NCT01161446

Brief Summary

The purpose of this study is to determine whether the availability of home self-testing for HIV will increase HIV testing frequency among men who have sex with men without negatively impacting their risk for HIV acquisition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable hiv

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, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

June 7, 2017

Completed
Last Updated

June 7, 2017

Status Verified

May 1, 2017

Enrollment Period

4.4 years

First QC Date

July 9, 2010

Results QC Date

May 10, 2017

Last Update Submit

May 10, 2017

Conditions

HIV

Keywords

HIVHome testingSelf-testingHIV Infections/diagnosisHIV Infections/prevention and controlAIDS SerodiagnosisOral fluidsHomosexuality, MaleSexually transmitted diseasesSexual behavior

Outcome Measures

Primary Outcomes (1)

  • HIV Testing Frequency

    Number of HIV tests during follow-up reported by participants at end-of-study visit

    15 months

Secondary Outcomes (3)

  • Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months

    From 6 to 9 months and 12 to 15 months of follow-up

  • Bacterial Sexually Transmitted Infections

    Assessed at 15 months

  • Number of Male Condomless Anal Intercourse Partners in Last 3 Months

    From 6 to 9 and 12 to 15 months

Study Arms (2)

Home Testing

EXPERIMENTAL
Behavioral: Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody TestDevice: Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test

Standard Testing

NO INTERVENTION

Interventions

Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody TestBEHAVIORAL

Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.

Home Testing

Eligibility Criteria

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

You may qualify if:

  • Male
  • Age ≥18
  • Has sex with men
  • HIV-negative
  • Meets PHSKC HIV/STD Program definition of "high risk"
  • Plans to live in Seattle for the next 15 months

You may not qualify if:

  • Unable to safely and confidentially receive or store a home testing kit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health - Seattle & King County STD Clinic, located at Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Katz DA, Golden MR, Hughes JP, Farquhar C, Stekler JD. HIV Self-Testing Increases HIV Testing Frequency in High-Risk Men Who Have Sex With Men: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):505-512. doi: 10.1097/QAI.0000000000001709.

    PMID: 29697595DERIVED

MeSH Terms

Conditions

HIV InfectionsDiseaseHomosexuality, MaleSexually Transmitted DiseasesSexual Behavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHomosexualitySexualityBehaviorDisease Attributes

Results Point of Contact

Title
Dr. David Katz
Organization
University of Washington
dkatz7@u.washington.edu
206-744-5877

Study Officials

  • Joanne D Stekler, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Division of Allergy & Infectious Diseases

Study Record Dates

First Submitted

July 9, 2010

First Posted

July 13, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 7, 2017

Results First Posted

June 7, 2017

Record last verified: 2017-05

Locations

US(1)