Improving Blood Safety and HIV Testing in Brazil

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Blood Systems Research Institute
Sponsor:
Information provided by (Responsible Party):
Blood Systems Research Institute
ClinicalTrials.gov Identifier:
NCT01681420
First received: February 29, 2012
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
HIV
Herpes Simplex 2
Hepatitis C
Hepatitis B
Chagas Disease
Behavioral: HIV Counseling and Testing
Behavioral: Blood Donation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving Blood Safety and HIV Testing in Brazil: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Blood Systems Research Institute:

Primary Outcome Measures:
  • HSV-2 Prevalence in Blood Donors [ Time Frame: Up to three years. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to three years. ] [ Designated as safety issue: No ]
    The impact of the intervention will be measured as an increase in persons receiving their test results, disclosure counseling and referrals.


Secondary Outcome Measures:
  • Prevalence of Transfusion-Transmitted Infections in Blood Donors [ Time Frame: Up to three years. ] [ Designated as safety issue: No ]
    Differences in prevalence of transfusion-transmitted infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease) between arms.


Estimated Enrollment: 12000
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Approved Intervention Counseling
Approved blood donors randomized to intervention and choosing HIV counseling option with no donation.
Behavioral: HIV Counseling and Testing
HIV counseling and testing in lieu of blood donation.
Experimental: Approved Intervention Donation
Approved blood donors randomized to intervention and choosing donation with no HIV counseling.
Behavioral: Blood Donation
Blood donation without HIV counseling
Experimental: Deferred Intervention
Deferred blood donors randomized to intervention with HIV counseling.
Behavioral: HIV Counseling and Testing
HIV counseling and testing in lieu of blood donation.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Exclusion Criteria:

  • All those not meeting inclusion criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681420

Contacts
Contact: Thelma T. Goncalez, MD, PhD 415-749-6685 tgoncalez@bloodsystems.org

Locations
Brazil
Fundação Pró-sangue Hemocentro de São Paulo Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Ester C. Sabino, MD, PhD       sabinoec@gmail.com   
Principal Investigator: Ester C Sabino, MD, PhD         
Sponsors and Collaborators
Blood Systems Research Institute
Investigators
Principal Investigator: Thelma T. Goncalez, MD, PhD Blood Systems Research Institute
  More Information

No publications provided

Responsible Party: Blood Systems Research Institute
ClinicalTrials.gov Identifier: NCT01681420     History of Changes
Other Study ID Numbers: 10849
Study First Received: February 29, 2012
Last Updated: April 11, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board
Brazil: National Committee of Ethics in Research

Keywords provided by Blood Systems Research Institute:
HIV counseling
Blood donor HIV testing
Brazil
Blood banks
Blood donors

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Herpes Simplex
Chagas Disease
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Herpesviridae Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014