Improving Blood Safety and HIV Testing in Brazil

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Blood Safety and HIV Testing in Brazil: a Randomized Controlled Trial

Conditions
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HIV, Herpes Simplex 2, Hepatitis C, Hepatitis B, Chagas Disease

Intervention / Treatment
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* Behavioral: HIV Counseling and Testing
* Behavioral: Blood Donation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Approved Intervention Counseling<br>Approved blood donors randomized to intervention and choosing HIV counseling option with no donation. | Behavioral: HIV Counseling and Testing<br>* HIV counseling and testing in lieu of blood donation.<br>|
| Experimental: Approved Intervention Donation<br>Approved blood donors randomized to intervention and choosing donation with no HIV counseling. | Behavioral: Blood Donation<br>* Blood donation without HIV counseling<br>|
| Experimental: Deferred Intervention<br>Deferred blood donors randomized to intervention with HIV counseling. | Behavioral: HIV Counseling and Testing<br>* HIV counseling and testing in lieu of blood donation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to three years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV counseling, Blood donor HIV testing, Brazil, Blood banks, Blood donors