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
  Purpose

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.


Condition Intervention
HIV
Dried Blood Spot Method
Other: Number of DBS Spots

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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.


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.


Estimated Enrollment: 45
Study Start Date: January 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043041

Contacts
Contact: Laura C Gravens, MS, MPH 404-712-8630 lauragravens@gmail.com

Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: AD McNaghten, PHD, MHSA Emory University
  More Information

No publications provided

Responsible Party: Patrick S Sullivan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02043041     History of Changes
Other Study ID Numbers: IRB00042405, P30AI050409
Study First Received: January 21, 2014
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014