A Key Link for Transmission Prevention
Condition: HIV
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Standard HIV prevention messages; BI: Information-Motivation-Behavioral Skills Model; Raltegravir; emtricitabine/tenofovir disoproxil fumarate
Intervention type(s): Behavioral; Behavioral; Drug; Drug
Intervention description(s): A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.; The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.; raltegravir (400 mg) administered orally twice daily for 12 weeks; emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks
Other intervention name(s): Isentress, RAL; Truvada, FTC/TDF
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Acute HIV; Transmission Prevention; Randomized Pilot study