THE President's Emergency Plan for AIDS Relief (PEPFAR) Tanzania is keeping a close eye on the completion of evaluations and new guidance of the outcome of clinical trial tests of a new approach for preventing HIV in women.
The PEPFAR Tanzania Media Outreach Coordinator, Mr Jim Yates, told the 'Daily News' over the weekend that before the vaginal ring that will be used once a month can be considered in the country, evaluations and guidance need to be in place.
"PEPFAR Tanzania along with the Ministry of Health and Social Welfare will have to wait for evaluations then determine if the ring is a viable method of HIV prevention in the country," he said.
ASPIRE - A Study to Prevent Infection with a Ring for Extended Use - is a Phase III trial evaluating a vaginal ring that contains dapivirine, a potent anti-retroviral (ARV) drug originally developed to treat HIV.
According to the Microbicide Trials Network (MTN) statement, the ring slowly releases dapivirine to cells inside the vagina throughout the one-month period that it's worn, potentially giving women discreet, long-acting protection against HIV transmitted through sex.
Dr Saidi Kapiga of the London School of Hygiene and Tropical Medicine, who is coordinating the ring study in Africa and has also conducted tests of vaginal gels for HIV protection, said there are already signs that women prefer the new option.
"It is acceptable. The fact that they use it only once in four weeks was a major advantage," Dr Kapiga said during XIX International AIDS Conference (AIDS 2012) in July, this year.
Of the more than 34 million people living with HIV, half are women and women account for 59 per cent of adults with HIV in sub-Saharan Africa, where unprotected heterosexual intercourse is the primary driver of the epidemic.
Young women are especially vulnerable; women aged 15 to 24 are up to five times more likely to become infected with HIV than young men. Efforts to promote abstinence, monogamy and the use of male condoms have not been enough to stop the HIV epidemic nor are these practical methods in many settings.
The results of ASPIRE, which are expected late 2014 or early 2015, together with results of The Ring Study, as well as smaller, supporting studies, will form the basis of an application that IPM plans to submit to regulatory authorities seeking approval of the dapivirine ring for widespread use.
Nearly 3,500 women in Africa will take part in ASPIRE, which is being led by the Microbicide Trials Network (MTN) and funded by the National Institute of Allergy and Infectious Diseases and the National Institute of Mental Health, which are part of the US National Institutes of Health.
Makerere University-Johns Hopkins University Research HIV Clinical Trial Unit in Kampala, Uganda, late last month began screening women interested in joining the study.
At a second site, at the Emavundleni Research Centre at the Desmond Tutu HIV Foundation, University of Cape Town, South Africa screening of potential participants also begun earlier this month. The MTN hopes to conduct ASPIRE at a total of 17 sites in Malawi, Uganda, South Africa, Zambia and Zimbabwe.
ASPIRE is designed to enroll approximately 3,476 HIV-negative women between the ages of 18 and 45 who will be randomly assigned to use either the dapivirine ring or a placebo ring that looks the same but contains no active drug.
Participants will be instructed on how to insert and remove the ring, which they will replace every four weeks over the course of the one to two years they are in the study. All participants will receive the on-going HIV risk reduction counselling, condoms and diagnosis and treatment of sexually transmitted infections (STIs).