Affordable HIV Research Articles

Affordable Access: Making HIV Testing and Counseling Available to All

HIV testing and counseling (HTC) are fundamental components of the global strategy to reduce the transmission of HIV and ensure early diagnosis and treatment. However, despite their critical importance, access to these services remains a challenge, especially in low- and middle-income countries. This review examines the importance of affordable access to HIV testing and counseling, the barriers to widespread availability, and strategies to overcome these challenges. It highlights the key role of HTC in the prevention and care continuum, emphasizing the need for universal access to achieve global health equity and reduce HIV-related morbidity and mortality. The review explores various factors that hinder access to affordable HIV testing and counseling, such as cost, stigma, and logistical challenges, including geographic barriers and inadequate healthcare infrastructure. These barriers disproportionately affect marginalized populations, including those in rural areas and high-risk groups. Furthermore, the review discusses the social and psychological factors that contribute to the underutilization of HTC services, such as fear of discrimination and lack of awareness about the importance of regular HIV testing. Keywords: HIV Testing, HIV Counseling, Affordable Healthcare, Global Health Equity, HIV Prevention

Prevalence and predictors of HIV testing among young men in Papua New Guinea: A cross-sectional analysis of a nationally representative sample.

HIV testing is an important component of HIV prevention and serves as a gateway to other HIV-related services. However, the uptake remains suboptimal among young people, particularly in highly prevalent settings such as Papua New Guinea (PNG). This study aimed to assess the prevalence and determine the predictors of HIV testing uptake among young men aged 15-24 years in PNG. The 2016-2018 PNG Demographic and Health Survey (DHS) data was used. A total of 1,275 young men aged 15-24 years were included in the final analysis. Descriptive, bivariate, and multivariable logistic regression analyses were performed to determine independent predictors of HIV testing. Adjusted odds ratios (AORs) with 95% confidence intervals (CIs) were reported. All analyses were adjusted using survey weights to account for unequal sampling probabilities. The overall prevalence of HIV testing among young men was 17.1% (95% CI: 15-19). Of those who were tested for HIV, about one-third (32.9%) had experienced a sexual debut at age <15 years, and 33.9% inconsistently used condoms during sex. In multivariable analysis, men aged 20-24 years (AOR 1.18, 95% CI: 1.00-2.31), who owned mobile phones (AOR 1.43, 95% CI: 1.00-2.55), who were aware that consistent condom use during sex can reduce HIV risk (AOR 2.18, 95% CI: 1.18-4.04), who had paid for sex (AOR 1.75, 95% CI: 1.01-5.83), and who had two or more sexual partners (AOR 1.37, 95% CI: 1.01-3.14) had increased odds of HIV testing. However, decreased odds of HIV testing were found among men who were never married (AOR 0.51, 95% CI: 0.29-0.88), lived in rural areas (AOR 0.54, 95% CI: 0.32-0.92), and consistently used condoms during sex (AOR 0.59, 95% CI: 0.34-1.01). The findings show that HIV testing is low among young men in PNG. To increase HIV testing uptake among young men, it is crucial to implement comprehensive youth-friendly HIV/STI education and tailored sensitization programs and enable more accessible and affordable HIV testing services. Also, outreach and community-based testing programs for young men in rural and prioritized areas requiring urgent prevention interventions are feasible options in PNG.

Measuring Spatial Access of Vulnerable Population to HIV Testing Facilities in the Baton Rouge Metropolitan Statistical Area, Louisiana.

Ensuring adequate and equitable access to affordable HIV testing is a crucial step toward ending the HIV epidemic (EHE). Using the high-burden Baton Rouge Metropolitan Statistical Area (MSA) as an example, we measure spatial access to HIV testing facilities for vulnerable populations and assess whether their access would improve if eliminating a considerable barrier-costs. Locations and status (free, low-cost, and full cost) of HIV testing facilities are searched on the Internet and confirmed through a field survey. Vulnerable populations include the uninsured and people living with HIV (PLWH), disaggregated from county-level HIV prevalence data. Spatial access is computed by a normalized urban-rural two-step floating catchment area (NUR2SFCA) method. Our survey confirms that only 11% and 37% of the 103 Internet-searched HIV testing facilities are indeed free and low-cost. Making more facilities cheaper or free increases the average access of PLWH, the uninsured, and the entire population but their geographic patterns vary. Free testing facilities, clustered in Baton Rouge city, are highly accessible to 82.6%, 69.4%, and 70.2% of three population groups living in East and West Baton Rouge Parish. In comparison, making all low-cost facilities free increases access in most outlying parishes but at the cost of reducing access in East Baton Rouge Parish, leaving west Livingston, north Iberville, and east Pointe Coupee Parish with the poorest access. Making all full-cost facilities cheaper or free exhibits a similar pattern. The study has important policy implications for where and how to improve access to HIV testing for vulnerable populations.

Portable Nanopore sequencing solution for next-generation HIV drug resistance testing

BackgroundTackling HIV drug resistance is one of major challenges for ending AIDS epidemic, but the elevated expense of cutting-edge genomics hampers the advancement of HIV genotype testing for clinical care. MethodsWe developed a HIV genotype testing pipeline that centers on a cost-efficient portable Nanopore sequencer. Accuracy verification was conducted through comparison with parallel data obtained via fixed-site Pacbio sequencing. Our complete pol-gene sequencing strategy coupled with portable high-throughput sequencing was applied to identify drug resistance mutations across 58 samples sourced from the ART-treated Los Angeles General Medical Center Rand Schrader Clinic (LARSC) cohort (7 samples from 7 individuals) and the ART-naïve Center for HIV/AIDS Vaccine Immunology (CHAVI) cohort (51 samples from 38 individuals). ResultsA total of 472 HIV consensus sequences, each tagged with a unique molecular identifier, were produced from over 1.4 million bases acquired through portable Nanopore sequencing, which matched those obtained independently via Pacbio sequencing. With this desirable accuracy, we first documented the linkage of multidrug cross-resistance mutations across Integrase Strand Transfer inhibitors (INSTIs) and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) from an individual failing a second-generation INSTI regimen. By producing more than 500 full-length HIV pol gene sequences in a single portable sequencing run, we detected Protease Inhibitor (PI), Nucleoside Reverse Transcriptase Inhibitor (NRTI), NNRTI and INSTI resistance mutations. All drug resistance mutations identified through portable sequencing were cross-validated using fixed-site Pacbio sequencing. ConclusionsOur accurate and affordable HIV drug resistance testing solution is adaptable for both individual patient care and large-scale surveillance initiatives.

A syndemic of inequitable gender norms and intersecting stigmas on condom self-efficacy and practices among displaced youth living in urban slums in Uganda: a community-based cross-sectional study

BackgroundAdverse socio-cultural factors compromise the implementation of HIV prevention strategies among displaced youth. While condoms are an affordable and effective HIV prevention strategy for youth, stigma and inequitable gender norms may constrain condom self-efficacy (i.e., knowledge, intentions, and relationship dynamics that facilitate condom negotiation) and use. Further, knowledge of contextually appropriate HIV prevention approaches are constrained by limited understanding of the socio-cultural conditions that affect condom self-efficacy and use among displaced youth. Guided by syndemics theory, we examine independent and joint effects of adverse socio-cultural factors associated with condom self-efficacy and use among displaced youth living in urban slums in Kampala, Uganda.MethodsWe conducted a community-based cross-sectional survey of displaced youth aged 16–24 years living in five slums in Kampala. We used multivariable logistic regression and multivariate linear regression to assess independent and two-way interactions among adverse socio-cultural factors (adolescent sexual and reproductive health-related stigma [A-SRH stigma], perceived HIV-related stigma, and beliefs in harmful inequitable gender norms) on condom self-efficacy and recent consistent condom use. We calculated the prevalence and co-occurrence of adverse socio-cultural factors; conducted regression analyses to create unique profiles of adverse socio-cultural factors; and then assessed joint effects of adverse socio-cultural factors on condom self-efficacy and practices.ResultsAmong participants (mean age: 19.59 years; SD: 2.59; women: n = 333, men: n = 112), 62.5% were sexually active. Of these, only 53.3% reported recent consistent condom use. Overall, 42.73% of participants reported two co-occurring adverse socio-cultural factors, and 16.63% reported three co-occurring exposures. We found a joint effect of beliefs in harmful inequitable gender norms with high A-SRH stigma (β = − 0.20; p < 0.05) and high A-SRH stigma with high perceived HIV stigma (β = − 0.31; p < 0.001) on reduced condom self-efficacy. We found a multiplicative interaction between high A-SRH stigma with high perceived HIV stigma (aOR = 0.52; 95% CI 0.28, 0.96) on recent consistent condom use. Additionally, we found that condom self-efficacy (aOR = 1.01; 95% CI 1.05, 1.16) and safer sexual communication (aOR = 2.12; 95% CI 1.54, 2.91) acted as protective factors on inconsistent condom use.ConclusionsDisplaced youth living in urban slums exhibited low consistent condom use. Intersecting stigmas were associated with lower condom self-efficacy—a protective factor linked with increased consistent condom use. Findings highlight the importance of gender transformative and intersectional stigma reduction approaches to increase sexual agency and safer sex practices among Kampala’s slum-dwelling displaced youth.

