Uganda has started screening women to participate in a multi-country HIV prevention trial testing the use of a vaginal ring at the Johns Hopkins University Research Collaboration (MUJHU CARE LTD) clinical research site, Mulago. The project, A Study to Prevent Infection with a Ring for Extended Use (ASPIRE), is a Phase III study that seeks to determine whether the use of a vaginal ring containing the antiretroviral drug dapivirine is a safe and effective method that protects against HIV infection among sexually active women at high risk.
Speaking in Kampala on Tuesday, ahead of the formal announcement later in the evening, at the ongoing 19th International Aids Conference in Washington, DC, the site Principal Investigator, Dr Flavia Matovu Kiweewa, said about 250 Ugandan participants will be among the 3,476 women targeted across 18 sites in South Africa, Malawi, Zambia and Zimbabwe.
“They will be randomized to receive either the 25mg dapivirine vaginal ring or a placebo vaginal ring,” Kiweewa said, adding that the participants would use the product for a maximum of 24 months.
“If proven effective, vaginal rings will only need to be replaced once every month — it’s like remembering to buy sanitary pads once every month — compared to taking a pill daily or relying on your partner to wear a condom.”
Dapivirine, according to Dr Kiweewa, was chosen because it demonstrated a potential for development as a microbicide, given its potency and fast-acting properties.
ASPIRE is one of the two effective studies of a long-acting microbicide.
The International Partnership for Microbicides is conducting another study called The Ring Study, in parallel with ASPIRE, at four sites in South Africa and one in Rwanda.
The studies come at a time when there are renewed efforts by scientists to find more prevention technologies, the latest being Truvada, a drug for pre-exposure prophylaxis in high-risk groups such as discordant couples.
The US Food and Drug Administration approved Truvada on July 16 and the World Health Organisation this week responded by issuing guidelines on the usage of the drug. It must be used in combination with other existing protective methods such as condom use.
Unlike in the early years when Uganda registered substantive efforts in the prevention of HIV/Aids, the country’s efforts have recently suffered a setback. The 2011 Aids indicator survey showed that HIV prevalence has risen to 7.3 percent from 6.4 per cent in 2006.
Experts blamed the rise on complacency and government’s failure to make use of evidence-based interventions. Ending the global HIV/Aids pandemic will only be possible if a multifaceted global effort that expands testing, treatment, and prevention programmes is implemented, according to a viewpoint in the July 25 issue of JAMA, a theme issue on HIV/Aids, released ahead of the ongoing International AIDS Conference in the US.