scholarly journals Putting the NHS England on trial: uncertainty-as-power, evidence and the controversy of PrEP in England

2020 ◽  
Vol 46 (3) ◽  
pp. 176-179 ◽  
Author(s):  
Maurice Nagington ◽  
Tony Sandset
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Hiv Prevention ◽  
Hiv Infections ◽  
Vulnerable Groups ◽  
Close Reading ◽  
Trial Protocol ◽  
Hiv Seroconversion ◽  
Exposure Prophylaxis ◽  
The Impact

Pre-exposure prophylaxis (PrEP) (Truvada) is a medication which if taken correctly is almost entirely effective in preventing HIV infection. In regions and countries where it has been widely taken up, HIV seroconversion rates have significantly decreased. Alongside testing and treatment, it offers the very real prospect of ending HIV infections. However, in England, commissioning it has (and still is) a controversial process, where NHS England has repeatedly raised supposed ‘uncertainties’, first legal and then scientific. The same has not happened in Scotland, where PrEP was commissioned to anyone who needed it in April 2017. This article presents a close reading of the IMPACT trial protocol, which we conclude cannot answer the questions it sets out to answer. We then suggest that the uncertainties the trial claims to address are in fact a tool of power which is deployed to strategically ration healthcare; introduce uncertainty about commissioning PrEP; and shift the boundary between individual responsibilities and state responsibilities for public health and HIV prevention. We conclude that all the above constitute an unethical use of clinical trial rhetoric, systematically discriminate against minority and vulnerable groups, and ration healthcare for those who most need it. As such, we call on all academics, clinicians and activists to resist further unethical misuses of clinical trial rhetoric.

scholarly journals Consequences of COVID-19 crisis for persons with HIV: the impact of social determinants of health

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kristie C. Waterfield ◽  
Gulzar H. Shah ◽  
Gina D. Etheredge ◽  
Osaremhen Ikhile
Keyword(s):  
Public Health ◽  
Health Care ◽  
Clinical Care ◽  
Hiv Infections ◽  
People Living With Hiv ◽  
Negative Consequences ◽  
Persons Who Inject Drugs ◽  
Persons Living With Hiv ◽  
Living With Hiv ◽  
The Impact

Abstract Background With the indiscriminate spread of COVID-19 globally, many populations are experiencing negative consequences such as job loss, food insecurity, and inability to manage existing medical conditions and maintain preventive measures such as social distancing and personal preventative equipment. Some of the most disadvantaged in the COVID-19 era are people living with HIV/AIDS and other autoimmune diseases. Discussion As the number of new HIV infections decrease globally, many subpopulations remain at high risk of infection due to lack of or limited access to prevention services, as well as clinical care and treatment. For persons living with HIV or at higher risk of contracting HIV, including persons who inject drugs or men that have sex with men, the risk of COVID-19 infection increases if they have certain comorbidities, are older than 60 years of age, and are homeless, orphaned, or vulnerable children. The risk of COVID-19 is also more significant for those that live in Low- and Middle-Income Countries, rural, and/or poverty-stricken areas. An additional concern for those living the HIV is the double stigma that may arise if they also test positive for COVID-19. As public health and health care workers try to tackle the needs of the populations that they serve, they are beginning to realize the need for a change in the infrastructure that will include more efficient partnerships between public health, health care, and HIV programs. Conclusion Persons living with HIV that also have other underlying comorbidities are a great disadvantage from the negative consequences of COVID-19. For those that may test positive for both HIV and COVID-19, the increased psychosocial burdens stemming from stress and isolation, as well as, experiencing additional barriers that inhibit access to care, may cause them to become more disenfranchised. Thus, it becomes very important during the current pandemic for these challenges and barriers to be addressed so that these persons living with HIV can maintain continuity of care, as well as, their social and mental support systems.

scholarly journals PO 8300 REGIONAL CENTER FOR REGULATORY EXCELLENCE IN CLINICAL TRIAL OVERSIGHT – TRAINING 2017

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A28.1-A28
Author(s):  
Delese Darko ◽  
Yvonne Adu-Boahen
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Good Clinical Practice ◽  
Training Programme ◽  
Fellowship Training ◽  
Training Methods ◽  
Health Technologies ◽  
Trial Oversight ◽  
The Impact

BackgroundThe competencies of the various national medicines regulatory agencies (NMRAs) in Africa vary which leads to generally porous regulatory systems for clinical trial oversight. Consequently, many trials have been conducted under unacceptable conditions compromising participants’ safety and data credibility and resulted in questionable outcomes that are used for making scientific judgement in addressing issues of public health in Africa.To improve the safety and quality of health technologies in Africa, the New Partnership for African Development (NEPAD) agency launched a programme to designate Regional Centres of Regulatory Excellence (RCOREs) with the specific objective of bridging existing gaps between African NMRAs through strengthening regulatory capacity of African Union member states. The Food and Drugs Authority (FDA), Ghana, was designated as RCORE for Clinical Trials oversight in May 2014.MethodsTo achieve the RCORE objectives, the FDA collaborated with the School of Public Health (SPH), University of Ghana to develop a training manual and piloted a training programme with funds from the International AIDS Vaccine Initiative (IAVI) through NEPAD.The programme, consisting of 4 compulsory modules, was organised from 6–30 November 2017 for 10 participants from Zambia, Sierra Leone, Liberia, Rwanda and Ghana. Interactive training methods in the form of theoretical and practical sessions were employed.ResultsThe pilot RCORE training was successful with expected training objectives achieved. Participants gained hands-on experience through activities like observing Good Clinical Practice inspection and a Technical Advisory Committee Meeting. Participants were given template tools to assist in developing regulatory guidelines and forms in their respective countries.A follow-up questionnaire was circulated to participants to assess the impact of the training on their work. Feedback „indicates that regulation of clinical trials has improved in their respective institutions.ConclusionThis pilot fellowship training was successful, „leading to the improvement of clinical trial regulation in the participating countries.

scholarly journals Active-Offer Nurse-Led PrEP (PrEP-RN) Referrals: Analysis of Uptake Rates and Reasons for Declining

2019 ◽  
Vol 24 (5) ◽  
pp. 1281-1289 ◽  
Author(s):  
Patrick O’Byrne ◽  
Lauren Orser ◽  
Marlene Haines
Keyword(s):  
Public Health ◽  
At Risk ◽  
Hiv Prevention ◽  
Qualitative Analysis ◽  
Thematic Analysis ◽  
Prevention Strategy ◽  
Perceptions Of Risk ◽  
Uptake Rates ◽  
Exposure Prophylaxis

AbstractWhile pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy, its uptake is limited. To address barriers, we piloted a nurse-led PrEP clinic in an STI clinic and had public health nurses refer patients during STI follow-up. We recorded the number of PrEP offers and declines and clinic uptake. We conducted a thematic analysis of patients’ responses from nursing notes written at the time patients declined PrEP. From August 6, 2018 to August 5, 2019, nurses offered a PrEP referral to 261 patients who met our criteria; only 47.5% accepted. Qualitative analysis identified four themes: (1) perceptions of risk, (2) lack of interest, (3) inability to manage, and (4) concerns about PrEP. Our patients did not feel sufficiently at-risk for HIV to use PrEP and maintained that PrEP was for a reckless “other”. This analysis sheds light on how assumptions about risk affect PrEP uptake, particularly among those at-risk for HIV.

scholarly journals Monoclonal Antibody Treatment, Prophylaxis and Vaccines Combined to Reduce SARS CoV-2 Spread

2021 ◽  
Author(s):  
Mohamed A. Kamal ◽  
Andreas Kuznik ◽  
Luyuan Qi ◽  
Witold Więcek ◽  
Mohamed Hussein ◽  
...  
Keyword(s):  
Public Health ◽  
Diagnostic Testing ◽  
Post Exposure Prophylaxis ◽  
Antibody Treatment ◽  
Viral Shedding ◽  
The Us ◽  
Monoclonal Antibody Treatment ◽  
Exposure Prophylaxis ◽  
Respiratory Coronavirus ◽  
The Impact

Background Antiviral monoclonal antibodies (mAbs) developed for treatment of COVID-19 reduce the magnitude and duration of viral shedding and can thus potentially contribute to reducing transmission of the causative virus, severe acute respiratory coronavirus 2 (SARS-CoV-2). However, use of these mAbs in combination with a vaccine program has not been considered in public health strategic planning. Methods We developed an agent-based model to characterize SARS-CoV-2 transmission in the US population during an aggressive phase of the pandemic (October 2020 to April 2021), and simulated the effects on infections and mortality of combining mAbs as treatment and post-exposure prophylaxis (PEP) with a vaccine program plus non-pharmaceutical interventions. We also interrogated the impact of rapid diagnostic testing, increased mAb supply, and vaccine rollout. Findings Allocation of mAbs as PEP or targeting those ≥65 years provided the greatest incremental benefits relative to vaccine in averting infections and deaths, by up to 17% and 41%, respectively. Rapid testing, facilitating earlier diagnosis and mAb use, amplified these benefits. The model was sensitive to mAb supply; doubling supply further reduced infections and mortality, by up to two-fold, relative to vaccine. mAbs continued to provide incremental benefits even as proportion of the vaccinated population increased. Interpretation Use of anti-viral mAbs as treatment and PEP in combination with a vaccination program would substantially reduce SARS-CoV-2 transmission and pandemic burden. These results may help guide resource allocation and patient management decisions for COVID-19 and can also be used to inform public health policy for current and future pandemic preparedness.

scholarly journals Characterizing Awareness of Pre-Exposure Prophylaxis for HIV Prevention in Manila and Cebu, Philippines: Web-Based Survey of Filipino Cisgender Men Who Have Sex With Men (Preprint)

2020 ◽  
Author(s):  
Arjee Restar ◽  
Anthony Surace ◽  
Alexander Adia ◽  
William Goedel ◽  
Adedotun Ogunbajo ◽  
...  
Keyword(s):  
Public Health ◽  
Hiv Prevention ◽  
Multivariable Analysis ◽  
College Education ◽  
The Philippines ◽  
Web Based ◽  
Hiv Test ◽  
Sex With Men ◽  
Prep Awareness ◽  
Exposure Prophylaxis

BACKGROUND The Philippines is experiencing an HIV crisis and is considering implementing pre-exposure prophylaxis (PrEP) as a national public health strategy for HIV prevention for cisgender men who have sex with men (cis-MSM). However, critical information on the awareness of PrEP among cis-MSM is needed to roll out this public health initiative. OBJECTIVE This study aims to assess PrEP awareness and related correlates (ie, sociodemographic variables, social factors, and health care access and use) among Filipino cis-MSM. METHODS We conducted a web-based survey with Filipino cis-MSM (n=179) residing in the cities of Manila and Cebu, Philippines. Multivariable analysis procedures were performed to examine the factors associated with PrEP awareness. RESULTS Our sample demonstrated high awareness (134/179, 74.9%) and interest (159/179, 88.8%) in taking PrEP. The adjusted model showed that greater odds of PrEP awareness were associated with having a college education or higher versus a high school education or lower (adjusted odds ratio [aOR] 7.30, 95% CI 1.01-52.47), earning between PHP 10,000 (US $198.6) and PHP 20,000 (US $397.2) versus <PHP 10,000 (US $198.60; aOR 9.32, 95% CI 1.41-6.22), having had a prior HIV test (aOR 6.06, 95% CI 1.20-13.55), having high HIV knowledge (aOR 3.50, 95% CI 1.11-10.98), and having friends who discussed PrEP (aOR 11.17, 95% CI 2.73-14.5). CONCLUSIONS Our findings demonstrate that Filipino cis-MSM are aware of and interested in taking PrEP, but there is currently an unmet need for such biomedical HIV prevention technologies among this population. Incorporating PrEP education into routine HIV screening and leveraging cis-MSM social networks may be useful in optimizing potential PrEP implementation in the Philippines.

scholarly journals Women’s estimated HIV infections from sex in trials of pre-exposure prophylaxis in Africa: Implications for HIV prevention strategies

2017 ◽  
Author(s):  
David Gisselquist
Keyword(s):  
Hiv Prevention ◽  
Hiv Infections ◽  
Common Belief ◽  
Prevention Strategies ◽  
Sexual Risks ◽  
Hiv Prevention Strategies ◽  
Vaginal Gels ◽  
Vaginal Rings ◽  
Exposure Prophylaxis ◽  
Oral Prep

AbstractIntroductionDuring 2004-15, nine randomized controlled trials (RCT) for HIV prevention tested pre-exposure prophylaxis (PrEP) with oral drugs, vaginal gels, or vaginal rings among more than 17,000 women in Africa.MethodsThis study uses information from the nine RCTs to estimate the proportions of HIV from sexual and bloodborne risks, to consider reasons for success or failure with oral PrEP, and to consider risks with vaginal PrEP.ResultsEstimating from women’s reported frequencies of unprotected coital acts in six RCTs, only a minority of women’s infections came from sex. Oral PrEP may have succeeded in at least one trial by reducing infections from both bloodborne and sexual risks. Oral PrEP may have failed in several trials, at least in part, because some women used oral PrEP when they had sexual risks rather than daily as advised. Relatively high incidence with PrEP vaginal gels and rings vs. oral placebo suggests vaginal PrEP had little impact at best and may have been harmful.DiscussionEvidence from this and other studies challenges the common belief most HIV in Africa comes from sex. This challenge has implications for HIV prevention strategies, including: warning about bloodborne risks; and reconsidering PrEP for young women.

Crossover and Repeated Randomization in Event Driven Trials for HIV Prevention: Addressing the Impact of Heterogeneity in Risk in the Trial Design

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Clara P. Domínguez Islas ◽  
Elizabeth R. Brown
Keyword(s):  
Hiv Prevention ◽  
Study Finding ◽  
Population Level ◽  
Ethical Considerations ◽  
On Demand ◽  
Higher Power ◽  
Event Driven ◽  
Exposure Prophylaxis ◽  
Future Work ◽  
The Impact

Abstract The availability of effective Pre-Exposure Prophylaxis (PrEP) for HIV introduces new challenges for testing novel on-demand, user-controlled HIV prevention products, including lower placebo arm incidence and increased between-participant variability in HIV risk. In this paper, we discuss how low HIV incidence may result in longer trials in which the variability in participants' risk may impact the estimate of risk reduction. We introduce a measure of per-exposure efficacy that may be more relevant than the population level reduction in incidence for on demand products and explore alternatives to the parallel arm design that could target better this parameter of interest: the crossover and the re-randomization designs. We propose three different ways in which crossover and re-randomization of intervention assignments could be implemented in event-driven trials. We evaluate the performance of these designs through a simulation study, finding that they allow for better estimation and higher power than the traditional event-driven parallel arm design. We conclude by discussing future work, practical challenges and ethical considerations that need to be addressed to take these designs closer to implementation.

HIV seroconversions among male non-occupational post-exposure prophylaxis service users: a data linkage study

Sexual Health ◽  
2011 ◽  
Vol 8 (2) ◽  
pp. 179 ◽  
Author(s):  
Anna B. Pierce ◽  
Keflemariam Yohannes ◽  
Rebecca Guy ◽  
Kerrie M. Watson ◽  
Jude Armishaw ◽  
...  
Keyword(s):  
Risk Behaviour ◽  
Linkage Study ◽  
Incidence Rates ◽  
Post Exposure Prophylaxis ◽  
Hiv Incidence ◽  
Hiv Surveillance ◽  
Post Exposure ◽  
Hiv Seroconversion ◽  
Exposure Prophylaxis ◽  
The Impact

Background: Despite widespread prescription of non-occupational post-exposure prophylaxis (NPEP) in Victoria, little is known about subsequent HIV acquisition among NPEP users. We linked the Victorian NPEP Service (VNPEPS) database and the Victorian HIV Surveillance Registry to determine the number, incidence rate and predictive factors of HIV seroconversions among users of the VNPEPS. Methods: Records from male patients that received NPEP in the VNPEPS database (n = 1420) between January 2001 and February 2008 were linked with all entries in the Victorian HIV Surveillance Registry up to May 2008. Results: Sixty-one men who presented to the VNPEPS were identified as HIV seropositive; 16 of these were diagnosed at initial presentation for NPEP. The incidence of HIV seroconversion in males who were HIV seronegative at first presentation for NPEP was 1.27 (95% confidence interval 0.95–1.70) per 100 person-years. There was no association between HIV seroconversion and number of NPEP presentations or age. The median age of seroconversion was 34.6 years. Conclusion: The incidence of HIV infection among men presenting to the VNPEPS is slightly lower than the HIV incidence in NPEP users in a recent Australian cohort study of men who have sex with men, but higher than HIV incidence in general gay male populations. Frequency of NPEP use was not associated with risk of HIV seroconversion. Examination of risk behaviour before and after NPEP use in this population is required to further assess the impact of NPEP availability and use on HIV incidence rates and risk behaviour in Australia.

Estimating the impact of HIV combination prevention in men who have sex with men, the Bangkok MSM Cohort Study, Thailand

2020 ◽  
Vol 31 (7) ◽  
pp. 637-641
Author(s):  
Sarika Pattanasin ◽  
Betsy L Cadwell ◽  
Dawn K Smith ◽  
Wichuda Sukwicha ◽  
Philip A Mock ◽  
...  
Keyword(s):  
Condom Use ◽  
Hiv Infections ◽  
Substantial Impact ◽  
Combination Prevention ◽  
Hiv Epidemic ◽  
Immunodeficiency Virus ◽  
Sex With Men ◽  
Exposure Prophylaxis ◽  
The Impact ◽  
Combined Interventions

In Thailand, pre-exposure prophylaxis (PrEP) is recommended for human immunodeficiency virus (HIV) prevention among at-risk men who have sex with men (MSM). We modeled the impact of PrEP and condom use as independent and combined interventions on the estimated number of HIV infections among a hypothetical population of 10,000 MSM in Bangkok, Thailand. Our model demonstrated a 92% (95% confidence interval 89.7, 94.2) reduction in HIV infections among Thai MSM who took daily PrEP and self-reported using condoms correctly and consistently (100% condom use). Increased use of PrEP and condoms likely would have a substantial impact on the HIV epidemic in Thailand.

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