Blog 4 Global Health

Interview with Jane Kengeya-Kayondo

In April, 2009 the Global Health Council had the opportunity to
interview Dr. Jane Kengeya- Kayondo from the WHO’s Special Programme for Tropical Disease Research (TDR). Jane presented on capacity building at the Global Health Council’s 2008 Research Symposium and will be facilitating a discussion on the need for more implementation/operational research for scaling up health action at the Global Health Council’s 2009 Research Symposium.

In this interview, Dr. Kengeya-Koyondo discusses:

• TB Diagnostics
• Community Health Workers Treating Malaria
• Shortening TB Treatment Regimens
• Traditional Medicinal Treatments
• Involving Women in Community Health
• Research to Policy Relevance? The Need for Access & Delivery Research

TB Diagnostics

Global Health Council: With a new report indicating the low success rate of rapid TB blood tests, what do you see as the next step in improving TB diagnostics for middle- to low-income countries? For areas of high HIV prevalence?¹

Dr. Jane Kengeya-Kayondo: Microscopic observation of Mycobacterium tuberculosis in sputum smears remains the mainstay of tuberculosis diagnosis in resource-poor countries. The next steps are  therefore to improve sputum smear microscopy through the use of improved microscopes such as light emitting diode(LED) fluorescence systems and to implement smear microscopy quality assurance programs. In appropriate settings, the implementation of new molecular based tests will continue. Research and development efforts into antigen and antibody based detection tools that can be used at the point of care is very important.

It is a priority that each of these interventions responds to the needs of TB patients co-infected with HIV.

Global Health Council: The recent initiative to implement a new molecular-based MDR-TB diagnostic in laboratories across 16 countries will greatly reduce the time lapse for obtaining diagnosis from weeks to days. How will this affect initial misdiagnosis rates of MDR-TB in various clinical settings?¹

Dr. Jane Kengeya-Kayondo: Clinical diagnosis is poorly predictive of drug resistance and new molecular based tests used in sputum smear positive patients have high performance and should allow eradication of misdiagnosis, if used appropriately and with appropriate follow up.

Community Health Workers Treating Malaria

Global Health Council: A recent rectal artesunate application has been found to significantly reduce the death rate and permanent disability incurred by long term (> 6hrs) inaccessibility to malaria treatment clinics. What is the next step to launching this treatment on a greater scale? Or, what research is being done to see if this intervention is suitable for scale-up?²

Dr. Jane Kengeya-Kayondo: These were very exciting results. When the treatment of malaria is delayed, the disease  either kills the child or leaves behind permanent neurological damage.

At the same time as implementing the study to show the impact on death rates and permanent disability, we were already thinking ahead. We carried out a parallel study in different  African countries to answer many of the questions that we knew would arise whether a benefit was shown or not. We called this study the “deployment” study. It was carried out in Ghana, Guinée Bissau, Tanzania and Uganda and evaluated whether rectal artesunate could be given in rural communities by people who are resident there, either because they are community health workers or because they are mothers of young children who get ill.

We knew that critics would say that the community health workers and mothers might be giving the drug in a substandard manner. So the studies also evaluated whether a health worker had any advantage over a mother in providing the drug, and advising the patient to go to the nearest clinic for follow up diagnosis and treatment.

The deployment study has been completed and data are being analysed. We hope that the results will help to answer outstanding questions such as: What is the coverage achieved by minimally trained treatment providers in providing near-home rectal artesunate treatment in real life setting? How should community personnel be trained and supported to make the drug available? Will patients and guardians feel that hospital referral can be deferred after their child has received a suppository or will they adhere to the advice to go to the hospital?

In another multi-country study about to begin in Africa, patients with uncomplicated malaria or severe malaria will be diagnosed with a rapid diagnostic test, and treated with either oral drugs or rectal artesunate depending on their condition. All severe cases will be referred to a hospital whether they are negative or positive for malaria.

In this study, we shall package together three important malaria interventions, that is, rapid diagnostic tests, oral drugs and rectal artesunate.  This will be the first time that such a package has been tried out for practical use. The questions are; is it practicable? Can it improve the number of children who are treated quickly for malaria, that is, within 24 hours of onset of symptoms?

Global Health Council: It is perfectly understandable to package the interventions for the treatment of malaria. However, when a child in malaria endemic parts of the world such as sub-Saharan Africa goes down with an acute fever, they could be suffering from other life threatening illnesses. What is being done to address the needs of an acutely febrile child more comprehensively and the community and home levels?

Dr. Jane Kengeya-Kayondo: This is a very important question. Evidence shows that in Africa, one in every three or four children with malaria will also be suffering from pneumonia. A large proportion of them will also have diarrhoea. In collaboration with UNICEF and other partners, TDR is initiating studies to look at a more comprehensive approach to the management of febrile kids in Africa. In addition to the treatment of malaria, community-based care providers are capable of treating diarrhoea using Oral Rehydration Salts, diagnosing pneumonia using breath rate counting timers and providing antibiotics to those who need them.

Shortening TB Treatment Regimens

Global Health Council: Studies on a shorter, 4-month treatment regimen for TB compared to the DOTS 6-month course are showing promising results. Do you foresee a shorter treatment regimen being successful in reducing patient noncompliance? Does most patient noncompliance occur within the first few months of treatment or the last few

Dr. Jane Kengeya-Kayondo: I indeed foresee a shorter treatment regimen being successful in reducing patient noncompliance. Patients’ adherence to the prescribed regimen is paramount for achieving a sustained conversion of sputum, healing of lesions and recovery. Shortening treatment duration in the context of the DOTS strategy will be a major advance in tuberculosis control.

The current treatment of tuberculosis requires a total of six or eight months of daily drug intake and is further complicated in patients who are infected with both TB and HIV. The results of preliminary studies in India showing that treatment may be shortened when using ofloxacin are extremely interesting.

With the use of other more potent fluoroquinolones such as gatifloxacin and moxifloxacin, there may be greater prospects. What is interesting with Gatifloxacin is that it is not patent-protected in the majority of high-burden countries and is relatively cheap.

With regards to the questions a to whether most patient noncompliance occur within the first few months of treatment or the last few months, this is what I can say.

In general TB patients become non-adherent during the last few months, that is, during the continuation phase of treatment because they  feel better or  become asymptomatic . On the other hand, HIV infected TB patients with oesophagitis due to opportunistic infection may find it difficult to swallow pills within the first few months of treatment, that is, in the intensive phase. Understanding better the determinants of noncompliance would make a good operational research topic!

Traditional Medicinal Treatments

Global Health Council: How is TDR partnering with private sector herbal practitioners in Kenya and other countries to derive potential medicines to be used on a widespread scale and capitalize on this existing knowledge?³

Is there aim to chemically synthesize any promising medicinal compounds found in TDR’s partnership with herbal practitioners and KEMRI (Kenya Medical Research Institute)? If so, how will the potential of resistance to and toxicity of the synthetic drugs be evaluated? If not, are there plans to scale-up production of the medicinal plants in order to ensure successful survival and availability of these compounds?³

Dr. Jane Kengeya-Kayondo: There is a lot of interest in developing countries on increased emphasis on traditional medicines and natural products as a source of innovation in the treatment of diseases. This interest is also expressed in the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property which was recently approved by the World Health Assembly.

TDR has been supporting screening of natural products and traditional medicines as a source of new drug leads for several years and is now seeking to expand this area of work through one of its business lines focusing on innovation for Product development in disease endemic countries. The activity is now helping in the establishment of regional networks of innovation exemplified by the African Network for Drugs and Diagnostics Innovation (ANDI). Challenges in the use of traditional medicines for treatment include standardization and regulation mechanisms. Systems also need to be established for better and proper evaluation and validation of traditional medicines.

Involving Women in Community Health

Global Health Council: At the 2008 Global Health Council’s Research Symposium, you mentioned that an increase in women’s participation in the community was one result of community-directed intervention (CDI). Did this study face any challenges or opposition from certain cultural groups in regards to its effects of empowering women in the community? If so, how were these challenges overcome?⁴

Dr. Jane Kengeya-Kayondo: The qualitative data collected as part of the process evaluation in the CDI study showed that there was an increase in women participation as a result of the general process of community empowerment. From the report, there is no data on “opposition from certain cultural groups to the effects of CDI on empowering women”. My first assumption was to say that if this was an important issue, it would have featured in the results of the qualitative data analysis.

To make sure, I contacted the principle investigators of the various study sites and although I did not receive any answers indicating differently, I received some interesting responses which I will share.

One of the investigators felt that although there were no special interventions trying to enhance women participation, the empowerment of women was a natural and logical consequence of the types of interventions that were used. In three out of the four interventions, women and children were the main beneficiaries. The health care of pregnant women and children is culturally accepted as more of a responsibility of women than of men in the communities.

