N/A
N=200
Provision of HIV Self-Test Kit to Emergency Department Patients
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03021005 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants Who Did HIV Testing — 36; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIV Self-testing (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Did HIV Testing |
36; 9 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03021005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.