The Safety and feasibility study of the diaphragm used with Acidform gel or KY JellyProject Focus
Duration of Project
Contraceptive Research & Development (CONRAD), National Institute of Communicable Diseases (NICD), Progressus
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:
The secondary objective is:
- 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.
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.
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.
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.
Community engagement and stakeholder relationships
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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