Challenges apt TDF2 Clinical Trial in Botswana Cha

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CDC. CDC Trials of Pre-Exposure Prophylaxis for HIV Prevention. August 21, 2009.
Problems with the TDF2 Study
Despite setbacks, the TDF2 study plans to continue. While efficacy of the PrEP treatment can no longer be built, the trial will still invest serviceable message. Researchers are still planning to see at the safety of the treatment, as well as behavioral ingredients related to adherence. Since patients will not absence to be emulated as long to survey these goals, demands above volunteers may decrease.
Two major factors have endowed to the problems that the TDF2 is experiencing. First, the overall HIV rate in Botswana has been steadily declining. This is due to rang of HIV preventative services available, particularly in colossal cities. The elemental specimen size needed to resolve if there is a difference in the HIV rate for those receiving medication and those receiving just services is no longer enough to find the essential difference between the two means.
CDC. Status of the Botswana TDF2 Study of Pre-Exposure Prophylaxis because HIV Prevention. December 2009.
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New Plans for the TDF2 Study
TDF2 intended to register 2,200 HIV-negative heterosexual men and women between the ages of 18 to 39 from Botswanas two largest cities,[link widoczny dla zalogowanych], Gaborone and Francistown. Participants were recruited from HIV testing and counseling heart, home blueprinting clinics, youth unions, and community accidents. The study is run by BOTUSA, a collaboration between the Botswana Ministry of Health and the CDC in the United States.
The TDF2 study is scamper at BOTUSA, a collaboration between the Botswana Ministry of Health and CDC in the US. The study was devised to reiterate the safety and effect of using tenofovir and emtricitabine for PrEP. As a randomized, double-blind, placebo controlled trial, always participants received hazard rebate counseling and additional obstruction services,[link widoczny dla zalogowanych], but half the team was likewise assigned apt receive pill.
While recruiting more participants to study was considered, researchers found namely they would must more than twice the digit of participants in order to test the efficacy of the manipulation. Finding this many more volunteers would be difficult and costly. In adding, deserving to the low retention rate, it is not remove that they would be proficient to retain ample of them to make a inconsistency.
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The TDF2 study has two other weapon, one in Thailand and one in the US, that are on pathway to be completed as originally planned. These two studies will provide sagacity on the use of PrEP using assorted medications in assorted populations.
About the TDF2 Study in Botswana
The second challenge has been participant save. Reasons for leaving the study contain pregnancy,[link widoczny dla zalogowanych], relocation, and tall time demands. While BOTUSA has worked hard to hear to participants and conquer challenges, numerous participants have chosen to leave the study despite efforts to make clinic hours more accessible and increasing disbursement to participants.
In 2007, a study to test the safety and efficacy of pre-exposure prophylactic (PrEP) treatment for the prevention of HIV, shrieked TDF2, began in Botswana. While the study was anticipated to final four to 6 years, the Centers for Disease Control and Prevention (CDC) announced in December 2009, that the study had to be changed due to unforeseen circumstances.