scholarly journals Technology-Based Stepped Care to Stem Transgender Adolescent Risk Transmission: Protocol for a Randomized Controlled Trial (TechStep) (Preprint)

2020 ◽  
Author(s):  
Cathy J Reback ◽  
Joshua A Rusow ◽  
Demetria Cain ◽  
David Benkeser ◽  
Sean Arayasirikul ◽  
...  

BACKGROUND Transgender youth demonstrate significantly higher rates of engagement in sexual risk behaviors relative to their cisgender or gender-conforming counterparts, including high rates of condomless anal intercourse and engagement in sex work. In addition, transgender youth experience increased physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness. Owing to these syndemic health disparities, transgender youth are at substantially increased risk of HIV infection. OBJECTIVE This protocol aims to describe a randomized controlled trial (RCT), Adolescent Medicine Trials Network 160 TechStep (N=250), which assesses the differential immediate and sustained effects of each of 3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake among high-risk, HIV-negative transgender youth and young adults (aged 15-24 years). METHODS Participants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies. Participants will be randomized into 1 of the 3 conditions: (1) text messaging, (2) WebApp, or (3) information-only control for 6 months. Assessments will occur at baseline and at 3, 6, and 9 months. Participants who do not show improvements in sexual risk or PrEP uptake at the 3-month assessment will be rerandomized to receive weekly electronic coaching (eCoaching) sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention using a 2:1 ratio. Participants originally assigned to the information-only condition are not eligible for rerandomization. RESULTS Funding for TechStep was awarded in June 2017. Phase 1 was approved by the Institutional Review Board (IRB) in April 2018. Recruitment began in November 2018 for phase 1, the formative phase. Initial phase 2 IRB approval came in June 2019. The data collection for phase 2, the RCT, is expected to be completed in April 2021. As of March 2020, 54 participants have been enrolled in TechStep. The final results are anticipated in May 2021. CONCLUSIONS By providing culturally responsive, technology-based interventions, TechStep aims to improve sexual health outcomes among HIV-negative transgender youth and young adults at high risk of HIV. TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence. The suite of technology-based interventions developed in TechStep, and assessed for efficacy in a 3-condition RCT, represents an important advancement in intervention science toward developing tailored and scalable interventions for transgender youth and young adults. CLINICALTRIAL ClinicalTrials.gov NCT04000724; http://clinicaltrials.gov/ct2/show/NCT04000724 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18326

10.2196/18326 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e18326
Author(s):  
Cathy J Reback ◽  
Joshua A Rusow ◽  
Demetria Cain ◽  
David Benkeser ◽  
Sean Arayasirikul ◽  
...  

Background Transgender youth demonstrate significantly higher rates of engagement in sexual risk behaviors relative to their cisgender or gender-conforming counterparts, including high rates of condomless anal intercourse and engagement in sex work. In addition, transgender youth experience increased physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness. Owing to these syndemic health disparities, transgender youth are at substantially increased risk of HIV infection. Objective This protocol aims to describe a randomized controlled trial (RCT), Adolescent Medicine Trials Network 160 TechStep (N=250), which assesses the differential immediate and sustained effects of each of 3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake among high-risk, HIV-negative transgender youth and young adults (aged 15-24 years). Methods Participants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies. Participants will be randomized into 1 of the 3 conditions: (1) text messaging, (2) WebApp, or (3) information-only control for 6 months. Assessments will occur at baseline and at 3, 6, and 9 months. Participants who do not show improvements in sexual risk or PrEP uptake at the 3-month assessment will be rerandomized to receive weekly electronic coaching (eCoaching) sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention using a 2:1 ratio. Participants originally assigned to the information-only condition are not eligible for rerandomization. Results Funding for TechStep was awarded in June 2017. Phase 1 was approved by the Institutional Review Board (IRB) in April 2018. Recruitment began in November 2018 for phase 1, the formative phase. Initial phase 2 IRB approval came in June 2019. The data collection for phase 2, the RCT, is expected to be completed in April 2021. As of March 2020, 54 participants have been enrolled in TechStep. The final results are anticipated in May 2021. Conclusions By providing culturally responsive, technology-based interventions, TechStep aims to improve sexual health outcomes among HIV-negative transgender youth and young adults at high risk of HIV. TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence. The suite of technology-based interventions developed in TechStep, and assessed for efficacy in a 3-condition RCT, represents an important advancement in intervention science toward developing tailored and scalable interventions for transgender youth and young adults. Trial Registration ClinicalTrials.gov NCT04000724; http://clinicaltrials.gov/ct2/show/NCT04000724 International Registered Report Identifier (IRRID) DERR1-10.2196/18326


2016 ◽  
Vol 28 (1) ◽  
pp. 59-76 ◽  
Author(s):  
David H. Jolly ◽  
Monique P. Mueller ◽  
Mario Chen ◽  
Le'Marus Alston ◽  
Marcus Hawley ◽  
...  

2001 ◽  
Vol 33 (5) ◽  
pp. 200 ◽  
Author(s):  
John S. Santelli ◽  
Leah Robin ◽  
Nancy D. Brener ◽  
Richard Lowry

10.2196/14833 ◽  
2020 ◽  
Vol 4 (7) ◽  
pp. e14833
Author(s):  
Larissa Jennings Mayo-Wilson ◽  
Nancy E Glass ◽  
Alain Labrique ◽  
Melissa Davoust ◽  
Fred M Ssewamala ◽  
...  

