BY DICKENS WASONGA – KENYA.
TUESDAY 31st August this year shall remain edged in the mind of Jane Akoth and several others in this part of the world.
Like many residents of Siaya district in Nyanza Province of western Kenya, the forty eight year old mother of three has been looking forward to this particular day with hope.
On this day, Akoth who is HIV positive witnessed Kenya’s Medical Services Minister Professor Anyan’g Nyon’go lead a high powered delegation of top Government officials and development partners from various international organizations in officially opening a multi-million Clinical Research Center [CRC] at the Siaya district hospital which is targetting to enhance health care provision in this region.
For the last eight years, Akoth who has been living positively with the virus has been making ten kilometer trips per month to the district hospital where she receives her anti-retroviral drugs.
But for each visit, She and her equally infected colleagues have to form long queues and scramble for the limited space to be served.
This is the scenario witnessed in most health facilities and research sites found in Africa where the capacity in terms of personnel and even equipment is still wanting.
From 1979 when Kenya Medical Research Institute[KEMRI] began its collaboration with the America’s Centers for Disease Control [CDC], alot of research activities has been on-going in Siaya.
But like in most health facilities linked to various scientific studies in Africa, this site had limited capability to handle large-scale clinical trials.
Now the demeaning experiences like that of Akoth and her colleagues will soon be a thing of the past thanks to spirited efforts by organizations like the Malaria Clinical Trial Alliance[MCTA] which are keen not only to refurbish the existing sites but also to create new and stronger research centers similar to this one in Siaya.
It is good news to people like Akoth because the CRC will also be used as HIV patient support center for the hospital besides hosting various research studies in the future.
Dr. Jactone Omoto the hospital’s medical supperintendent once said when the construction of the CRC was mooted.”We are happy because we will have more space for our patient support center and we will also not have to take our trainings elsewhere anymore.We will do it all here”.
In Nyanza province where the CRC has been built, HIV prevalence is double the national prevalence, at approximately 15 per cent.
According to the Kenya AIDS indicator Survey , among 15-64 year olds in 2007 , 7.1 per cent of the population, which is about 1.4 million people were infected with HIV.
66 per cent had never been tested for HIV among those infected with the deadly virus while 84 per cent did not know their status and among those who knew their status, access to HIV care services was over 75 per cent.
Built at a cost of about ninety million Kenya Shillings , the Siaya Center has a state-of-the art clinical laboratory, a pharmacy , multiple clinics, counseling rooms, training and conference facility, offices and operating theatre.
Its construction was supported through the funding given by KEMRI/CDC, Presidential Emergency Program For Aids Relief [PEPFAR], The Malaria Vaccine Initiative, The Malaria Clinical Trials Alliance, Aeras Global TB Foundation and the Eouropean and Developing Countries Trials Parnership.
” This facility is not only a new and welcome addition to the hospital and the local community, but also to the Kenya Medical Research Institute and Centers For Disease Control’s collaboration which have been conducting extensive research and service delivery activities in the district for the last thirty years.” Said Prof. Nyon’go.
However, the involvement of MCTA in boosting the capacity of many research sites in Africa transforming most of them into mordern centers ready for large-scale clinical trials puts it in a class of its own.
The Alliance which partnered with various organizations to put up the Siaya Center was established in 2006 as a new initiative by the International INDEPTH Network to help conduct clinical trials of new drugs and vaccines to fight malaria, a disease that kills 2000 African children every day.
Malaria had grown resistance to the cheapest and widely used treatment in Africa creating urgent need for the creation of new drugs and vaccines.
Alot was taking place in the world of research with several promising drugs and vaccines being developed. It became increasingly necessary therefore to build African capacity to conduct large-scale trials of these drugs and vaccines over the next decade.
Since its establishment the Alliance has provided training and technical assistance to research centers in several countries across Africa and helped to leverage the capabilities of INDEPTH Network to strengthen global research and development activities targeting malaria.
In Siaya district where the Alliance had a central role in the construction of the CRC, malaria is still a big issue although cases are begining to drop. Currently 40 per cent of children below five years of age and 32 per cent of those above fives years have malaria parasites in their blood.
Besides causing acute illness , malaria infections in this area has resulted in missed school and work days leading to reduced productivity.Cronic malaria infections has also affected growth of children and their performance in school.
Dr. Simon Karuiki, a principal investigator for the malaria vaccine candidate RTS’S at the Siaya site has very kind words for the Alliance.
”MCTA gave this center a huge support.It provided training for our technical staff engaged in the phase three trials of this vaccine.It also provided a digital X-Ray machine, the first of its kind here. In fact this type of machine is only available in the three study sites in Kenya and nowhere at our public hospitals.”Said Dr. Karuiki.
The site which is also supported through KEMRI/CDC collaboration is expected to enroll a total of 1800 children below five years as participants into the final study of the vaccine which has been dubbed the ”magic bullet ”for the malaria parasite.
Kombewa is yet another study site in Nyanza province where 1,360 children under five years of age will be participating in the trials and where MCTA has done a commendable job.
The Center was initially developed by the US Army Medical Research Unit-Kenya[USAMRU-K] and the Kenya Medical Research Institute[KEMRI] with other partners for the study of malaria vaccines and drugs.
According to Dr. Walter Otieno, a Principal Investigator for the RTS’S trial at the center, MCTA donated equipment worth thousands of shillings to establish the microbiology laboratory and today Kombewa joins other centers in the world with the capacity to conduct micribiological investigations.
A scientist at the center was sponsored by MCTA for a masters of science training in Clinical trial and several others attended short trainings in malaria microscopy and also on Good Clinical Practice [GCP].
At the Kombewa site the Alliance also refurbished eleven health facilities in the out-lying areas within Kisumu West district which were linked to the on-going vaccine study.
Numerous exchange programs between participating sites affilliated to MCTA such as the Wellcom Trust/KEMRI site in Kilifi at the country’s coastal strip were also organized and hugely benefitted the staff at the sites.
”Our site is now able to take part in external quality assurance programs and we are more ready now to conduct large-scale clinical trials unlike before.” Said Dr. Otieno.
The Alliance also provided X-Ray facility to Kombewa district hospital which is located right opposite the trial site.
Before the assistance from MCTA, the X-Ray services were lacking at the hospital and all cases where such services were required had to be reffered to to the provincial hospital in Kisumu town which is 40 kiliometers away an patients had to foot huge bills on transport.
According to Dr. Joel Okumu, the hospital’s medical supperintendent, the X-Ray machine has not only improved efficiency but has also increased earnings at the facility.
” Because we are now offering the services at the hospital , our income levels has gone up.We charge a small fee to patients who receive X-Ray services from us as part of cost sharing and we are happy with the MCTA’s support.”Said Dr. Okumu.
Kombewa has developed into a facility that is capable of conducting regulated clinical trials to evaluate vaccines,drugs or diagnostic platforms for a variety pathogens found in sub-Saharan Africa.
The CRC consist of an out-patient clinic,urgent care treatment area, clinical laboratory, specimen processing center, pharmacy and a four- bed observation suite. This center was specifically designed for conducting clinical trials.
Staffed with clinical officers, nurses, lab technicians, pharmacy technicians, drivers and administrative personnel , it is capable of a 24 hour operations through-out the year.
The Kenya’s medical services minister was particularly impressed by the MCTA’s early lead in ensuring that a sustained framework to strengthen clinical trial research centers in sub-Saharan Africa is created.
But even as the MCTA winds up its four year activities at the African sites, hopes and expectations are still very high.
According to Dr. Otieno, there is still need to rehabilitate more of the out-lying health facilities which are linked to the research sites.
He also called for more trainings of personnel working at the sites especially at the masters and PHD levels.
The lead Investigator also noted that most sites still expect mentorship programs to go on and that exchange programs be encouraged so that the sites that are more mature in clinical trials can mentor the younger ones.
And as a parting shot the minister said.”We must bear in mind that the need to continue to develop the human capacity which will move clinical trials agenda in Africa to the next level is still very real and important. Having readily available network of centers with the capacity to conduct GCP compliant clinical trials for timely evaluation of new products and interventions is welcome news that all of us from this continent should appreciate.”
ENDS.
