Planned research

Acceptability of the DVD2
Acceptability Study
Location: South Africa

Family Health International (FHI) has developed a new product that makes it easier for women to insert medications and lubricants into the vagina. If shown to be safe and effective, it could be used to apply vaginal microbicides. Known as DVD2, the device is an oval piece of white, non-woven fabric with a string attached to one end to facilitate removal. The soft, pliable material can easily deliver gels, liquids, and creams. In an upcoming acceptability trial in South Africa, women will be asked to assess both the general comfort and the ease of insertion and removal of the device. In the trial, DVD2 will be treated with Pre’® – a vaginal lubricant said to be sperm-friendly. If researchers conclude that the device is acceptable to women, future clinical trials will go on to evaluate whether DVD2 is safe and effective when used with a microbicide to protect against HIV. It could also be used with an anti-fungal cream, a spermicide, or other medication.

Family Health International (FHI) will conduct this study with the Reproductive Health and HIV Research Unit (RHRU) in Durban, South Africa.

Phase III
Location: Madagascar

This study is expected to start in the spring of 2009. The objective is to evaluate the effectiveness of the Ortho All-Flex® diaphragm with BufferGel®, a candidate microbicide, at preventing the acquisition of N. gonorrhea and/or C. trachomatis (GC/CT). Approximately 1540 HIV-negative women aged 15 to 55 with laboratory-confirmed GC/CT infection at screening will be enrolled in this randomized controlled trial consisting of four arms: diaphragm plus placebo gel (HEC), diaphragm plus active microbicide, active microbicide alone, placebo gel alone.  Participants will be followed for six months.
Update June 2009: Because of recent political events in Madagascar, plans for MIARADIA are being revised.

Key Findings: This study has not yet started.

This trial will be conducted by researchers at the University of North Carolina, Chapel Hill; the CDC; and CONRAD. Funding is being provided by the CDC, USAID, and NIAID.

Link to:

• Completed Research
• Ongoing Research