Improving Blood Safety and HIV Testing in Brazil

HIV Clinical Trial

Official title:

Improving Blood Safety and HIV Testing in Brazil: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681420
• Other study ID #: 10849
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: January 16, 2018
• Start date: August 1, 2012
• Est. completion date: January 31, 2015

Study information

• Verified date: January 2018
• Source: Blood Systems Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11900
• Est. completion date: January 31, 2015
• Est. primary completion date: May 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chagas Disease
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Herpes Simplex
• Herpes Simplex 2
• HIV

Intervention

Behavioral:
• HIV Counseling and Testing
HIV counseling and testing in lieu of blood donation.
• Blood Donation
Blood donation without HIV counseling

Locations

Country	Name	City	State
Brazil	Fundação Pró-sangue Hemocentro de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Blood Systems Research Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HSV-2 Prevalence in Blood Donors	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.	Up to three years.
Primary	Intervention Impact in Blood Donors	The impact of the intervention will be measured as an increase in persons receiving their test results, disclosure counseling and referrals.	Up to three years.
Secondary	Prevalence of Transfusion-Transmitted Infections in Blood Donors	Differences in prevalence of transfusion-transmitted infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease) between arms.	Up to three years.