Title: Behavioral And Social Science Monitoring Of CONRAD Phase III Clinical Trial Of Cellulose Sulfate 6% Microbicide Gel

Sponsor : CONRAD
Funded by : Family Health International

Principal Investigator
 
Nii Hammond
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Study Summary

The objectives of the BSS study were to assess how communities and trial staff understood the decision to terminate a multi-site Phase III clinical trial to test the effectiveness of Cellulose Sulfate as a topical microbicide agent to prevent HIV transmission to women.

The Cellulose Sulphate (CS) study was to last approximately two years and had been ongoing in India, Benin, Burkina Faso, Uganda, and South Africa. Although the trial had not begun in Zimbabwe (Chitungwiza), the  sudden closure of the trial at other sites had the potential to raise questions among the research communities, current and potential participants of  ongoing microbicides trials, clinical trial  staff and other various stakeholders in which the CS trial was likely to take place.  

The Independent Data Monitoring Committee (IDMC) recommended that the study be stopped after interim results showed more HIV infections among those who used Cellulose Sulphate than those who used an inactive gel.

The BSS collected Data (perceptions and concerns) from in-depth interviews and focus group discussions aimed at individuals and stakeholders that were likely to be affected by the closure of the CS Study. These interviews were conducted in Chitungwiza and Harare.

Project period : March 2007 to July 2007

The Zimbabwe site completed data collection end of July 2007. Data is still being analysed.

Study Contacts

1)  Constancia Watadzaushe ( Study Coordinator )
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2)  Nii Patty Alleman
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