August – NATIONAL WOMEN’S MONTH
WE INTERVIEW PROF CINDY FIRNHABER, A CHAMPION FOR WOMEN’S HEALTH
By Nora-Jean Freeman
August is National Women’s Month, and who better to chat to about afflictions suffered by women in South Africa than a doctor passionate about medicine in the field of infectious diseases, Prof Cindy Firnhaber. Prof Firnhaber is the Technical Director of the Clinical HIV Research Unit (CHRU) in Johannesburg, and is the Manager of Right to Care, another non-profit organisation which is involved in the implementation and improvement of care for HIV patients in South Africa.
Prof Firnhaber has been involved with HIV care for many years, with her passion being the improvement of health for women. “Women with HIV are more susceptible to cervical cancer, and from a younger age,” says Firnhaber. “The problem in the past has been a lack of accessibility for screening for cervical cancer, as most HIV centres did not have facilities to conduct pap smears. A real obstruction to treatment is the follow-up evaluations where there is an abnormal pap”. It has been thanks to Prof Firnhaber that this accessibility has increased and there are now an additional 25 centres in government and NGO clinics around the country able to provide this service.
In 2014 CHRU was awarded a grant by Merck, manufacturers of the vaccine, Gardasil, which is a three dose injection that guards against the strains of papillomavirus that can lead to cervical, and other cancers. The vaccine only helps as a preventative treatment, not if the patient already has (dysplasia)pre-cancer or cancer, but if administered after the dysplasia (pre-cancer) has been cut out, it is hoped that it will prevent reoccurrence. The Merck grant is to study the effects of this vaccine, to see if it will reduce the persistence or recurrence of the cancer after it has been cut out. The study has been running for ten months under Prof Firnhaber’s leadership, and so far a cohort of 65 HIV positive women have been recruited to participate in the study – 180 HIV women are needed to complete the study cohort. This is the first study of its kind in the world, and the reason for the importance of this study is that, if it is found that the vaccine will reduce persistence or reoccurrence, it is simple to administer (as opposed to vaginal treatment), and would therefore greatly reduce the number of women suffering from HIV related cervical cancer. “The problem with HIV positive patients with cervical cancer is that they require frequent follow-up, and we need to find a way to reduce the follow-up required.” Firnhaber says. Hopefully the study will reveal that the vaccine will fulfil this role.
Prof Firnhaber was born and raised in the USA, where she graduated at the University of Colorado. She has been married to Kurt Firnhaber, CEO of Right to Care, for 31 years and they have six adopted children. It was her stint volunteering as a medical officer at Musami Mission in Zimbabwe in 1990 that caused her to fall in love with, and settle in Africa.
PAMELA TSHANDU, A DRIVING FORCE IN THE CHRU COMMUNITY ADVISORY BOARD
The first thing that strikes me when I meet Pamela Tshandu, is her open, friendly face – I’m immediately drawn to her. August being Women’s Month I asked to interview a prominent female member of the Community Advisory Board (CAB) whose passion is women’s health. Pamela is just such a person, although her humility belies the fact.
Having been a member of the CAB since 2006, Pamela also holds a position on the Community Scientific Sub-committee, an international body whose policies are filtered down to the local CABs. Her involvement includes discussing protocols, and providing feedback to the communities. She advocates for cultural participation to ensure that clinical trials are efficient and timeous and that all populations are involved with none being marginalised.
Asked what drives her, Pamela says, “I am passionate about women issues, and believe that women do not have much of a voice, and we all know that much more women than men are infected with HIV. It is important that women are educated and empowered.” Pamela finds the women in the communities to be very open and receptive to the counselling offered by the CAB.
CAB members meet once a month and strategise what topic and which area should be focussed on in the following month. Outreach programmes are then planned accordingly. The CAB is made up of people from various backgrounds; teachers, social workers, health workers, traditional healers and trainers and each plays a role that suits their strengths. For example, in Youth Month, an educator will give talks on sexuality, HIV prevention etc at schools. Outreach programmes are made up of community visits, counselling, distribution of pamphlets, and provision of screening and health services.
Pamela is also a consultant to corporates where she offers HIV and Wellness Programmes for employees. She is a single mother of a 17 year old son … her biggest challenge!
June – MEN’S HEALTH MONTH
ETHICS AND MALE CIRCUMCISION
(Edited by Nora-Jean Freeman from presentation by Dr Khumbulani Moyo, Right To Care)
There are various reasons for circumcision, which is the surgical removal of the foreskin from the human penis – mainly religious or cultural, and obviously in some case, for medical reasons. There are several benefits of medical male circumcision (MMC) :
· Easier hygiene;
· Fewer urinary tract infections;
· Less risk of STDs including HIV (although practicing safe sex is still essential);
· Prevention of penile problems;
· Reduced risk of penile cancer;
· Reduced risk of cervical cancer in women.
Medical Male Circumcision and HIV
HIV can be transmitted through :
· Sexual contact;
· Pregnancy, childbirth, breastfeeding;
· Injection/drug abuse;
· Occupational exposure;
· Blood transfusion/organ transplant.
Risks associated with male circumcision :
· The frequency of severe adverse complications following neonatal, infant and child male circumcisions is 0%;
· The median frequency of any complication was 1.5%, with more occurrence in older children than in neonatal or infant cases;
· Complication rates in adult male circumcision are 2-8%, with the most common complications being pain, bleeding, infection, unsatisfactory appearance.
There are few well designed studies of sexual sensation following male circumcision, but most report either and improvement or no change.
· Governments need to ensure that safe, voluntary, informed, affordable male circumcision is available to all who seek it, without any discrimination.
· The male circumcision services must be respectful of medical ethics, offered and delivered in a culturally appropriate manner, and all necessary information on the risks and benefits must be provided.
· In the case of children, Government should consider the best interests of the children in designing and implementing male circumcision services.
· Health providers must obtain full and free informed consent from the patient before performing the male circumcision.
· Women should be involved as much as possible, without compromising men’s right to consent or privacy
· Health providers should ensure good quality, sanitised services are provided;
· Health providers must protect the privacy and confidentiality of individuals seeking male circumcision;
· Health providers should recommend HIV testing and counselling to all individuals seeking male circumcision services, but this should not be a prerequisite for performing the operation.
Men who have sex with men (exclusively)
· Available data do not indicate that male circumcision reduces the overall risk for HIV among SMS, but it is plausible, and some epidemiologic data suggests that there is partial protection from male circumcision during penile-anal sex. However, being circumcised no plausible HIV risk reduction benefit for the partner engaging in anal-receptive sex, which carries a higher risk for acquisition of HIV.
· MSM should be fully informed of these findings, and should be encouraged to continue to use other proven HIV and STD risk-reduction strategies.
· There is no evidence that male circumcision directly affects the risk of transmitting HIV from HIV positive men to women.
In summary …
· Male circumcision
Ø Reduces the risk that a man will acquire HIV from an infected female partner, and
Ø Also lowers the risk of other STD’s, penile cancer, and
Ø Infant urinary tract infection
Ø In female partners, it reduces the risk of cervical cancer, and several other conditions.
· Although male circumcision has risks including pain, bleeding and infection, more serious complications are rare;
· Uncircumcised, HIV-infected men and male adolescents are at increased risk for HIV acquisition through penile-vaginal sex should be counselled about the risks and benefits of male circumcision;
· Men to choose to be circumcised should be referred for surgical consultation and provided access to high quality, voluntary male circumcision surgical services.
June – NATIONAL YOUTH MONTH
GETTING IN TOUCH WITH HIV AND SA ADOLESCENTS
Interview conducted by Nora-Jean Freeman
In line with June being National Youth Month, I touched base with Dr Marnie Vujovic, Adolescent Programme Manager, of Right To Care, about the effect of HIV in South African adolescents. Following are the questions and very interesting answers :
NJF : What are the statistics for HIV in adolescents?
MV : The World Health Organisation defines adolescence as those between the ages of 10-19. In this age group there are 320 000 young people infected with HIV in South Africa.
NJF : Has there been an increase/decrease?
MV : Incidence rates have declined and prevalence is stabilising. However controlling incidence in young girls is a high priority. They are a high risk group and we need to be particularly concerned with prevention efforts in this population. Nearly a third of all new HIV infections in South Africa occur in 15-24 year olds with young women in this age group being up to eight times more likely to be infected with HIV that their male counterparts. There are various reasons for this, including the physiological vulnerability of girls. However age disparate relationships are an important contributing factor. In all other age groups mortality due to AIDS is decreasing however in the adolescent population the mortality has doubled, with 120 000 adolescents dying from AIDS in 2013.
NJF : What are your objectives in tackling this matter?
MV : In light of the severe vulnerability of adolescent girls to HIV infection, we need to move beyond what has been called ‘single-problem’ thinking to focus on combination interventions that deal with the multiple causes of risk behaviours. We need to tailor programmes to local contexts and circumstances and take behavioural, biological and structural factors into account if we are to develop effective intervention frameworks.
A key objective is to support the implementation of a well-targeted package of interventions that can address some of the most pressing challenges we face, for example worrying levels of sexual coercion and violence, high rates of teen pregnancy and so forth. Ensuring that these issues are addressed effectively calls for a co-ordinated, multi-sectorial response which can help strengthen the support systems available to young women at various levels for example family, school, and healthcare facility, and which meet individual needs for knowledge and education around issues such as sexuality and HIV risk.
NJF : Are you successfully achieving your objectives
MV : Helping young women build skills to increase personal and social competence, and providing them with health knowledge that is age-appropriate and contributes to health promoting decision-making is an important component of our programme. A 20-session support group resource that addresses issues ranging from contraception, to teen pregnancy, gender relations, self-esteem, HIV and treatment adherence, provides facilitators of facility, community and school based support groups with a means of addressing key health issues in a manner that is age appropriate.
Feeling supported, heard and provided with an opportunity to share worries and concerns with others of the same age can help to foster healthier outcomes. Support groups and adolescent adherence clubs are a way of achieving this. An important step has therefore been to provide technical assistance and mentoring to those wanting to start and run groups. We have made great strides across the provinces in this area.
We will be growing this package in the coming months to provide parents and caregivers with the skills necessary for open and honest communications around sexual and reproductive health. We will also be providing technical assistance to support the needs of educators engaging with learners around sexual and reproductive health and other health related issues, and in building an appreciation amongst healthcare providers of the special health challenges faced by positive and non-positive adolescents. A core component is the strengthening of linkages, for example between school, clinic and community-based organisations to ensure that young people are supported at every level.
The support group resource and its value for use with young people is currently being evaluated. A combination prevention package – “Catch them Young” is to be piloted shortly. Monitoring and evaluation will provide valuable insight into the extent to which objectives are met and will inform opportunities for scale-up.
NJF : How do they deal with stigmatisation in their communities
MV : Great efforts have been made to address the problem of stigma and discrimination in our communities. The National Strategic Plan on HIV, STIs and TB (2012 – 2016) states as one of five key objectives, the need to reduce self-reported stigma related to HIV by at least 50%. On World AIDS Day 2014 the call was made for “Zero Stigma” and “Zero Discrimination’’. In this regard the recently announced SANAC HIV Stigma Survey Results are interesting. Over 10 000 people of 15 years and older were interviewed in the study which found that whilst external stigma has decreased in South Africa, levels of internal stigma are still high. Over 40% of the study participant’s experienced internalised stigma with women and young people aged 15-24 years reporting the highest levels.
Adolescents find different ways of coping, one of the most common strategies being to avoid the possibility of stigma by keeping their status a secret and not disclosing beyond the immediate family. Concealment of status is generally regarded as a maladaptive coping mechanism, however the extent to which it is employed suggests that stigma is still a significant factor in determining how young people deal with HIV infection.
Having said this however, adolescents confront the reality of infection in different ways. Whilst some may not wish to disclose, others cope by educating their peers and through activism, for example speaking out against stigma at public gatherings.
