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Trial record 1 of 386 for:    know@home
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Implementation of Rapid HIV Self-Testing Among MSM Project (iSTAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04219878
Recruitment Status : Completed
First Posted : January 7, 2020
Last Update Posted : March 25, 2022
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Patrick S Sullivan, Emory University

Brief Summary:
This study will use online materials and strategies to recruit 3600 Black and Hispanic men who have sex with men (MSM) and transgender women (TGW) to participate in a study evaluating the effectiveness of the Know@Home mobile app compared to control condition with respect to linkage of participants to appropriate services, as well as cost-effectiveness outcomes.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Know@Home Other: Self-test Kit Not Applicable

Detailed Description:

To evaluate the effectiveness of mailing out rapid HIV home-testing kits and additional testing promotion components among African-American or black and Hispanic or Latino gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW), the study "Implementation of Rapid HIV Self-Testing among MSM Project", known as iSTAMP, is being conducted in 11 US states. This study is interested in the most cost-effective ways to recruit people at high risk for HIV infection. The researchers want to study a sample of 3600 adult MSM and TGW who are not known to be living with HIV; 1800 black/African-American and 1800 Hispanic/Latino participants will be enrolled.

All participants will be mailed two rapid HIV self-test kits upon randomization. All participants, regardless of study arm, will also complete a follow-up survey at the end of a 4-month follow-up period. At the end of the 4-month follow-up period, participants will be mailed a dried blood spot (DBS) collection kit for research purposes, as well as another rapid HIV self-test kit for immediate testing. Participants in each of the arms will have access to videoconferencing-delivered prevention counseling, and all participants, regardless of assigned arm, will be contacted if they report seroconversion and/or a preliminary positive test during the study period for active linkage to care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Engaging African American and Hispanic/Latino MSM for HIV Testing and Prevention Services Through Technology
Actual Study Start Date : February 17, 2020
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Know@Home App or Website and Test Kit
Participants in this study arm will have access to Know@Home, a mobile HIV prevention app or website and will receive mail-out HIV self-testing kits.
Behavioral: Know@Home
Participants randomly assigned to the Know@Home arm will access the features of Know@Home by downloading the app or accessing the website. The contents were developed to serve as a comprehensive mobile HIV prevention platform for MSM or TGW, with HIV prevention and care information and links to resources. This intervention arm provides an toolkit that allows users to access information about prevention services as their needs change. Participants will have access to Know@Home for the study period. The Know@Home arm will offer participants the opportunity to order free condoms and lubricant as well as an at-home sexually transmitted infection (STI) testing kit.

Other: Self-test Kit
All participants will be shipped two at-home HIV self-tests. They will also receive a link to a previously-produced video that fully describes the specimen collection process, pointing out common errors and providing tips for successful collection. Participants will interact with study staff through phone, email, or text. Information to schedule a video HIV testing and counseling session with study staff will be made available to participants in all arms via a website, email, and/or text.
Other Name: OraQuick® In-Home HIV Test

Active Comparator: Mail-Out Testing Kit Only
Participants in this study arm will receive mail-out HIV self-testing kits.
Other: Self-test Kit
All participants will be shipped two at-home HIV self-tests. They will also receive a link to a previously-produced video that fully describes the specimen collection process, pointing out common errors and providing tips for successful collection. Participants will interact with study staff through phone, email, or text. Information to schedule a video HIV testing and counseling session with study staff will be made available to participants in all arms via a website, email, and/or text.
Other Name: OraQuick® In-Home HIV Test




Primary Outcome Measures :
  1. Number of participants initiating HIV treatment [ Time Frame: Up to Month 4 ]
    Effectiveness of the interventions will be assessed by linkage of participants to HIV treatment.

  2. Number of participants initiating PrEP treatment [ Time Frame: Up to Month 4 ]
    Effectiveness of the interventions will be assessed by linkage of participants to PrEP treatment.

  3. Number of participants testing for STIs [ Time Frame: Up to Month 4 ]
    Effectiveness of the interventions will be assessed by linkage of participants to STI testing.

  4. Number of participants engaging in HIV prevention services [ Time Frame: Up to Month 4 ]
    Effectiveness of the interventions will be assessed by linkage of participants to HIV prevention services.

  5. Number of participants engaging in HIV social services [ Time Frame: Up to Month 4 ]
    Effectiveness of the interventions will be assessed by linkage of participants to HIV social services.

  6. Cost of different online venues for study enrollment [ Time Frame: Baseline ]
    Enrollment in the study defined as completion of the baseline survey and downloading of the study app. The cost (in US dollars) to enroll participants (online banner advertisement placement, study staff time to manage enrollment, validating participant eligibility, monitoring and evaluation of enrollment data) will be compared between the study arms.

