Tag: South Africa

Categories : HIVTags :

Stigma, Lack of Awareness Holding Back Use of HIV Prevention Pills, Experts Say

On By ModernMedia

By Thabo Molelekwa for Spotlight

Photo by Miguel Á. Padriñán: https://www.pexels.com/photo/syringe-and-pills-on-blue-background-3936368/

Over the last four years South Africa has taken large strides in making HIV prevention pills available at public sector clinics, but uptake has not been as good as some may have hoped. Thabo Molelekwa asks several experts why this might be.

HIV prevention pills, also referred to as oral pre-exposure prophylaxis (PrEP), contain a combination of two antiretroviral medicines. They  are highly effective at preventing HIV infection when taken as prescribed by someone not living with HIV.

But while the pills are now available through most public sector clinics in the country, not as many people are using them as one might have expected. According to the most recent estimates from Thembisa, the leading mathematical model of HIV in South Africa, only around 4% of sexually active adolescent girls and young women used PrEP in 2022. This is a substantial improvement on 0.6% in 2020, but given that the rate of new HIV infections in adolescent girls and young women has remained stubbornly high, one may have expected this number to be higher by now.

“So the rates of uptake are definitely increasing in South Africa, but not to the point that we would hope. There’s still definitely a gap between people who would benefit from being on PrEP or alternative HIV prevention methods and those who are actually accessing the biomedical daily oral prevention,” says Cheryl Hendrickson, a Senior Researcher at the Health Economics and Epidemiology Research Office (HE²RO) at the University of the Witwatersrand.

Ongoing stigma

One explanation for uptake not being better is the ongoing impact of HIV-related stigma. A recent study conducted among young people in Gauteng found that stigma and a lack of confidentiality continue to impede PrEP adoption. The researchers identified several barriers for PrEP-naive participants, including limited knowledge, negative staff attitudes, and misconceptions about side effects. Structural factors like healthcare provider bias and a lack of culturally sensitive interventions were also found to hinder PrEP uptake. The research was conducted by HE²RO – Hendrickson was a co-author.

“Participants were worrying about their families or friends thinking they were taking ARVs,” says Constance Mongwenyana-Makhutle, a research associate and co-author of the study.

Professor Linda-Gail Bekker, CEO of the Desmond Tutu HIV Centre, also emphasises the persistent role of stigma. “People don’t want to be associated with HIV, HIV risk or any misconception that they may be living with HIV and on antiretroviral therapy,” she tells Spotlight.

The perception around PrEP, says Dr Fareed Abdullah, Director of AIDS and TB Research at the South African Medical Research Council, is similar to that of contraception. “Basically, a young person would consider it an admission that they are sexually active and consider themselves to be at risk of HIV; thereby inviting judgement and stigma from others, especially healthcare workers,” he says.

Not enough awareness?

Closely related to the issue of stigma is awareness. Here COVID-19 may have played a role. As the provision of PrEP through public sector clinics gained momentum in 2020, many potential PrEP users would have stayed away from clinics due to pandemic-related restrictions and fear of contracting SARS-CoV-2. The pandemic also meant that any plans to build awareness of PrEP would have had a hard time finding purchase, at least in 2020 and 2021.

Reflecting on past HIV awareness campaigns, Bekker stresses the need for increased public demand creation for PrEP

“I think we have not had enough public demand creation- if you think of the campaigns for getting people to take up COVID vaccines….then we really haven’t done enough in this regard. It is a new concept- a pill a day to prevent HIV ……and so people need to have the idea socialised and normalised so that there is also a reduction in stigma,” she says.

What happens at the clinic

Another barrier to PrEP uptake is likely that while PrEP is being made available through public sector clinics, not everyone feels welcome at, or like to visit, their local clinic.

Bekker says youth complain that government clinics are often a barrier for them to access PrEP. “Their hours, their long queues, their discrimination and sometimes the prejudicial attitudes drive young people away,” she says.

Bekker argues that some of these barriers would be removed if HIV prevention measures was taken outside of health facilities and into community spaces.

“PrEP for young people in the public sector is free. If they want to use private pharmacies though, they would need to pay currently. I think more can be done to make PrEP and other sexual and reproductive health services more readily available so that young people, in a way, have no excuses not to make sure they are using them … colleges, universities and even secondary schools could also reach more young people. If we want to reduce STIs and unintended pregnancies in our adolescents, we are going to have to be sure there are very few barriers to these contraceptive and prophylactic services,” says Bekker.

Hendrickson points out that there are several projects around the country that are looking at alternative service delivery methods. “There’s a project that’s looking at prep delivery in pharmacies. Currently, they are providing oral prep, and hopefully soon, they will provide injectable prep within several pharmacies in Gauteng and the Western Cape,” she says. According to her, the pharmacy model appeals especially to men.

Healthcare worker attitudes and training

Related to the issue of visiting public healthcare facilities to access PrEP, healthcare worker attitudes and training has also been flagged as a concern.

Bekker says some health care professionals are not trained to deal with young people in their diversity. “Adolescents are a very distinct population – they can be offended, they value their privacy, and they can make health choices and decisions but need supportive, empathic and tailored information that they can use,” she says.

Abdullah makes a similar point. If some health care workers are properly trained, can identify people at high-risk and understand the efficacy of the intervention, then the vast majority would follow and offer the service in a professional manner, he says.

Ritshidze, a community-based healthcare monitoring group, say they have observed an increase in the number of healthcare facilities where staff say they prioritise offering PrEP to members of key populations such as young women and adolescent girls or men who have sex with men. Of 394 clinic staff surveyed earlier this year, 97% said they prioritise young women and adolescent girls.

But when Ritshidze asked users of healthcare facilities whether they’ve been offered PrEP, the numbers were much lower. “Compared to data collected in 2022, our 2023 data report a lower percentage of people saying they have been offered PrEP for most population groups,” Ritshidze say in a recent report. Complaints about negative staff attitudes have been a running theme in Ritshidze’s reports on public sector healthcare facilities over the last three years.

Actual and perceived risk

Abdullah suggests another barrier to PrEP uptake. There is a perception that HIV is no longer an urgent priority and that the risk of infection is low. This, he says, has led to lower public awareness of the importance of behaviour change and the need for young people at risk to protect themselves.

Recent data from a Human Sciences Research Council survey and the District Health Barometer indicate that condom use is declining in South Africa. While the reasons for the decline are not clear, one theory is that it is driven by the perceived risk of HIV infection having reduced over time.

Will more choice help?

Currently only oral PrEP is routinely available in the public sector, but PrEP in the form of a two-monthly injection and a monthly vaginal ring have been approved by the South African Health Products Regulatory Authority and is being offered to people taking part in pilot projects. It is likely that the prevention injection will become much more widely available once its price drops sufficiently – which is anticipated to happen once generic manufacturers enter the market in around three years’ time. Products that combine PrEP and a contraceptive into a single pill or injection are also under development.

Mitchell Warren, director of Avac, a global HIV advocacy organisation, is optimistic about people being offered a choice between the three types of PrEP. While condoms were widely available in public clinics in the 1990s, Warren says he noted the desire of people to buy condoms from spaza shops, shebeens, or pharmacies. This didn’t replace clinic supplies, he clarifies, but it did bring into sharper focus the importance of providing choice to people.

“But even with three different PrEP options, what we clearly have known for many years now is that PrEP is not only about the products, PrEP is really a programme, helping people identify not just their personal risk, but their desires, what they want and need out of relationships,” he says.

Government perspective

Foster Mohale, spokesperson for the National Department of Health, says the department is aware of reports of youth experiencing problems accessing PrEP at healthcare facilities.

Mohale maintains that healthcare workers are sufficiently trained to provide comprehensive HIV prevention services to all groups of people. He says that clinicians, counsellors, health promotors and peer educators have access to online training platforms. “These training modules are availed offline on flash drives to facilitate access to facilities and health care providers that do not have easy access to wifi or data to access the online version of the training materials,” he says.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : Respiratory Diseases VaccinesTags :

Massive TB Vaccine Trial Kicks off in SA – it could be the First TB Vaccine in over a Century

On By ModernMedia

A massive and long-awaited study of an experimental tuberculosis vaccine has kicked off in South Africa. Marcus Low reports.

Photo by National Cancer Institute

By Marcus Low for Spotlight

The first jabs in a much-anticipated clinical trial of an experimental tuberculosis (TB) vaccine have been administered at a clinical trial site at the University of the Witwatersrand in Johannesburg. Up to 20 000 people are anticipated to take part in the study, according to study sponsor, the Bill and Melinda Gates Medical Research Institute (Gates MRI).

The study will be conducted at 60 different sites in South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam. The researchers estimate that between 50% and 60% of the study participants will be in South Africa.

The experimental vaccine called M72/AS01E (M72 for short) made waves in 2018 and 2019  when it was found to be around 50% effective at preventing people with latent TB infection from falling ill with TB over a three-year period in a phase 2b clinical trial. In June 2023, it was announced that, after some delays, $550 million in funding had been secured for a phase 3 study of the vaccine. Medicines or vaccines are typically only registered and brought to market after being shown to be safe and effective in large, phase 3 clinical trials.

While most cases of TB can be cured using a combination of four antibiotics for four or six months, TB rates are declining relatively slowly and it is widely thought that an effective vaccine would help bring TB rates down much more quickly. The World Health Organization estimates that at the level of protection seen in the phase 2b trial, the vaccine could potentially save 8.5 million lives and prevent 76 million people from falling ill with TB over a 25-year period. The one TB vaccine we already have, called bacille Calmette-Guerin (BCG), is over a century old and only provides limited protection against severe illness for children and no protection for adolescents or adults.

“Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities,” said Dr Lee Fairlie,  national principal investigator for the trial in South Africa, in a media statement released by Gates MRI.

“South Africa also has considerable experience with TB- and vaccine-related clinical trials and a strong track record for protecting patient safety and generating high quality data essential for regulatory approvals.”

Fairlie is also the Director of Maternal and Child Health at the Wits Reproductive Health and HIV Institute at Wits University.

The initial response from TB activists was positive.

“TB Proof (a South African TB advocacy group) is delighted that the M72 phase 3 trial has been launched,” the organisation’s Ruvandhi Nathavitharana and Ingrid Schoeman told Spotlight.  “Having an effective TB vaccine is critical for TB elimination efforts.”

While he said it is good to finally see the phase 3 trial of M72 get underway, Mike Frick, TB co-director at Treatment Action Group, a New York-based TB advocacy organisation, went on to say:

“The fact that we had to wait so long between phase II and phase III says everything one needs to know about the headwinds – financial, political, commercial – that TB research is up against.”

How the study will work

Half of the up to 20 000 study participants will receive the M72 jab and the other half a placebo. The vaccine is administered as two intramuscular injections given a month apart. After being jabbed, study participants, all aged 15 to 44, will be followed for four years from the date of the first study participant being enrolled to see if they fall ill with TB.

“The plan is to complete enrolment in 2 years,” Fairlie and Alemnew Dagnew, clinical lead for the trial, told Spotlight in response to written questions. They explained that the actual duration of the trial will depend on how long it takes for 110 people in the study to fall ill with TB. According to the Gates MRI statement, the study is expected to take around five years to complete.

According to Fairlie and Dagnew, the majority of study participants (around 18 000 people) will be people who are HIV negative and who have latent TB infection – that is to say people who have TB bacteria in their lungs, but who are not ill with TB. Latent TB infection is thought to be very common in South Africa and only around 10% of people with latent infection ever fall ill with TB. In the study, latent infection will be tested for using a type of test called an IGRA (Interferon-Gamma Release Assay).

Around 1000 HIV negative people with no TB infection will also be recruited to the study. This is being done to make sure the vaccine is safe and effective in this group of people – while latent infection will be tested for in the study, in the real world such testing may not always be feasible prior to vaccination.

It is anticipated that 1000 of the 20 000 study participants will be people living with HIV. Establishing how well the vaccine works in people living with HIV is important since around 13% of people in South Africa are living with HIV and HIV substantially increases the risk of falling ill with TB. The main phase 2b study of M72 did not include people living with HIV although another phase 2 study looked specifically at the safety and immunogenicity of M72 in people living with HIV – according to Fairlie and Dagnew, “that trial “was completed and supported the inclusion of such participants in a phase 3 trial”.

Smaller than previously thought

When funding for the phase 3 trial was announced last year, it was estimated that 26 000 people would participate in the study. That number has now been revised down to 20 000.

“As a result of ongoing discussions between the institute and our funders, the decision was taken to review the study protocol with the intent of simplifying the study given its size and complexity.  This will not affect the safety of the trial. It is common to continue to refine a protocol. We found a way to expedite the study that would potentially allow us to offer the public health impact of this vaccine to those in need sooner. All partners, including the trial funders, are fully aligned to the protocol refinements,” Fairlie and Dagnew explained to Spotlight.

“Some assumptions used to inform the design of the first protocol were deemed overly conservative, so the clinical team used slightly less conservative assumptions on vaccine efficacy and TB incidence rate, thus allowing for a reduction in the number of participants in the trial, while still retaining the primary goal of confirming the safety and efficacy of the M72/AS01-E-4 vaccine for prevention of TB, guided by the final results of the phase 2b study completed several years ago.”

Planning for access

The development of M72 has taken a somewhat unusual path – with the pharmaceutical company GSK leading development up to the end of phase 2b and then largely passing the baton to Gates MRI with the conclusion of a licensing deal in 2020. GSK has come in for some criticism for not moving more quickly after the initial publication of the phase 2b results in 2018. A ProPublica article published last year suggested that the development of M72 slowed because GSK were focussing on more profitable vaccines.

According to the Gates MRI statement, GSK continues to provide technical assistance to the Gates MRI, supplies the adjuvant component of the vaccine for the phase 3 trial, and will provide the adjuvant post licensure should the trial be successful. An adjuvant is an agent included in the vaccine that improves the immune response elicited by the vaccine – in the case of M72/AS01E the AS01E refers to the adjuvant made by GSK.

This ongoing dependence on a single company for the adjuvant has some activists worried. “We are concerned about reports that scaling this vaccine may be difficult due to limited availability of the vaccine adjuvant. Access for everyone who needs it should be part of the early phases of the research process – not an afterthought,” said Nathavitharana and Schoeman.

“The press release announcing the study’s start in several places refers to the ‘complexity’ of ‘developing and ensuring access’ to a new vaccine. Part of the unspoken complexity here is the opaque licensing deal GSK and Gates MRI signed in 2020 in which GSK gave rights to develop and commercialise M72 to Gates MRI while retaining control over the AS01E adjuvant,” Frick told Spotlight. “There are legitimate concerns that the fine print of this arrangement could work against equitable access, but terms of the licence remain unknown to the public.”

When asked about supply concerns, Gates MRI told Spotlight:  “Gates MRI collaboration with GSK includes provisions to ensure there is sufficient supply of adjuvant for the clinical development and first adoption in low-income countries with high TB burden, at an affordable price, should the vaccine candidate be successful in phase 3 trials and approved for use. For broader implementation, GSK has committed to working with its partners to ensure there is sufficient supply.”

Disclosure: The Gates MRI is a non-profit subsidiary of the Bill and Melinda Gates Foundation. Spotlight receives funding from the Bill and Melinda Gates Foundation. Spotlight is editorially independent and a member of the South African Press Council.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : Addiction Substance UseTags :

New Online Recovery School a First for South Africa

On By ModernMedia

South Africa is a traumatised nation

Photo by Steinar Engeland on Unsplash

Dr Siya Mjwara, founder of the AskDrSiya Psychotherapy and Wellness Coaching Practice, has just launched the first online recovery school in South Africa. The Recovery School will support individuals in identifying and confronting their challenges and businesses in developing and implementing wellness solutions in order to reduce absenteeism and improve productivity, as well as overall workplace culture. Dr Mjwara will provide a supportive and transformative environment where healing and growth are possible for all.

She says, “We create a virtual sanctuary where individuals can find healing, empowerment and community support. We strive to cultivate a space where you can reclaim your life and thrive, no matter what you’ve been through.

“After 17 years of working with individuals, couples and families, I can say, without a doubt, that we South Africans are a traumatised nation. Unfortunately, many of us are completely unaware of how our traumas are negatively impacting our lives, as well as the decisions we take on a daily basis. Recently, I’ve been hearing people say, “avoid dating anyone who has never been to therapy”. This is an indication that more of us are recognising how unresolved trauma can negatively impact our relationships.

“Besides our personal experiences, such as childhood trauma, relationship, family and workplace traumas, many of us are still dealing with the effects of intergenerational trauma.

This is part of the background that informs the vision for The Recovery School. My wish is for individuals to not only cope with trauma, but also to be able to thrive and become the best version of themselves. It takes courage to face your fears and begin living authentically, and you don’t need to walk the journey alone.

The school’s programmes are primarily designed to enable individuals to

  1. Rediscover themselves
  2. Break free from limiting beliefs
  3. Cultivate resilience
  4. Forge meaningful connections
  5. Live fully in the present
  6. Achieve their goals

Dr Mjwara BSW Hons (UWC), MA FCS (UWC), Dphil (UNIZULU) can be contacted on Ask@DrSiya.co.za or 079 772 1950.

Categories : Expert Opinion General InterestTags :

We Need to Fight for Sleep Equity in SA, Say Leading Researchers

On By ModernMedia

By Ufrieda Ho for Spotlight

Photo by Andrea Piacquadio

Research into the link between disordered sleep and disease show an outsized burden on the most vulnerable. It’s sounding alarms for sleep equity to have a place on the public health agenda, reports Ufrieda Ho.

Scientists are increasingly connecting the dots on how a lack of sleep places a disproportionate health burden on at-risk population groups, including people living with HIV, women, informal workers, the elderly and the poor.

This year’s World Sleep Day on 15 March focuses on sleep equity. Researchers say that tackling sleep inequity and raising awareness for the importance of sleep as a pillar of good health could help stave off several looming public health pressures.

The lack of healthy sleep is linked to cardiovascular disease, obesity, hypertension, diabetes, mental health conditions and dementia. In South Africa, understanding the connection between sleep and HIV is also key to managing the health of the large ageing population of people living with the disease.

Karine Scheuermaier is associate professor at the Wits University Brain Function Research Group. The country’s oldest sleep laboratory founded in 1982 is based at the university’s medical school in Parktown, Johannesburg.

“Society understands the role of exercise and diet in good health but somehow sleep has not had the same kind of awareness or priority, even if sleep is linked to how well your body functions and your chances of developing disease,” she says. “We do everything else at the expense of sleep. Sleep is somehow a symbol of laziness in a work-driven society and we need to change this thinking.”

Sleep inequity in SA

Sleep inequity is linked to socio-economic realities, she says. Sleep inequity might affect the person who lives in an environment where safety and security is neglected or where there is a high threat of gender-based violence. It could also be having to navigate apartheid city planning that forced black people to live far from job hubs. This legacy means today many workers still wake up early to face long work commutes daily. There could also be inequity in division of labour in households, when one person wakes up to take care of children or elderly family members in the home.

Living in overcrowded informal settlements also presents disturbances for good sleep, including high levels of noise and bright floodlights as street lighting. Those who work in unregulated or informal sectors, including shift work or digital platform workers, like e-hailing drivers, are prone to lose out on quality sleep.

clinic that does clinical work, research, and training. Chandiwana says homing in on the intersection of HIV and sleep is critical in a South African context.

“The average person living with HIV who has started antiretroviral treatment on time should live as long as a person who doesn’t have HIV. But what we know is that the person with HIV is on average, living 16 years less of good health. They are more likely to develop type II diabetes, mental health issues, obesity, and heart disease – and we know poor sleep is linked to this,” she says.

Chandiwana says sleep science is still a relatively new field of medicine and the nascent research is still looking to better understand how sleep deprivation triggers immune pathways and chronic inflammation in people living with HIV, even those who are healthy and respond positively on treatment.

A current study at the clinic is looking into the intersection of obesity, sleep apnoea, and women living with HIV. Chandiwana says because so much is unknown, the issue of sleep equity extends to support and funding for more locally appropriate sleep research. Medical school curricula needs to change and more avenues to train people in sleep research needs to be established, she says.

“We have very little African data on sleep disorders and disordered sleep,” she says. She argues we need better data on things like how many people are affected by poor sleep, a better understanding of what is causing it and what it means, and then we need to present these findings to public health authorities to look at it as a public health issue.

“We do have specific challenges in our country. If you are trying to explain to someone, who isn’t South African, how the impact of load-shedding affects sleep or how living in a shack affects sleep, it’s not always easy to do,” she says.

Chandiwana says countries in the global North are already counting insufficient quality sleep as an economic cost measured in loss of productivity, efficiency, safety and society’s well-being. They are also changing public health policies accordingly. South Africa and the rest of the continent stand to be left behind, she says.

How to get better sleep in SA

Chandiwana says: “There is no lab in South Africa that does sleep studies for people in the public sector and no place in the public sector for people to even be diagnosed for a sleep disorder – so services are extremely limited. With something like sleep apnoea, we can’t offer patients in the public sector the gold standard intervention of CPAP [continuous positive airway pressure, which is a device of a face mask, a nose piece, and a hose that delivers a steady flow of air pressure to keep airways open while someone sleeps] because this is financially out of reach. Instead, we have to work with patients to help them lose weight and do positional therapy like training them to sleep on their backs.”

Other ways to get better sleep without costly intervention or sleeping tablets, the two scientists say, include getting exercise, not having food, stimulants or alcohol two to three hours before bedtime, limiting screen time of all kinds in the hour around bedtime, getting exposure to the early morning sunlight each day, keeping sleeping areas dark, quiet and at a comfortable temperature, and developing fixed sleep routines and sleep time rituals – like brushing your teeth, putting on pyjamas, reading for a short period and then going to sleep.

Ultimately, Chandiwana suggests it all comes back to building awareness that healthy sleep is part of health rights.

“We have to fight for sleep equity and we need people to know that sleep is not elitist – it’s not just reserved for some,” she says, “and we should not be accepting poor sleep as the norm”.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : COVID Ethics and LawTags :

Pretoria High Court Judgement On COVID-19 Vaccinations

On By ModernMedia
Photo by Bill Oxford on Unsplash

On 05 January 2023, the COVID Care Alliance NPC and other applicants brought an urgent court application against the South African Health Products Regulatory Authority (SAHPRA), including the President of the Republic of South Africa and others to prevent people from being vaccinated.

The applicants wanted the court to order that all COVID-19 vaccines programs must be stopped and that all COVID-19 vaccination sections in healthcare facilities in South Africa must be closed, and the effective withdrawal from circulation of the vaccines. The applicants also sought an order interdicting the approval of vaccines for emergency authorisation or registration.

On 27 February 2024, the Pretoria High Court dismissed with costs an application filed by the applicants on the grounds that the applicants do not have the right to prevent others, who do not share in their beliefs or opinions, from being vaccinated.

SAHPRA submitted evidence to the Court to show that the applicants’ attempt to prevent government from using vaccines to address the COVID-19 pandemic was misguided, and the applicants heavily relied on hearsay and speculation, as well as supported their arguments with the opinion of persons who were not experts.

Source: SAHPRA

Categories : Expert Opinion Substance UseTags :

Proposed Update to Schedule 6 of the Medicines and Related Substances Act

On By ModernMedia
Photo by Kindel Media on Unsplash

By Rodney Africa, Partner, Adriano Esterhuizen, Partner & Daveraj Sauls, Associate at Webber Wentzel

The Minister of Health (the Minister) in terms of section 22A(2) of the Medicines and Related Substances Act 101 of 1965 (the Medicines Act), and on the recommendation of the South African Health Products Regulatory Authority, has invited interested persons to submit substantiated comments or representations on the proposed update of Schedule 6 to the Medicines Act.

