KAMPALA, 3 July 2013 (IRIN) - In May, the UN World Health Organization (WHO) announced the prequalification of PrePex, the first non-surgical device for adult male circumcision. Compared to surgical circumcision, the device has fewer complications and is easier and quicker to use, allowing lower-cadre medical workers to be trained to perform the procedure.
Randomized, controlled trials in 2006 found that male circumcision reduced a man's risk of contracting HIV through vaginal intercourse by as much as 60 percent.
Fourteen African countries in eastern and southern Africa plan on circumcising a total of 20 million men by 2016 in an effort to curb the transmission of HIV. A number of these countries are lagging behind on their targets, and feel the PrePex device will give their programmes a much-needed boost, while others are more cautious.
Malawi's Ministry of Health plans to adopt and roll out the PrePex device once it has completed safety and acceptability studies targeting 2,000 clients in the districts of Nsanje, Lilongwe and Mulanje. The studies are due for completion in August.
"We hope that the results will assist us to scale-up the services, because already more males have been asking for this device," said Henry Chimbali, health promotion and communications officer for HIV prevention and behaviour change at the Ministry of Health. "It is also most likely going to reduce costs of providing VMMC [voluntary medical male circumcision], because currently we use VMMC disposable kits, as well as costs of human resource and also perhaps adverse events."
As of March 2013, a total of 42,700 Malawian men had been circumcised since the October 2011 start of the programme - an estimated 350,000 adult males were circumcised prior to the programme. The ministry aims to reach some 1.8 million adult males by 2015.
In Kenya, the Male Circumcision Consortium (MCC), in collaboration with the National AIDS and STIs (sexually transmitted infections) Control Programme (NASCOP) and the Nyanza Reproductive Health Society (NRHS), welcomed the approval of PrePex, but called for more studies to assess its acceptability and safety in local healthcare settings. The organizations are currently conducting the second phase of study to assess the efficacy of PrePex-assisted male circumcision among 425 men in routine health-care settings in western Kenya's districts of Kisumu and Rachuonyo; results are expected by September.
"The outcome will provide the government with information and recommendations on the adoption of this device," MCC project manager Mathews Onyango told IRIN. "There are some issues that have not been addressed by the WHO prequalification, such as cost, acceptability... These might vary from country to country and, thus, like in Kenya, our study will address its safety and acceptability, especially within a larger population."
"Different countries have varying needs and they would need to ensure that they introduce the non-surgical devices to fit within their context," he added.
The first phase of the Kenyan study assessed 50 men to ascertain the safety of the device in Kisumu. The committee of independent experts reviewed the results, found no safety concerns, and recommended that the study proceed to the second phase.
Kenya's programme aims to reach 80 percent of men between 15 and 49 years old - some 860,000 men. Since the programme was launched in 2008, it has reached more than 420,000 men.
In Rwanda, the government plans to roll out the device and scale it up to health facilities, following its successful trials at Nyamata and Kanombe military hospitals. Officials say it saves both time and money. Following the research, Rwanda announced in 2011 that it would be rolling out its VMMC programme using PrePex.
"We believe that the PrePex is the only circumcision method that will allow us to meet the goal of [circumcising] over 1.5 million men in two years," Vincent Mutabazi, lead investigator in the Rwandan PrePex studies. "Several campaigns and numerous training[s] of new PrePex healthcare providers have taken place. Some 5,000 men were circumcised outside of [the] clinical environment in Rwanda since [February 2012]... In the upcoming months, more than 200,0000 procedures are expected."
"Safer, faster and reduces discomfort"
In Botswana, the health ministry, in collaboration with the US Embassy, the African Comprehensive HIV/AIDS Partnership (ACHAP) and Jhpiego, an affiliate of the US's Johns Hopkins University, are carrying out pilot research at Nkoyaphiri Clinic, Mogoditshane and Block 8 Clinic in the capital, Gaborone. The study targets 1,000 HIV-negative men aged 18 to 49 to evaluate the effectiveness and safety of PrePex; so far 330 adults have been circumcised in the study, which ends in September.
"The results of this study will determine its roll out in the country. There is no doubt that the PrePex and any other acceptable and safe circumcision device will boost circumcision not only in Botswana but in all countries involved in the programme," said Benjamin Binagwa, VMMC programme manager at ACHAP. "The advantage of having these devices is that they can be used by other health staff other than doctors."
He continued: "Any device that makes a surgical procedure safer, faster and reduces discomfort or pain is always a welcome component of the health service. From current experiences with the PrePex, the device provides the aforementioned to a great extent. Therefore its incorporation in the Safe Male Circumcision programme... is a welcome development."
"Training of both nurses and doctors on use of the PrePex device is less technically demanding since it does not involve use of injections to prevent pain, there is no cutting of live tissues and thus no need to control bleeding, and no need for stitches," Adrian M Musiige, safe male circumcision programme manager for Jhpiego, told IRIN. "The same technical properties of the device also address some important barriers to male circumcision for some men who still associate conventional male circumcision surgery [with] pain because of the involvement of injections, surgical blades, some bleeding and stitches."
A total of 75,604 men aged 13 to 49 years have been circumcised in Botswana since the campaign was launched in 2009; the national target is 385,000 men by 2016.
In Tanzania, where some 415,000 people out of the targeted 2.8 million had been circumcised as of March 2013, participants in one ongoing study in the country's central-western region of Tabora are already showing high levels of acceptability. But rolling out the procedure using PrePex may face operational challenges.
"I am definitely sure that the use of device in Tanzania will be approved," said Jackson Lija, head of biomedical prevention in Tanzania's Clinical STI, HIV and Circumcision Services. "Our main problem to scale it up will be funding. We are struggling. Currently, we have a funding problem that is affecting the conventional male circumcision. PrePex is likely also to be affected with the same."
In South Africa, the health department plans to have "formal talks" with traditional leaders about the possibility of introducing a Prepex device to circumcision ceremonies, Thobile Mbengashe, national HIV director, told the Mail & Guardian.
He said the country was behind on its male circumcision targets - 4.3 million men by 2016 - and was "unlikely to achieve its goals if additional modalities that can help to scale up the medical circumcision process are not introduced".
Ugandan officials say WHO prequalification of PrePex was anxiously awaited and will boost the country's programme, which has, since 2010, reached 380,000 men - a fraction of the 4.2 million men it aims to have circumcised by 2015.
"The National Task Force [on safe male circumcision] and the ACP [AIDS Control Programme] welcomes the approval and will go through the process of including its use in the guidelines," said Alex Ario, programme manager for the ACP. "The device will definitely lead to increased access and acceptability of safe male circumcision among young males."