HIV Prevention Research Unit
A
Feasibilty Study in Preparation for Phase III Microbicide Trials Among Women
Attending Postnatal and Family-Planning Clinics in Tongaat and Verulam Health
Clinics
http://www.mdp.mrc.ac.uk
Principle Investigator: Dr Gita Ramjee
Project Leader/s: Dr Brindha Ramkylas and Ms Shamantha Naiker
Sites: Tongaat and Verulam, Kwazulu-Natal
Background
The Microbicides Development Programme (MDP) is a partnership set up to develop
vaginal microbicides for the prevention of HIV transmission, funded by the
UK Department for International Development through the UK Medical Research
Council and co-ordinated by the MRC Clinical Trials Unit and Imperial College
London. The ultimate goal of the MDP is to develop effective microbicides.
Two vaginal microbicides:
dextrin sulphate and PRO2000 have undergone safety assessments in the UK,
Belgium, and South Africa. These agents are ready to enter a proposed Phase
III trial in 2004. Dr Gita Ramjee, in collaboration with the British MRC and
other scientists submitted a proposal for a programme grant for Vaginal Microbicides
to the Department for International Development (DFID). Funding of £16
million was awarded to the group.
However prior to embarking
on the Phase III microbicide study, it was necessary to conduct a Feasibility
Study to establish whether a significant number of women could be recruited
and retained in the study for its duration. The information obtained in this
study provides data on the suitability of the site for a future Microbicide
study.
The Feasibility Study
is currently being conducted over a 15-month period in Tongaat and Verulam,
areas in northern Durban.
Objectives
Primary
 |
to investigate the
incidence and prevalence of HIV infection |
|
to investigate the
frequency of male condom usage, assessed with a semi – structured
questionnaire and coital log. |
|
To determine the
retention of the study population in a 12 month follow up period |
Secondary
|
To estimate incidence
and prevalence of STIs |
|
Acceptance of gynecological
examinations |
|
