Study Details
To determine the effectiveness of a simple pre- and post-coital penile BZK microbicide wipe in reducing heterosexual acquisition of HIV in men.
A Phase III, two-arm, community-randomized controlled trial.
A total of 24 communities will be randomized in and near the Nchalo Sugar Estate in Malawi (SUCOMA).
24 communities in and near SUCOMA. Approximately 5040 HIV- uninfected men (210 men in 24 communities) will be followed for the primary endpoint.
42 months total.
Pilot study 6 months.
Enrollment 12 months.
Follow-up 24 months.
Intervention communities: will be provided with BZK microbicide wipes and men will be asked to clean the penis before and after every act of sexual intercourse.
Control communities: will not receive the wipes. Both intervention and control communities will receive the following:
Active monitoring of HIV.
Monitoring, diagnosis and treatment of STDs.
Health education, condom promotion and distribution, voluntary HIV counseling and testing.
To determine the effectiveness of a simple pre- and post-coital penile BZK microbicide wipe in reducing heterosexual acquisition of HIV in men.
To determine the effect of a pre- and post-coital penile BZK microbicide wipe in reducing the incidence of sexually transmitted diseases (STDs) in men.