HIVNCT04000724

TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission

A study testing Text Messaging (Text+Step), WebApp (App+Step) and Information/No Step in people with HIV, run by Friends Research Institute, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 24 yearsHealthy volunteers can take part
Conditions the study is for: HIV
What is being tested?: Text Messaging (Text+Step), WebApp (App+Step) and Information/No Step
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 254 participants
Where: 5 sitesUnited States
Study dates: 18 Oct 2019to 31 May 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 24 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Report vaginal or anal sex (either insertive or receptive; excluding sex toys) with another person in the previous 12 months;
Confirmed negative HIV test;
Availability to meet with research staff in person or online at either the Baylor College of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, the PRIDE Health Research Consortium in New York City, or the Fenway Institute in Boston
Have a mobile device with short messaging service (SMS; i.e. "texting") and Internet access capabilities; and
Read and speak English (since the intervention is built in English)

Who cannot join

Does not report vaginal or anal sex (either insertive or receptive; excluding sex toys) with another person in the previous 12 months;
Reactive or indeterminate HIV test;
Unable to meet with research staff in person or online at either the Baylor College of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, the PRIDE Health Research Consortium in New York City, or the Fenway Institute in Boston
Does not have a mobile device with SMS and Internet access capabilities;
Unable to read and speak English (since the intervention is built and delivered in English)
Unwilling or unable to comply with protocol requirements;
Unable to understand the Informed Consent/Assent Form.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

The Fenway Institute
Boston, Massachusetts, 02215
Baylor College of Medicine
Houston, Texas, 77030
Children's Hospital Los Angeles
Los Angeles, California, 90027
PRIDE Health Research Consortium at Hunter CUNY
New York, New York, 10018
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Read the detailed description

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.

Conditions: HIV
Being tested: Text Messaging (Text+Step), WebApp (App+Step), Information/No Step
Keywords: Text Messaging, mHealth, HIV, AIDS, PrEP
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Text Messaging (Text+Step)Behavioural
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.
WebApp (App+Step)Behavioural
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 StepBehavioural
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.

Study groups in NCT04000724
Study group	Role	What they receive
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. Receives: Behavioral: Text Messaging (Text+Step)
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. Receives: Behavioral: WebApp (App+Step)
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. Receives: Behavioral: Information/No Step

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 9 Months
HIV Seroconversion
HIV tests will be collected at each time point. Incident infections will be recorded.
Measured: 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.
Measured: 9 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 201931 May 2022

First posted27 Jun 2019
Study start18 Oct 2019
Primary completion31 May 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04000724
Sponsor's protocol ID: ATN160
Status last verified: Feb 2024
First submitted: 16 Mar 2019
Last updated: 20 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 39304589
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.
PubMed 32788149

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
ClinicalTrials.gov ID: NCT04000724
Acronym / sponsor ID: ATN160
Conditions: HIV
Keywords: Text Messaging, mHealth, HIV, AIDS, PrEP
Study type: Interventional
Recruitment status: Completed
Enrolment: 254 participants (actual)
Lead sponsor: Friends Research Institute, Inc.University, hospital or other
Collaborators: San Diego State University, University of North Carolina, Emory University, Baylor College of Medicine, Children's Hospital of Philadelphia, The Fenway Institute, Hunter College of City University of New York, Children's Hospital Los Angeles
Study start: 18 Oct 2019 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 27 Jun 2019 (actual)
Results: Posted 20 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Text+Step	Experimental	Behavioral: Text Messaging (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.
WebApp+Step	Experimental	Behavioral: WebApp (App+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.
Information	Experimental	Behavioral: Information/No StepThe 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.

Who may qualify

Ages: 15 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Report vaginal or anal sex (either insertive or receptive; excluding sex toys) with another person in the previous 12 months;
Confirmed negative HIV test;
Availability to meet with research staff in person or online at either the Baylor College of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, the PRIDE Health Research Consortium in New York City, or the Fenway Institute in Boston
Have a mobile device with short messaging service (SMS; i.e. "texting") and Internet access capabilities; and
Read and speak English (since the intervention is built in English)

Key exclusion criteria (7 listed)

Does not report vaginal or anal sex (either insertive or receptive; excluding sex toys) with another person in the previous 12 months;
Reactive or indeterminate HIV test;
Unable to meet with research staff in person or online at either the Baylor College of Medicine (BCM) Adolescent Medicine Trials Unit in Houston, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, the PRIDE Health Research Consortium in New York City, or the Fenway Institute in Boston
Does not have a mobile device with SMS and Internet access capabilities;
Unable to read and speak English (since the intervention is built and delivered in English)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Text+Step
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.	Behavioural	WebApp+Step
Information/No StepParticipants 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.	Behavioural	Information

Primary outcome

Condomless Intercourse Events
Time frame: 9 Months
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.
Condomless Intercourse Events While High on Drugs/Alcohol
Time frame: 9 Months
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.
Condomless Intercourse Events During Sex Work
Time frame: 9 Months
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.
HIV Seroconversion
Time frame: 9 Months
HIV tests will be collected at each time point. Incident infections will be recorded.
Incident STIs
Time frame: 9 Months
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.

Results and safety

Results posted to the registry on 20 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Information	85	69
Text+Step	82	72
WebApp+Step	87	70

Primary outcome: Condomless Intercourse Events

Time frame: 9 Months. Mean (95% Confidence Interval). Unit: Expected events

Measure	Text+Step n = 82	WebApp+Step n = 87	Information n = 85
Value	3.14 (2.45 to 3.82)	3.17 (2.59 to 3.74)	3.68 (3.16 to 4.20)

Text+Step vs Information: Average treatment effect: -0.54 (95% CI -1.26 to 0.18), p = 0.141, Longitudinal Targeted Maximum Likelihood
WebApp+Step vs Information: Average treatment effect: -0.51 (95% CI -1.16 to 0.14), p = 0.123, Longitudinal Targeted Maximum Likelihood

Primary outcome: Condomless Intercourse Events While High on Drugs/Alcohol

Time frame: 9 Months. Mean (95% Confidence Interval). Unit: Expected events

Measure	Information n = 85	Text+Step n = 82	WebApp+Step n = 87
Value	1.04 (0.74 to 1.33)	0.79 (0.55 to 1.04)	1.02 (0.74 to 1.29)

Information vs Text+Step: Average treatment effect: -0.24 (95% CI -.56 to .07), p = .127, Longitudinal Targeted Maximum Likelihood
Information vs WebApp+Step: Average treatment effect: -.02 (95% CI -.34 to .30), p = .899, Longitudinal Targeted Maximum Likelihood

Primary outcome: Condomless Intercourse Events During Sex Work

Time frame: 9 Months. Mean (95% Confidence Interval). Unit: Expected events

Measure	Information n = 75	Text+Step n = 78	WebApp+Step n = 77
Value	0 (0 to 0)	0.03 (0.00 to 0.10)	0 (0 to 0)

Population analysed: Participants who answered the relevant survey questions necessary to assess the 3-month step-up criteria were included in the analytical sample.

Primary outcome: HIV Seroconversion

Time frame: 9 Months. Count of participants. Unit: Participants

Measure	Information n = 85	Text+Step n = 82	WebApp+Step n = 87
Value	0	0	0

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Information	0 of 85 (0%)	2 of 85 (2.4%)	0 of 85
Text+Step	0 of 82 (0%)	1 of 82 (1.2%)	0 of 82
WebApp+Step	0 of 87 (0%)	3 of 87 (3.4%)	0 of 87

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39304589Reback 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.
Derived from this study: PubMed 32788149Reback 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.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa Hightow-Wideman, MD, MPH study chair

University of North Carolina

Travis Sanchez, DVM, MPH study chair

Emory University

Cathy J Reback, PhD principal investigator

Friends Research Institute, Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Text Messaging (Text+Step), WebApp (App+Step) and Information/No Step in people with HIV, run by Friends Research Institute, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Condomless Intercourse Events (time frame: 9 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04000724, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.