for PrEP continuum indicators and structural barriers (e.g. employment, homelessness).ResultsTranswomen were more likely than MSM to be Latino/a (30.4% vs. 25.8%; prevalence ratio (PR)=1.08, 95% CI 1.02 to 1.14) or African American (7.1% vs. 4.5%; PR = 1.12, 1.02 to 1.24), live at or below the poverty limit (70.7% vs. 15.8%; PR = 1.47; 1.41 to 1.53), be unemployed (50.1% vs. 26.3%; PR = 1.18, 1.13 to 1.24), be homeless (8.4% vs. 3.5%; PR = 1.15, 1.06 to 1.25) and to have less than a college degree (PR = 1.41, 1.34 to 1.48). Trans women were more likely than MSM to have health insurance (95.7% vs. 89.7%, PR = 1.17, 1.06 to 1.28), but less likely than MSM to have heard of PrEP (79.1% vs. 96.7%; PR = 0.77, 0.73 to 0.81), talked with a provider about PrEP (35.5% vs. 54.9%; PR = 0.87, 0.83 to 0.91) and less likely than MSM to have used PrEP in the past six months (14.6% vs. 39.8%; PR = 0.80, 0.76 to 0.84). Among PrEP users, trans women were less likely to report being adherent to PrEP than MSM (70.4% vs. 87.4%; PR = 0.80, 0.70 to 0.91).ConclusionsWe found PrEP disparities for trans women compared to MSM and the need for differentiated implementation strategies to meet the specific PrEP barriers trans women face. Inclusion of trans women's HIV risks is needed in CDC guidance for PrEP. Interventions to increase trans women's awareness of PrEP including at the provider and community level are also needed. Finally, programming that addresses trans women's barriers to housing and income is also needed to reduce PrEP disparities.

IntroductionWeight gain following antiretroviral therapy (ART) initiation is common, potentially predisposing some persons with HIV (PWH) to cardio-metabolic disease. We assessed relationships between ART drug class and weight change among treatment-naïve PWH initiating ART in the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD).MethodsAdult, treatment-naïve PWH in NA-ACCORD initiating integrase strand transfer inhibitor (INSTI), protease inhibitor (PI) or non-nucleoside reverse-transcriptase inhibitor (NNRTI)-based ART on/after 1 January 2007 were followed through 31 December 2016. Multivariate linear mixed effects models estimated weight up to five years after ART initiation, adjusting for age, sex, race, cohort site, HIV acquisition mode, treatment year, and baseline weight, plasma HIV-1 RNA level and CD4+ cell count. Due to shorter follow-up for PWH receiving newer INSTI drugs, weights for specific INSTIs were estimated at two years. Secondary analyses using logistic regression and all covariates from primary analyses assessed factors associated with >10% weight gain at two and five years.ResultsAmong 22,972 participants, 87% were male, and 41% were white. 49% started NNRTI-, 31% started PI- and 20% started INSTI-based regimens (1624 raltegravir (RAL), 2085 elvitegravir (EVG) and 929 dolutegravir (DTG)). PWH starting INSTI-based regimens had mean estimated five-year weight change of +5.9kg, compared to +3.7kg for NNRTI and +5.5kg for PI. Among PWH starting INSTI drugs, mean estimated two-year weight change was +7.2kg for DTG, +5.8kg for RAL and +4.1kg for EVG. Women, persons with lower baseline CD4+ cell counts, and those initiating INSTI-based regimens had higher odds of >10% body weight increase at two years (adjusted odds ratio = 1.37, 95% confidence interval: 1.20 to 1.56 vs. NNRTI).ConclusionsPWH initiating INSTI-based regimens gained, on average, more weight compared to NNRTI-based regimens. This phenomenon may reflect heterogeneous effects of ART agents on body weight regulation that require further exploration.

IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.

IntroductionIn the era of HIV treatment as prevention (TasP), evidence-based interventions that optimize viral suppression among people who use stimulants such as methamphetamine are needed to improve health outcomes and reduce onward transmission risk. We tested the efficacy of positive affect intervention delivered during community-based contingency management (CM) for reducing viral load in sexual minority men living with HIV who use methamphetamine.MethodsConducted in San Francisco, this Phase II randomized controlled trial tested the efficacy of a positive affect intervention for boosting and extending the effectiveness of community-based CM for stimulant abstinence to achieve more durable reductions in HIV viral load. From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use were randomized to receive a positive affect intervention (n = 55) or attention-control condition (n = 55). All individual positive affect intervention and attention-control sessions were delivered during three months of community-based CM where participants received financial incentives for stimulant abstinence. The 5-session positive affect intervention was designed to provide skills for managing stimulant withdrawal symptoms as well as sensitize individuals to natural sources of reward. The attention-control condition consisted of neutral writing exercises and self-report measures.ResultsMen randomized to the positive affect intervention displayed significantly lower log10 HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition. Men in the positive affect intervention also had significantly lower risk of at least one unsuppressed HIV RNA (≥200 copies/mL) over the 15-month follow-up. There were concurrent, statistically significant intervention-related increases in positive affect as well as decreases in the self-reported frequency of stimulant use at six and twelve months.ConclusionsDelivering a positive affect intervention during community-based CM with sexual minority men who use methamphetamine achieved durable and clinically meaningful reductions in HIV viral load that were paralleled by increases in positive affect and decreases in stimulant use. Further clinical research is needed to determine the effectiveness of integrative, behavioural interventions for optimizing the clinical and public health benefits of TasP in sexual minority men who use stimulants such as methamphetamine.

Introduction: Human immunodeficiency virus (HIV) continues to rise in young people among low‐ and middle‐income countries (LMIC). The US National Institutes of Health (NIH) supports the largest public investment in HIV research globally. Despite advancements in the last decade, adolescents and young adults (AYA) remain underrepresented in research to improve HIV prevention and care. We undertook a programme analysis of NIH grants and conducted a targeted review of linked publications on international AYA research across the HIV prevention and care continuum (HPCC) to inform new initiatives to address the needs of AYA in these settings. Methods: NIH‐funded grants from 2012 to 2017, pertaining to AYA in LMIC, and evaluating areas of HIV prevention, care and/or treatment were identified. A systematic review of publications limited to funded grants was performed in two waves: 2012–2017 and 2018–2021. The review included a landscape assessment and an evaluation of NIH‐defined clinical trials, respectively. Data on outcomes across the HPCC were abstracted and analysed. Results: Among grant applications, 14% were funded and linked to 103 publications for the analytic database, 76 and 27 from the first and second waves, respectively. Fifteen (15%) wave 1 and 27 (26%) wave 2 publications included an NIH‐defined clinical trial. Among these, 36 (86%) did not target a key population (men who have sex with men, drug users and sex workers) and 37 (88%) were exclusively focused on sub‐Saharan Africa. Thirty (71%) publications addressed at least one HPCC milestone. Specific focus was on milestones in HIV prevention, care or both, for 12 (29%), 13 (31%) and five (12%) of publications, respectively. However, few addressed access to and retention in HIV care (4 [14%]) and none included microbicides or treatment as prevention. More focus is needed in crucial early steps of the HIV care continuum and on biomedical HIV prevention interventions. Discussion and Conclusions: Research gaps remain in this portfolio across the AYA HPCC. To address these, NIH launched an initiative entitled Prevention and Treatment through a Comprehensive Care Continuum for HIV‐affected Adolescents in Resource Constrained Settings (PATC3H) to generate needed scientific innovation for effective public health interventions for AYA affected by HIV in LMIC. [ABSTRACT FROM AUTHOR]

Introduction: In 2016, South Africa (SA) initiated a national programme to scale‐up pre‐exposure prophylaxis (PrEP) among female sex workers (FSWs), with ∼20,000 PrEP initiations among FSWs (∼14% of FSW) by 2020. We evaluated the impact and cost‐effectiveness of this programme, including future scale‐up scenarios and the potential detrimental impact of the COVID‐19 pandemic. Methods: A compartmental HIV transmission model for SA was adapted to include PrEP. Using estimates on self‐reported PrEP adherence from a national study of FSW (67.7%) and the Treatment and Prevention for FSWs (TAPS) PrEP demonstration study in SA (80.8%), we down‐adjusted TAPS estimates for the proportion of FSWs with detectable drug levels (adjusted range: 38.0–70.4%). The model stratified FSW by low (undetectable drug; 0% efficacy) and high adherence (detectable drug; 79.9%; 95% CI: 67.2–87.6% efficacy). FSWs can transition between adherence levels, with lower loss‐to‐follow‐up among highly adherent FSWs (aHR: 0.58; 95% CI: 0.40–0.85; TAPS data). The model was calibrated to monthly data on the national scale‐up of PrEP among FSWs over 2016–2020, including reductions in PrEP initiations during 2020. The model projected the impact of the current programme (2016–2020) and the future impact (2021–2040) at current coverage or if initiation and/or retention are doubled. Using published cost data, we assessed the cost‐effectiveness (healthcare provider perspective; 3% discount rate; time horizon 2016–2040) of the current PrEP provision. Results: Calibrated to national data, model projections suggest that 2.1% of HIV‐negative FSWs were currently on PrEP in 2020, with PrEP preventing 0.45% (95% credibility interval, 0.35–0.57%) of HIV infections among FSWs over 2016–2020 or 605 (444–840) infections overall. Reductions in PrEP initiations in 2020 possibly reduced infections averted by 18.57% (13.99–23.29). PrEP is cost‐saving, with $1.42 (1.03–1.99) of ART costs saved per dollar spent on PrEP. Going forward, existing coverage of PrEP will avert 5,635 (3,572–9,036) infections by 2040. However, if PrEP initiation and retention doubles, then PrEP coverage increases to 9.9% (8.7–11.6%) and impact increases 4.3 times with 24,114 (15,308–38,107) infections averted by 2040. Conclusions: Our findings advocate for the expansion of PrEP to FSWs throughout SA to maximize its impact. This should include strategies to optimize retention and should target women in contact with FSW services. [ABSTRACT FROM AUTHOR]

Introduction: HIV pre‐exposure prophylaxis (PrEP) has been government subsidized in Australia since April 2018 and while uptake is high among men who have sex with men, rates of discontinuation are also high. The aims of this study were to examine the impact of discontinuation on overall PrEP usage, the proportion of PrEP users who discontinue and the predictors of discontinuation. Methods: We used linked de‐identified dispensing records of all government subsidized PrEP in Australia between April 2018 and September 2021: a whole‐of‐population data set. Defining discontinuation as 180 days or more without PrEP after the final dispensed supply, we calculated the number of people who discontinued at each 6‐month interval during the study period, the proportion who had discontinued 2 years after the first supply and, using Cox regression, predictors of discontinuation. Results: Of 49,164 people dispensed PrEP (98.5% male, median age 34 years), 40.3% (19,815) had discontinued by September 2021. Within 2 years of their first supply, 11,150 (37.7%) of 29,549 PrEP users had discontinued, including 10.0% after a single dispensed supply. Large variations were observed, particularly according to prescriber characteristics: discontinuation was higher among people prescribed PrEP by low caseload (≤10 patients) prescribers (61.2%) than by high caseload (>100 patients) prescribers (31.1%, p<0.001), and by prescribers practising in areas with low estimated prevalence (<1.0%) of gay men (64.1%) than high (>5%) prevalence (36.7%, p<0.001). Women and younger people were more likely to discontinue, while patients receiving a higher level of government subsidy were less likely. The independent predictors of discontinuation with the greatest effect size were female sex (adjusted hazards ratio [aHR] 2.99, p<0.001), low estimated gay prevalence of prescriber location (aHR 1.98, p<0.001) and low prescriber PrEP caseload (aHR 1.79, p<0.001). Conclusions: There are high rates of PrEP discontinuation in Australia and some populations are at increased risk of discontinuation. Strategies are needed to support persistence on PrEP and the re‐starting of PrEP during periods of risk. [ABSTRACT FROM AUTHOR]

IntroductionSince 2015, the World Health Organization (WHO) has recommended that all people living with HIV (PLHIV) initiate antiretroviral treatment (ART), irrespective of CD4+ count or clinical stage. National adoption of universal treatment has accelerated since WHO's 2015 "Treat All" recommendation; however, little is known about the translation of this guidance into practice. This study aimed to assess the status of Treat All implementation across regions, countries, and levels of the health care delivery system.MethodsBetween June and December 2017, 201/221 (91%) adult HIV treatment sites that participate in the global IeDEA research consortium completed a survey on capacity and practices related to HIV care. Located in 41 countries across seven geographic regions, sites provided information on the status and timing of site-level introduction of Treat All, as well as site-level practices related to ART initiation.ResultsAlmost all sites (93%) reported that they had begun implementing Treat All, and there were no statistically significant differences in site-level Treat All introduction by health facility type, urban/rural location, sector (public/private) or country income level. The median time between national policy adoption and site-level introduction was one month. In countries where Treat All was not yet adopted in national guidelines, 69% of sites reported initiating all patients on ART, regardless of clinical criteria, and these sites had been implementing Treat All for a median period of seven months at the time of the survey. The majority of sites (77%) reported typically initiating patients on ART within 14 days of confirming diagnosis, with 60% to 62% of sites implementing Treat All in East, Southern and West Africa reporting same-day ART initiation for most patients.ConclusionsBy mid- to late-2017, the Treat All strategy was the standard of care at almost all IeDEA sites, including rural, primary-level health facilities in low-resource settings. While further assessments of site-level capacity to provide high-quality HIV care under Treat All and to support sustained viral suppression after ART initiation are needed, the widespread introduction of Treat All at the service delivery level is a critical step towards global targets for ending the HIV epidemic as a public health threat.

