Improving Blood Safety and HIV Testing in Brazil
Condition: HIV; Herpes Simplex 2; Hepatitis C; Hepatitis B; Chagas Disease
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis B; Herpes Simplex; Chagas Disease; Hepatitis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): HIV Counseling and Testing; Blood Donation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): HIV counseling and testing in lieu of blood donation.; Blood donation without HIV counseling
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV counseling; Blood donor HIV testing; Brazil; Blood banks; Blood donors