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| Name | Class |
|---|---|
| San Diego State University | OTHER |
| University of North Carolina | OTHER |
| Emory University | OTHER |
| Baylor College of Medicine |
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TechStep is a three-arm, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative transgender feminine, transgender masculine, and gender non-conforming youth and young adults for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake. Participants are randomized into one of three conditions for a 6-month intervention: Group 1: culturally relevant theory-based text messages (Text+Step); or, Group 2: culturally relevant mobile-enhanced website (WebApp+Step); or, Group 3: informational website control condition with no theoretically based text messages or WebApp.
TechStep is a three-arm, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative transgender feminine, transgender masculine, and gender non-conforming youth and young adults for reducing sexual risk behaviors and increasing PrEP uptake. Transgender youth and young adults are enrolled for 9 months in the RCT. During the RCT, 250 participants will be enrolled and randomized to either: (1) text messaging (n=83), (2) WebApp (n=83), or (3) an informational website control (n=83) condition. Participants will include HIV-negative youth and young adults (ages 15-24) who are self-identified transgender feminine, transgender masculine or gender non-conforming. Participants will be recruited from venues in Boston, Houston, Los Angeles, New York, and Philadelphia. There will be four data collection time points: baseline, 3-, 6-, and 9-month. Visits will be conducted in-person at the venues, online, or some combination of in person or online. An ACASI will be completed using online survey tools. An HIV test, sexually transmitted infection (STI) panel, urine screen for recent illicit drug use, and blood microsampling or dried blood spot, for those who report PrEP uptake, to verify PrEP adherence will be collected in-person at the participants local venue, or via mailed self-collection kits. Process data of each participant activity at each step of the intervention, as well as the control intervention, will be collected. The study aims to measure the effects of the information-only (Info) arm compared to a text messaging intervention (Text+Step) to a WebApp intervention (WebApp+Step) for reducing sexual risk behaviors and increasing PrEP uptake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text+Step | Experimental | The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence. |
|
| WebApp+Step | Experimental | The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence. |
|
| Information | Experimental | The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Messaging (Text+Step) | Behavioral | Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Condomless Intercourse Events | Participants will report the frequency of condomless sexual intercourse events they have engaged in for the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up. | 9 Months |
| Condomless Intercourse Events While High on Drugs/Alcohol | Participants will report the number of condomless sexual intercourse events they have engaged in while high on drugs or alcohol during their three most recent sexual encounters in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up. | 9 Months |
| Condomless Intercourse Events During Sex Work | Participants will report the number of exchange partners in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up. | 9 Months |
| HIV Seroconversion | HIV tests will be collected at each time point. Incident infections will be recorded. | 9 Months |
| Incident STIs | Participants will be tested for gonorrhea and chlamydia via throat, rectal, and urogenital swab specimen collection, as well as via urine samples at each time point. Incident STIs will be recorded. | 9 Months |
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Inclusion Criteria:
Exclusion Criteria:
Participants will include youth and young adults who are self-identified trans feminine, trans masculine or gender non-conforming OR whose birth sex and current gender differ
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Hightow-Wideman, MD, MPH | University of North Carolina | Study Chair |
| Travis Sanchez, DVM, MPH | Emory University | Study Chair |
| Cathy J Reback, PhD | Friends Research Institute, Inc. | Principal Investigator |
| Keith J Horvath, PhD | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| The Fenway Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39304589 | Derived | Reback CJ, Cain D, Rusow JA, Benkeser D, Schader L, Gwiazdowski BA, Skeen SJ, Hannah M, Belzer M, Castillo M, Mayer KH, Paul ME, Hill-Rorie J, Johnson ND, McAvoy-Banerjea J, Sanchez T, Hightow-Weidman LB, Sullivan PS, Horvath KJ. Technology-Based Interventions, with a Stepped Care Approach, for Reducing Sexual Risk Behaviors and Increasing PrEP Initiation Among Transgender and Gender Expansive Youth and Young Adults. AIDS Behav. 2024 Dec;28(12):3956-3969. doi: 10.1007/s10461-024-04513-w. Epub 2024 Sep 20. | |
| 32788149 |
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The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the data set. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.
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A confirmed negative HIV test was required to enroll in the study. Participants who used a remote enrollment option were offered at-home STI testing which included an HIV test. Participants who did not return at least the HIV test portion of the kit were subsequently and retroactively ineligible for the study, withdrawn, and not considered randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Information | The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons. Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons. |
| FG001 | Text+Step | The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence. Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. |
| FG002 | WebApp+Step | The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence. WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Text+Step | The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence. Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Condomless Intercourse Events | Participants will report the frequency of condomless sexual intercourse events they have engaged in for the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up. | Posted | Mean | 95% Confidence Interval | Expected events | 9 Months |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Information | The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons. Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated mental health issues | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathy Reback | Friends Research Institute, Inc. | 3234631601 | reback@friendsresearch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2021 | May 31, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2021 | May 31, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| OTHER |
| Children's Hospital of Philadelphia | OTHER |
| The Fenway Institute | OTHER |
| Hunter College of City University of New York | OTHER |
| Children's Hospital Los Angeles | OTHER |
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|
| WebApp (App+Step) | Behavioral | Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. |
|
| Information/No Step | Behavioral | Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons. |
|
| Boston |
| Massachusetts |
| 02215 |
| United States |
| PRIDE Health Research Consortium at Hunter CUNY | New York | New York | 10018 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Derived |
| Reback CJ, Rusow JA, Cain D, Benkeser D, Arayasirikul S, Hightow-Weidman L, Horvath KJ. Technology-Based Stepped Care to Stem Transgender Adolescent Risk Transmission: Protocol for a Randomized Controlled Trial (TechStep). JMIR Res Protoc. 2020 Aug 13;9(8):e18326. doi: 10.2196/18326. |
| BG001 | WebApp+Step | The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence. WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. |
| BG002 | Information | The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons. Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | WebApp+Step | The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence. WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. |
| OG002 | Information | The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons. Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons. |
|
|
|
| Primary | Condomless Intercourse Events While High on Drugs/Alcohol | Participants will report the number of condomless sexual intercourse events they have engaged in while high on drugs or alcohol during their three most recent sexual encounters in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up. | Posted | Mean | 95% Confidence Interval | Expected events | 9 Months |
|
|
|
|
| Primary | Condomless Intercourse Events During Sex Work | Participants will report the number of exchange partners in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up. | Participants who answered the relevant survey questions necessary to assess the 3-month step-up criteria were included in the analytical sample. | Posted | Mean | 95% Confidence Interval | Expected events | 9 Months |
|
|
|
| Primary | HIV Seroconversion | HIV tests will be collected at each time point. Incident infections will be recorded. | Posted | Count of Participants | Participants | 9 Months |
|
|
|
| Primary | Incident STIs | Participants will be tested for gonorrhea and chlamydia via throat, rectal, and urogenital swab specimen collection, as well as via urine samples at each time point. Incident STIs will be recorded. | Participants who answered the relevant survey questions necessary to assess the 3-month step-up criteria were included in the analytical sample. | Posted | Mean | 95% Confidence Interval | Expected infections | 9 Months |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 2 |
| 85 |
| EG001 | Text+Step | The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence. Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. | 0 | 82 | 0 | 82 | 1 | 82 |
| EG002 | WebApp+Step | The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence. WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks. | 0 | 87 | 0 | 87 | 3 | 87 |
| Protocol related mental health concern | Psychiatric disorders | Systematic Assessment |
|
| COVID | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| 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 |
| Average treatment effect |
| -.02 |
| 2-Sided |
| 95 |
| -.34 |
| .30 |
| Superiority |