Background Text messages offer the potential to better evaluate HIV behavioral interventions using repeated longitudinal measures at a lower cost and research burden. However, they have been underused in US minority settings. Objective This study aims to examine the feasibility of assessing economic and sexual risk behaviors using text message surveys. Methods We conducted a single-group study with 17 African-American young adults, aged 18-24 years, who were economically disadvantaged and reported prior unprotected sex. Participants received a text message survey once each week for 5 weeks. The survey contained 14 questions with yes-no and numeric responses on sexual risk behaviors (ie, condomless sex, sex while high or drunk, and sex exchange) and economic behaviors (ie, income, employment, and money spent on HIV services or products). Feasibility measures were the number of participants who responded to the survey in a given week, the number of questions to which a participant responded in each survey, and the number of hours spent from sending a survey to participants to receiving their response in a given week. One discussion group was used to obtain feedback. Results Overall, 65% (n=11/17) of the participants responded to at least one text message survey compared with 35% (n=6/17) of the participants who did not respond. The majority (n=7/11, 64%) of the responders were women. The majority (n=4/6, 67%) of nonresponders were men. An average of 7.6 participants (69%) responded in a given week. Response rates among ever responders ranged from 64% to 82% across the study period. The mean number of questions answered each week was 12.6 (SD 2.7; 90% of all questions), ranging from 72% to 100%. An average of 6.4 participants (84%) answered all 14 text message questions in a given week, ranging from 57% to 100%. Participants responded approximately 8.7 hours (SD 10.3) after receiving the survey. Participants were more likely to answer questions related to employment, condomless sex, and discussions with sex partners. Nonresponse or skip was more often used for questions at the end of the survey relating to sex exchange and money spent on HIV prevention services or products. Strengths of the text message survey were convenience, readability, short completion time, having repeated measures over time, and having incentives. Conclusions Longitudinal text message surveys may be a valuable tool for assessing HIV-related economic and sexual risk behaviors. Trial Registration ClinicalTrials.gov NCT03237871; https://clinicaltrials.gov/ct2/show/NCT03237871


2019 ◽  
Author(s):  
David Cordova ◽  
Jaime Munoz-Velazquez ◽  
Frania Mendoza Lua ◽  
Kathryn Fessler ◽  
Sydni Warner ◽  
...  

BACKGROUND Preventing and reducing substance use disorders, sexually transmitted infections (STIs)/HIV, and teen pregnancy, and the associated risk behaviors (ie, substance use and sexual risk behaviors) among youth remain public health priorities in the United States. Equally important is improving the uptake of STI/HIV testing among the youth. Mobile health (mHealth) apps may be a solution to ameliorate these public health concerns; however, few mHealth preventive interventions have demonstrated efficacy in reducing substance use or sexual risk behaviors or improving the uptake of STI/HIV testing among the youth, particularly in clinic settings. OBJECTIVE This small-scale study aimed to examine the feasibility of conducting a pilot randomized controlled trial (RCT). We evaluated the effects of Storytelling 4 Empowerment (S4E), relative to enhanced usual practice, on the potential mechanisms by which behavior change occurs, namely clinician-youth risk communication, prevention knowledge, and substance use and sexual risk refusal self-efficacy. We also assessed the ability to measure targeted outcomes of past 30-day substance use (ie, alcohol, tobacco, and other drug use), condomless sex, and alcohol or drug use before sex, as well as the uptake of STI/HIV testing. METHODS Employing community-based participatory research principles, 50 youths aged 13 to 21 years were recruited from a youth-centered community health clinic in Southeast Michigan, randomized sequentially to either S4E or enhanced usual practice, and assessed at baseline, immediately postintervention, and 30 days postintervention. S4E consists of 3 modules, including alcohol and drug use, tobacco, and STI/HIV. RESULTS Relative to youth in the enhanced usual practice group, S4E participants demonstrated higher youth-clinician risk communication (mean 3.22, SD 1.67) and increases in prevention knowledge (∆ score mean 0.36, SD 0.51) and self-efficacy (∆ score mean 0.16, SD 0.47). In addition, youth in the S4E group showed reductions in the proportions of past 30-day overall substance use (Cohen <i>h</i>=0.71, 95% CI 0.15 to 1.27), as well as past 30-day alcohol (Cohen <i>h</i>=0.71, 95% CI 0.15 to 1.27), tobacco (Cohen <i>h</i>=0.17, 95% CI −0.39 to 0.73), and drug use (Cohen <i>h</i>=1.28, 95% CI 0.72 to 1.84). The results also suggest a reduction in the proportion of youths who reported past 30-day condomless sex (Cohen <i>h</i>=0.18, 95% CI −0.38 to 0.74) and alcohol use before sex (Cohen <i>h</i>=0.44, 95% CI −0.12 to 1.00). Finally, the findings also demonstrated an increase in the proportion of youths who reported STI/HIV testing over time (Cohen <i>h</i>=0.16, 95% CI −0.39 to 0.72). CONCLUSIONS The findings suggest the feasibility of a small-scale pilot RCT. S4E demonstrated shifts in the hypothesized direction, reducing substance use, sexual risk behaviors, and improving the uptake of STI/HIV testing among youth in a clinic setting. The findings suggest that a larger RCT may be warranted. CLINICALTRIAL ClinicalTrails.gov NCT03855410, https://clinicaltrials.gov/ct2/show/NCT03855410.


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