Stakeholders’ perception of a total market approach to HIV self-testing (HIVST) for the private sector in Nigeria

BackgroundThe continuous supply of affordable and quality HIV self-test (HIVST) is a key pillar toward achieving the global HIV 95–95-95 target in Nigeria. This was a descriptive qualitative study that explored private sector stakeholders’ perceptions of the enablers and barriers of the HIVST market in Nigeria.MethodsA total of 29 In-depth interviews (IDIs) were conducted with HIVST supply chain stakeholders and private sector providers (PPMVs and Community Pharmacies). Responses were analyzed using Nvivo software and we systematically developed a total market approach analysis for supply chain stakeholders and archetypes for community Pharmacies and PPMVs based on insights gathered from their journey map.ResultsChallenges to the supply side dynamics include forecasting, point of care service delivery, the availability of free and subsidized HIVST kits in the market, neglect of private sector providers (Community Pharmacists and PPMVs) in the healthcare delivery system, limited demand for HIVST, and regulatory bottlenecks influences the overall market dynamics. High cost of the HIVST kit, which triggers low availability, accessibility and affordability from the demand side, depicts the need to understand the market dynamics. Addressing the barriers and optimizing the enablers of the three-model pharmacist and PPMV’s will change the market dynamic and service delivery to generate demand.ConclusionTo address challenges which already exist, the government need to revise the process guidelines for introducing new HIVST products in the Nigerian market, developing contingency plans to ensure the supply of HIVST remains sufficient when experiencing economic shocks, and create a sustainable roadmap toward optimizing the market for HIVST kits.

Barriers to and facilitators of accessing HIV services for street-involved youth in Canada and Kenya

IntroductionUNICEF estimates that there are as many as 100 million street-involved youth (SIY) globally. Marginalized conditions put SIY at higher risk of HIV and adverse outcomes once HIV-positive. The objective of this analysis was to describe barriers and facilitators of accessing HIV prevention, testing, and treatment services as Phase I of an implementation study evaluating the use of peer navigators to increase access to HIV services.MethodsSemi-structured interviews, focus group discussions (FGD), and theatre testing were conducted with individuals who identify as SIY, health care providers, and community stakeholders living in Canada (Toronto, Montreal, London) and Kenya (Eldoret, Huruma, Kitale). Data were analyzed using a directed content approach, guided by the socio-ecological model (SEM).ResultsAcross the six sites were 195 participants: 64 SIY, 42 healthcare providers, and 97 community-based stakeholders. Barriers were identified at the societal (e.g. intersectional stigma and discrimination), public policy (e.g., inadequate access to basic needs, legal documentation, lack of health insurance, and limited community-based funding), institutional (e.g. lack of inclusive education and training, inadequate HIV educational outreach, and restrictive service provision), interpersonal (e.g., ineffective communication from healthcare providers), and intrapersonal levels (e.g. lack of trust and associated fear, low perception for healthcare, and lack of self-esteem). These contributed to limited HIV services utilization among SIY. Conversely, numerous facilitators were also identified at the public policy (e.g. affordable HIV services and treatment), institutional (e.g. available and accessible HIV prevention tools, HIV education and awareness programs, and holistic models of care), interpersonal level (e.g., systems navigation support, peer support, and personal relationships), and intrapersonal levels (e.g. self-efficacy) as positively supporting SIY access to HIV services.ConclusionIntersectional stigma was a critical barrier in all sites, and policies and programs that foster welcoming environments for youth from diverse backgrounds and living circumstances may be better able to respond to the HIV service needs of this high risk population. Social support and navigation services were reported to facilitate access to HIV services in all sites.

Accelerating access and scale-up of optimized antiretroviral therapy in low-income and middle-income countries: results of a coordinated end-to-end approach.

