Evaluation of the Quality of Self-collected Blood Spot Specimens for Laboratory HIV Testing - An InvolveMENt Sub Study

HIV Clinical Trial

Official title:

Explaining the Differences in HIV Prevalence and Incidence Between Black and White Men Who Have Sex With Men in Atlanta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043041
• Other study ID #: IRB00042405
• Secondary ID: P30AI050409
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: June 24, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

We will invite a convenience sample of up to 45 enrolled subjects to participate in an optional, self-administered blood specimen collection procedure to determine optimal procedures for collection.

Description:

Participants will be recruited to this one-time assessment during their follow-up visits. After completing a consent procedure specific to this study component, participants will be provided with instructions on how to fully self-administer the procedure of a finger stick and also blotting to collect a blood specimen using a 1, 3 or 5 blood spot specimen collection card. These specimens will be labeled with the participant's unique identification number, and no other identifying information. The dried blood spots will be evaluated by a laboratorian to assess quality, but will not be tested for HIV. This evaluation will help determine what number of self-collected dried blood spots yields the highest usable quantity of sample for HIV testing. There will be a separate monetary incentive of $30 for this procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be either currently enrolled or previously enrolled in the InvolveMENt Study through Emory University

• Over 18 years old

• HIV Negative

Exclusion Criteria:

• Not enrolled or previously enrolled in the InvolveMENt Study through Emory University

• Under 18 years old

• HIV Positive

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Number of DBS Spots
The number of DBS spots on the card constitutes the experimental condition.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viable sample for HIV Testing	Samples will be examined and not tested by a lab technician for acceptability for HIV testing.	Outcome measure will be assessed with in two weeks of all samples being collected	No