IntroductionTo examine the HIV care continuum for transwomen living in San Francisco and to determine factors associated with poor HIV-related health outcomes.MethodsData were collected from 2016 to 2017 with transwomen in San Francisco. Respondent-driven sampling (RDS) was used to recruit a population-based sample. Bivariate associations were assessed, and RDS-weighted multivariable logistic regression was used to identify associations between exposures and outcomes along the HIV care continuum.ResultsOf the 123 self-identified transwomen in this analysis, ages ranged from 23 to 71 years with a majority identifying as Latina (40.8%) and African American (29.2%). An estimate of 14.3% of participants were not engaged in care, 13% were not currently on antiretroviral therapy (ART), 22.2% had a self-reported detectable viral load and 13.5% had unknown viral load. Those using hormones had lower odds of not being on ART compared to those who did not use hormones. Those with unstable housing had a higher relative risk ratio of having a detectable viral load. Those who experienced both anti-trans discrimination and racism had higher odds of not being in HIV care.ConclusionsSan Francisco has made substantial progress engaging transwomen in the HIV care continuum, but the final push to ensure viral suppression will require addressing social determinants. Future interventions to increase HIV care engagement, ART use and viral suppression among transwomen must address housing needs and risks related to the overlapping effect of both anti-trans discrimination and racism.

IntroductionGeographic and transportation barriers are associated with poorer HIV-related health outcomes in sub-Saharan Africa, but data on the impact of these barriers on prevention interventions are limited. We estimated the association between distance to clinic and other transportation-related barriers on pre-exposure prophylaxis (PrEP) uptake and initial clinic visit attendance in a rural community in southwestern Uganda enrolled in the ongoing SEARCH study (NCT01864603).MethodsCommunity-wide HIV testing was conducted and offered to adult (≥15 years) participants in Ruhoko. Participants were eligible for PrEP based on an empiric risk score, having an HIV-discordant partner, or self-referral at either the community health campaign or during home-based testing from March to April 2017. We collected data from PrEP-eligible households on GPS-measured distance to clinic, walking time to clinic and road difficulty. A sample of participants was also asked to identify their primary barriers to PrEP use with a semi-quantitative questionnaire. We used multivariable logistic regression to evaluate the association between transportation barriers and (1) PrEP uptake among PrEP-eligible individuals and (2) four-week clinic visit attendance among PrEP initiators.ResultsOf the 701 PrEP-eligible participants, 272 (39%) started PrEP within four weeks; of these, 45 (17%) were retained at four weeks. Participants with a distance to clinic of ≥2 km were less likely to start PrEP (aOR 0.34; 95% CI 0.15 to 0.79, p = 0.012) and less likely to be retained on PrEP once initiated (aOR 0.29; 95% CI 0.10 to 0.84; p = 0.024). Participants who were deemed eligible during home-based testing and did not have the option of same-day PrEP start were also substantially less likely to initiate PrEP (aOR 0.16, 95% CI 0.07 to 0.37, p

IntroductionPeople who inject drugs (PWID) experience high HIV incidence and face significant barriers to engagement in HIV care and substance use treatment. Strategies for HIV treatment as prevention and substance use treatment present unique challenges in PWID that may vary regionally. Understanding differences in the risk structure for HIV transmission and disease progression among PWID is essential in developing and effectively targeting intervention strategies of HIV treatment as prevention.MethodsWe present a baseline analysis of HIV Prevention Trials Network (HPTN) 074, a two-arm, randomized controlled trial among PWID in Indonesia (n = 258), Ukraine (n = 457) and Vietnam (n = 439). HPTN 074 was designed to determine the feasibility, barriers and uptake of an integrated intervention combining health systems navigation and psychosocial counselling for the early engagement of antiretroviral therapy (ART) and substance use treatment for PWID living with HIV. Discordant PWID networks were enrolled, consisting of an HIV-positive index and their HIV-negative network injection partner(s). Among the enrolled cohort of 1154 participants (502 index participants and 652 network partners), we examine regional differences in the baseline risk structure, including sociodemographics, HIV and substance use treatment history, and injection and sexual risk behaviours.ResultsThe majority of participants were male (87%), with 82% of the enrolled females coming from Ukraine. The overall mean age was 34 (IQR: 30, 38). Most commonly injected substances included illegally manufactured methadone in Ukraine (84.2%), and heroin in Indonesia (81.8%) and Vietnam (99.5%). Injection network sizes varied by region: median number of people with whom participants self-reported injecting drugs was 3 (IQR: 2, 5) in Indonesia, 5 (IQR: 3, 10) in Ukraine and 3 (IQR: 2, 4) in Vietnam. Hazardous alcohol use, assessed using the Alcohol Use Disorders Identification Test - Alcohol Consumption Questions (AUDIT-C), was prominent in Ukraine (54.7%) and Vietnam (26.4%). Reported sexual risk behaviours in the past month, including having two or more sex partners and giving/receiving money or drugs in exchange for sex, were uncommon among all participants and regions.ConclusionsWhile regional differences in risk structure exist, PWID particularly in Ukraine need immediate attention for risk reduction strategies. Substantial regional differences in risk structure will require flexible, tailored treatment as prevention interventions for distinct PWID populations.

IntroductionAdolescent girls and young women (AGYW) in South Africa bear a disproportionate burden of HIV. Community mobilization (CM), defined as community members taking collective action to achieve a common goal related to health, equity and rights, has been associated with increased HIV testing and condom use and has been called a 'critical enabler' for addressing the HIV epidemic. However, limited research has examined whether CM is associated with HIV incidence among AGYW.MethodsWe examine the association of CM with incident HIV among AGYW (ages 13 to 21) enrolled in the HPTN 068 cohort in the Agincourt Health and socio-Demographic Surveillance System, South Africa. This analysis includes 2292 participants residing in 26 villages where cross-sectional, population-based surveys were conducted to measure CM among 18- to 35-year-old residents in 2012 and 2014. HPTN 068 participants completed up to five annual visits that included an HIV test (2011 to 2016). Household-level data were collected from AGYW parents/guardians and census data is updated annually. Mean village-level CM scores were created using a validated community mobilization measure with seven components (social cohesion, social control, critical consciousness, shared concerns, organizations and networks, leadership and collective action). We used pooled generalized estimating equation regression with a Poisson distribution to estimate risk ratios (RR) for the association of village-level CM score and CM components with incident HIV infection, accounting for village-level clustering and adjusting for key covariates.ResultsThere were 194 incident infections over the follow-up period. For every additional standard deviation of village-level CM there was 12% lower HIV incidence (RR: 0.88, 95% CI: 0.79, 0.98) after adjusting for individual, household and community characteristics. CM components associated with lower HIV incidence included critical consciousness (RR: 0.88; CI: 0.79, 0.97) and leadership (RR: 0.87; CI: 0.79, 0.95); while not statistically significant, social cohesion (RR: 0.91; CI: 0.81, 1.01), shared concerns (RR: 0.90; CI: 0.81, 1.00), and organizations and networks (RR: 0.91; CI: 0.79, 1.03) may also play a protective role.ConclusionsThese results suggest that having strong community social resources will reduce AGYW's risk of HIV acquisition. Work to mobilize communities, focusing on building social cohesion, shared concerns, critical consciousness, and effective and accountable leadership, can fortify prevention programming for AGYW.

Abstract Introduction In 2016, South Africa (SA) initiated a national programme to scale‐up pre‐exposure prophylaxis (PrEP) among female sex workers (FSWs), with ∼20,000 PrEP initiations among FSWs (∼14% of FSW) by 2020. We evaluated the impact and cost‐effectiveness of this programme, including future scale‐up scenarios and the potential detrimental impact of the COVID‐19 pandemic. Methods A compartmental HIV transmission model for SA was adapted to include PrEP. Using estimates on self‐reported PrEP adherence from a national study of FSW (67.7%) and the Treatment and Prevention for FSWs (TAPS) PrEP demonstration study in SA (80.8%), we down‐adjusted TAPS estimates for the proportion of FSWs with detectable drug levels (adjusted range: 38.0–70.4%). The model stratified FSW by low (undetectable drug; 0% efficacy) and high adherence (detectable drug; 79.9%; 95% CI: 67.2–87.6% efficacy). FSWs can transition between adherence levels, with lower loss‐to‐follow‐up among highly adherent FSWs (aHR: 0.58; 95% CI: 0.40–0.85; TAPS data). The model was calibrated to monthly data on the national scale‐up of PrEP among FSWs over 2016–2020, including reductions in PrEP initiations during 2020. The model projected the impact of the current programme (2016–2020) and the future impact (2021–2040) at current coverage or if initiation and/or retention are doubled. Using published cost data, we assessed the cost‐effectiveness (healthcare provider perspective; 3% discount rate; time horizon 2016–2040) of the current PrEP provision. Results Calibrated to national data, model projections suggest that 2.1% of HIV‐negative FSWs were currently on PrEP in 2020, with PrEP preventing 0.45% (95% credibility interval, 0.35–0.57%) of HIV infections among FSWs over 2016–2020 or 605 (444–840) infections overall. Reductions in PrEP initiations in 2020 possibly reduced infections averted by 18.57% (13.99–23.29). PrEP is cost‐saving, with $1.42 (1.03–1.99) of ART costs saved per dollar spent on PrEP. Going forward, existing coverage of PrEP will avert 5,635 (3,572–9,036) infections by 2040. However, if PrEP initiation and retention doubles, then PrEP coverage increases to 9.9% (8.7–11.6%) and impact increases 4.3 times with 24,114 (15,308–38,107) infections averted by 2040. Conclusions Our findings advocate for the expansion of PrEP to FSWs throughout SA to maximize its impact. This should include strategies to optimize retention and should target women in contact with FSW services.

Abstract Introduction HIV pre‐exposure prophylaxis (PrEP) has been government subsidized in Australia since April 2018 and while uptake is high among men who have sex with men, rates of discontinuation are also high. The aims of this study were to examine the impact of discontinuation on overall PrEP usage, the proportion of PrEP users who discontinue and the predictors of discontinuation. Methods We used linked de‐identified dispensing records of all government subsidized PrEP in Australia between April 2018 and September 2021: a whole‐of‐population data set. Defining discontinuation as 180 days or more without PrEP after the final dispensed supply, we calculated the number of people who discontinued at each 6‐month interval during the study period, the proportion who had discontinued 2 years after the first supply and, using Cox regression, predictors of discontinuation. Results Of 49,164 people dispensed PrEP (98.5% male, median age 34 years), 40.3% (19,815) had discontinued by September 2021. Within 2 years of their first supply, 11,150 (37.7%) of 29,549 PrEP users had discontinued, including 10.0% after a single dispensed supply. Large variations were observed, particularly according to prescriber characteristics: discontinuation was higher among people prescribed PrEP by low caseload (≤10 patients) prescribers (61.2%) than by high caseload (>100 patients) prescribers (31.1%, p5%) prevalence (36.7%, p

IntroductionCommunity mobilization (CM) is increasingly recognized as critical to generating changes in social norms and behaviours needed to achieve reductions in HIV. We conducted a CM intervention to modify negative gender norms, particularly among men, in order to reduce associated HIV risk.MethodsTwenty two villages in the Agincourt Health and Socio-Demographic Surveillance Site in rural Mpumalanga, South Africa were randomized to either a theory-based, gender transformative, CM intervention or no intervention. Two cross-sectional, population-based surveys were conducted in 2012 (pre-intervention, n = 600 women; n = 581 men) and 2014 (post-intervention, n = 600 women; n = 575 men) among adults ages 18 to 35 years. We used an intent-to-treat (ITT) approach using survey regression cluster-adjusted standard errors to determine the intervention effect by trial arm on gender norms, measured using the Gender Equitable Mens Scale (GEMS), and secondary behavioural outcomes.ResultsAmong men, there was a significant 2.7 point increase (Beta Coefficient 95% CI: 0.62, 4.78, p = 0.01) in GEMS between those in intervention compared to control communities. We did not observe a significant difference in GEMS scores for women by trial arm. Among men and women in intervention communities, we did not observe significant differences in perpetration of intimate partner violence (IPV), condom use at last sex or hazardous drinking compared to control communities. The number of sex partners in the past 12 months (AOR 0.29, 95% CI 0.11 to 0.77) were significantly lower in women in intervention communities compared to control communities and IPV victimization was lower among women in intervention communities, but the reduction was not statistically significant (AOR 0.53, 95% CI 0.24 to 1.16).ConclusionCommunity mobilization can reduce negative gender norms among men and has the potential to create environments that are more supportive of preventing IPV and reducing HIV risk behaviour. Nevertheless, we did not observe that changes in attitudes towards gender norms resulted in desired changes in risk behaviours suggesting that more time may be necessary to change behaviour or that the intervention may need to address behaviours more directly.Clinical trials numberClinicalTrials.gov NCT02129530.

IntroductionScreening of modifiable cardiovascular disease (CVD) risk factors is recommended but not routinely provided for HIV-infected patients, especially in low-resource settings. Potential concerns include limited staff time and low patient acceptability, but little empirical data exists. As part of a pilot study of screening in a large urban HIV clinic in Swaziland, we conducted a time-motion study to assess the impact of screening on patient flow and HIV service delivery and exit interviews to assess patient acceptability.MethodsA convenience sample of patients ≥40 years of age attending routine HIV clinic visits was screened for hypertension, diabetes, hyperlipidemia and tobacco smoking. We observed HIV visits with and without screening and measured time spent on HIV and CVD risk factor screening activities. We compared screened and unscreened patients on total visit time and time spent receiving HIV services using Wilcoxon rank-sum tests. A separate convenience sample of screened patients participated in exit interviews to assess their satisfaction with screening.ResultsWe observed 172 patient visits (122 with CVD risk factor screening and 50 without). Screening increased total visit time from a median (range) of 4 minutes (2 to 11) to 15 minutes (9 to 30) (p

DesignUniversal voluntary HIV counselling and testing followed by prompt initiation of antiretroviral therapy (ART) for all those diagnosed HIV-infected (universal test and treat, UTT) is now a global health standard. However, its population-level impact, feasibility and cost remain unknown. Five community-based trials have been implemented in sub-Saharan Africa to measure the effects of various UTT strategies at population level: BCPP/YaTsie in Botswana, MaxART in Swaziland, HPTN 071 (PopART) in South Africa and Zambia, SEARCH in Uganda and Kenya and ANRS 12249 TasP in South Africa. This report describes and contrasts the contexts, research methodologies, intervention packages, themes explored, evolution of study designs and interventions related to each of these five UTT trials.MethodsWe conducted a comparative assessment of the five trials using data extracted from study protocols and collected during baseline studies, with additional input from study investigators. We organized differences and commonalities across the trials in five categories: trial contexts, research designs, intervention packages, trial themes and adaptations.ResultsAll performed in the context of generalized HIV epidemics, the trials highly differ in their social, demographic, economic, political and health systems settings. They share the common aim of assessing the impact of UTT on the HIV epidemic but differ in methodological aspects such as study design and eligibility criteria for trial populations. In addition to universal ART initiation, the trials deliver a wide range of biomedical, behavioural and structural interventions as part of their UTT strategies. The five studies explore common issues, including the uptake rates of the trial services and individual health outcomes. All trials have adapted since their initiation to the evolving political, economic and public health contexts, including adopting the successive national recommendations for ART initiation.ConclusionsWe found substantial commonalities but also differences between the five UTT trials in their design, conduct and multidisciplinary outputs. As empirical literature on how UTT may improve efficiency and quality of HIV care at population level is still scarce, this article provides a foundation for more collaborative research on UTT and supports evidence-based decision making for HIV care in country and internationally.

Introduction: We aimed to evaluate daily oral pre‐exposure prophylaxis (PrEP) uptake, retention, and adherence and predictors of study non‐attendance and low PrEP adherence in a Brazilian trans‐specific 48‐week study (PrEParadas). Methods: We enrolled transgender women (TGW) engaging in high‐risk sexual behaviours between August 2017 and December 2018. PrEP adherence was based on tenofovir diphosphate concentrations in dried blood spots (DBS). We used random effects logistic regression models and ordinal models to estimate the odds of having a missed visit and of low PrEP adherence, respectively. Multivariable models were adjusted for variables with p‐value<0.10 in the univariate analysis. Results: From the 271 eligible, 130 participants were enrolled in the study (PrEP uptake: 48%), out of which 111 (85.4%) were retained at 48 weeks. Multivariable model for study non‐attendance included study visit, age, main sexual partner and stimulant use. The odds of missing a visit increased after the week 24. Participants aged 18–24 (adjusted odds ratio [aOR] = 8.76, 95% CI: 2.09–36.7) and 25–34 years (aOR = 6.79, 95% CI: 1.72–26.8) compared to TGW aged 35+ years had significantly higher odds of having a missed visit. The odds of a missed visit were higher among participants reporting stimulant use (aOR = 4.99, 95% CI: 1.37–18.1) compared to no stimulant use. DBS levels at week 48 showed that 42 (38.5%), 14 (12.8%) and 53 (48.6%) of 109 participants had low, moderate and high PrEP adherence. Multivariable model for low PrEP adherence included study visit, age, schooling, race/colour, housing, binge drinking, stimulant use, feminizing hormone therapy (FHT) use and received text message. Low PrEP adherence was significantly higher among participants with less years of schooling (aOR = 6.71, 95% CI: 1.30–34.5) and had a borderline association with Black colour/race (aOR = 6.72, 95% CI: 0.94–47.8). Participants using the FHT available at the site had decreased odds of low PrEP adherence (aOR = 0.38, 95% CI: 0.16–0.88). No participant seroconverted over the course of the study. Conclusions: Although high PrEP retention can be achieved in a gender‐affirming setting, PrEP adherence may be an important challenge faced among TGW due to social disparities. The scale‐up of prevention tools like PrEP will have to address systemic social determinants as these stand as important barriers for TGW's access to health services. [ABSTRACT FROM AUTHOR]

Introduction: The COVID‐19 pandemic has affected women and children globally, disrupting antiretroviral therapy (ART) services and exacerbating pre‐existing barriers to care for both pregnant women and paediatric populations. Methods: We used the Spectrum modelling package and the CEPAC‐Pediatric model to project the impact of COVID‐19‐associated care disruptions on three key populations in the 21 Global Plan priority countries in sub‐Saharan Africa: (1) pregnant and breastfeeding women living with HIV and their children, (2) all children (aged 0–14 years) living with HIV (CLWH), regardless of their engagement in care and (3) CLWH who were engaged in care and on ART prior to the start of the pandemic. We projected clinical outcomes over the 12‐month period of 1 March 2020 to 1 March 2021. Results: Compared to a scenario with no care disruption, in a 3‐month lockdown with complete service disruption, followed by 3 additional months of partial (50%) service disruption, a projected 755,400 women would have received PMTCT care (a 21% decrease), 187,800 new paediatric HIV infections would have occurred (a 77% increase) and 516,800 children would have received ART (a 35% decrease). For children on ART as of March 2020, we projected 507,200 would have experienced ART failure (an 80% increase). Additionally, a projected 88,400 AIDS‐related deaths would have occurred (a 27% increase) between March 2020 and March 2021, with 51,700 of those deaths occurring among children engaged in care as of March 2020 (a 54% increase). Conclusions: While efforts will continue to curb morbidity and mortality stemming directly from COVID‐19 itself, it is critical that providers also consider the immediate and indirect harms of this pandemic, particularly among vulnerable populations. Well‐informed, timely action is critical to meet the health needs of pregnant women and children if the global community is to maintain momentum towards an AIDS‐free generation. [ABSTRACT FROM AUTHOR]

IntroductionPolice officers are at an elevated risk for needle-stick injuries (NSI), which pose a serious and costly occupational health risk for HIV and viral hepatitis. However, research on NSIs among police officers is limited, especially in low- and middle-income countries. Despite the legality of syringe possession in Mexico, half of people who inject drugs (PWID) in Tijuana report extrajudicial syringe-related arrests and confiscation by police, which has been associated with needle-sharing and HIV infection. We assessed the prevalence and correlates of NSIs among Tijuana police officers to inform efforts to improve occupational safety and simultaneously reduce HIV risks among police and PWID.MethodsTijuana's Department of Municipal Public Safety (SSPM) is among Mexico's largest. Our binational, multi-sectoral team analyzed de-identified data from SSPM's 2014 anonymous self-administered occupational health survey. The prevalence of NSI and syringe disposal practices was determined. Logistic regression with robust variance estimation via generalized estimating equations identified factors associated with ever having an occupational NSI.ResultsApproximately one-quarter of the Tijuana police force was given the occupational health survey (N=503). Respondents were predominantly male (86.5%) and ≤35 years old (42.6%). Nearly one in six officers reported ever having a NSI while working at SSPM (15.3%), of whom 14.3% reported a NSI within the past year. Most participants reported encountering needles/syringes while on duty (n=473, 94%); factors independently associated with elevated odds of NSIs included frequently finding syringes that contain drugs (adjusted odds ratio (AOR): 2.98; 95% confidence interval (CI): 1.56-5.67) and breaking used needles (AOR: 2.25; 95% CI: 1.29-3.91), while protective factors included being willing to contact emergency services in case of NSIs (AOR: 0.39; 95% CI: 0.22-0.69), and wearing needle-stick resistant gloves (AOR: 0.43; 95% CI: 0.19-0.91).ConclusionsTijuana police face an elevated and unaddressed occupational NSI burden associated with unsafe syringe-handling practices, exposing them to substantial risk of HIV and other blood-borne infections. These findings spurred the development and tailoring of training to reduce NSI by modifying officer knowledge, attitudes and enforcement practices (e.g. syringe confiscation) - factors that also impact HIV transmission among PWID and other members of the community.

IntroductionHIV incidence is an important measure for monitoring the development of the epidemic, but it is difficult to ascertain. We combined serial HIV prevalence and mortality data to estimate HIV incidence among key affected populations (KAPs) in China.MethodsSerial cross-sectional surveys were conducted among KAPs from 2010 to 2014. Trends in HIV prevalence were assessed by the Cochran-Armitage test, adjusted by risk group. HIV incidence was estimated from a mathematical model that describes the relationship between changes in HIV incidence with HIV prevalence and mortality.ResultsThe crude HIV prevalence for the survey samples remained stable at 1.1 to 1.2% from 2010 to 2014. Among drug users (DUs), HIV prevalence declined from 4.48 to 3.29% (p

IntroductionHIV-affected women and couples often desire children and many accept HIV risk in order to attempt pregnancy and satisfy goals for a family. Risk reduction strategies to mitigate sexual and perinatal HIV transmission include biomedical and behavioural approaches. Current efforts to integrate HIV and reproductive health services offer prime opportunities to incorporate strategies for HIV risk reduction during pregnancy attempts. Key client and provider values about services to optimize pregnancy in the context of HIV risk provide insights for the design and implementation of large-scale "safer conception" programmes.DiscussionThrough our collective experience and discussions at a multi-disciplinary international World Health Organization-convened workshop to initiate the development of guidelines and an algorithm of care to support the delivery of services for HIV-affected women and couples attempting pregnancy, we identified four values that are key to the implementation of these programmes: (1) understanding fertility care and an ability to identify potential fertility problems; (2) providing equity of access to resources enabling informed decision-making about reproductive choices; (3) creating enabling environments that reduce stigma associated with HIV and infertility; and (4) creating enabling environments that encourage disclosure of HIV status and fertility status to partners. Based on these values, recommendations for programmes serving HIV-affected women and couples attempting pregnancy include the following: incorporation of comprehensive reproductive health counselling; training to support the transfer and exchange of knowledge between providers and clients; care environments that reduce the stigma of childbearing among HIV-affected women and couples; support for safe and voluntary disclosure of HIV and fertility status; and increased efforts to engage men in reproductive decision-making at times that align with women's desires.ConclusionsProgrammes, policies and guidelines that integrate HIV treatment and prevention, sexual and reproductive health and fertility care services in a manner responsive to user values and preferences offer opportunities to maximize demand for and use of these services. For HIV-affected women and couples attempting pregnancy, the provision of comprehensive services using available tools - and the development of new tools that are adaptable to many settings and follow consensus recommendations - is a public health imperative. The impetus now is to design and deliver value-driven inclusive programming to achieve the greatest coverage and impact to reduce HIV transmission during pregnancy attempts.

IntroductionHIV and cervical cancer are intersecting epidemics that disproportionately affect one of the most vulnerable populations in the world: women in low- and middle-income countries (LMICs). Historically, the disparity in cervical cancer risk for women in LMICs has been due to the lack of organized screening and prevention programmes. In recent years, this risk has been augmented by the severity of the HIV epidemic in LMICs. HIV-positive women are at increased risk for developing cervical precancer and cancer, and while the introduction of antiretroviral therapy has dramatically improved life expectancies among HIV-positive women it has not been shown to improve cancer-related outcomes. Therefore, an increasing number of HIV-positive women are living in LMICs with limited or no access to cervical cancer screening programmes. In this commentary, we describe the gaps in cervical cancer prevention, the state of evidence for integrating cervical cancer prevention into HIV programmes and future directions for programme implementation and research.DiscussionDespite the biologic, behavioural and demographic overlap between HIV and cervical cancer, cervical cancer prevention has for the most part been left out of sexual and reproductive health (SRH) services for HIV-positive women. Lower cost primary and secondary prevention strategies for cervical cancer are becoming more widely available in LMICs, with increasing evidence for their efficacy and cost-effectiveness. Going forward, cervical cancer prevention must be considered a part of the essential package of SRH services for HIV-positive women. Effective cervical cancer prevention programmes will require a coordinated response from international policymakers and funders, national governments and community leaders. Leveraging the improvements in healthcare infrastructure created by the response to the global HIV epidemic through integration of services may be an effective way to make an impact to prevent cervical cancer among HIV-positive women, but more work remains to determine optimal approaches.ConclusionsCervical cancer prevention is an essential part of comprehensive HIV care. In order to ensure maximal impact and cost-effectiveness, implementation strategies for screening programmes must be adapted and rigorously evaluated through a framework that includes equal participation with policymakers, programme planners and key stakeholders in the target communities.