  7. Cost of different online venues for HIV test results returned [ Time Frame: Month 1 ]

    The cost (in US dollars) of HIV tests returned within 1 month of enrollment will be compared between the study arms. The costs involved with having HIV tests returned include:

    • Online banner advertisement placement
    • Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data
    • HIV test kits
    • Shipping for HIV test kits
    • Staff/personnel time to manage mailing/return of test kits
    • Other general and administrative time, office supplies, equipment, rents, utilities

  8. Cost of different online venues for identifying new HIV diagnoses [ Time Frame: Month 1 ]

    The cost (in US dollars) of identifying established HIV infections will be compared between the study arms. The costs involved with identifying established HIV infections include:

    • Online banner advertisement placement
    • Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data
    • HIV test kits
    • Shipping for HIV test kits
    • Staff/personnel time to manage mailing/return of test kits
    • Study staff time to manage monitoring and evaluation of HIV test result data
    • Study staff time to provide phone counseling to those with established infections
    • Other general and administrative time, office supplies, equipment, rents, utilities


Secondary Outcome Measures :
  1. Cost of linkage to HIV counseling [ Time Frame: Month 4 ]

    The cost (in US dollars) of linking participants testing positive for HIV to HIV counseling will be compared between the study arms, including:

    • Study staff time spent contacting participants
    • Study staff time for intervention maintenance (e.g., app management)
    • HIV counseling costs to the healthcare system
    • Other general and administrative time, office supplies, equipment, rents, utilities

  2. Cost of linkage to HIV treatment [ Time Frame: Month 4 ]

    The cost (in US dollars) of linking participants testing positive for HIV to HIV treatment will be compared between the three study arms, including:

    • Study staff time for intervention maintenance (e.g., app management)
    • HIV treatment costs to the healthcare system
    • Other general and administrative time, office supplies, equipment, rents, utilities

  3. Cost of linkage to PrEP counseling [ Time Frame: Month 4 ]

    The cost (in US dollars) of linking participants testing negative for HIV to PrEP counseling will be compared between the study arms, including:

    • Study staff time contacting participants
    • Study staff time for intervention maintenance (e.g., app management)
    • PrEP counseling costs to the healthcare system
    • Other general and administrative time, office supplies, equipment, rents, utilities

  4. Cost of linkage to PrEP uptake [ Time Frame: Month 4 ]

    The cost (in US dollars) of linking participants testing negative for HIV to initiate PrEP treatment will be compared between the study arms, including:

    • Study staff time contacting participants
    • Study staff time for intervention maintenance (e.g., app management)
    • PrEP uptake costs to the healthcare system
    • Other general and administrative time, office supplies, equipment, rents, utilities

  5. Cost of Sexually Transmitted Infection (STI) testing [ Time Frame: Month 4 ]

    The cost (in US dollars) of providing at-home STI testing be compared between the study arms, including:

    • Cost of STI testing materials and shipping
    • Laboratory STI testing
    • Study staff time processing orders and contacting participants
    • Study staff time for intervention maintenance (e.g., app management)
    • STI testing costs to the healthcare system
    • Other general and administrative time, office supplies, equipment, rents, utilities

  6. Cost of linkage to STI treatment [ Time Frame: Month 4 ]

    The cost (in US dollars) of providing treatment for STIs discovered through at-home STI testing be compared between the three study arms, including:

    • Study staff time processing orders and contacting participants
    • Study staff time for intervention maintenance (e.g., app management)
    • STI treatment costs to the healthcare system
    • Other general and administrative time, office supplies, equipment, rents, utilities



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study includes participants who were assigned male sex at birth and identify as male or female.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for MSM Participants:

  • Black/African-American race or Hispanic/Latino ethnicity
  • Male sex at birth
  • Currently identify as male
  • Reported anal sex with at least one man in the past 12 months
  • Aged 18 or over
  • Has an Android or Apple mobile phone with currently active service
  • Currently resides in a study state: North Carolina, South Carolina, Georgia, Alabama, Mississippi, Florida, Louisiana, California, Nevada, Texas, New York
  • Willing to download a study participation management mobile app
  • Willing to provide valid contact information so that study HIV testing kits and other materials (condoms, lubricants, STI testing kits) can be mailed to participants.
  • Successful completion of baseline survey

Exclusion Criteria for MSM Participants:

  • Currently participating in another HIV prevention research study or program
  • Has a bleeding disorder preventing use of dried blood spot testing
  • Has previously participated in an HIV vaccine study.
  • Currently taking PrEP for HIV prevention
  • Self-reports living with HIV
  • Has plans to move out of a study state during the study period (4 months)

Inclusion Criteria for TGW:

  • Male sex at birth
  • Currently identify as transgender woman or female
  • Aged 18 or over
  • Has an Android or Apple mobile smartphone with currently active service
  • Currently resides in a study state: North Carolina, South Carolina, Georgia, Alabama, Mississippi, Florida, Louisiana, California, Nevada, Texas, New York
  • Willing to provide valid contact information so that study HIV testing kits and other materials (condoms, lubricants, STI testing kits) can be mailed to participants
  • Successful completion of baseline survey

Exclusion Criteria for TGW:

  • Currently participating in another HIV prevention clinical trial or intervention
  • Has a bleeding disorder preventing use of dried blood spot testing
  • Has previously participated in an HIV vaccine study
  • Currently taking PrEP for HIV prevention
  • Self-reports living with HIV
  • Has plans to move out of a study state during the study period (4 months)

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): NCT04219878


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Patrick Sullivan, PhD Emory University
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Responsible Party: Patrick S Sullivan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT04219878    
Other Study ID Numbers: IRB00099710
1U01PS005181 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data collected during the trial will be available for sharing with other researchers, after deidentification. Some data may be provided as categorical variables.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will be made available 30 months after data collection and cleaning have ended until five years after data are made available.
Access Criteria: Data will be available to anyone affiliated with public health organizations, agencies or accredited universities requesting to access the data for any research purpose that is approved by the Centers for Disease Control and Prevention (CDC) Project Officer and Emory University Principal Investigator. Proposals should be directed to rmacgowan@cdc.gov. To gain access, data requestors must work as a member of the study team on data analysis and manuscript preparation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patrick S Sullivan, Emory University:
Sexually transmitted infections
Behavioral intervention
Public health
HIV preexposure prophylaxis (PrEP)
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases