Bophelo Pele have started to create Cohorts for possible research. In these Cohorts we can then select what type of population researchers need for the study they want to undertake. We created Cohorts with consent in terms of the POPIA Act, to make it legal and ethical for us to contact possible participants for studies.
We have background demographics on a large number of individuals in three provinces already. A strong point of these cohorts that we have built, is that we in most cases have a clinical or medical record of patients. Some individuals in the cohort are healthy and have not visited a health facility for treatment. We are thus also able to draw a sample of specific clinical profiles or completely healthy individuals.
We also started capturing COVID details of individuals, if they had COVID and when, as well as their vaccination status. Recruitment of Trial participants remain one of the most challenging parts of most trials. Our pre-prepared cohort can help to greatly reduce the time and cost for recruitment of Trial Participants for your clinical, or behavioral trails. Performing trails in South Africa is very Economical, but there is enough expertise available locally to ensure the highest level of quality and scientific rigor. So, our network in South Africa is a good compromise for any researcher. Please don’t hesitate to use “Contact Us” on the site for initiating a comprehensive discussion or just to have a chat.
Randomized controlled trails
Community based trails
Phase 1 up to Phase 3 trials – Safety and Efficacy trails
- 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, USAID through ANOVA Health Institute
- Early Infant Male Circumcision Trial: (USAID through a Partnership Cooperative agreement with UNICEF) 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 – Reproductive Health Research Unit [Now called Wits Reproductive Health Institute (WRHI)]
- 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 (U88) Saint-Maurice the Hôpital, France
- Male Circumcision Kits trial: A randomized controlled trial conducted in South Africa, Safety of a disposable male circumcision kit
Dr Dirk Taljaard has been a Project Manager, Local Principal Investigator and Study Principal Investigator on most of these trails.
Various clinicians, administrative and data professionals, as well as Community partners with substantial experience with Trials work in association with Bophelo.
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 a number of available sites for Clinical Trials in 4 Provinces (Gauteng, Free State, Northern Cape and North West) of South Africa.
One of our sites available for Clinical and Community based trials is the world famous Orange Farm site, where the first Randomised Controlled Trial for Voluntary Male Circumcision was performed.
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.
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