CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Raltegravir +3 moredrug
Likely dose
Raltegravir 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01450189
NCT01450189N/ACompleted
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Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study

University of North Carolina, Chapel Hill·interventional·Posted Oct 12, 2011·Updated Apr 19, 2018

In Brief

A clinical study evaluating Standard HIV prevention messages, BI: Information-Motivation-Behavioral Skills Model, and 2 other interventions for HIV. Completed, enrolled 46 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesMalawi
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2011
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.7 years ago

Interventions

Standard HIV prevention messagesbehavioral

A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.

BI: Information-Motivation-Behavioral Skills Modelbehavioral

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.

Raltegravirdrug

raltegravir (400 mg) administered orally twice daily for 12 weeks

emtricitabine/tenofovir disoproxil fumaratedrug

emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks