NCT02876926

Brief Summary

This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 19, 2019

Completed
Last Updated

April 19, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

August 17, 2016

Results QC Date

February 15, 2018

Last Update Submit

January 17, 2019

Conditions

HIV

Keywords

HIV testingSelf-testingCounselingReferral

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Who Received HIV Testing

    Count of the number of participants who reported receiving HIV testing.

    Up to 28 weeks

  • Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis

    Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional.

    Up to 28 weeks

  • Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis

    Count of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional.

    Up to 28 weeks

Study Arms (3)

"Enhanced" home-based testing

EXPERIMENTAL

These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.

Behavioral: "Smart" home-based test for HIV

Home-based testing alone

ACTIVE COMPARATOR

These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.

Behavioral: Home-based testing only

Reminders for clinic-based testing

SHAM COMPARATOR

Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.

Behavioral: Reminder letters for clinic-based testing

Interventions

"Smart" home-based test for HIVBEHAVIORAL

A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.

"Enhanced" home-based testing
Home-based testing onlyBEHAVIORAL

A standard home-based HIV test kit.

Home-based testing alone
Reminder letters for clinic-based testingBEHAVIORAL

Letters reminding patients to get tested at a free clinic location

Reminders for clinic-based testing

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sex with a partner met online in the past year
  • Anal sex (either insertive or receptive) with a casual male partner in the past 6 months without using condoms or pre-exposure prophylaxis
  • Own a smartphone (iOS or Android) with a service contract and data plan
  • Have a stable address where mail can be received
  • Speak English fluently

You may not qualify if:

  • Having tested for HIV in the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Interventions

Seroconversion

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Results Point of Contact

Title
Dr. Tyler Wray
Organization
Brown University School of Public Health
tyler_wray@brown.edu
401-863-6659

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 24, 2016

Study Start

July 1, 2016

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

April 19, 2019

Results First Posted

April 19, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)