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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02043041
Enrollment
45
Registered
2014-01-23
Start date
2014-01-31
Completion date
2015-05-31
Last updated
2015-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

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.

Interventions

OTHERNumber of DBS Spots

The number of DBS spots on the card constitutes the experimental condition.

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Viable sample for HIV TestingOutcome measure will be assessed with in two weeks of all samples being collectedSamples will be examined and not tested by a lab technician for acceptability for HIV testing.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026