The proposed update to Schedule 6 of the Medicines Act intends to exclude certain cannabis products containing Tetrahydrocannabinol (THC), the psychoactive compound in cannabis, from the operation of the Schedules to the Medicines Act and will, inter alia, permit the manufacturing of cannabis consumer items and products, with no limitation on the percentage of THC content, provided that the items and products have no pharmacological action or medicinal purpose. This will also allow adults to cultivate and possess cannabis in private for personal consumption, with no limitation on the percentage of THC content.

This proposed update appears to be a move away from utilising THC content as a threshold to distinguish between consumable and industrial cannabis. This shift seemingly comes in response to the growing South African market for cannabis products and aims to augment the Cannabis for Private Purposes Bill 2023 [B19 – 2020] recently passed by the National Council of Provinces and submitted to the President for his assent and signature.

Interested persons have until Thursday, 14 March 2024 to submit any substantiated comments or representations by emailing mihloti.mushwana@health.gov.za or paul.tsebe@health.gov.za.

Categories : HIVTags :

SA Company Set to Manufacture HIV Prevention Ring

On By ModernMedia

By Catherine Tomlinson for Spotlight

Photo by Miguel Á. Padriñán: https://www.pexels.com/photo/syringe-and-pills-on-blue-background-3936368/

A company headquartered in Johannesburg will start making flexible silicone rings to protect women from HIV. The move signals a strong vote of confidence in an African firm to supply the ring at adequate scale and affordable prices, and a crucial step to making the continent self-reliant, reports Catherine Tomlinson.

A South African company has secured the rights to manufacture a vaginal ring used to prevent HIV infection. The ring, which is inserted and removed by the user, provides protection for a month, after which it has to be replaced with a new ring. The ring contains an antiretroviral drug called dapivirine.

While studies show that the dapivirine vaginal ring is less effective at preventing HIV than HIV prevention pills and injections, it has benefits over other tools that have led the World Health Organization (WHO) to recommend its inclusion in the package of sexual health services available to women.

One advantage of the ring over HIV prevention pills is that it can be used discreetly by women, allowing users to use the ring without having to negotiate or discuss its use and purpose with their sexual partners. This is particularly important in the context of South Africa where women face high rates of gender-based violence, which erodes their autonomy over their bodies and sexual and reproductive health.

“We need to give women more control over their health and bodies and access to a range of safe and effective options, including the dapivirine ring, to choose from so they can decide to use what works best for them at different times of their lives,” wrote several prominent women African activists in 2022.

Limited access

While the WHO recommended that the ring is offered to women, its current price is a barrier to broad use and rollout in South Africa. The only dapivirine vaginal ring approved by the South African Health Products Regulatory Authority that is currently available in the country is called the DapiRing.

The DapiRing is manufactured by a Swedish company, Sever Pharma Solutions, under a licence from the Population Council (formerly the International Partnership for Microbicides). It can be bought in South Africa’s private sector for R320, excluding dispensing fees.

The DapiRing is not available in South Africa’s public sector outside of study and pilot sites, as the National Essential Medicines List Committee, the body that determines which health technologies should be available in the country’s public health facilities, determined that the product is unaffordable at its current price. They estimate that the product will become affordable for South Africa’s public sector at a threshold price of R52 per ring.

Local company to boost access

The Population Council, the entity that owns the intellectual property on the dapivirine vaginal ring, selected South African pharmaceutical company Kiara Health to manufacture and supply the ring across Africa.

Kiara Health’s CEO, Dr Skhumbuzo Ngozwana, told Spotlight that while it is not yet known what the price of the Kiara manufactured ring will be, it is expected to be lower than the current price of the Swedish-manufactured DapiRing.

Licensc to manufacture

The council told Spotlight that the initial focus of the licence and partnership will be to develop manufacturing capacity at Kiara Health to supply the dapivirine vaginal ring across Africa. In the long term it is hoped that Kiara will be able to serve markets outside of Africa where there is a need for the ring.

The Population Council’s selection of an African-based manufacturing partner is notable as holders of intellectual property protections on HIV health technologies have typically sought out companies in Asia, and India in particular, as manufacturing partners.

Professor Linda-Gail Bekker, CEO of the Desmond Tutu HIV Foundation, told Spotlight: “If the “COVID-19 pandemic taught us anything, it is the value of being self-reliant as a region – being able to manufacture the vaginal ring is a step closer to Southern African self-reliance.”

Ngozwana said that Kiara Health appreciates that the Population Council have bucked the trend by not going to the East. “[A]ll these new technologies tend to go to the East, but instead they’ve partnered with an African company”.

Dapivirine vaginal ring. Credit: Columbia University Mailman School of Public Health

He added that future technology transfers to other manufacturers in Africa may be pursued if there is a need.

Exclusive supply licence

The Council told Spotlight that it intends to pursue an exclusive supply licence with Kiara Health for the sole supply of the dapivirine ring in Africa. The pursuit of an exclusive supply licence is a strong vote of confidence by the Population Council in the ability of Kiara Health to supply the ring at adequate scale and affordable prices.

Since Kiara Health’s exclusivity is for the supply of the ring, if there is a need, the company will be able to supply a dapivirine vaginal ring that is made by the Population Council’s Swedish manufacturing partner, Sever Pharma Solutions, that is already widely authorised for use in countries in Africa.

This would also guard against supply shortfalls that sometimes occur when only one manufacturer supplies a market, doctor Brid Devlin, the Population Council’s chief scientific officer, told Spotlight. “We would have two registered manufacturers right out the gate to guard against any shortfalls and have the opportunity to continue the supply as the demand grows.”

Why Kiara Health was chosen

Devlin added that the Population Council did not have a formal bid process through which Kiara Health was selected as the manufacturing partner for the ring, but rather that Kiara Health was selected following years of engagement with the company.

“We had a team that went to Kiara last year to see this site and it was a really impressive operation, both in terms of the staff but also the entire manufacturing operation,” she said.

