Open Label Extension (OLE) of the TDF2 Study, Botswana
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      This study is an open label and is an extension to the TDF2 study in which the investigators
      offered daily oral tenofovir/emtricitabine (TDF/FTC) for a maximum of 12 months to HIV
      uninfected former participants of the TDF2 study.
    

Detailed description: 
      This open label phase builds on a unique opportunity provided by the end of the randomized
      phase of the TDF 2 study. The randomized study provided a well-characterized cohort of
      persons who received standard prevention interventions, including monthly testing,
      counseling, and condoms. The primary intervention that will change in the open label phase is
      the provision of information about the demonstrated efficacy and safety of PrEP including
      counseling about how PrEP is not 100% effective, provision of open label rather than blinded
      study medication, and a shortened visit schedule designed to more closely approximate what
      would be feasible in an implementation program. This open label phase will therefore serve as
      an opportunity to gather additional information relevant to the delivery and uptake of daily
      oral PrEP that may help inform eventual more wide scale PrEP implementation in Botswana.The
      OLE also leverages unique opportunities to address important questions about how information
      about PrEP safety and efficacy might affect risk behavior. The randomized trial showed that
      condom use (81.9% in the TDF/FTC group and 79.7% in the placebo group, p = 0.21) and the
      number of participants with more than one sexual partner in the previous month (14.2% in the
      TDF/FTC group and 14.1% in the placebo group, p = 0.86) between the two groups was similar.
      The underlying premise of this OLE is that information about PrEP efficacy and the knowledge
      of taking active drug rather than placebo might alter perception of HIV risk. This extension
      seeks to determine whether this trend will occur in the cohort after individuals receive
      information and counseling about the partial protective efficacy of PrEP and to identify risk
      factors for changes in risk behavior. The randomized trial revealed that reported drug
      adherence between the two arms was almost identical at 84.1% in the TDF/FTC group and 83.7%
      in the placebo arm (p = 0.79). The investigators have designed this open label phase in order
      to determine 1) if the knowledge of receiving active drug and the receipt of information
      about PrEP safety and partial efficacy at the onset of the open label phase could have
      substantial effects on pill use and 2) to identify individual factors associated with this
      impact. In addition, the open label extension will provide more information about the long
      term safety of Truvada.
    

Intervention name(s): Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg
Intervention type(s): Drug
Other intervention name(s): Truvada
Intervention MeSH terms: Tenofovir; Emtricitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV incidence; HIV prevention; Tenofovir; Emtricitabine; Botswana; HIV seronegativity; PrEP