Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
UN Integrated Regional Information System - November 14, 2008
"The aim of the study is to find out whether pre-exposure prophylaxis [PrEP] prevents HIV acquisition within HIV discordant couples," said Dr Jonathan Wangisi, principal investigator of the study.
The AIDS Support Organisation (TASO), the Institute of Infectious Diseases (IDI) and the US Centres for Disease Control (CDC) will conduct the study in various districts of Uganda. The trials are being undertaken in partnership with the University of Washington, Seattle, and the Bill and Melinda Gates Foundation.
If successful, the project will present a new HIV-prevention method that focuses on a non-traditional high-risk group that has not adequately been targeted. According to the government, at least 42 percent of all new infections in Uganda occur in stable sexual relationships.
The study could also make PrEP a major tool in the fight against HIV/AIDS, and present discordant couples - where one partner is HIV-positive and the other negative - with a means to have children without fear of infecting the HIV-negative partner.
Wangisi said a pill with either tenofovir, or a combination of tenofovir and truvada - both highly effective life-prolonging antiretroviral (ARV) drugs - or a placebo, would be given to the HIV-negative partner. The pill is to be taken orally every day at a time agreed among the participants in the different study sites.
Several recent studies have shown that the odds of the negative partner in a discordant heterosexual relationship becoming infected are very low when the positive person's viral load has dropped significantly as a result of treatment.
The study has a high risk of transmission, so all participating discordant couples will be counselled and encouraged to use all available HIV-prevention measures, including male circumcision, abstinence and condoms.
"PrEP is not a substitute for condoms or other proven HIV-prevention strategies, it is an addition," Wangisi said. "Condoms, if used regularly and properly, are the best medical intervention in HIV prevention for those that cannot abstain."
Dr Kihumuro Apuuli, director-general of the Uganda AIDS Commission, said the study was necessary because of the reported low condom use among HIV-discordant couples and few people knew the HIV status of their long-term sexual partners.
Only 21 percent of Uganda's 30 million people have ever been tested for HIV, but estimates have put the number of new infections at over 100,000 annually, and at least 1.1 million people are infected with HIV.
Modes of transmission include multiple sexual partners, which accounts for 37.3 percent; mutually monogamous partnerships, 35.1 percent, and mother-to-child transmission, 18.1 percent.
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