Ngozwana told Spotlight that Kiara Health has existing manufacturing facilities in Johannesburg where capacity to produce the ring will be established.

Kiara Health’s manufacturing facilities already hold the quality assurance certifications (cGMP certification) required to manufacture medicines and have adequate space in Johannesburg to establish and scale manufacturing capacity for the ring, Ngozwana told Spotlight.

What is needed to manufacture the ring locally?

Critical steps include technology transfer, securing financing, procuring and importing manufacturing equipment, developing validation batches, and seeking regulatory approvals.

At this stage, there are still unknowns regarding the extent of data and testing that will be required to gain regulatory approval of Kiara Health’s dapivirine vaginal ring. To aid regulatory authorisation, Ngozwana and Devlin noted that Kiara Health would use the same manufacturing technology and inputs, including active pharmaceutical ingredients (API) used by Sever Pharma Solutions. This will require Kiara Health to import manufacturing equipment and API from Europe.

However, in the long term, Ngozwana said that Kiara Health would hope to increasingly procure manufacturing inputs, including potentially dapivirine API from the Pretoria-based API manufacturer CPT Pharma. (Spotlight previously reported on CPT Pharma’s work on API production here).

Ngozwana and Devlin told Spotlight that the anticipated time-limiting factors for establishing manufacturing capacity are securing financing and procuring and importing manufacturing equipment.

Funding has long been a challenge for African-based pharmaceutical companies since it has historically been scarce and only available on unfavourable terms. However, Ngozwana told Spotlight that Kiara Health is already engaging potential funders for support and exploring different financing sources, including grants and debt instruments.

Ngozwana and Devlin noted that technology transfer, which is a process for transferring manufacturing skills and knowledge, has already begun.

Can this license boost further domestic manufacturing capacity?

While vaginal rings are a relatively new type of health technology, they have multiple potential applications. A vaginal ring to prevent pregnancy has been available since the early 2000s and work is underway to develop a ring that is effective in combating both HIV and pregnancy. A dapivirine ring that reduces one’s risk of contracting HIV for three months – as opposed to one month – is also under development.

Kiara Health will seek to position itself to manufacture other vaginal rings entering the market, Ngozwana said. He added that in the long term, the company hoped that the partnership with the Population Council will be broadened to allow for local manufacturing of other sexual and reproductive health technologies in their product portfolio.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : Healthcare Politics and RegulationsTags :

Health Budget 2024: Tangible Investment Needed to Alleviate Poverty-related Health Issues and Build Trust for NHI

On By ModernMedia
Finance Minister Enoch Godongwana tables his 2024 Budget during a joint seating of the National Assembly in the Cape Town City Hall. (Photo: National Treasury)

By Wanga Zembe, Donela Besada, Funeka Bango, Tanya Doherty, Catherine Egbe, Charles Parry, Darshini Govindasamy, Renee Street, Caradee Wright and Tamara Kredo

The 2024 national budget offers some glimmers but allocations for direct health benefits fall short of making a difference to people’s health and wellbeing. These include a ring-fenced allocation to crack down on corruption in health to inspire trust for the National Health Insurance, taxing accessories for e-cigarettes, a jacked up child-support grant, clarity on plans dealing with climate change and its impacts on human health, and finally greater investment to enhance women’s capabilities alongside the Covid-19 grant, researchers from the South African Medical Research Council write exclusively for Spotlight.

The 2024 national budget presented last week by Finance Minister Enoch Godongwana contained several key elements that have an impact on systems, services and wellbeing from a health perspective.

Importantly, not only direct health spend, but budget allocated to social protection and climate infrastructure has implications for health outcomes such as nutrition, growth and food security. Health taxes, to address illness caused by alcohol, cigarettes and e-cigarettes amongst others, are also key revenue streams with taxation intended to deter use.

As researchers at the South African Medical Research Council we are dedicated to improving the health of people in South Africa through research and innovation. We wish to share some insights into positive areas in the budget and to point out areas where there are gaps with potentially dire consequences for the health of our nation.

In real terms, the health budget is shrinking.

Health has been allocated a total of R848-billion over the medium-term expenditure framework. This includes R11.6-billion to address the 2023 wage agreement, R27.3-billion for infrastructure and R1.4-billion for the National Health Insurance (NHI) grant.  Compared to the medium-term budget policy statement in October last year, government is now adding R57.6-billion to pay salaries of teachers, nurses and doctors, among other critical services.

In real terms, the health budget is shrinking. The allocation to cover last year’s higher-than-anticipated wage settlement is a positive step to try to fill posts for essential health workers. But this allocation falls short of fully funding the centrally agreed wage deal, meaning that provincial health departments will be unable to fill all essential posts.

Treasury’s Chief Director for Health and Social Development, Mark Blecher, was quoted as saying that the “extra money would not be sufficient to hire all the recently qualified doctors who have been unable to secure jobs with the state, and provincial Health Departments will need to determine which posts should be prioritised”. He added: “There will be less downsizing, and more posts will be filled, but it is unlikely they all will be.”

South Africa has a ratio of only 7.9 physicians per 100 000 people in the public health system, while it has been estimated that there are more than 800 unemployed newly qualified doctors. Considering the health-workforce shortfalls, the amount of money allocated appears optimistic for service coverage for the increasing population.

The World Health Organization (WHO) considers building a health workforce a highly cost-effective strategy. Salaries continue to consume the largest share of provincial health budgets, estimated at 64% since 2018. The Human Resources for Health strategy lacks clarity on the implementation of workforce-planning approaches with significant implications for how provinces prioritise workforce cadres to keep up with the increasing needs – particularly in light of NHI.

Nutrition support on the decline

The Minister described protecting the budgets of critical programmes such as school-nutrition programmes, which includes almost 20 000 schools. He noted that the early childhood development (ECD) grant will be allocated R1.6-billion rising to R2-billion over the medium term.

Ensuring nutrition support to children under-five for optimal physical and cognitive growth is vital. The 2023 National Food and Nutrition Security Survey by the Human Sciences Research Council found that 29% of children under five in South Africa are stunted (short for their age). The proportion of children experiencing both acute and chronic under-nutrition has increased over the past decade. Stunted children are more likely to earn less and have a higher risk of obesity and non-communicable diseases such as diabetes and heart disease as adults.

Currently, only registered or conditionally registered Early Learning Programmes (ELPs) serving poor children (determined by income-means testing) are eligible to receive the ECD subsidy. This is not aligned with inflation and the real value of the R17 per child per day subsidy and the contribution to nutrition costs  have decreased over time. The subsidy is not enough to cover the costs of running quality programmes, let alone the costs of providing nutritious meals. The World Bank suggests a minimum of R31 per child per day.

There is also concern about the children missed who attend informal or unregistered programmes. According to the 2021 Early Childhood Development Census, only 41% of ELPs are registered and only 33%, registered or not, receive the subsidy. Unregistered ELPs are more likely to be based in vulnerable communities and attended by children from vulnerable households. Further, although about 1.7 million children are enrolled in ELPs, enrolment rates vary across provinces from 40% in Gauteng to 26% in the Eastern Cape. This means many young children are not enrolled, and, of those enrolled, most do not benefit from the subsidy.

Child grants increase not keeping up with inflation

Child grants appear in the budget every year, but the increases do not keep up with inflation, and particularly not with the basket of goods needed for a growing child. In real terms grant amounts are decreasing – visible in the way hunger is increasing throughout the country, particularly in the Eastern Cape where uptake of social grants is very high.

A recent Department of Social Development report – Reducing Child Poverty: A review of child poverty and the value of the Child Support Grant – recommended, as a minimum, an immediate increase of the child-support grant to the food poverty level (R760 last year), as more than 8 million children receiving it were found to be going hungry/missing a meal at least once a day. The R20 increase falls far short of that recommendation.

The Social Relief of Distress Grant and women’s economic empowerment

As part of pandemic recovery efforts, we commend government for the roll-out of the Social Relief of Distress (SRD) grant and its plans to extend this beyond March 2025. While SRD continues to suffer implementation challenges related to the amount and roll-out; it  presents an opportunity for renewed attention to a comprehensive and inclusive approach to women’s economic empowerment.

The recent Stats SA labour survey reported a higher unemployment rate among women (35.7%) versus men (30.7%). Our research also finds that women caregivers of children and adolescents living with HIV are particularly vulnerable to poor health and economic outcomes. Greater investment in programmes that enhance women’s opportunities alongside the SRD could promote the sustainability of pandemic-recovery efforts.

The NHI, health-system reforms and dealing with corruption in health

The Minister indicated that the allocation for NHI – government’s policy for implementing universal health coverage – demonstrates commitment to this policy. He also noted that there are a range of system-strengthening activities, that are key enablers of an improved public healthcare system, including strengthening the health-information system; upgrading facilities; enhancing management at district and facility level; and developing reference pricing and provider payment mechanisms for hospitals. He recognised that these require further development before NHI can be rolled out at scale.

The NHI allocation must show a tangible commitment to health-system reforms. Funding needs to be allocated for the creation of organisational infrastructure that ensures transparent, trustworthy decisions will be made about the benefits package and programmes to be funded. Specifically, funding for conducting Health Technology Assessments with credible processes that manage interests and ensure coverage decisions are informed by independent appraisal of the best-available evidence, measures of affordability, and with public input. Some areas of government already undertake such work, for example the National Essential Medicine Committee, but how these processes will expand beyond medicine to include decisions about health-systems arrangements and public-health interventions remain unclear, and apparently unfunded.

Undoubtedly, facilities need to be upgraded. It’s positive to see this as a named activity. It is however unclear how the upgrade of health facilities and quality of care will be ensured, given that tertiary infrastructure grants have been reduced due to underspending of conditional grants. Currently, health facilities’ quality is assessed by the Office of Health Standards Compliance whose role is to inspect and certify facilities. This is a prerequisite for accreditation under NHI. This means the watchdog agency will need adequate budget. Implementation research is also required to test out the different NHI public-private contracting models. Furthermore, a ring-fenced allocation to deal with corruption in health, would be welcomed and inspire trust for NHI.

‘Sin’ taxes vs ’health taxes’

The Minister proposed excise duties and above-inflation increases of between 6.7 and 7.2% for 2024/25 for alcohol products and indicated that tobacco-excise duties will be increased by 4.7% for cigarettes and cigarette tobacco and by 8.2% for pipe tobacco and cigars. And, based on inputs from citizens, the Minister also tabled an increase in excise duties on electronic nicotine and non-nicotine delivery systems (vapes).

While there may be a concern that increasing taxes on products consumed by the poor is regressive, there are ways to direct revenue gained back to those sub-populations and it’s not fair to deny them the benefits of consuming less alcohol products.

It is notable that excise taxes on wine have been increased to a greater percentage than spirits, but the health effects of alcohol come from the ethanol not the type of liquor product so it would make more sense to make the excise tax rate per litre of absolute alcohol equal across all products. The budget has not moved this forward in any meaningful way.

The proposed tax on tobacco products is not in line with WHO recommendations and is below inflation. This should be at least 70% of the retail price to have a positive impact on public health by reducing tobacco use, especially in a country with one of the highest tobacco-use rates in the region. In South Africa, the tax is currently between 50 – 60%. Although the tax on electronic cigarettes has increased, it is still below inflation. We hope that this increase will deter more young people from starting to use e-cigarettes and encourage current users to quit. We also hope that this increase is not just once-off and that future increases are made with the goal of reducing e-cigarette use.

Overall, the taxes on tobacco products and electronic nicotine and non-nicotine delivery systems are below inflation. This means that manufacturers can absorb the increases, and consumers may not be deterred from using them. This is a missed opportunity, as there is a clear link between these products and the development of non-communicable diseases, like hypertension, and the worsening of communicable diseases, like tuberculosis.

The impact of climate change on lives and livelihoods

Climate and health are closely related, with more attention being paid by the global research community  to potential impacts of climate change and natural disasters on lives and livelihoods. The Minister noted a multi-layered risk-based approach to manage some of the fiscal risks associated with climate change. These include a Climate Change Response Fund; disaster-response grants; support and funding from multilateral development banks and international funders to support climate adaptation, mitigation, energy transition and sustainability initiatives; and, municipal-level adaptation and mitigation initiatives.

There are numerous health co-benefits to these strategies. For example, investing in renewable energy sources can improve air quality, leading to reduced respiratory illness. There is a need to highlight these co-benefits and to foster intersectoral collaboration.

Overall, from the perspective of health researchers, we note the mention of NHI plans, social protection, nutrition, health workforce, health taxes and climate. However, we all agree that the allocations for direct health benefits and to address social determinants of health, such as education and poverty-alleviation, fall short of what is recommended, from global and national research evidence, to make a difference to people’s health and wellbeing.

*SAMRC researchers: Wanga Zembe, Donela Besada, Funeka Bango, Tanya Doherty, Catherine Egbe, Charles Parry, Darshini Govindasamy, Renee Street, Caradee Wright and Tamara Kredo.

Republished from Spotlight under a Creative Commons licence.

Source: Spotlight

Categories : Healthcare Politics and RegulationsTags :

Unemployed Doctors March to Union Buildings

On By ModernMedia

They are calling for the president to intervene and make sure medical professionals are employed

By Silver Sibiya for GroundUp

Scores of unemployed doctors, nurses and other health workers marched to the Union Buildings in Pretoria on Monday, calling for the Presidency to intervene in the ongoing financial problems facing the health sector.

One of their main demands is for the health budget to be increased to absorb about 800 medical professionals.

Joining the march, Mandla Matshabe, said he never imagined being unemployed when he completed his community service at Sefako Makgatho University in December last year after studying in Cuba.

“Now I’m sitting at home with a medical qualification when there is a dire need. It’s appalling to think there are medical professionals at home,” he said.

Matshabe, who lives in Hazyview in Mpumalanga, said many unemployed health workers were becoming depressed at home. He said hiring qualified doctors could help alleviate some of the burnout among doctors in the public sector.

“Doctors in communities are overburdened because we don’t have enough medical professionals, including physiotherapists and dieticians or everyone in the hospital,” he said.

University of Cape Town graduate Lerato Jaca said it was discouraging to be an unemployed doctor. “I come from KwaNzimakwe in Port Shepstone where there were literally no doctors when I was growing up.”

Jaca was raised by an unemployed single mother who relied on the money she made during Jaca’s three-year community service employment at Ermelo Hospital.

She said they now rely on her brother’s disability grant and his children’s child support grants to buy food.

Deputy President of the South African Medical Association, Dr Nkateko Minisi, said: “Other health professionals in the allied sectors, including pharmacy, are here with us to hand over a memorandum to build up the health system. But to do so, we feel that human capital must be optimised by hiring all these unemployed professionals. Not tomorrow, not next week but now!” she said.

Mnisi said more than 80% of the population depends on public health services. “Healthcare is not a privilege that should be enjoyed by some; it is a basic human right that every single person deserves.”

Communications Manager at The Presidency, Phil Mahlangu accepted the group’s memorandum.

He said that the presidency was “immensely worried as the presidency about the negative issues affecting the medical industry”. He promised the protestors a response within a week.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : AgeingTags :

Old Age Grant is not Enough to Cover Care Needs, Researchers Find

On By ModernMedia
Photo by Thought Catalog on Unsplash

By Daniel Steyn for GroundUp

Researchers at the University of Cape Town (UCT) have found that in most cases, the Older Persons Grant is not sufficient to meet the needs of elderly people in South Africa.

Professor Elena Moore and other researchers from Family Caregiving, based in the Department of Sociology at UCT, interviewed 30 families in rural KwaZulu-Natal and 50 families in the Western Cape to find out how families headed by pensioners are making ends meet and whether older persons are able to get the care they need.

About 3.9 million people in South Africa receive the monthly Older Persons Grant, also known as the Old Age Grant, currently at R2080 per person per month.

Family Caregiving analysed data from Wave 5 of UCT’s National Income Dynamics Study (NIDS), which shows that the vast majority of beneficiaries live in households of five people where the average household income is R6850.

Older people have significant and unique care needs, the researchers argue. According to StatsSA data from 2021, the majority of older people need chronic medication and need to access healthcare facilities: 24% of older persons in South Africa have diabetes, 68% live with hypertension, and 14% have arthritis. Older people also often have difficulties with sight, mobility and cognition, meaning they need additional support to go about their day-to-day lives, say the researchers.

In a rural area in KwaZulu-Natal, Family Caregiving found that most households had between eight and nine members and were struggling to cover the cost of food, medical supplies, and transport to clinics.

In this area, accessing healthcare is expensive, the team found. A round trip to town by taxi cost R46 and a trip to the closest clinic and back costs R82. Physically disabled older people often have to hire a car for between R200 and R600 to get to a clinic and back. A pack of adult incontinence products costs R219 and lasts only seven days.

Because of the costs of transport and medical supplies, many of these large households were spending an average of only R1000–R1500 a month on food, according to the report. A lack of access to water and electricity creates an additional burden for older people in rural areas.

In urban areas, such as Cape Town, there is greater access to water and electricity, health facilities are closer, and households are smaller, meaning the Older Persons Grant is not stretched as far. But still, the researchers found, older people are often required to carry households at the expense of their own care.

Low income and low-middle income families in Khayelitsha and Eerste River told the researchers that the only way to make ends meet is to spend less on food. Many families are stuck in debt cycles, borrowing from loan sharks from month-to-month with extremely high interest rates. Unpaid utility bills stack up, and electricity tariff hikes and rising rental prices put further pressure on older persons.

The monthly cost of nutritious food for a family of seven is R5324, according to Pietermaritzburg Economic Justice and Dignity’s household affordability index. Family Caregiving found that low-income households headed by older persons are often spending less than half that amount on food because of other household expenses. This has serious consequences for older people, especially those who need to eat before taking medication.

The report recommends additional investment by the government to care for older people, such as free transport to health facilities and consistent supply of incontinence products.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp