HIV Clinical Trial
Official title:
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.
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