Improving Blood Safety and HIV Testing in Brazil
1 other identifier
interventional
11,900
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2015
CompletedJanuary 18, 2018
January 1, 2018
10 months
February 29, 2012
January 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Up to three years.
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.
Up to three years.
Secondary Outcomes (1)
Prevalence of Transfusion-Transmitted Infections in Blood Donors
Up to three years.
Study Arms (3)
Approved Intervention Counseling
EXPERIMENTALApproved blood donors randomized to intervention and choosing HIV counseling option with no donation.
Approved Intervention Donation
EXPERIMENTALApproved blood donors randomized to intervention and choosing donation with no HIV counseling.
Deferred Intervention
EXPERIMENTALDeferred blood donors randomized to intervention with HIV counseling.
Interventions
HIV counseling and testing in lieu of blood donation.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundação Pró-sangue Hemocentro de São Paulo
São Paulo, 05403-000, Brazil
Related Publications (1)
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.
PMID: 25646883DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thelma T. Goncalez, MD, PhD
Vitalant Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2012
First Posted
September 10, 2012
Study Start
August 1, 2012
Primary Completion
May 31, 2013
Study Completion
January 31, 2015
Last Updated
January 18, 2018
Record last verified: 2018-01