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Provision of HIV Self-Test Kit to Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT03021005
Recruitment Status : Active, not recruiting
First Posted : January 13, 2017
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

The proposed pilot research has three aims: 1) to determine the feasibility and acceptability of provision of HIV self-testing kit in order to increase uptake and engagement of HIV testing among emergency department patients who decline conventional emergency department HIV testing and to increase the engagement of HIV testing at a regular basis for those with an increased risk for HIV (the index participants); 2) to determine the uptake and engagement of HIV testing by provision of HIV self-testing kit; and 3) to determine the feasibility and acceptability of HIV self-testing kit referral among partners or peers of the index participants.

The investigators will conduct a pilot randomized study at Johns Hopkins Hospital emergency department on (1) patients who decline routine HIV testing offer and (2) patients who are at an increased risk for HIV. The consented patient will be randomized to HIV self-testing kit group which the investigators will provide a free Food and Drug Administration-approved HIV self-testing home kit for the participant to take it home or to reference group which the investigators will not provide the self-testing kit. Consented patients in both groups will fill out a short survey regarding their socio-demographic information as well as their experience and perceptions regarding HIV testing. For patients who are in the HIV self-testing kit group, they will be asked if they would like to take a free HIV self-testing home kit home. Participants in this group will also receive information regarding how to access "I Want The Kit" website to report the completion of HIV self-testing at home. For patients who are in the reference group, a standard pamphlet regarding the importance of HIV testing and HIV testing venues in Baltimore City used by emergency department-based HIV testing program will be provided to the patients.

Follow-up questionnaires will inquire regarding the patient's experience regarding HIV testing since their index visit.

When the participants in the HIV self-testing kit group in Aim 1, they will also be provided 5 referral cards for their partners and peers for them to request a free HIV self-testing kit from the "I Want The Kit" website. At the 1-month phone follow-up, the investigators will ask participants if they are able to give the referral cards to their partner(s) or friend(s), how they think if their partner(s) and/or friend(s) will request an HIV self-testing kit from the "I Want The Kit" website.


Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: HIV Self-testing Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Provision of HIV Self-Test Kit to Increase Uptake of HIV Testing Among Emergency Department Patients Who Decline Emergency Department-Based HIV Screening.
Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Self Testing Kit
This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will also be provided 5 referral cards to give to their partners and peers in the drug, sex, and social networks for them to request a free HIV self-testing kit from the "I Want The Kit" website.
Behavioral: HIV Self-testing
No Intervention: No Self Testing Kit
This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the "I Want The Kit" website.



Primary Outcome Measures :
  1. HIV testing rate [ Time Frame: up to 1 months after enrollment ]
    HIV testing rate will be determined by a telephone follow-up at 1 month after the index emergency department visit (enrollment).

  2. HIV testing rate [ Time Frame: up to 3 month after enrollment ]
    HIV testing rate will be determined by a telephone follow-up at 3 months after the index emergency department visit (enrollment).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Johns Hopkins Hospital emergency department patients who decline routine HIV testing offer ("Decliners") or patients who are offered an HIV test as the standard of care in the emergency department , accept the standard of care (SOC) HIV testing, and who have at increased risk for HIV "High Risk").

Exclusion Criteria:

  • Any person who is already known to be HIV positive. Patients with a chief complaint of sexual assault, patients with chief complaint of occupational exposure and patients who are otherwise ineligible to consent to an HIV test due to medical condition (e.g., severe illness, altered mental status). Any person who has previously enrolled in this study. Any person less than 18 years of age. Any person who is not able to provide contact information for follow-up survey. Any person who reports they are unable to access the internet.

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): NCT03021005


Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Yu-Hsiang Hsieh, PhD Johns Hopkins University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03021005     History of Changes
Other Study ID Numbers: IRB00090921
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes