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Improving Blood Safety and HIV Testing in Brazil

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Blood Systems Research Institute
Sponsor:
Information provided by (Responsible Party):
Blood Systems Research Institute
ClinicalTrials.gov Identifier:
NCT01681420
First received: February 29, 2012
Last updated: April 11, 2013
Last verified: April 2013

February 29, 2012
April 11, 2013
March 2012
September 2013   (final data collection date for primary outcome measure)
  • HSV-2 Prevalence in Blood Donors [ Time Frame: Up to three years. ] [ Designated as safety issue: No ]
    As a biological marker for elevated risk for HIV, we will compare the prevalence of HSV-2 among donors choosing testing to those choosing to donate when offered the choice.
  • Intervention Impact in Blood Donors [ Time Frame: Up to three years. ] [ Designated as safety issue: No ]
    The impact of the intervention will be measured as an increase in persons receiving their test results, disclosure counseling and referrals.
Same as current
Complete list of historical versions of study NCT01681420 on ClinicalTrials.gov Archive Site
Prevalence of Transfusion-Transmitted Infections in Blood Donors [ Time Frame: Up to three years. ] [ Designated as safety issue: No ]
Differences in prevalence of transfusion-transmitted infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease) between arms.
Same as current
Not Provided
Not Provided
 
Improving Blood Safety and HIV Testing in Brazil
Improving Blood Safety and HIV Testing in Brazil: a Randomized Controlled Trial

Conduct a randomized controlled trial (RCT) to test the hypothesis that offering client-centered HIV counseling and testing (HCT) to blood donor candidates will reduce the risk of HIV contamination in the blood supply and also increase appropriate referrals to preventive and care services to persons in need in São Paulo, Brazil.

Although all donated blood is screened for HIV antibodies, a residual risk of contamination persists due to the immunological window period before antibodies are detectable. Deferral of donors with behavioral risks for HIV is one means to reduce window period contamination; recruitment of voluntary donors from the community (versus family replacement donors) is held to be another. Contrary to expectation, a shift to community donors has not resulted in a decrease in HIV prevalence in units of blood collected by the investigators transfusion service. The investigators preliminary research indicates that some persons at elevated risk use donation as a means of testing for HIV. These test-seeking donors have high trust in the blood bank, do not know other places to receive testing, have low understanding of the immunological window period and believe it is acceptable to deny risk in order to be tested through donation. The test-seeking phenomenon may therefore threaten the safety of the blood supply. Test seeking at blood banks also ill serves persons who need risk reduction counseling because they cannot disclose their true behavior during the donation process and still be tested. Donors also have a low rate of return for test results and therefore do not receive confirmation or referrals to care.

To assess whether HCT at the time of donation will improve blood safety and address prevention and care needs, the investigators will randomize donor candidates to be offered this service on-site. As a biological marker for elevated risk for HIV, the investigators will compare the prevalence of HSV-2 among donors choosing testing to those choosing to donate when offered the choice (Aim 1). The impact of the intervention will be measured as an increase in persons receiving their test results, disclosure counseling and referrals (Aim 2). Secondary outcomes include differences in prevalence of transfusion-transmitted infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease), donor motivations (e.g., test-seeking vs. altruism), donor deferral rates, use of confidential unit exclusion, satisfaction with procedures of the blood bank and volume of blood available for use. RCT results will provide rigorous evidence for or against the provision of on-site HCT as an effective means to improve blood safety and link individuals to needed health services.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • Herpes Simplex 2
  • Hepatitis C
  • Hepatitis B
  • Chagas Disease
  • Behavioral: HIV Counseling and Testing
    HIV counseling and testing in lieu of blood donation.
  • Behavioral: Blood Donation
    Blood donation without HIV counseling
  • Experimental: Approved Intervention Counseling
    Approved blood donors randomized to intervention and choosing HIV counseling option with no donation.
    Intervention: Behavioral: HIV Counseling and Testing
  • Experimental: Approved Intervention Donation
    Approved blood donors randomized to intervention and choosing donation with no HIV counseling.
    Intervention: Behavioral: Blood Donation
  • Experimental: Deferred Intervention
    Deferred blood donors randomized to intervention with HIV counseling.
    Intervention: Behavioral: HIV Counseling and Testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12000
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Study subjects will be Portuguese-speaking persons age 18-65 years (determined by Brazilian law to be the age of donation), who present to donate blood at our center during the study period and who provide written informed consent.

Exclusion Criteria:

  • All those not meeting inclusion criteria.
Both
18 Years to 65 Years
Yes
Contact: Thelma T. Goncalez, MD, PhD 415-749-6685 tgoncalez@bloodsystems.org
Brazil
 
NCT01681420
10849
Yes
Blood Systems Research Institute
Blood Systems Research Institute
Not Provided
Principal Investigator: Thelma T. Goncalez, MD, PhD Blood Systems Research Institute
Blood Systems Research Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP