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TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
NA trial testing Text Messaging (Text+Step) in HIV in 254 participants. Completed in 31 May 2022.
| Lead sponsor | Friends Research Institute, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 254 |
| Start date | 18 October 2019 |
| Primary completion | 31 May 2022 |
| Estimated completion | 31 May 2022 |
| Sites | 5 locations across United States |
Friends Research Institute, Inc.
Adults 15 to 24, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Text+Step | 3.14 | 2.45 – 3.82 |
| WebApp+Step | 3.17 | 2.59 – 3.74 |
| Information | 3.68 | 3.16 – 4.20 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Information | 1.04 | 0.74 – 1.33 |
| Text+Step | 0.79 | 0.55 – 1.04 |
| WebApp+Step | 1.02 | 0.74 – 1.29 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Information | 0 | 0 – 0 |
| Text+Step | 0.03 | 0.00 – 0.10 |
| WebApp+Step | 0 | 0 – 0 |
HIV tests will be collected at each time point. Incident infections will be recorded.
| Group | Value | 95% CI |
|---|---|---|
| Information | 0 | |
| Text+Step | 0 | |
| WebApp+Step | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Information | 0.06 | 0 – 0.16 |
| Text+Step | 0.02 | 0 – 0.07 |
| WebApp+Step | 0.04 | 0 – 0.14 |
Time frame: 9 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Information | Text+Step | WebApp+Step |
|---|---|---|---|---|
| Unrelated mental health issues | Psychiatric disorders | — | — | — |
| Protocol related mental health concern | Psychiatric disorders | — | — | — |
| COVID | Respiratory, thoracic and mediastinal disorders | — | — | — |
Data from ClinicalTrials.gov NCT04000724 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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