Adolescents who access support structures, such as support groups or clubs that have enabled them to build a strong sense of self-worth are in a better position to deflect stigma. Apart from building coping skills that assist in dealing with stigmatisation in their communities, they benefit from supportive networks that foster interpersonal and communication skills.
NJF : What are the challenges that you face?
MV : There are a number of challenges, one of which is the capacitation of healthcare providers and educators to work with young people in a way that is sensitive to their needs, and which does not reflect their own personal values and attitudes regarding adolescent sexuality. An appreciation of adolescent development issues is important. However whilst many of us have a good understanding of adult and paediatric treatment, care and support, the same understanding is not always evident when it comes to the adolescent population.
Other challenges include difficulties experienced in getting groups started and ensuring sustainability. For example there are challenges around space, accessibility and the transport costs involved in regular attendance. In response to this we have put together a trouble-shooting guide that provides guidance on how to overcome some of these issues.
NJF : How do you convince youth that they are not immortal and that HIV isn’t discriminatory?
MV : Adolescence is a time of transition which is best appreciated by understanding what happens to young people physically, cognitively and socially at this stage of development. For example, in order to understand why adolescents may believe that they are invincible, it is important to recognise that a young person’s brain is still developing and is much less mature than the adult brain. The “personal fable” which reflects an “It can’t happen to me” orientation is an example of an immature brain structure that gives rise to feelings of invulnerability. This is not to say that adolescents cannot and do not develop new skills and behaviours. Cognitive functioning can be greatly improved when young people are encouraged and supported towards the development of skills such as decision-making and problem solving. The resource that Right to Care has developed for use in adolescent support groups is a good example of how a psycho-educational tool can help young people to evaluate their decision making.
CHRU COMMUNITY ADVISORY
The enthusiasm emanating from the CHRU Head of Counselling Department, Tshidi Lelaka and CAB Executive Secretary and Community Health Worker, Isaac Sedumedi, is contagious, and leaves me with a ‘warm fuzzy’ feeling about the work these individuals, along with the rest of the CHRU CAB members, are doing in their community.
The CHRU CAB’s focus is on educating the community about diseases in general, but specifically the most prevalent cancers (e.g. breast, skin, cervical), tuberculosis (TB) and of course, HIV/AIDS. Education methods are varied according to the reception received in the community. Educational flyers are produced and distributed, with recipients invited to ask questions, either immediately, or at a later stage, in which case they’re told where they can find the CAB representatives. In some cases, the strategy of doing door-to-door visits, or even engaging with a group of individuals playing board games outside a shebeen, has been found to be successful, with several taking up the invitation to visit the CAB base to ask questions.
The stigma that participants in Clinical Trials are ‘guinea pigs’ is a challenge that needs to be overcome. There are many benefits to participating in Clinical Trials, not least of which is the feeling of self-worth for having played a part in the positive outcome of research into a particular disease. Added benefits are medical care, and the difference made to family, friends and the community as a whole. The CAB representatives are tireless in their efforts to recruit more clinical trial participants – there are no risks, only benefits.
The CHRU CAB meets for a six-monthly strategy session, where they look at the monthly ‘theme’s coming up e.g. Cancer Awareness Month; the statistics of the various diseases, e.g. a rise in incidence of HIV in a certain area, etc, around which they shape their activities. For instance, in June, Youth Month, the CAB is concentrating on education at schools, with emphasis on HIV/AIDS awareness and prevention, although the outreach will only take place early in July owing to June being school examination month.
The CAB measures the success of its campaigns by the number of pamphlets distributed as a percentage of the size of the community, and increased questions and interest shown by the community. An important success would be an increase in willing clinical trial participants. In some communities there is a request for more services, such as TB screening, which the CHRU CAB facilitates on a regular, ongoing basis.
The CHRU CAB has three sites, the main one being based at the Helen Joseph Hospital, covering the Johannesburg city area, with the other two being at Witkoppen Hospital (covering Diepsloot), and Sizwe Hospital (covering Alexandra).
