Clinical trial NCT01450189
Conditions: HIV
Keywords: Acute HIV Transmission Prevention Randomized Pilot study
Sponsor: University of North Carolina, Chapel Hill
Start date: 2011-10-01; Completion date: 2014-07-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection. arm 2: Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 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. arm 3: The BIA arm consists of the behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.
Interventions: intervention 1: Standard HIV prevention messages intervention 2: BI: Information-Motivation-Behavioral Skills Model intervention 3: Raltegravir intervention 4: emtricitabine/tenofovir disoproxil fumarate
Intervention descriptions: intervention 1: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection. intervention 2: 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. intervention 3: raltegravir (400 mg) administered orally twice daily for 12 weeks intervention 4: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks

Protocol documents: