Clinical Trial Experience

Our team has extensive experience in conducting high quality clinical trials across South Africa. Over
the years, we have partnered with leading national and international research institutions to deliver
scientifically robust studies focused on HIV prevention, sexual health, medical devices, and public
health interventions.

Overview of Key Trials we have supported:

HIV Prevention: Male Circumcision Trials

ANRS 1265 Randomized Controlled Trial

A landmark intervention trial assessing whether male circumcision reduces the risk of HIV infection.

ANRS 12126 CommunityLevel Expansion Study (Orange Farm 2)

Evaluation of the implementation and impact of safe male circumcision services at a community scale.

Early Infant Male Circumcision (EIMC) Pilot Study (USAID / UNICEF)

A feasibility, cost, safety, and acceptability evaluation of an early infant circumcision
programme in South Africa.

Reproductive Health & HIV Prevention Trials

ACIFORM Gel Study (Wits Reproductive Health Institute)

A safety and feasibility study examining a diaphragm and ACIDFORM Gel for reproductive
health applications. Bophelo Trials did not conduct this trial, but was part of the evaluation
team.

Male Genital Hygiene Trial (INSERM)

A Phase III trial assessing whether improved genital hygiene can reduce HIV and STI acquisition among young males.

Medical Device & Safety Trials

Tara Klamp Trial (INSERM & NICD)

A randomized trial in young adult males evaluating the Tara Klamp circumcision device in
South Africa.

PrePex™ Device Trial (USAID / ANOVA Health Institute Institute)

Assessment of the safety and efficacy of the PrePex™ nonsurgical circumcision device.

CircumQ Device Trial

A randomized controlled trial to build the clinical profile for a new VMMC (Voluntary Medical
Male Circumcision) device undergoing prequalification.

Male Circumcision - single use, disposable commodity procedure - Kits Trial

A randomized controlled trial evaluating the safety of disposable male circumcision kits used
in South Africa.