Implementation of Rapid HIV Self-Testing Among MSM Project

NCT04219878 | Completed

• 2 other identifiers: IRB000997101U01PS005181
• Study Type: interventional
• Target: 2,195
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Cost of linkage to HIV counseling

  Month 4

• Cost of linkage to HIV treatment

  Month 4

• Cost of linkage to PrEP counseling

  Month 4

• Cost of linkage to PrEP uptake

  Month 4

• Cost of Sexually Transmitted Infection (STI) testing

  Month 4

Study Arms (2)

Know@Home App or Website and Test Kit

ACTIVE COMPARATOR

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; Other: Self-test Kit

Mail-Out Testing Kit Only

ACTIVE COMPARATOR

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

Other: Self-test Kit

Interventions

Know@Home BEHAVIORAL

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.

Know@Home App or Website and Test Kit

Self-test Kit OTHER

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.

Also known as: OraQuick® In-Home HIV Test

Know@Home App or Website and Test Kit; Mail-Out Testing Kit Only

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study includes participants who were assigned male sex at birth and identify as male or female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• Currently participating in another HIV prevention clinical trial or intervention
• Has a bleeding disorder preventing use of dried blood spot testing

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• MacGowan RJ, Chavez PR, Dana R, Hannah M, Raiford JL, Caldwell JA, Wall KM, Johnson JA, Sharma A, Hightow-Weidman L, Stephenson R, Sanchez T, Smith AJ, Sullivan S, Jones J, Sullivan PS. Efficacy of Internet Recruitment and HIV Self-Testing for Diagnosing HIV Infections Among Black and Hispanic/Latino MSM and Transgender Women in 11 US States, 2020-2021. J Acquir Immune Defic Syndr. 2024 Oct 1;97(2):133-141. doi: 10.1097/QAI.0000000000003476.

  PMID: 39250647 DERIVED

• Dana R, Sullivan S, MacGowan RJ, Chavez PR, Wall KM, Sanchez TH, Stephenson R, Hightow-Weidman L, Johnson JA, Smith A, Sharma A, Jones J, Hannah M, Trigg M, Luo W, Caldwell J, Sullivan PS. Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial. JMIR Res Protoc. 2023 Jan 6;12:e43414. doi: 10.2196/43414.

  PMID: 36607707 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Sullivan, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Study Start: February 17, 2020
• Primary Completion: September 1, 2021
• Study Completion: January 15, 2022
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)