Improving Blood Safety and HIV Testing in Brazil

Not Applicable

Completed

• Conditions: HIV; Hepatitis B; Hepatitis C; Herpes Simplex 2; Chagas Disease
• Interventions: Behavioral: HIV Counseling and Testing; Behavioral: Blood Donation

• Registration Number: NCT01681420
• Lead Sponsor: Vitalant Research Institute

Brief 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.

Study Timeline

• Study First Submitted: 2012-02-29
• Study Start: 2012-08-01
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-10
• Primary Completion: 2013-05-31
• Study Completion: 2015-01-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11900

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Approved Intervention Counseling	HIV Counseling and Testing	Approved blood donors randomized to intervention and choosing HIV counseling option with no donation.
Approved Intervention Donation	Blood Donation	Approved blood donors randomized to intervention and choosing donation with no HIV counseling.
Deferred Intervention	HIV Counseling and Testing	Deferred blood donors randomized to intervention with HIV counseling.

Primary Outcome Measures

Name	Time	Method
HSV-2 Prevalence in Blood Donors	Up to three years.	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	Up to three years.	The impact of the intervention will be measured as an increase in persons receiving their test results, disclosure counseling and referrals.

Secondary Outcome Measures

Name	Time	Method
Prevalence of Transfusion-Transmitted Infections in Blood Donors	Up to three years.	Differences in prevalence of transfusion-transmitted infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease) between arms.

Trial Locations

Locations (1)

Fundação Pró-sangue Hemocentro de São Paulo; 🇧🇷 Sao Paulo, Brazil