HIVNCT01681420
Improving Blood Safety and HIV Testing in Brazil
A study testing HIV Counseling and Testing and Blood Donation in people with HIV and Herpes Simplex 2, run by Vitalant Research Institute at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Herpes Simplex 2, Hepatitis C
- What is being tested?
- HIV Counseling and Testing and Blood Donation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,900 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2012to 31 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- All those not meeting inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- HIV Counseling and Testing, Blood Donation
- Keywords
- HIV counseling, Blood donor HIV testing, Brazil, Blood banks, Blood donors
- Medical subject headings
- Hepatitis C, Hepatitis B, Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Counseling and TestingBehavioural
HIV counseling and testing in lieu of blood donation.
Blood DonationBehavioural
Blood donation without HIV counseling
| Study group | Role | What they receive |
|---|---|---|
| Approved Intervention Counseling | Experimental | Approved blood donors randomized to intervention and choosing HIV counseling option with no donation. Receives: Behavioral: HIV Counseling and Testing |
| Approved Intervention Donation | Experimental | Approved blood donors randomized to intervention and choosing donation with no HIV counseling. Receives: Behavioral: Blood Donation |
| Deferred Intervention | Experimental | Deferred blood donors randomized to intervention with HIV counseling. Receives: Behavioral: HIV Counseling and Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to three years.
Secondary outcomes (1)
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.
Measured: Up to three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study start1 Aug 2012
- Primary completion31 May 2013
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 11,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitalant Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thelma T. Goncalez, MD, PhD, Principal investigator, Vitalant Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681420
- Sponsor's protocol ID
- 10849
- Status last verified
- Jan 2018
- First submitted
- 29 Feb 2012
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25646883
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Blood Safety and HIV Testing in Brazil: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01681420
- Acronym / sponsor ID
- 10849
- Conditions
- HIV, Herpes Simplex 2, Hepatitis C, Hepatitis B, Chagas Disease
- Keywords
- HIV counseling, Blood donor HIV testing, Brazil, Blood banks, Blood donors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,900 participants (actual)
- Lead sponsor
- Vitalant Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Approved Intervention Counseling | Experimental | Behavioral: HIV Counseling and TestingApproved blood donors randomized to intervention and choosing HIV counseling option with no donation. |
| Approved Intervention Donation | Experimental | Behavioral: Blood DonationApproved blood donors randomized to intervention and choosing donation with no HIV counseling. |
| Deferred Intervention | Experimental | Behavioral: HIV Counseling and TestingDeferred blood donors randomized to intervention with HIV counseling. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- All those not meeting inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV Counseling and TestingHIV counseling and testing in lieu of blood donation. | Behavioural | Approved Intervention Counseling, Deferred Intervention |
| Blood DonationBlood donation without HIV counseling | Behavioural | Approved Intervention Donation |
Primary outcome
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.
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.
1 secondary outcome
Prevalence of Transfusion-Transmitted Infections in Blood Donors
Time frame: Up to three years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Derived from this study: PubMed 25646883Goncalez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thelma T. Goncalez, MD, PhD principal investigator
Vitalant Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Counseling and Testing and Blood Donation in people with HIV and Herpes Simplex 2, run by Vitalant Research Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HSV-2 Prevalence in Blood Donors (time frame: Up to three years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.