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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Know@Home; Other: Self-test Kit

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.

• Study Type: Interventional
• Enrollment (Actual): 2195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: OraQuick® In-Home HIV Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants initiating HIV treatment	Effectiveness of the interventions will be assessed by linkage of participants to HIV treatment.	Up to Month 4
Number of participants initiating PrEP treatment	Effectiveness of the interventions will be assessed by linkage of participants to PrEP treatment.	Up to Month 4
Number of participants testing for STIs	Effectiveness of the interventions will be assessed by linkage of participants to STI testing.	Up to Month 4
Number of participants engaging in HIV prevention services	Effectiveness of the interventions will be assessed by linkage of participants to HIV prevention services.	Up to Month 4
Number of participants engaging in HIV social services	Effectiveness of the interventions will be assessed by linkage of participants to HIV social services.	Up to Month 4
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.	Baseline
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	Month 1
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	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Month 4
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	Month 4
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	Month 4
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	Month 4
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	Month 4
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	Month 4

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Patrick Sullivan, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Behavioral intervention; Sexually transmitted infections; Public health; HIV preexposure prophylaxis (PrEP)
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: IRB00099710; 1U01PS005181 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No