Back to results

Implementation of Rapid HIV Self-Testing Among MSM Project (iSTAMP)

Primary Purpose

HIV/AIDS

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Know@Home

Self-test Kit

About this trial

This is an interventional health services research trial for HIV/AIDS focused on measuring Sexually transmitted infections, Behavioral intervention, Public health, HIV preexposure prophylaxis (PrEP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Know@Home App or Website and Test Kit

Mail-Out Testing Kit Only

Arm Description

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.

Participants in this study arm will receive mail-out HIV self-testing kits.

Outcomes

Primary Outcome Measures

Number of participants initiating HIV treatment

Effectiveness of the interventions will be assessed by linkage of participants to HIV treatment.

Number of participants initiating PrEP treatment

Effectiveness of the interventions will be assessed by linkage of participants to PrEP treatment.

Number of participants testing for STIs

Effectiveness of the interventions will be assessed by linkage of participants to STI testing.

Number of participants engaging in HIV prevention services

Effectiveness of the interventions will be assessed by linkage of participants to HIV prevention services.

Number of participants engaging in HIV social services

Effectiveness of the interventions will be assessed by linkage of participants to HIV social services.

Cost of different online venues for study enrollment

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.

Cost of different online venues for HIV test results returned

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

Cost of different online venues for identifying new HIV diagnoses

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

Cost of linkage to HIV counseling

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

Cost of linkage to HIV treatment

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

Cost of linkage to PrEP counseling

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

Cost of linkage to PrEP uptake

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

Cost of Sexually Transmitted Infection (STI) testing

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

Cost of linkage to STI treatment

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

Full Information

NCT ID

NCT04219878

First Posted

January 3, 2020

Last Updated

March 24, 2022

Sponsor

Emory University

Collaborators

Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT04219878

Brief Title

Implementation of Rapid HIV Self-Testing Among MSM Project

Acronym

iSTAMP

Official Title

Engaging African American and Hispanic/Latino MSM for HIV Testing and Prevention Services Through Technology

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

February 17, 2020 (Actual)

Primary Completion Date

September 1, 2021 (Actual)

Study Completion Date

January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS

Keywords

Sexually transmitted infections, Behavioral intervention, Public health, HIV preexposure prophylaxis (PrEP)

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2195 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Know@Home App or Website and Test Kit

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Mail-Out Testing Kit Only

Arm Type

Active Comparator

Arm Description

Participants in this study arm will receive mail-out HIV self-testing kits.

Intervention Type

Behavioral

Intervention Name(s)

Know@Home

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Self-test Kit

Other Intervention Name(s)

OraQuick® In-Home HIV Test

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants initiating HIV treatment

Description

Effectiveness of the interventions will be assessed by linkage of participants to HIV treatment.

Time Frame

Up to Month 4

Title

Number of participants initiating PrEP treatment

Description

Effectiveness of the interventions will be assessed by linkage of participants to PrEP treatment.

Time Frame

Up to Month 4

Title

Number of participants testing for STIs

Description

Effectiveness of the interventions will be assessed by linkage of participants to STI testing.

Time Frame

Up to Month 4

Title

Number of participants engaging in HIV prevention services

Description

Effectiveness of the interventions will be assessed by linkage of participants to HIV prevention services.

Time Frame

Up to Month 4

Title

Number of participants engaging in HIV social services

Description

Effectiveness of the interventions will be assessed by linkage of participants to HIV social services.

Time Frame

Up to Month 4

Title

Cost of different online venues for study enrollment

Description

Time Frame

Baseline

Title

Cost of different online venues for HIV test results returned

Description

Time Frame

Month 1

Title

Cost of different online venues for identifying new HIV diagnoses

Description

Time Frame

Month 1

Secondary Outcome Measure Information:

Title

Cost of linkage to HIV counseling

Description

Time Frame

Month 4

Title

Cost of linkage to HIV treatment

Description

Time Frame

Month 4

Title

Cost of linkage to PrEP counseling

Description

Time Frame

Month 4

Title

Cost of linkage to PrEP uptake

Description

Time Frame

Month 4

Title

Cost of Sexually Transmitted Infection (STI) testing

Description

Time Frame

Month 4

Title

Cost of linkage to STI treatment

Description

Time Frame

Month 4

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

This study includes participants who were assigned male sex at birth and identify as male or female.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Sullivan, PhD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

Data will be made available 30 months after data collection and cleaning have ended until five years after data are made available.

IPD Sharing 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.

Learn more about this trial

Implementation of Rapid HIV Self-Testing Among MSM Project

We'll reach out to this number within 24 hrs