Improving Blood Safety and HIV Testing in Brazil

January 16, 2018 updated by: Blood Systems Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Fundação Pró-sangue Hemocentro de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HSV-2 Prevalence in Blood Donors
Time Frame: 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.
Up to three years.
Intervention Impact in Blood Donors
Time Frame: 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.
Up to three years.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blood Systems Research Institute

Investigators

  • Principal Investigator: Thelma T. Goncalez, MD, PhD, Blood Systems Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

May 31, 2013

Study Completion (Actual)

January 31, 2015

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10849 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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