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

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ClinicalTrials.gov Identifier: NCT02043041
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : June 25, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
HIV Other: Number of DBS Spots

Detailed 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.

Study Design

Study Type : Observational
Actual Enrollment : 45 participants
Time Perspective: Cross-Sectional
Official Title: Explaining the Differences in HIV Prevalence and Incidence Between Black and White Men Who Have Sex With Men in Atlanta
Study Start Date : January 2014
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Rashes
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1 Dried Blood Spot (DBS)
Number of DBS Spots Participants will be asked to fill one spot on a dried blood spot collection card.
Other: Number of DBS Spots
The number of DBS spots on the card constitutes the experimental condition.
3 DBS Spots
Number of DBS Spots Participants will be asked to fill three spots on a dried blood spot collection card.
Other: Number of DBS Spots
The number of DBS spots on the card constitutes the experimental condition.
5 DBS Sports
Number of DBS Spots Participants will be asked to fill five spots on a dried blood spot collection card.
Other: Number of DBS Spots
The number of DBS spots on the card constitutes the experimental condition.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043041


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: AD McNaghten, PHD, MHSA Emory University
More Information

Responsible Party: Patrick S Sullivan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02043041     History of Changes
Other Study ID Numbers: IRB00042405
P30AI050409 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015