Study Details

Protocol Status:
Study Purpose:

To determine the effectiveness of a simple pre- and post-coital penile BZK microbicide wipe in reducing heterosexual acquisition of HIV in men.

Study Design:

A Phase III, two-arm, community-randomized controlled trial.

Study Population:

A total of 24 communities will be randomized in and near the Nchalo Sugar Estate in Malawi (SUCOMA).

Study Size:

24 communities in and near SUCOMA. Approximately 5040 HIV- uninfected men (210 men in 24 communities) will be followed for the primary endpoint.

Study Duration:

42 months total.
Pilot study 6 months.
Enrollment 12 months.
Follow-up 24 months.

Treatment Regimen:

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.

Primary Objectives:

To determine the effectiveness of a simple pre- and post-coital penile BZK microbicide wipe in reducing heterosexual acquisition of HIV in men.

Secondary Objectives:

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.

Study Sites List