The global HIV community invested in multiple, high-profile partnerships and shepherded unprecedented political support to expedite the transition to dolutegravir (DTG)-based regimens. The goal? To accelerate access to simpler, safer, more robust, and more affordable HIV treatment by harnessing the collective power of scientists, regulators, drug companies, donors, implementers, advocates, and people with HIV (PWH). The inspiration? End-to-end approaches to introducing new products that mitigate risk and encourage early planning and resource allocation for all aspects of product introduction and preparation for scale-up. This approach of planning with the 'end-in-mind' - and the belief that this end-to-end mindset can facilitate healthy markets, catalyze the application of new health technologies, and accelerate the development of improved products - is increasingly being applied across HIV prevention, care, and treatment (e.g. for biomedical prevention), and across health sectors (e.g. in maternal and child health, food security and water, and sanitation). This review of antiretroviral treatment (ART) optimization efforts from 2015 through 2020 discusses what worked, what is next, and how the learnings from HIV treatment can inform the broader global health community looking for innovative partnership models to accelerate adoption and enable scale-up of promising new products and programs.

Stable, high yield expression of gp145 Env glycoprotein from HIV-1 in mammalian cells

The HIV-1 derived gp145 protein is being investigated by research groups as preclinical studies have shown high promise for this protein as a vaccine against HIV. However, one of the main challenges with manufacturing this promising protein has been ascribed to the low yield obtained in mammalian cell cultures. Significant improvements in gp145 production are needed to address this issue to test the gp145 protein as a potentially effective, safe, and affordable HIV vaccine. Here we describe the application of a novel expression technology to create GMP-grade CHO cell lines expressing approximately 50 μg/ml in non-optimized fed-batch culture, which is an order of magnitude higher than that obtained in existing processes. Top producing clones show a high degree of similarity in the glycosylation patterns of the purified protein to the reference standard. Conformational integrity and functionality was demonstrated via high-affinity binding to soluble CD4, using a panel of antibodies including VRC01, F105, Hk20, PG9 and 17b. In summary, we were able to generate CHO cell lines expressing HIV gp145 with significantly higher overall expression yields than currently accessible, and high product quality that could potentially be suitable for future studies assessing the efficacy and safety of gp145-based HIV vaccines.

Design of a care pathway for pharmacy-based PrEP delivery in Kenya: results from a collaborative stakeholder consultation

IntroductionIn Kenya, pre-exposure prophylaxis (PrEP) for HIV prevention is almost exclusively delivered at HIV clinics. Developing novel PrEP delivery models is important for increasing the reach of PrEP. Delivery of PrEP through pharmacies is one approach utilized in the US to improve accessibility. Retail pharmacies are commonly used as a first-line access point for medical care in Kenya, but have not been utilized for PrEP delivery. We conducted a collaborative consultative meeting of stakeholders to develop a care pathway for pharmacy-based PrEP delivery in Kenya.MethodsIn January 2020, we held a one-day meeting in Nairobi with 36 stakeholders from PrEP regulatory, professional, healthcare service delivery, civil society, and research organizations. Attendees reviewed a theory of change model, results from formative qualitative research with pharmacy providers and clients, and anticipated core components of pharmacy-based PrEP delivery: counseling, HIV testing, prescribing, and dispensing. Stakeholders participated in small and large group discussions to identify potential challenges and solutions. We synthesized the key findings from these discussions.ResultsStakeholders were enthusiastic about a model for pharmacy-based PrEP delivery. Potential challenges identified included insufficient pharmacy provider knowledge and skills, regulatory hurdles to providing affordable HIV testing at pharmacies, and undefined pathways for PrEP procurement. Potential solutions identified included having pharmacy providers complete the Kenya Ministry of Health-approved PrEP training, use of a PrEP prescribing checklist with remote clinician oversight and provider-assisted HIV self-testing, and having the government provide PrEP and HIV self-testing kits to pharmacies during a pilot test. A care pathway was developed over the course of the meeting.ConclusionsPrEP delivery stakeholders in Kenya were strongly supportive of developing and testing a model for pharmacy-based PrEP delivery to increase PrEP access. We collaboratively developed a care pathway for pilot testing that has the potential to expand PrEP delivery options in Kenya and other similar settings.

Eligibility for HIV Preexposure Prophylaxis, Intention to Use Preexposure Prophylaxis, and Informal Use of Preexposure Prophylaxis Among Men Who Have Sex With Men in Amsterdam, the Netherlands.

Before 2019, availability of affordable HIV preexposure prophylaxis (PrEP) was limited in the Netherlands. Consequently, some men who have sex with men and transgender persons obtained PrEP informally, that is, without a prescription. Between September 2017 and August 2018, we enrolled informal PrEP users in a cohort study (Informal PrEP [InPrEP]) at the Amsterdam Sexually Transmitted Infections (STI) Clinic. We compared PrEP use, PrEP eligibility and intention, chemsex, and STI positivity between 3 groups: (1) informal PrEP users enrolled in InPrEP, (2) nonenrolled informal PrEP users, and (3) non-PrEP users. Also, we assessed intention and associated characteristics among non-PrEP users who were eligible for PrEP. During the study period, we enrolled 118 informal PrEP users in InPrEP who were compared with 224 nonenrolled informal PrEP users and 4975 non-PrEP users. Preexposure prophylaxis eligibility rates were 83.1%, 93.4%, and 63.0%; chemsex were reported by 39.1%, 48.1%, and 11.7%; and STI positivity was reported by 28.0%, 42.5%, and 20.3%, respectively. Among PrEP-eligible non-PrEP users, PrEP intention was 16.6% and associated with increasing age, non-Dutch origin, higher educational level, receptive condomless anal sex, increasing number of sex partners, chemsex, and sex with men only. Most informal PrEP users are eligible to use PrEP and have a clear sexual health care need. Especially in settings with limited PrEP access, providing the necessary care for informal PrEP users is important. The intention to use PrEP is low among PrEP-eligible STI clinic visitors. Further research should investigate modes to increase PrEP intention among PrEP-eligible persons.

An immunoassay cassette with a handheld reader for HIV urine testing in point-of-care diagnostics.

Currently, most HIV tests are performed with blood samples, or alternatively saliva samples are used for HIV testing. Simple HIV tests need to be performed in hospitals or other medical agencies instead of more invasive HIV blood tests. To enable point-of-care (POC) HIV diagnostics, based on a recently developed lateral flow strip for HIV urine testing, a microfluidic immunoassay cassette with a handheld optical reader is developed. Based on lateral flow strip with gold colloid reporter, the integrated immunoassay cassette can perform sample introduction, metering, discharging, applying and detection which simplifies HIV testing. An indicator is incorporated into the cassette to guide sample introduction based on color change, and further, the excess test sample is stored inside the sealed cassette to avoid any contamination. The low-cost handheld optical reader can provide a test result within a few seconds, which is useful for simple, sensitive and affordable HIV onsite detection. Instead of using normal white LEDs, a customized back light module embedded with green LEDs is adopted to illuminate the lateral flow strip with an appropriate working current to achieve optimal performance. Compared to the standard lateral flow strips using a benchtop reader, with the disposable immunoassay cassette assisted by the handheld optical reader, more convenient, easier-to-operate, and more affordable HIV urine testing can be achieved in POC diagnostics.

HIV Research for Prevention 2018: From Research to Impact Conference Summary and Highlights.

The HIV Research for Prevention (HIVR4P) conference is dedicated to advancing HIV prevention research, responding to a growing consensus that effective and durable prevention will require a combination of approaches as well as unprecedented collaboration among scientists, practitioners, and community workers from different fields and geographic areas. The conference theme in 2018, “From Research to Impact,” acknowledged an increasing focus on translation of promising research findings into practical, accessible, and affordable HIV prevention options for those who need them worldwide. HIVR4P 2018 was held in Madrid, Spain, on 21–25 October, with >1,400 participants from 52 countries around the globe, representing all aspects of HIV prevention research and implementation. The program included 137 oral and 610 poster presentations. This article presents a brief summary of highlights from the conference. More detailed information, complete abstracts as well as webcasts and daily Rapporteur summaries may be found on the conference website.

Does the political will exist to bring quality-assured and affordable drugs to low- and middle-income countries?

ABSTRACTBackground: Increased coverage with antiretroviral therapy for people living with HIV in low- and middle-income countries has increased their life expectancy associated with non-HIV comorbidities and the need for quality-assured and affordable non-communicable diseases drugs . Funders are leaving many middle-income countries that will have to pay and provide quality-assured and affordable HIV and non-HIV drugs, including for non-communicable diseases.Objective: To estimate costs for originator and generic antiretroviral therapy as the number of people living with HIV are projected to increase between 2016 and 2026, and discuss country, regional and global factors associated with increased access to generic drugs.Methods: Based on estimates of annual demand and prices, annual cost estimates were produced for generic and originator antiretroviral drug prices in low- and middle-income countries and projected for 2016–2026.Results: Drug costs varied between US$1.5 billion and US$4.8 billion for generic drugs and US$ 8.2 billion and US$16.5 billion for originator drugs between 2016 and 2026.Discussion: The global HIV response increased access to affordable generic drugs in low- and middle-income countries. Cheaper active pharmaceutical ingredients and market competition were responsible for reduced drug costs. The development and implementation of regulatory changes at country, regional and global levels, covering intellectual property rights and public health, and flexibilities in patent laws enabled prices to be reduced. These changes have not yet been applied in many low- and middle-income countries for HIV, nor for other infectious and non-communicable diseases, that lack the profile and political attention of HIV. Licensing backed up with Trade-Related Aspects of Intellectual Property Rights safeguards should become the norm to provide quality-assured and affordable drugs within competitive generic markets.Conclusion: Does the political will exist among policymakers and other stakeholders to develop and implement these country, regional and global frameworks for non-HIV drugs as they did for antiretroviral drugs?

HIV testing and counselling couples together for affordable HIV prevention in Africa.

BackgroundThe impact and cost-effectiveness of couples’ voluntary HIV counselling and testing (CVCT) has not been quantified in real-world settings. We quantify cost-per-HIV-infection averted by CVCT in Zambia from the donor’s perspective.MethodsFrom 2010 to 2016, CVCT was established in 73 Zambian government clinics. The cost-per-HIV-infection averted (CHIA) of CVCT was calculated using observed expenditures and effectiveness over longitudinal follow-up. These observed measures parameterized hypothetical 5-year nationwide implementations of: ‘CVCT’; ‘treatment-as-prevention (TasP) for discordant couples’ identified by CVCT; and ‘population TasP’ for all HIV+ cohabiting persons identified by individual testing.ResultsIn all, 207 428 couples were tested (US $52/couple). Among discordant couples in which HIV+ partners self-reported antiretroviral therapy (ART), HIV incidence was 8.5/100 person-years before and 1.8/100 person-years after CVCT (79% reduction). Corresponding reductions for non-ART-using discordant and concordant negative couples were 63% and 47%, respectively. CVCT averted an estimated 58% of new infections at US $659 CHIA. In nationwide implementation models, CVCT would prevent 17 times the number of infections vs ‘TasP for discordant couples’ at 86% of the cost, and nine times the infections vs ‘population TasP’ at 28% of the cost.ConclusionsCVCT is a cost-effective, feasible prevention strategy in Zambia. We demonstrate the novel, added effectiveness of providing CVCT to ART users, for whom ART use alone only partially mitigated transmission risk. Our results indicate a major policy shift (supporting development of CVCT indicators, budgets and targets) and have clinical implications (suggesting promotion of CVCT in ART clinics as a high-impact prevention strategy).

Treatment advocate tactics to expand access to antiviral therapy for HIV and viral hepatitis C in low- to high-income settings: making sure no one is left behind.

IntroductionWorldwide, 71 million people are infected with hepatitis C virus (HCV), which, without treatment, can lead to liver failure or hepatocellular carcinoma. HCV co‐infection increases liver‐ and AIDS‐related morbidity and mortality among HIV‐positive people, despite ART. A 12‐week course of HCV direct‐acting antivirals (DAAs) usually cures HCV – regardless of HIV status. However, patents and high prices have created access barriers for people living with HCV, especially people who inject drugs (PWID). Inadequate access to and coverage of harm reduction interventions feed the co‐epidemics of HIV and HCV; as a result, the highest prevalence of HCV is found among PWID, who face additional obstacles to treatment (including stigma, discrimination and other structural barriers). The HIV epidemic occurred during globalization of intellectual property rights, and highlighted the relationship between patents and the high prices that prevent access to medicines. Indian generic manufacturers produced affordable generic HIV treatment, enabling global scale‐up. Unlike HIV, donors have yet to step forward to fund HCV programmes, although DAAs can be mass‐produced at a low and sustainable cost. Unfortunately, although voluntary licensing agreements between originators and generic manufacturers enable low‐income (and some lower‐middle income countries) to buy generic versions of HIV and HCV medicines, most middle‐income countries with large burdens of HCV infection and HIV/HCV co‐infection are excluded from these agreements. Our commentary presents tactics from the HIV experience that treatment advocates can use to expand access to DAAs.DiscussionA number of practical actions can help increase access to DAAs, including new research and development (R&D) paradigms; compassionate use, named‐patient and early access programmes; use of TRIPS flexibilities such as compulsory licences and patent oppositions; and parallel importation via buyers’ clubs. Together, these approaches can increase access to antiviral therapy for people living with HIV and viral hepatitis in low‐, middle‐ and high‐income settings.ConclusionsThe HIV example provides helpful parallels for addressing challenges to expanding access to HCV DAAs. HCV treatment access – and harm reduction – should be massively scaled‐up to meet the needs of PWID, and efforts should be made to tackle stigma and discrimination, and stop criminalization of drug use and possession.

Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya.

Background1.5 million Kenyans are living with HIV/AIDS as per 2015 estimates. Though there is a notable decline in new HIV infections, continued effort is still needed to develop an efficacious, accessible and affordable HIV vaccine. HIV vaccine clinical trials bear risks, hence a need to understand volunteer motivators for enrolment, retention and follow-up. Understanding the factors that motivate volunteers to participate in a clinical trial can help to strategize, refine targeting and thus increase enrolment of volunteers in future HIV vaccine clinical trials. The health belief model classifies motivators into social benefits such as ‘advancing research’ and collaboration with science, and personal benefits such as health benefits and financial interests.MethodA thematic analysis was carried out on data obtained from four HIV clinical trials conducted at KAVI-Institute of Clinical Research in Nairobi Kenya from 2009 to 2015. Responses were obtained from a Questionnaire administered to the volunteers during their screening visit at the research site.ResultsOf the 281 healthy, HIV-uninfected volunteers participating in this study; 38% were motivated by personal benefits including, 31% motivated by health benefits and 7% motivated by possible financial gains. In addition, 62% of the volunteers were motivated by social benefits with 20% of who were seeking to help their family/society/world while 42% were interested in advancing research.ConclusionThe majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation) to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine clinical trials.

Can the generic antiretroviral industry support access to a universal antiretroviral regimen?

The generic antiretroviral (ARV) industry played a critical role in the massive scale-up of HIV treatment in low-income and middle-income countries since 2000. As the global community looks ahead to a universal antiretroviral regimen, this article considers the industry's role in supporting universal access to affordable, simpler, more durable, and tolerable HIV treatment regimens. Generic manufacturers made treatment scale-up in low-income and middle-income countries possible through reducing prices, combining molecules from different originator companies to develop optimal fixed-dose combinations, and investing in production capacity to meet escalating demand. Achieving scale-up of a universal regimen will require continued partnership in these areas. Collaboration on the demand and supply sides of the ARV marketplace will be required to foster a healthy and sustainable marketplace for new regimens. This includes clear priority setting from the global treatment community on priority products; predictable demand; regulatory prioritization of optimal products; effective tendering and procurement practices that enable multiple suppliers to participate in the market; coordinated product introduction efforts between Ministries of Health, partners, and civil society; and transparency from both buyers and suppliers to promote and monitor supply security. New regimens will benefit people living with HIV, as well as buyers and generic suppliers, by maximizing existing production capacity and treatment budgets to reach the 90-90-90 goals.

Accelerating access and scale-up of optimized ART in low-income and middle-income countries: a call for a coordinated end-to-end approach.

To discuss how aligning the collective power of scientists, regulators, drug companies, donors, implementers and advocates to achieve a single goal - accelerating access to simpler, safer, more robust and more affordable HIV treatment - can rapidly advance antiretroviral optimization efforts and enable scale-up. Harmonization of traditionally sequential processes can address the delays commonly experienced in introducing new products to low-income and middle-income countries, by facilitating an 'end-to-end' approach that mitigates risk and encourages early planning for all aspects of product introduction. Planning with the 'end-in-mind' can facilitate healthy markets, benefit the application of new technologies, and accelerate the development of improved products in parallel (versus traditionally sequential efforts).

Yusuf Hamied: leader in the Indian generic drug industry

Yusuf Hamied: leader in the Indian generic drug industry