Women who took part in two clinical trials on the efficacy of a vaginal ring as an HIV prevention tool in Uganda, South Africa, Malawi and Zimbabwe, will now be enrolled in an open label extension study.
Results from the two trials — Aspire and Ring — were released in February and showed an overall 27 per cent and 31 per cent risk reduction in HIV infection respectively among trial participants. A total of 4,588 women volunteers aged 18-45 were enrolled in the two clinical trials.
Dr Flavia Matovu, a researcher on the Aspire study at the Uganda site said that the open label extension trial aims to further establish if the ring can offer increased protection against HIV in a setting where all those enrolled are using the ring containing the antiretroviral drug dapivirine.
The ring, which is made of a flexible silicone material impregnated with the ARV drug is inserted into the vagina, where for a month it slowly releases the drug to the site of potential infection in the body. This subsequently helps protect women from contracting HIV from their positive partners.
“In this follow-up study, we shall largely be gathering data on adherence and acceptability of the ring,” said Dr Matovu.
One of the challenges the previous study faced was low adherence, especially among women aged 18 to 21, as researchers found women in this age category across the four countries did not use the ring consistently compared with their older counterparts.
“Some would remove it before the one-month period elapsed for various reasons, thereby leading to non-or low adherence,” said Dr Matovu.
Dr Clemensia Nakabiito, the principal investigator of the Aspire study at the Makerere University-Johns Hopkins University Research collaboration centre said the new study is similar in design to the previous one, and participants will be followed up for a period of one year.
Three rings, three months
They will also be regularly tested for HIV and other sexually transmitted infections, offered counselling, tested for pregnancy and given other HIV prevention options such as condoms.
In the new study, the participants will be given a monthly ring for the first three months and thereafter three rings to last three months before they return to the facility for new ones.
“We want to assess the feasibility of a three-month follow up instead of the monthly follow-up that we used in the previous study,” said Dr Matovu.
After three months, the participants will return to the health facility with all the used rings, which will then be tested to establish the level of drug in them. This will help the health workers to ascertain the level of adherence or consistency in the use of the ring.
Health experts say because women are disproportionately affected by HIV, especially in sub-Saharan Africa, where they account for 60 per cent of all adults living positively, developing prevention tools that specifically target them will be key in reducing the risk of infection.