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

Emory University

Status: Completed

Conditions: HIV

Treatments: Other: Number of DBS Spots

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02043041

P30AI050409 (U.S. NIH Grant/Contract)

IRB00042405

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 3 patient groups

1 Dried Blood Spot (DBS)

Description:

Number of DBS Spots Participants will be asked to fill one spot on a dried blood spot collection card.

Treatment:

Other: Number of DBS Spots

3 DBS Spots

Description:

Number of DBS Spots Participants will be asked to fill three spots on a dried blood spot collection card.

Treatment:

Other: Number of DBS Spots

5 DBS Sports

Description:

Number of DBS Spots Participants will be asked to fill five spots on a dried blood spot collection card.

Treatment:

Other: Number of DBS Spots