Asked how his role as Community Health Worker made him feel, Isaac responded, “It makes me feel I am needed, and an important person to the community. I believe I am making a difference in terms of education and growth in my community. People look up to me and show me respect. People can testify that I am doing a good job, and are proud of what I’m doing.”
March – (Press Release) High-dose rifampicin demonstrates an improvement in TB response rates
(South African scientists and patients involved)
Nijmegen, Netherlands / Munich, Germany 2 March 2015: At the annual Conference on Retroviruses and Opportunistic Infections (CROI), the Pan-African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA), presented the results of its most recent phase IIb study (MAMS-TB-01). The most exciting finding from the study is that high-dose rifampicin results in faster killing of TB bacilli during treatment, compared to the current standard treatment.
The standard WHO-recommended TB treatment regimen (2 months of daily ethambutol, isoniazid, rifampicin and pyrazinamide followed by 4 months of daily isoniazid and rifampicin (2EHRZ/4HR)) involves taking the drugs daily for 6 months. This can make adherence to treatment hard, and has substantial costs to the health system and patients. Shortening the length of time treatment needs to be taken for, may help to reduce the burden on health systems, the costs of treatment, and make treatment easier for patients. PanACEA MAMS-TB-01 was set up to address this.
High-dose (35mg/kg) rifampicin, in combination with standard dose of isoniazid, pyrazinamide and ethambutol, showed a significant shortening of time to culture conversion with a covariate-adjusted hazard ratio of 1.75, 95% confidence interval (1.21-2.55) over the 12 weeks of experimental treatment. For comparison to previous TB trials, covariate-adjusted hazard ratios compared to control over 8 weeks were 1.99, 95% confidence interval (1.21-3.29). It was not possible to culture TB bacilli in sputum by 8 weeks in 56% of patients on the 35mg/kg arm compared to 42% of patients on the standard of care arm. These proportions were 80% and 70% respectively after 12 weeks. Culture on solid media, which was a secondary endpoint, showed a similar although less marked result.
Chief Investigator Martin Boeree (Radboud University Nijmegen) says: “This is the largest reduction in time to culture conversion seen in any previous TB trial, to our knowledge. High doses of rifampicin may be an important component in shorter TB regimens in the future.”
The arm containing moxifloxacin with rifampicin 20mg/kg, pyrazinamide and ethambutol showed a borderline significance, hazard ratio 1.42 (95% confidence interval, 0.98-2.05) for improvement over control.
In an interim analysis conducted in early 2014, recruitment to both arms that included the new drug SQ109 were terminated, as it was clear that both regimens would not meet the predetermined hazard ratio of 1.8 using liquid culture and thus were unlikely to result in substantially improved regimen. Patients on these arms remained on treatment and in follow-up, and the now available data confirms the interim analysis decision.
Preliminary analysis of safety events showed no differences in side-effects in any of the arms as compared to control.
The MAMS-TB-01 trial enrolled 365 patients from 7 sites in Tanzania and South Africa in only 11 months. It used an innovative adaptive clinical trial design that allows several new regimens to be compared to the current standard, and incorporates interim analyses that allow for regimens that show little treatment shortening potential to be excluded from the trial at an early stage.
Data on treatment up to week 26 and post-treatment follow-up will be analyzed and reported together with the results mentioned above in the main publication.
“We would like to thank our main donor, the EDCTP, for its support of this African-European consortium,” said Michael Hoelscher, sponsor representative. “We are pleased to have optimized one potential component of a future treatment-shortening regimen. This is, however, only the beginning of a series of phase I and II studies that will evaluate in a systematic manner at least 5 novel and improved TB drugs. “
In South Africa contact:
Prof Ian Sanne, Divisional Director, Clinical HIV Research Unit, Wits Health Consortium T +27 82 457 5223 firstname.lastname@example.org or Michelle K Blumenau, Turquoise PR & Marketing Communications T +27 83 273 9891 email@example.com
Note to editor:
It is the mission of PanACEA (Pan African Consortium for the Evaluation of Antituberculosis Antibiotics) to develop TB regimens that significantly shorten treatment duration. The PanACEA consortium is a partnership of 11 African and 7 European institutions.
African institution partners are:
• University of Cape Town Lung Institute(Rodney Dawson);
• University of Stellenbosch (Andreas Diacon);
• University of the Witwatersrand (Ian Sanne);
• The Aurum Institute (Gavin Churchyard);
• University of Zambia, Lusaka, Zambia (Shabir Lakhi); NIMR–Mbeya Medical Research Centre, Mbeya, Tanzania (Nyanda Elias); Ifakara Health Institute– Bagamoyo Research and Training Centre, Bagamoyo, Tanzania (Lilian Tina Minja); Swiss Tropical and Public Health Institute (Klaus Reither); Kilimanjaro Clinical Research Institute, Moshi, Tanzania (Gibson Kibiki); Medical Research Unit, Albert Schweitzer Hospital, Lambarene, Gabon (Abraham Alabi); Kenya Medical Research Institute, Nairobi, Kenya (Evans Amukoye); Makerere University, Kampala, Uganda (Alphonse Okwera, Moses Joloba).
January – Skin Cancer Awareness Month
Kaposi Sarcoma (KS) is a skin lesion most commonly linked with HIV/AIDS. There are three other sub-types apart from AIDS related KS, namely Classic KS (affects men of Mediterranean descent); African endemic KS and KS in iatrogenically immunosuppressed (organ transplant) patients. The African endemic KS and AIDS related KS are the most aggressive forms, the latter of which quickly develops from a mild rash to plaques and nodules found mostly on the upper body, face and mouth.
KS is a cancer of the blood vessels, which usually manifests as skin lesions. But it can presentas lesions in other organs; including the gut, mouth cavity, lungs etc. Most people with KS dismiss it as a mild rash to start with, and therefore don’t seek medical assistance early. As such, most of those who do seek medical attention, do so at a more advanced stage of KS. There is limited knowledge of KS in the community and thus there is a need for education and awareness in this area. The CHRU has developed a pamphlet on KS to assist counsellors and the Community Advisory Board (CAB) to share the knowledge with the community.
KS is treatable and can be curable if found early enough. The AIDS Clinical Trials Group is looking at treatment options for people presenting with HIV related KS. One of the studies is A5264 under the guidance of Principle Investigator, Dr Noluthando Mwelase, of the CHRU. Dr Mwelase says that the main challenge presented to the unit is the recruitment of patients into this study. As mentioned earlier, the appearance of a rash or lesions is not taken seriously enough for patients to seek medical help early. And there is lack of knowledge in the community regarding this disease. The Unit works hard to proactively seek HIV patients with KS to include in the study.
Methods of recruitment:
• Counsellors visiting patients at HIV and Dermatology clinics to try to identify and recruit KS sufferers;
• Community Advisory Board (CAB) does healthcare awareness campaigns to educate the community regarding KS and encourage people to seek medical attention early.
on the study; they sign a letter of consent and are monitored on an ongoing basis. The group is split into two sub-groups. The first sub-group will receive Chemotherapy together with anti-retroviral (ARV) treatment from the start of study; the second sub-group starts only with
The recruited patients receive a full explanation of what the study is about, what to expect (benefits and potential risks) and study treatment. If the patient is agreeable to participate on the study; they sign a letter of consent and are monitored on an ongoing basis. The group is split into two sub-groups. The first sub-group will receive Chemotherapy together with anti-retroviral (ARV) treatment from the start of study; the second sub-group starts only with ARV treatment, with chemotherapy being introduced at a later stage if indicated. The aim is to compare the two subgroups to see which with treatment option works best in treating early KS. However, with the shortage of participants presenting with early stage KS to health care centres, this study is severely hampered.
Below are statistics from pre-screening KS participants from May 2012 to May 2014. In total all 95 KS patients were referred for the study many of whom could not be on the study due to different reasons.
|Reason for Failure
|Already on Art
||these patients were on ART for 2 months - 8yrs
|Less than 5 KS lesions
||other skin conditions e.g. PPE, folliculitis
||did not want to be part of study/ did not want medical treatment / did not want to do HIV test
||renal failure, thrombocytopenia