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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01PS005181 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Mail-Out Testing Kit Only | Active Comparator | Participants in this study arm will receive mail-out HIV self-testing kits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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:
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Inclusion Criteria for MSM Participants:
Exclusion Criteria for MSM Participants:
Inclusion Criteria for TGW:
Exclusion Criteria for TGW:
This study includes participants who were assigned male sex at birth and identify as male or female.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Sullivan, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39250647 | Derived | 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. | |
| 36607707 | Derived |
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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.
Data will be made available 30 months after data collection and cleaning have ended until five years after data are made available.
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 17, 2020 | Jan 24, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 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. |
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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:
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| 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:
| Month 1 |
| 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:
| 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:
| 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:
| 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:
| 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:
| Month 4 |
| 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. |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |