Provision of HIV Self-Test Kit to Emergency Department Patients

NCT03021005 | Completed Results

• 2 other identifiers: IRB00090921U54EB007958
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Did HIV Testing

  Number of participants who did the HIV testing (HIV testing rate) will be determined by a telephone follow-up at 1 month after the index emergency department visit (enrollment).

  At 1 month post enrollment

Study Arms (2)

Self Testing Kit

EXPERIMENTAL

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 Self Testing Kit

NO INTERVENTION

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.

Interventions

HIV Self-testing BEHAVIORAL

Self Testing Kit

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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").

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Related Publications (11)

• Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, Clark JE; Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17; quiz CE1-4.

  PMID: 16988643 BACKGROUND

• Centers for Disease Control and Prevention (CDC). Missed opportunities for earlier diagnosis of HIV infection--South Carolina, 1997-2005. MMWR Morb Mortal Wkly Rep. 2006 Dec 1;55(47):1269-72.

  PMID: 17136020 BACKGROUND

• Czarnogorski M, Brown J, Lee V, Oben J, Kuo I, Stern R, Simon G. The Prevalence of Undiagnosed HIV Infection in Those Who Decline HIV Screening in an Urban Emergency Department. AIDS Res Treat. 2011;2011:879065. doi: 10.1155/2011/879065. Epub 2011 May 9.

  PMID: 21738860 BACKGROUND

• Johnson C, Baggaley R, Forsythe S, van Rooyen H, Ford N, Napierala Mavedzenge S, Corbett E, Natarajan P, Taegtmeyer M. Realizing the potential for HIV self-testing. AIDS Behav. 2014 Jul;18 Suppl 4:S391-5. doi: 10.1007/s10461-014-0832-x.

  PMID: 24986599 BACKGROUND

• Vargo S, Agronick G, O'Donnell L, Stueve A. Using peer recruitment and OraSure to increase HIV testing. Am J Public Health. 2004 Jan;94(1):29-31. doi: 10.2105/ajph.94.1.29.

  PMID: 14713690 BACKGROUND

• Gaydos CA, Hsieh YH, Harvey L, Burah A, Won H, Jett-Goheen M, Barnes M, Agreda P, Arora N, Rothman RE. Will patients "opt in" to perform their own rapid HIV test in the emergency department? Ann Emerg Med. 2011 Jul;58(1 Suppl 1):S74-8. doi: 10.1016/j.annemergmed.2011.03.029.

  PMID: 21684413 BACKGROUND

• Nour S, Hsieh YH, Rothman RE, Jett-Goheen M, Langhorne O, Wu L, Peterson S, Gaydos CA. Patients Can Accurately Perform Their Own Rapid HIV Point-of-Care Test in the Emergency Department. Point Care. 2012 Dec 1;11(4):176-179. doi: 10.1097/POC.0b013e3182666eb7.

  PMID: 24031999 BACKGROUND

• Chai SJ, Aumakhan B, Barnes M, Jett-Goheen M, Quinn N, Agreda P, Whittle P, Hogan T, Jenkins WD, Rietmeijer CA, Gaydos CA. Internet-based screening for sexually transmitted infections to reach nonclinic populations in the community: risk factors for infection in men. Sex Transm Dis. 2010 Dec;37(12):756-63. doi: 10.1097/OLQ.0b013e3181e3d771.

  PMID: 20644498 BACKGROUND

• Gaydos CA, Barnes M, Aumakhan B, Quinn N, Agreda P, Whittle P, Hogan T. Can e-technology through the Internet be used as a new tool to address the Chlamydia trachomatis epidemic by home sampling and vaginal swabs? Sex Transm Dis. 2009 Sep;36(9):577-80. doi: 10.1097/OLQ.0b013e3181a7482f. No abstract available.

  PMID: 19543145 BACKGROUND

• Gaydos CA, Dwyer K, Barnes M, Rizzo-Price PA, Wood BJ, Flemming T, Hogan MT. Internet-based screening for Chlamydia trachomatis to reach non-clinic populations with mailed self-administered vaginal swabs. Sex Transm Dis. 2006 Jul;33(7):451-7. doi: 10.1097/01.olq.0000200497.14326.fb.

  PMID: 16652069 BACKGROUND

• Patel AV, Abrams SM, Gaydos CA, Jett-Goheen M, Latkin CA, Rothman RE, Hsieh YH. Increasing HIV testing engagement through provision of home HIV self-testing kits for patients who decline testing in the emergency department: a pilot randomisation study. Sex Transm Infect. 2019 Aug;95(5):358-360. doi: 10.1136/sextrans-2018-053592. Epub 2018 Jun 14.

  PMID: 29903889 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Yu-Hsiang Hsieh
• Organization: Johns Hopkins University

yhsieh1@jhmi.edu

410-735-6413

Study Officials

• Yu-Hsiang Hsieh, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 13, 2017
• Study Start: March 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 8, 2021
• Results First Posted: March 20, 2020

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share