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Improving Blood Safety and HIV Testing in Brazil

Primary Purpose

HIV, Herpes Simplex 2, Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
HIV Counseling and Testing
Blood Donation
Sponsored by
Vitalant Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV counseling, Blood donor HIV testing, Brazil, Blood banks, Blood donors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fundação Pró-sangue Hemocentro de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Approved Intervention Counseling

Approved Intervention Donation

Deferred Intervention

Arm Description

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

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

Deferred blood donors randomized to intervention with HIV counseling.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 29, 2012
Last Updated
January 16, 2018
Sponsor
Vitalant Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01681420
Brief Title
Improving Blood Safety and HIV Testing in Brazil
Official Title
Improving Blood Safety and HIV Testing in Brazil: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2012 (Actual)
Primary Completion Date
May 31, 2013 (Actual)
Study Completion Date
January 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitalant Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Herpes Simplex 2, Hepatitis C, Hepatitis B, Chagas Disease
Keywords
HIV counseling, Blood donor HIV testing, Brazil, Blood banks, Blood donors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Approved Intervention Counseling
Arm Type
Experimental
Arm Description
Approved blood donors randomized to intervention and choosing HIV counseling option with no donation.
Arm Title
Approved Intervention Donation
Arm Type
Experimental
Arm Description
Approved blood donors randomized to intervention and choosing donation with no HIV counseling.
Arm Title
Deferred Intervention
Arm Type
Experimental
Arm Description
Deferred blood donors randomized to intervention with HIV counseling.
Intervention Type
Behavioral
Intervention Name(s)
HIV Counseling and Testing
Intervention Description
HIV counseling and testing in lieu of blood donation.
Intervention Type
Behavioral
Intervention Name(s)
Blood Donation
Intervention Description
Blood donation without HIV counseling
Primary Outcome Measure Information:
Title
HSV-2 Prevalence in Blood Donors
Description
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.
Time Frame
Up to three years.
Title
Intervention Impact in Blood Donors
Description
The impact of the intervention will be measured as an increase in persons receiving their test results, disclosure counseling and referrals.
Time Frame
Up to three years.
Secondary Outcome Measure Information:
Title
Prevalence of Transfusion-Transmitted Infections in Blood Donors
Description
Differences in prevalence of transfusion-transmitted infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease) between arms.
Time Frame
Up to three years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. Exclusion Criteria: All those not meeting inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thelma T. Goncalez, MD, PhD
Organizational Affiliation
Vitalant Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundação Pró-sangue Hemocentro de São Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25646883
Citation
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.
Results Reference
derived

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Improving Blood Safety and HIV Testing in Brazil

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