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The Safety and feasibility study of the diaphragm used with Acidform gel or KY Jelly

Project Focus
HIV/AIDS;STIs; Contraception

Project Location
Yeoville, Johannesburg

Duration of Project

Project Partners
Contraceptive Research & Development (CONRAD), National Institute of Communicable Diseases (NICD), Progressus

Project Donors


Dr Claire Von Mollendorf

Project Aims /Objectives
There has been a resurgence of interest in the role of the cervix in HIV transmission and therefore the potential of a cervical barrier in the prevention of HIV transmission needs to be explored. The diaphragm is a well established moderately effective barrier contraceptive which has been safely used in combination with spermicides for many years. The RHRU examined the safety and acceptability of a fitted latex diaphragm when used with ACIDFORM or a placebo gel.

The main outcome of interest in this study is the safety and acceptability of using the diaphragm, with a microbicide gel, the specific objectives are:
  • To compare and assess the effect of a diaphragm and ACIDFORM gel or K-Y Jelly use for 6 months by HIV negative sexually active women on symptoms and signs of irritation of the external genitalia, vagina and cervix, including disruption of the epithelium as seen on colposcopy;
  • To assess the participant’s willingness and ability to use the diaphragm with a gel applied prior to each vaginal sexual act for a period of 6 months.
The secondary objective is:
To assess and compare the effect of 6 months use of a diaphragm with ACIDFORM gel or K-Y Jelly on wet mounts, pH, gram stains, urinary tract infection and cervico-vaginal lavages for cykotines.

Project Activities
The study ran for a total period of 18 months, starting in April 2004 and involved recruitment of 120 sexually active, low risk women from the community, followed up for 6 months. At enrollment, month 2,4 and 6 a gynecological examination, colposcopy, cykotine assessment and urine test for infection and pregnancy was done. At enrollment, month 3,5 and 6 a questionnaire was administered to obtain behavioral data.

Enrolment, follow up and clinical close out have been completed, with the focus now on data analysis and dissemination.

Anticipated/Actual Results
The outcome of this research will provide the foundation for the planning and implementation of a Phase III trial of a microbicide and diaphragm to prevent HIV infection in the future.

Additional Outputs
Community engagement and stakeholder relationships

Future Plans
Further Phase I/II clinical trials in this community; further development of microbicide research and phase III trials

Projects in the STI's & HIV Research Cluster:

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