Introduction: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co‐infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy‐specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next‐generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co‐infections research. Discussion: The 26‐member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics‐centred guidance for advancing timely, responsible HIV/co‐infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug‐related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post‐approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co‐infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. Conclusions: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for – and the promise of – advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children. [ABSTRACT FROM AUTHOR]

Introduction: HIV pre‐exposure prophylaxis (PrEP) is effective in preventing HIV transmission. United States Public Health Service (USPHS) clinical practice guidelines define biobehavioral indications for initiation. To assess guideline implementation, it is critical to quantify PrEP nonusers who are indicated and PrEP users who are not indicated. We sought to estimate current PrEP use among US men who have sex with men (MSM), characterize whether their PrEP use aligned with their current indications for PrEP, and assess whether the association between PrEP indications and PrEP use differed by demography or geography. Methods: Using data from a US web‐based sexual network study of MSM between 2017 and 2019, we measured PrEP usage and assessed whether respondents met indications for PrEP. Log‐binomial regression was used to estimate the relationship between PrEP indications and PrEP use, with adjustment for geography, age and race/ethnicity. Results: Of 3508 sexually active, HIV‐negative MSM, 34% met indications for PrEP. The proportion with current PrEP use was 32% among MSM meeting indications and 11% among those without indications. Nearly 40% of those currently using PrEP did not meet indications for PrEP, and 68% of MSM with indications for PrEP were not currently using PrEP. After adjusting for geography and demographics, MSM with PrEP indications were about three times as likely to be currently using PrEP. This association varied slightly, but not significantly, by geographic region, age and race/ethnicity. Conclusions: Indications for PrEP strongly predicted current PrEP use among US MSM. However, we identified substantial misalignment between indications and use in both directions (indicated MSM who were not benefitting from PrEP, and MSM taking PrEP while not presently being indicated). PrEP underuse by those at greatest risk for HIV acquisition may limit the projected impact of PrEP implementation, despite reported increases in PrEP provision. This calls for further implementation efforts to improve PrEP delivery to those most in need during periods of elevated sexual risk and to close the gap between indications and uptake. [ABSTRACT FROM AUTHOR]

IntroductionWithin healthcare settings, HIV-related stigma is a recognized barrier to access of HIV prevention and treatment services and yet, few efforts have been made to scale-up stigma reduction programs in service delivery. This is in part due to the lack of a brief, simple, standardized tool for measuring stigma among all levels of health facility staff that works across diverse HIV prevalence, language and healthcare settings. In response, an international consortium led by the Health Policy Project, has developed and field tested a stigma measurement tool for use with health facility staff.MethodsExperts participated in a content-development workshop to review an item pool of existing measures, identify gaps and prioritize questions. The resulting questionnaire was field tested in six diverse sites (China, Dominica, Egypt, Kenya, Puerto Rico and St. Christopher & Nevis). Respondents included clinical and non-clinical staff. Questionnaires were self- or interviewer-administered. Analysis of item performance across sites examined both psychometric properties and contextual issues.ResultsThe key outcome of the process was a substantially reduced questionnaire. Eighteen core questions measure three programmatically actionable drivers of stigma within health facilities (worry about HIV transmission, attitudes towards people living with HIV (PLHIV), and health facility environment, including policies), and enacted stigma. The questionnaire also includes one short scale for attitudes towards PLHIV (5-item scale, α=0.78).ConclusionsStigma-reduction programmes in healthcare facilities are urgently needed to improve the quality of care provided, uphold the human right to healthcare, increase access to health services, and maximize investments in HIV prevention and treatment. This brief, standardized tool will facilitate inclusion of stigma measurement in research studies and in routine facility data collection, allowing for the monitoring of stigma within healthcare facilities and evaluation of stigma-reduction programmes. There is potential for wide use of the tool either as a stand-alone survey or integrated within other studies of health facility staff.

Introduction: People who inject drugs (PWID) in Ukraine have high prevalences of HIV and hepatitis C (HCV). Since the turn of the century, various organizations have funded non‐governmental organizations (NGOs) in Ukraine to provide PWID with needles and syringes, condoms, HIV and HCV testing, and improve linkage to opioid agonist therapy (OAT) and HIV treatment. We investigated whether contact with these NGOs was associated with improved HIV prevention and treatment outcomes among PWID. Methods: Five rounds of respondent‐driven sampled integrated bio‐behavioural survey data (2009 [N = 3962], 2011 [N = 9069], 2013 [N = 9502], 2015 [N = 9405], and 2017 [N = 10076]) among PWID in Ukraine (including HIV/HCV testing and questionnaires) were analysed using mixed‐effect logistic regression models (mixed‐effects: city, year). These regression models assessed associations between being an NGO client and various behavioural, OAT, HIV testing and HIV treatment outcomes, adjusting for demographic characteristics (age, gender, lifetime imprisonment, registration in a drug abuse clinic, education level). We also assessed associations between being an NGO client and being HIV positive or HCV positive, likewise adjusting for demographic characteristics (as above). Results: NGO clients were more likely to have received HIV testing ever (adjusted odds ratio [aOR] 5.37, 95% confidence interval [95% CI]: 4.97 to 5.80) or in the last year (aOR 3.37, 95% CI: 3.20 to 3.54), to have used condoms at last sexual intercourse (aOR 1.37, 95% CI: 1.30 to 1.44) and sterile needles at last injection (aOR 1.37, 95% CI: 1.20 to 1.56), to be currently (aOR 4.19, 95% CI: 3.48 to 5.05) or ever (aOR 2.52, 95% CI: 2.32 to 2.74) on OAT, and to have received syringes (aOR 109.89, 95% CI: 99.26 to 121.66) or condoms (aOR 54.39, 95% CI: 50.17 to 58.96) in the last year. PWID who were HIV positive (aOR 1.40, 95% CI: 1.33 to 1.48) or HCV positive (aOR 1.57, 95% CI: 1.49 to 1.65) were more likely to have contact with NGOs, with HIV positive PWID in contact with NGOs being more likely to be registered at AIDS centres (aOR 2.34, 95% CI: 1.88 to 2.92) and to be on antiretroviral therapy (aOR 1.60, 95% CI: 1.40 to 1.83). Conclusions: Contact with PWID targeted NGOs in Ukraine is associated with consistently better preventive, HIV testing and HIV treatment outcomes, suggesting a beneficial impact of harm reduction NGO programming. [ABSTRACT FROM AUTHOR]

Introduction: Surveillance of recent HIV infections in national testing services has the potential to inform primary prevention programming activities. Focusing on procedures required to accurately determine recent infection, and the potential for recent infection surveillance to inform prevention efforts, we present the results of three independent but linked pilots of recency testing. Methods: To distinguish recently acquired HIV infection from long‐standing infection, in 2018 we applied a Recent Infection Testing Algorithm that combined a laboratory‐based Limiting Antigen Avidity Enzyme Immunoassay with clinical information (viral‐load; history of prior HIV diagnosis; antiretroviral therapy‐exposure). We explored potential misclassification of test results and analysed the characteristics of participants with recent infection. We applied the algorithm in antenatal clinics providing prevention of mother‐to‐child transmission services in Siaya County, Kenya, outreach sites serving female sex workers in Zimbabwe, and routine HIV testing and counselling facilities in Nairobi, Kenya. In Nairobi, we also conducted recency testing among partners of HIV‐positive participants. Results: In Siaya County, 2.3% (10/426) of HIV‐positive pregnant women were classified as recent. A risk factor analysis comparing women testing recent with those testing HIV‐negative found women in their first trimester were significantly more likely to test recent than those in their second or third trimester. In Zimbabwe, 10.5% (33/313) of female sex workers testing HIV‐positive through the outreach programme were classified recent. A risk factor analysis of women testing recent versus those testing HIV‐negative, found no strong evidence of an association with recent infection. In Nairobi, among 532 HIV‐positive women and men, 8.6% (46) were classified recent. Among partners of participants, almost a quarter of those who tested HIV‐positive were classified as recent (23.8%; 5/21). In all three settings, the inclusion of clinical information helped improve the positive predictive value of recent infection testing by removing cases that were likely misclassified. Conclusions: We successfully identified recently acquired infections among persons testing HIV‐positive in routine testing settings and highlight the importance of incorporating additional information to accurately classify recent infection. We identified a number of groups with a significantly higher proportion of recent infection, suggesting recent infection surveillance, when rolled‐out nationally, may help in further targeting primary prevention efforts. [ABSTRACT FROM AUTHOR]

Introduction: In settings where both daily and event-driven pre-exposure prophylaxis (PrEP) are offered to men who have sex with men (MSM), a clear understanding of the motives to choose between the different dosing-regimens can facilitate more effective PrEP implementation. We therefore studied the motives for choosing for, switching between, and stopping daily or event-driven PrEP. Methods: We used data (August 2015-June 2017) from the prospective, longitudinal, open-label Amsterdam PrEP demonstration study, in which daily (dPrEP) and event-driven PrEP (edPrEP) were offered to 374 HIV-negative MSM and two transgender persons. Participants self-selected the preferred PrEP-regimen at baseline and could switch regimens at three-monthly follow-up visits. We measured motives for choosing PrEP-regimen at baseline and for switching and stopping PrEP at follow-up visits. Open- and closed-end items were combined and qualitatively analysed. Results: Choices of PrEP-regimens were determined by personal and contextual factors, involving the perceived self-efficacy concerning adherence, the risk-context, and the anticipated impact of PrEP on physical and sexual wellbeing. dPrEP was preferred because of the anticipated better adherence and the fear of side-effects relating to edPrEP re-initiations. Moreover, dPrEP was perceived to be more effective than edPrEP. Motives to choose edPrEP were the expected physical burden of dPrEP, anticipated side-effects of dPrEP, and fear to forget daily doses. Regarding the risk-context: dPrEP was preferred for unplanned and/or frequent sex, while edPrEP was chosen when risk was predictable and/or less frequent. While some chose for dPrEP to gain more sexual freedom, others chose for edPrEP to minimize sexual risk episodes. Changes in the above factors, such as changing risk patterns, changing relationships or changing physical conditions, resulted in switching regimens. Choices to stop PrEP were related to lower sexual risk, adherence issues and side-effects. Conclusions: The great diversity of motives illustrates the importance of offering a choice of PrEP-regimens. In counselling of MSM starting PrEP, choices for PrEP-regimens may be addressed as a continuum of flexible and changeable options over time. This may help individuals choose the PrEP-regimen that best fits their current sexual context, priorities and personal capabilities and therefore will be more easily adhered to. [ABSTRACT FROM AUTHOR]

Introduction: Pre‐exposure prophylaxis (PrEP) to prevent HIV infection is being rolled out in Africa. The uptake of PrEP to date has varied across populations and locations. We seek to understand the drivers of demand for PrEP through analysis of qualitative data collected in conjunction with a PrEP demonstration project involving East African HIV serodiscordant couples. Our goal was to inform demand creation by understanding what PrEP means – beyond HIV prevention – for the lives of users. Methods: The Partners Demonstration Project evaluated an integrated strategy of PrEP and antiretroviral therapy (ART) delivery in which time‐limited PrEP served as a "bridge" to long‐term ART. Uninfected partners in HIV serodiscordant couples were offered PrEP at baseline and encouraged to discontinue once infected partners had taken ART for six months. We conducted 274 open‐ended interviews with 93 couples at two Ugandan research sites. Interviews took place one month after enrolment and at later points in the follow‐up period. Topics included are as follows: (1) discovery of serodiscordance; (2) decisions to accept/decline PrEP and/or ART; (3) PrEP and ART initiation; (4) experiences of using PrEP and ART; (5) PrEP discontinuation; (6) impact of PrEP and ART on the partnered relationship. Interviews were audio‐recorded and transcribed. We used an inductive, content analytic approach to characterize meanings of PrEP stemming from its effectiveness for HIV prevention. Relevant content was represented as descriptive categories. Results: Discovery of HIV serodiscordance resulted in fear of HIV transmission for couples, which led to loss of sexual intimacy in committed relationships, and to abandonment of plans for children. As a result, partners became alienated from each other. PrEP countered the threat to the relationship by reducing fear and reinstating hopes of having children together. Condom use worked against the re‐establishment of intimacy and closeness. By increasing couples' sense of protection against HIV infection and raising the prospect of a return to "live sex" (sex without condoms), PrEP was perceived by couples as solving the problem of serodiscordance and preserving committed relationships. Conclusions: The most effective demand creation strategies for PrEP may be those that address the everyday life priorities of potential users in addition to HIV prevention. Clinical Trial Number: NCT02775929 [ABSTRACT FROM AUTHOR]