Clinical Trials

Trials

Randomized controlled trails

Community based trails

Clinical trials

Phase 1 up to Phase 3 trials – Safety and Efficacy trails

 

Trial Experience: 

 

  • Male Circumcision Trial: ANRS 1265 Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk

 

  • Male Circumcision Trial: ANRS 12126  Evaluation of the Extension at Community Level of Safe Male Circumcision (Orange Farm 2)

 

  • Tara Klamp Trial: INSERM (Paris, France) NICD (Johannesburg SA) Tara Klamp technique for medical circumcision of young male adults: A randomized trial in South Africa.

 

  • PrePex™ Device Trail: Safety and Efficacy of the PrePex™ Male Circumcision Device South Africa.

 

  • Early Infant Male Circumcision Trial: A Pilot Study Evaluating the Feasibility, Cost, Safety and Acceptability of an Integrated Early Infant Medical Circumcision (EIMC) Program in South Africa

 

  • CircumQ Circumcision Device Trial: A Randomized Control Trial for Building the Clinical Profile for a New VMMC Device Application for Pre-qualification Dossier

 

  • ACIFORM Gel Trial: Safety and Feasibility Study of the diaphragm and ACIDFORM Gel – RHRU

 

  • Hygiene Trial: Phase III trial to evaluate the preventive effect of male genital hygiene on the acquisition of HIV and other STIs by young males in South Africa – INSERM

 

  • Male Circumcision Kits trial: A randomized controlled trial conducted in South Africa, Safety of a disposable male circumcision kit.

 

Trial expertise:

 

Dr Dirk Taljaard has been a Project Manager, Local Principal Investigator and Study Principal Investigator on some of these trails.

 

Dr Ntlotleng Mabena has been a project manager, Clinical Expert and Investigator on some of these trials.

 

 

Clinical Trial considerations:

 

Bophelo Pele have scientific and management, but importantly, also technical and recruitment staff who have years of experience in performing Clinical Trials.

 

Bophelo has access to a number of communities where trials can be performed, but the most important of these is the Orange Farm site, where the first randomized Trial for Medical Male Circumcision was performed.  A world famous site.

 

Bophelo has a number of sites available for Clinical trials in the City of Johannesburg District, in Gauteng Province, of South Africa.

 

Bophelo Pele has built excellent relationships with communities over years, facilitating quick access, but more importantly, community approval and support.

 

Bophelo has a great track record of completing studies, within budget, on time!

 

Anyone who has ever done a trial will know: recruitment of participants in your trail is one of the most challenging aspects.  Imagine trying to convincing a large number of healthy young men to undergo a medical male circumcision procedure!  Yet… we were able to demonstrate benefits to the young men in the community that persuaded them to take part in the trail.  We completed inclusion in the trial on time and within budget!  We can definitely recruit participants for your trial.

 

Bophelo can be as involved in your study as you want us to be.  If you are just looking for an additional site, but want to manage the trial yourself, we can certainly provide you with an array of different services you can pick from as may be required.

 

The balance Bophelo can strike between cost, scientific rigor and excellent management, we believe, is unrivaled.

 

 

 

Research Interests

 

The Directors and the team have a huge amount of experience in this area, as well as a wealth of historical data that can be used as baselines for many research related endeavors

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Research Projects

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Operational Research Projects

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Clinical Trials

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Program Implementation

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Medical Projects

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Bio-medical Projects