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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University
ClinicalTrials.gov Identifier:
NCT02043041
First received: January 21, 2014
Last updated: January 23, 2014
Last verified: January 2014

January 21, 2014
January 23, 2014
January 2014
May 2014   (final data collection date for primary outcome measure)
Viable sample for HIV Testing [ Time Frame: Outcome measure will be assessed with in two weeks of all samples being collected ] [ Designated as safety issue: No ]
Samples will be examined and not tested by a lab technician for acceptability for HIV testing.
Same as current
Complete list of historical versions of study NCT02043041 on ClinicalTrials.gov Archive Site
Not Provided
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Evaluation of the Quality of Self-collected Blood Spot Specimens for Laboratory HIV Testing - An InvolveMENt Sub Study
Explaining the Differences in HIV Prevalence and Incidence Between Black and White Men Who Have Sex With Men in Atlanta

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

Not Provided
Observational
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:

Dried blood spots will be collected and inspected for quality. Once quality is determined, samples will be destroyed. No identifying information will be associated with the sample.

Non-Probability Sample

Participants will be enrolled or previously enrolled in the InvolveMENt Study through Emory University. They will be assesed for study interest either at the end of their scheduled appointment with InvolveMENt, or will be contacted if consent to contact them for future studies was previously obtained through InvolveMENt.

  • HIV
  • Dried Blood Spot Method
Other: Number of DBS Spots
  • 1 Dried Blood Spot (DBS)
    Number of DBS Spots Participants will be asked to fill one spot on a dried blood spot collection card.
    Intervention: Other: Number of DBS Spots
  • 3 DBS Spots
    Number of DBS Spots Participants will be asked to fill three spots on a dried blood spot collection card.
    Intervention: Other: Number of DBS Spots
  • 5 DBS Sports
    Number of DBS Spots Participants will be asked to fill five spots on a dried blood spot collection card.
    Intervention: Other: Number of DBS Spots
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
45
Not Provided
May 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Laura C Gravens, MS, MPH 404-712-8630 lauragravens@gmail.com
Not Provided
 
NCT02043041
IRB00042405, P30AI050409
No
Patrick S Sullivan, Emory University
Emory University
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: AD McNaghten, PHD, MHSA Emory University
Emory University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP