HIV Clinical Trial
Official title:
Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study
This pilot study will assess the feasibility for the potential public health benefit of
behavioral and antiretroviral interventions during acute HIV infection.
Central Hypothesis The investigators hypothesize that delivering behavioral and
antiretroviral interventions to acutely infected persons will reduce onward transmission.
The HIV epidemic in sub-Saharan Africa is severe and continues to grow. In urban areas of
Malawi, 19% of pregnant women seeking antenatal care and 15.6% of Malawians aged 15-49 years
were infected with HIV in 2007. Prevention interventions that prevent onward transmission of
HIV are urgently needed.
Persons with acute HIV infection (AHI) may be responsible for a substantial proportion of
onward transmission of HIV infection. AHI is characterized by unfettered replication of HIV
in a "ramp up viremia". The high concentration of HIV in blood and genital secretions remains
elevated for up to 10-12 weeks before it declines to the levels observed in established
infection. These high levels of HIV shedding in the genital tract are likely to produce very
efficient sexual transmission and the proportion of virions that are infectious may be
substantially higher during acute compared to chronic infection. Consequently, the
probability of transmission during unprotected intercourse for those with AHI is very high.
Identifying persons with AHI and intervening to reduce onward transmission represents a
tantalizing, but unproven, opportunity for HIV prevention.
To have maximal impact, a prevention program targeting AHI must identify a substantial number
of acutely infected persons and intervene quickly to minimize onward transmission. An
effective immediate intervention would require behavioral modification to limit sexual
partners and unprotected sex acts, and a biological intervention to reduce infectious viral
burden in genital secretions. This is the first study to pilot a combined behavioral and
biomedical intervention in individuals with AHI to reduce onward transmission of HIV.
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