ATN 160: TECHSTEP
ClinicalTrials.gov Number: NCT04000724
TechStep is a two-condition, technology-based randomized controlled trial (RCT), with a stepped care approach, among high-risk HIV-negative trans feminine, trans masculine, and gender non-conforming (here after: trans*) youth for reducing sexual risk behaviors (e.g., condomless anal intercourse, engagement in sex work, sex while feeling the effects of alcohol or drugs) and increasing PrEP uptake.
Trans youth will be recruited from 5 SRVs (Boston, Houston, Los Angeles, New York, and Philadelphia) to participate in a 3-arm RCT to determine immediate and sustained effects of the Text+Step intervention versus the App+Step intervention compared to an information-only control condition (“Info” arm). All participants will receive one of the interventions for 6 months, with assessments occurring at baseline and every 3 months thereafter until month 9. Trans youth randomized to either of the technology-based intervention arms (Text or App) will be evaluated at the 3-month follow-up assessment time points to determine if they remain at the current level of intervention, or if they are eligible for randomization to also receive e-coaching sessions in addition to their originally assinged intervention. All participants assigned to the Text+Step intervention arm will begin with the text messaging intervention. Participants assigned to the App+Step intervention arm will begin with the WebApp intervention. At the first follow-up assessment time point, information about their sexual behavior in the past 3 months and whether they began or stopped using PrEP will be used to determine if they require a more intensive intervention approach. Participants who do not demonstrate intervention responsiveness at the 3-month follow-up assessment will be re-randomized, in a 2:1 ratio, to either remain in the original technology-based intervention (i.e., Text or App) or add e-coaching to the original technology-based intervention (i.e., Text+E-coaching or App+E-coaching). This re-randomization will allow for a comparison of intervention effects between the technology-based interventions (i.e., text or app) plus e-coaching to the technology-based intervention alone. The control condition will receive the same information-only intervention for the entire 6-month intervention period.
TechStep participants in the RCT will be enrolled for 9 months.
Total study sample is 330 of which the following will be enrolled for each phase: 1) up to 80 participants for focus groups to inform intervention adaption; 2) 250 participants for a randomized controlled trial of TechStep, with participants randomized to either text messaging stepped care (n=83), WebApp stepped care (n=83) or control (n=83) condition.
Eligibility for RCT:
- Self-identified as trans feminine, trans masculine or gender non-conforming OR birth sex and current gender differ;
- Between the ages of 15 to 24 years old;
- Have a mobile device with SMS and Internet access capabilities; and
- More information on eligibility and exclusion criteria available on ClinicalTrials.gov
- Conduct formative research to develop the stepped care (text messaging, WebApp, and e-coaching) interventions and refine iterations through input from focus groups with trans youth at the four study sites (n=80) and a youth advisory board (YAB).
- In a 3-arm RCT (N=250), assess the differential immediate and sustained effects of a low intensity Information (“Info”) arm compared to a text messaging stepped care intervention (“Text+Step”) arm compared to a WebApp stepped care intervention (“App+Step”) arm among high-risk, HIV-negative trans (15-24 years old) for reducing sexual risk behaviors and increasing PrEP uptake.
- Determine the added benefit of Text+e-coaching or WebApp+e-coaching versus Text alone or WebApp alone for reducing sexual risk behaviors and increasing PrEP uptake.
- Determine the impact of structural- (e.g., transphobia, housing insecurity, educational attainment, access to healthcare) and individual-level (e.g., identity formation, gender transition, gender expression, stigma, discrimination) trans-specific factors as moderators of intervention outcomes.
Cathy Reback, PhD
Keith J. Horvath, PhD