Another indicated that women were given equal opportunities like men and were recruited to different positions on merit. However, on some occasions, women were given preference particularly on matters that were considered to be of major concern to women and children.

One investigator indicated that there was some initial resentment from the health workers, not any cultural group, and this was not because the implementers were women but because of the fear in the health workers that “lay” persons with limited professional skills and competence were taking away their duties. By engaging the health workers as the trainers of the implementers, this fear was quickly overcome.

An investigator in one site where the population was predominantly Muslim said that an initial rumour from the Muslim areas said that some of the CDI interventions for children and women may have been adulterated with sterilization drugs. If this rumour had been allowed to spread, because of the religious and cultural systems that makes men dominant in family decision-making, there would have been the possibility that husbands would have instructed their wives to reject the CDI interventions. This challenge was quickly overcome through mobilizing the support of traditional, opinion, political and religious leaders for CDI by using them as credible sources of information.

Research to Policy Relevance? The Need for Access & Delivery Research

Global Health Council: TDR’s website featured an article on your presentation on access and delivery research during a panel session at the annual meeting of the Royal Society of Tropical Medicine and Hygiene in September 2008. According to the article, panel participants discussed difficulties posed by the lack of understanding among donors and health policy makers of research-to-policy relevance. Can you elaborate a bit about this lack of understanding of research-to-policy relevance? What are your current thoughts on how to tackle this? What role could an organization like the Global Health Council play?

Dr. Jane Kengeya-Kayondo: The discussion was around the issue of the research on access and delivery for new tools and strategies. The evidence needed in that space between the time when a new tool or strategy becomes available and when it can become part of a policy or an implementation strategy. There is generally a lack of understanding of the relevance of this research and it does not easily strike a cord with donors. This is not surprising because there is a lack of coherence and coordination, a vagueness in precision of definition and ambiguity in methodological standardization. There is a lack of shared targets and indicators as well as limited opportunities for cross learning and transparency.

The strengths of well-undertaken access and delivery research such as (i) its harmonic cutting across the public and the private sectors, (ii) bringing together researchers from the bio-medical, social sciences, public health and health economics sectors, (iii) its power to bridge the “know-do gap” and  (iv) its immediate relevance and utility for meeting health targets and closing the inequity gap have so far remained largely untapped.

TDR plans to bring together those engaged in research for delivery and access for new and improved tools and strategies for communicable diseases, potential beneficiaries of this research, donors and other stakeholders to work together as a constituency  to address the aforementioned shortcoming. The Global Health Council could partner with TDR on this activity.

The timing is right because, on one hand, there are increasing amounts of resources going into the development of new tools such as vaccines, drugs and diagnostics resulting in rich pipelines. On the other hand, resources for large scale application of tools and strategies  are becoming available through various initiatives such as the Global Fund, GAVI and others.

It is pertinent that greater efforts go into access and delivery research for new tools and strategies so that the delay between their availability or formulation and their full utility is minimized.

Global Health Council: What are your views about  having a time dedicated specifically to Research during the annual Global Health Council Conference. How is TDR planning to participate in the 2009 Research Symposium?

Dr. Jane Kengeya-Kayondo: It is an excellent idea to have half a day or even a full day dedicated to research. Scattered all over the conference are sessions, presenters and discussants sharing research results. This is good. The research symposium however provides a neutral platform and  an opportunity to take a strategic view of research, bring relevant leaders and interested participants together, share generic and broad perspectives, raise important questions and agree on follow-up actions.

During the Research Symposium this year, TDR will put on the table for discussion the need for more implementation/operational research for scaling up health action.

References

¹ World Health Organization. 2008. Laboratory-based evaluation of 19 commercially available rapid diagnostic tests for tuberculosis. Diagnostics Evaluation Series No 2. Available from:  http://www.who.int/tdr/publications/tdr-research-publications/diagnostics-evaluation-2/pdf/diagnostic-evaluation-2.pdf

² Gomes MF, Faiz MA, Gyapong JO, Warsame M, Agbenyega T, Babiker A, et al. 2009. Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial. Lancet 373:357-66.

³ BBC World News. BBC World’s Survivors Guide TV series (accessed March 20, 2009), Available from: http://www.who.int/tdr/

⁴ World Health Organization. 2008. Community-directed interventions for major health problems in Africa. Available from:  http://www.who.int/tdr/publications/publications/cdi_report_08.htm