Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 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: February 18, 2015
Last verified: February 2015

January 21, 2014
February 18, 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 ] [ 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
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.
 
Recruiting
45
Not Provided
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
Male
18 Years and older
No
Contact: Laura C Gravens, MS, MPH 404-712-8630 lauragravens@gmail.com
United States
 
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
February 2015

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