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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02043041
First Posted: January 23, 2014
Last Update Posted: June 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University
January 21, 2014
January 23, 2014
June 25, 2015
January 2014
May 2015   (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 ]
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
Not Provided
Not Provided
Not Provided
 
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 to determine optimal procedures for collection.
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.
Observational
Time Perspective: Cross-Sectional
Not Provided
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
Other: Number of DBS Spots
The number of DBS spots on the card constitutes the experimental condition.
  • 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.
 
Completed
45
May 2015
May 2015   (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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02043041
IRB00042405
P30AI050409 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
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
June 2015