HIV Prevention

Despite countless policies and interventions by global bodies and organisations, the HIV infection rate continues to rise worldwide, with recent statistics accounting for 38 million HIV infections worldwide, with the majority (66%) of these infections occurring in Sub-Saharan Africa.

 

Male circumcision has been recognised by the WHO and UNAIDS as a priority intervention in reducing the incidence of HIV.

 

According to the WHO, globally there are 5. 500 new HIV infections every day. The overwhelming majority of transmission occurs through sexual intercourse.

As for the emergency response to HIV/Aids, the implementation of evidence-based scientific studies in upscaling programs is challenging but more readily achievable.

Antiretroviral medication (ARV’s) is proven to be effective in the prevention of HIV transmissions (up to 90%), but this is a costly solution. Adding pressure to the already overburdened health services in priority countries in Sub-Saharan Africa is not a scalable, cost-effective or timeous solution.

 

Current methods for managing sexual HIV transmissions include:

  • Abstinence
  • ARV’s
  • Use of condoms
  • Circumcision

 

Circumcision is the only one of these methods that offers a once-off solution that is not behaviour-dependent.

 

Presently, male circumcision is the most cost effective way of fighting HIV as it reduces the incidence of HIV transmission by 60%.

 

Circumcisions can be performed by surgical method or by using a circumcision device. The search for a circumcision device that can safely and cost effectively fast track male circumcisions continues.

The Unicirc® target market is male circumcision from infants to adults in Southern Africa, Africa, and globally.

THE EPIDEMIC IN NUMBERS IN ABOUT 2009:  

 

More than half of all people living with HIV, globally, are women (59%).

 

Eastern and Southern Africa

 

  • 2 million people living with HIV.
  • 940 000 people newly infected with HIV, of which 93 000 are children
  • 460 000 people died from Aids-related causes in 2014

 

 Western and Central Africa

 

  • 6 million people living with HIV, including 3.8 million

women and 730 000 children

  • 420 000 people acquired HIV, and 330 000 people

died from Aids-related causes

 

Asia and the Pacific

 

  • 5 million people living with HIV, 90% of which reside in six countries: China, India, Indonesia, Myanmar, Thailand, and Vietnam.
  • Women account for a growing proportion of new HIV

infections, up from 17% in 1990, to 34% in 2014.

  • New infections rose by 3% between 2010 and 2014,

reaching 340 000 in 2014

 

 Latin America

 

  • 7 million people living with HIV
  • 87 000 people acquired HIV in 2014 – one third were

people aged 15 to 24 years

 

 

Eastern Europe and Central Asia

 

  • 5 million people living with HIV
  • Number of people acquiring HIV rose by 8% between 2010 and 2014, reaching 140 000 in 2014, primarily among people and their sexual partners who inject drugs.

 

 

North America

 

  • Nearly 1.4 million people living with HIV, with 1.2

million living in the USA

  • One in eight people living with HIV in the USA and

one in four in Canada are unaware of their HIV status.

  • In 2013, the highest rates of new diagnoses occurred

among people aged 25 to 29 years old, followed by

people aged 20 to 24 years

 

 

Western and Central Europe

 

  • More than 1 million people living with HIV, nearly 80% of them are men
  • The number of men who have sex with men acquiring HIV increased by 33% in the past decade and represented 52% of people reported to have acquired HIV with known mode of transmission in 2013.

 

 

Middle East and North Africa

 

  • 240 000 people living with HIV, of which almost
  • 70% live in the Islamic Republic of Iran, Somalia and Sudan
  • The number of people dying from AIDS-related causes has more than tripled between 2000 and 2014 with 12 000 deaths in 2014
  • 14% of adults and 15% of children aged 0 to 14 years living with HIV have access to antiretroviral therapy, lower than any other region.

UNICIRC® CLINICAL TRIALS

 

 

UNICIRC® 001 RCT, January 2014 (Version UC, manufacturing date February 2013).
http://www.samj.org.za/index.php/samj/article/view/ 7357/5745

 

UNICIRC® 002 Quasi-experimental study July 2014 (50 surgical vs 50 Unicirc). (Version UC0, manufacturing date April 2014). All relevant details with regard to anaesthesia, tissue adhesive and dressing are found in the above paper. https://clinicaltrials.gov/ct2/showNCT01998360 term=unicirc&rank=4

 

UNICIRC® 003 Case series. September 2014. “No-needle, single visit adult male circumcision with Unicirc: a multi-centre field trial” (Version UC0, manufacturing date April 2014). http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0121686

 

UNICIRC® 004 RCT Rustenberg / Marikana, Sept 2015.
(Version UC0, manufacturing date April 2014). “Sutureless adult voluntary male circumcision with topical anaesthetic: a randomized field trial of Unicirc, a single-use surgical instrument PONE-D-15-51577R1”.

 

UNICIRC® 005 RCT  Minimally invasive, suture less young adolescent male circumcision with topical anaesthetic:  field trial of Unicirc, a single use surgical instrument: Trans Andrology and Urology 2019 http.//dx.doi.org/10.21037/tau.2019.12.16

UNICIRC® PUBLICATIONS

WORLD WIDE PUBLICATIONS AND SCIENTIFIC EVIDENCE of use of UNICIRC

 

1.Millard PS, Wilson HR, Goldstuck ND, Anaso C. Rapid, minimally invasive adult voluntary male circumcision: A randomised trial of Unicirc, a novel disposable device. South African Med J. 2014; 104:52-7.

http://dx.doi.org/10.7196/samj.7357

 

2.Millard PS. A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision (NCT01877408). Accessed 08/12/2014; Available from:

http://clinicaltrials.gov/ct2/show/NCT01877408? term=unicirc&rank=3.

 

3.Millard PS. Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study (NCT01998360). Accessed 08/12/2014; Available from:

http://clinicaltrials.gov/ct2/show/NCT01998360?term=unicirc&rank=2.

 

4.Goldstuck N, Millard PS, No-needle, one-stop adult male circumcision with Unicirc: a multi-centre field trial. Minimally invasive male circumcision 2014, Plos one: March 2015

 

5.Millard PS (2012) Circumcision – whats wrong with plastic rings? S Afr Med J 102 126-128

 

6.Goldstuck N, Androl Gynecol: Curr Res 2014, 2:3

http://dx.doi.org/10.4172/2327-4360.1000123

 

7.The characteristics of circular disposable devices and in situ devices for optimizing male circumcision: a network meta-analysis. By Fan et al., May 2016
http://www.ncbi.nlm.nih.gov/pubmed/271563682016

 

8.Review – European Urology Focus: Novel Devices for Adolescent and Adult Male Circumcision Omar Al Hussein Alawamlh, Soo Jeong Kim, Philip S. Li, Richard K. Lee * Department of Urology, James Buchanan Brady Foundation, Weill Cornell Medical College of Cornell University, New York, NY, USA

http://www.europeanurology.com/eufocus(2018) 239-332.

 

9.Minimally invasive, sutureless, young adolescent male circumcision with topical anesthetic: a field trial of Unicirc, a single-use surgical instrument

Peter S. Millard, MD PhD1 Norman Goldstuck, MBBCh2

Trans Andrology and Urology 2019

http.//dx.doi.org/10.21037/tau.2019.12.16

 

The Unicirc® is the only surgical assist instrument for circumcision, discussed in the recent WHO circumcision guidelines (August 2020). Preventing HIV Through safe voluntary medical male circumcision for adolescent boys and men in generalized HIV epidemics: recommendations and key considerations. Geneva: World Health Organisation :2020.Licence:CC BY-NY-SA-3.0 IGO 

 

Unicirc Regulatory

CE 1434 Certified
SAHPRA License (South African Healthcare Products Regulatory Authority)
ISO 13485:2016 Certificate for Legal Manufacturer
HPCSA (Health Practitioners Council of South Africa) accredited training program

FSC -Free Sales Certificates

Discovery Health SA (private health fund) approved for Health Provider re-imbursement in South Africa