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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
46
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
Lighthouse Trust, Kamuzu Central Hospital
Lilongwe, Malawi
UNC Project
Lilongwe, Malawi
Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
Time frame: 1 year
Prevalence of AHI Among Persons Screened
Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.
Time frame: 1 year
Proportion of Persons With AHI Successfully Recruited Into the Study
This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.
Time frame: 1 year
Proportion of Participants Completing Full Course of ARVs in Arm BIA
Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that
Time frame: 1 year
Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.
In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.
Time frame: 1 year
Proportion of Persons Completing All Scheduled Visits in Each Study Arm
Time frame: 1 year
Number of Adverse Events
Mean number of adverse events per group
Time frame: one year
Unprotected Sex Acts in Previous One Week - 12 Weeks
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emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks
The mean number of unprotected sex acts in previous one week, assessed at 12 weeks
Time frame: 12 weeks
Unprotected Sex Acts in Previous One Week - 26 Weeks
The mean number of unprotected sex acts in previous one week, assessed at 26 weeks
Time frame: 26 weeks
Unprotected Sex Acts in Previous One Week - 52 Weeks
The mean number of unprotected sex acts in previous one week, assessed at 52 weeks
Time frame: 52 weeks
Unprotected Sex Acts in Previous One Month - 12 Weeks
The mean number of unprotected sex acts in previous one month, assessed at 12 weeks
Time frame: 12 weeks
Unprotected Sex Acts in Previous One Month - 26 Weeks
The mean number of unprotected sex acts in previous one month, assessed at 26 weeks
Time frame: 26 weeks
Unprotected Sex Acts in Previous One Month - 52 Weeks
The mean number of unprotected sex acts in previous one month, assessed at 52 weeks
Time frame: 52 weeks
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis
Time frame: 26 weeks
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
At least one incident infection with either gonorrhea, chlamydia or trichomoniasis
Time frame: 52 weeks
Cumulative Incidence Herpes Simplex Virus Type 2
cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.
Time frame: 26 weeks
Cumulative Incidence Herpes Simplex Virus Type 2
cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded.
Time frame: 52 weeks
Number of Partners Reporting for HIV Testing
Number of partners per index reporting for HIV testing at any time during follow-up
Time frame: 52 weeks
Proportion of Partners Reporting for HIV Testing
Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants
Time frame: 52 weeks
Suppression of HIV RNA to <1000c/ml at 12 Weeks
Proportion of persons in each arm with viral load \<1000copies/ml at 12 weeks
Time frame: 12 weeks
Time to HIV RNA Suppression <1000 c/ml
median time to viral load suppression (\<1000 c/ml)
Time frame: From date of randomization until viral load suppression, up to 52 weeks
Blood HIV RNA Concentration at Week 12
Time frame: 12 weeks
Blood HIV RNA Concentration at Week 26
Time frame: 26 weeks
Blood HIV RNA Concentration at Week 52
Time frame: 52 weeks
Genital HIV RNA Concentration - Week 12, Women
median HIV RNA concentration in cervical lavage fluid
Time frame: 12 weeks
Genital HIV RNA Concentration - Week 26, Women
median HIV RNA concentration in cervical lavage fluid
Time frame: 26 weeks
Genital HIV RNA Concentration - Week 52, Women
median HIV RNA concentration in cervical lavage fluid
Time frame: 52 weeks
Genital HIV RNA Concentration - Week 12, Men
median HIV RNA concentration as measured in semen
Time frame: 12 weeks
Genital HIV RNA Concentration - Week 26, Men
median HIV RNA concentration as measured in semen
Time frame: 26 weeks
Genital HIV RNA Concentration - Week 52, Men
median HIV RNA concentration as measured in semen
Time frame: 52 weeks