Improving Blood Safety and HIV Testing in Brazil

NCT ID: NCT01681420

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-01
• Study Completion Date: 2015-01-31

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.

Conditions

HIV; Herpes Simplex 2; Hepatitis C; Hepatitis B; Chagas Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Approved Intervention Counseling

Approved blood donors randomized to intervention and choosing HIV counseling option with no donation.

Group Type: EXPERIMENTAL

HIV Counseling and Testing

Intervention Type: BEHAVIORAL

HIV counseling and testing in lieu of blood donation.

Approved Intervention Donation

Approved blood donors randomized to intervention and choosing donation with no HIV counseling.

Group Type: EXPERIMENTAL

Blood Donation

Intervention Type: BEHAVIORAL

Blood donation without HIV counseling

Deferred Intervention

Deferred blood donors randomized to intervention with HIV counseling.

Group Type: EXPERIMENTAL

HIV Counseling and Testing

Intervention Type: BEHAVIORAL

HIV counseling and testing in lieu of blood donation.

Interventions

HIV Counseling and Testing

HIV counseling and testing in lieu of blood donation.

Intervention Type: BEHAVIORAL

Blood Donation

Blood donation without HIV counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vitalant Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thelma T. Goncalez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vitalant Research Institute

Locations

Fundação Pró-sangue Hemocentro de São Paulo

São Paulo, , Brazil

Countries

Brazil

References

Goncalez TT, Blatyta PF, Santos FM, Montebello S, Esposti SP, Hangai FN, Salles NA, Mendrone A, Truong HM, Sabino EC, McFarland W. Does offering human immunodeficiency virus testing at the time of blood donation reduce transfusion transmission risk and increase disclosure counseling? Results of a randomized controlled trial, Sao Paulo, Brazil. Transfusion. 2015 Jun;55(6):1214-22. doi: 10.1111/trf.13009. Epub 2015 Feb 3.

Reference Type: DERIVED

PMID: 25646883 (View on PubMed)

Other Identifiers

10849

Identifier Type: -

Identifier Source: org_study_id