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

Completed

• Conditions: HIV
• Interventions: Other: Number of DBS Spots

• Registration Number: NCT02043041
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

Inclusion Criteria

• Must be either currently enrolled or previously enrolled in the InvolveMENt Study through Emory University
• Over 18 years old
• HIV Negative

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Exclusion Criteria

• Not enrolled or previously enrolled in the InvolveMENt Study through Emory University
• Under 18 years old
• HIV Positive

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3 DBS Spots	Number of DBS Spots	Number of DBS Spots Participants will be asked to fill three spots on a dried blood spot collection card.
1 Dried Blood Spot (DBS)	Number of DBS Spots	Number of DBS Spots Participants will be asked to fill one spot on a dried blood spot collection card.
5 DBS Sports	Number of DBS Spots	Number of DBS Spots Participants will be asked to fill five spots on a dried blood spot collection card.

Primary Outcome Measures

Name	Time	Method
Viable sample for HIV Testing	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.

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States