A Mobile Intervention to Improve Uptake of Pre-Exposure Prophylaxis (PrEP) for Southern Black MSM: A Protocol for Intervention Development and Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Laura Whiteley ◽  
Anne-Emilie Rouffiac ◽  
Larry Brown ◽  
Leandro Mena ◽  
Lacey Craker ◽  
...  
Keyword(s):  
Text Messaging ◽  
Controlled Trial ◽  
Cost Effective ◽  
Text Messages ◽  
Southern United States ◽  
Structural Barriers ◽  
Randomized Controlled ◽  
Youtube Videos ◽  
Sex With Men ◽  
Exposure Prophylaxis

BACKGROUND The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex with men (BMSM) living in the Southern United States. This is a significant issue because eight of the ten states with the highest rates of new HIV infections are located in the South. Jackson, MS (the site of this proposed project) has the second highest AIDS diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men who have sex with men. This study will develop and test an engaging, interactive, and cost- effective mobile messaging intervention to improve engagement in PrEP care for BMSM (18-35 yrs) living in Jackson, MS. OBJECTIVE The goals of this project are 1) to conduct qualitative interviews with young BMSM in Jackson, MS, to understand individual, community, and structural barriers affecting engagement in PrEP-related care, 2) to assemble a PrEP Mobile Messaging Intervention that includes text messages with publicly available internet content (websites and YouTube videos) that provide factual information, motivational materials, and behavioral skills related to PrEP and HIV prevention, and 3) to evaluate the preliminary efficacy of a text messaging intervention composed of publicly available internet content in a randomized controlled study with PrEP eligible BMSM receiving care in STI/HIV testing clinics located in Jackson, MS. METHODS This research protocol will be conducted in 2 phases: a development phase involving in-depth interviews (n = 30) with PrEP eligible BMSM who receive care in STI/HIV testing clinics in MS. These interviews will allow researchers to select the texted material that will be sent out during the intervention. The second phase will consist of a small randomized controlled trial among 66 new participants to examine the preliminary efficacy of the intervention (compared to enhanced standard of care) on attendance at a PrEP Services Appointment (the first step in initiating PrEP care) and receipt of a PrEP prescription. The publicly available material will be sent to PrEP eligible BMSM in 8- 16 interactive text messages over 4 weeks. Study assessments will occur at enrollment and at 4- and 16-weeks post-enrollment. RESULTS IRB approval was received on January 16, 2017. Research activities began in February 2018 and are still ongoing. CONCLUSIONS This PrEP Mobile Messaging Intervention aims to increase uptake of PrEP by BMSM in the Southern United States. This intervention uses interactive, tailored text messaging and appealing free web content (publicly accessible educational websites and YouTube videos) to promote linkage to PrEP care and increase HIV preventative behaviors. A cost-effective digital PrEP Mobile messaging intervention has great potential to improve information about PrEP, improve motivation to use PrEP, and decrease stigma and structural barriers that often prevent engagement in PrEP-related medical care. CLINICALTRIAL Trial Registration: NCT03308097 International Registered Report Identifier (IRRID): NCT03308097

scholarly journals A Mobile Intervention to Improve Uptake of Pre-Exposure Prophylaxis for Southern Black Men Who Have Sex With Men: Protocol for Intervention Development and Pilot Randomized Controlled Trial

10.2196/15781 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e15781
Author(s):  
Anne-Emilie Rouffiac ◽  
Laura Whiteley ◽  
Larry Brown ◽  
Leandro Mena ◽  
Lacey Craker ◽  
...  
Keyword(s):  
Black Men ◽  
Controlled Trial ◽  
Cost Effective ◽  
Text Messages ◽  
Southern United States ◽  
Structural Barriers ◽  
Randomized Controlled ◽  
Youtube Videos ◽  
Sex With Men ◽  
Exposure Prophylaxis

Background The uptake of pre-exposure prophylaxis (PrEP) has been slow for young black men who have sex with men (BMSM) living in the southern United States. This is a significant issue because 8 of the 10 states with the highest rates of new HIV infections are in the South. Jackson, Mississippi (MS), the site of this project, has the second highest AIDS diagnosis rate in the nation and the highest rate of HIV infection for young, urban BMSM. This study will develop and test an engaging, interactive, and cost-effective mobile messaging intervention to improve engagement in PrEP care for BMSM aged 18 to 35 years living in Jackson, MS. Objective The goals of this mixed methods study are to (1) conduct qualitative interviews with young BMSM in Jackson, MS, to understand individual, community, and structural barriers affecting engagement in PrEP-related care, (2) assemble a PrEP mobile messaging intervention that includes text messages with publicly available internet content (websites and YouTube videos) that provide factual information, motivational materials, and behavioral skills related to PrEP and HIV prevention, and (3) evaluate the preliminary efficacy of the intervention in a randomized controlled study with PrEP-eligible BMSM receiving care in STI/HIV testing clinics in Jackson, MS. Methods This research protocol will be conducted in 2 phases. A development phase will involve in-depth interviews (n=30) with PrEP-eligible BMSM who receive care in STI/HIV testing clinics in MS. These interviews will allow researchers to select the texted material that will be sent out during the intervention. The second phase will consist of an unblinded, small, randomized controlled trial among 66 new participants to examine the preliminary efficacy of the intervention compared with enhanced standard of care (ESC) on attendance at a PrEP services appointment (the first step in initiating PrEP care) and receipt of a PrEP prescription, based on self-report and electronic medical records. The free, publicly available material will be sent to PrEP-eligible BMSM in 8 to 16 interactive text messages over 4 weeks. Study assessments will occur at enrollment and at 4- and 16-weeks postenrollment and can be completed online or in person. All participants will be recruited from a local clinic. Results Institutional review board approval was received on January 16, 2017, and research activities, subsequently, began in February 2018. Recruitment for the study concluded in November 2019. In total, 65 participants were randomized with 33 being assigned to the intervention and 32 to ESC. Collection of follow-up data is ongoing. Conclusions This PrEP mobile messaging intervention aims to increase uptake of PrEP by BMSM in the southern United States. This intervention uses interactive, tailored text messaging and appealing free Web content (publicly accessible educational websites and YouTube videos) to promote linkage to PrEP care and increase HIV preventative behaviors. A cost-effective PrEP mobile messaging intervention has great potential to improve information about PrEP, improve motivation to use PrEP, and decrease stigma and structural barriers that often prevent engagement in PrEP-related medical care. Trial Registration ClinicalTrials.gov NCT03308097; https://clinicaltrials.gov/ct2/show/NCT03308097 International Registered Report Identifier (IRRID) DERR1-10.2196/15781

scholarly journals A Theoretically-Based Mobile App to Increase Pre-exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

10.2196/16231 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e16231 ◽  
Author(s):  
Jeb Jones ◽  
Karen Dominguez ◽  
Rob Stephenson ◽  
Joanne D Stekler ◽  
Amanda D Castel ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Mobile App ◽  
Southern United States ◽  
Randomized Controlled ◽  
Southern Us ◽  
Sex With Men ◽  
Exposure Prophylaxis

Background HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low. Objective To assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States. Methods In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription. Results Participant recruitment is expected to begin in January 2020. Conclusions This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States. Trial Registration ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942 International Registered Report Identifier (IRRID) PRR1-10.2196/16231

scholarly journals Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Sara LeGrand ◽  
Kelly Knudtson ◽  
David Benkeser ◽  
Kathryn Muessig ◽  
Andrew Mcgee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Networking ◽  
Text Messaging ◽  
Controlled Trial ◽  
Formative Research ◽  
Mobile App ◽  
Ongoing Research ◽  
Randomized Controlled ◽  
Sex With Men ◽  
Exposure Prophylaxis

BACKGROUND HIV prevalence is high among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM), particularly among minorities. Despite its proven efficacy and safety, the uptake of and adherence to pre-exposure prophylaxis (PrEP) among YMSM and YTWSM is currently limited. To date, evidence-based interventions to promote and sustain PrEP adherence have been limited and not shown to be highly efficacious. Given the widespread adoption of smartphones, mobile apps can be utilized to increase PrEP adherence for many YMSM and YTWSM. OBJECTIVE The study consists of a formative research phase to develop an app-based intervention, P3 (Prepared, Protected, emPowered), to increase PrEP adherence, and a randomized controlled trial (RCT) to test its efficacy. P3 is a mobile app built on an established health platform, which includes social networking and game-based components to encourage PrEP adherence among YMSM and YTWSM. P3+ includes all P3 features plus adherence counseling delivered via two-way text messaging (short message service, SMS) through the app. METHODS The formative research phase includes usability testing to assess users’ comprehension of P3’s educational content, understanding and use of intervention features, and overall impressions of app functionality, followed by app refinements. A subsequent field trial will identify and resolve any remaining technical challenges. A three-arm RCT (P3, P3+, and standard of care) will then be conducted at 6 iTech subject recruitment venues to assess intervention efficacy and to conduct a comparison of costs to deliver the 2 intervention arms. RESULTS This is an ongoing research project with initial results from the formative work expected in 2020 and those from the RCT in 2021. CONCLUSIONS P3 aims to provide an engaging, interactive experience that is highly appealing for the target population, leveraging technology already heavily integrated into the lives of young people, and thus meeting users’ needs in a familiar, stimulating way. If efficacious, P3 could be a sustainable, easily disseminated, lower-cost PrEP intervention for YMSM and YTWSM. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions. CLINICALTRIAL ClinicalTrials.gov NCT03320512; https://clinicaltrials.gov/ct2/show/NCT03320512 (Archived by WebCite at http://www.webcitation.org/74OVZkICl) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10448

scholarly journals The Use of Text Messaging to Improve the Hospital-to-Community Transition in Patients With Acute Coronary Syndrome (Txt2prevent): Results From a Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Emily S Ross ◽  
Brodie M Sakakibara ◽  
Martha H Mackay ◽  
David GT Whitehurst ◽  
Joel Singer ◽  
...  
Keyword(s):  
Study Protocol ◽  
Resource Use ◽  
Self Efficacy ◽  
Text Messaging ◽  
Controlled Trial ◽  
Text Messages ◽  
Self Management ◽  
Coronary Syndrome ◽  
Randomized Controlled

BACKGROUND Acute coronary syndrome (ACS) is a leading cause of hospital admission in North America. Many patients with ACS experience challenges after discharge that impact their clinical outcomes and psychosocial well-being. Text messaging has the potential to provide support to patients during this post-discharge period. OBJECTIVE This study pilot-tested a 60-day text-messaging intervention (Txt2Prevent) for patients with ACS. The primary objective was to compare self-management domains between usual care and usual care plus Txt2Prevent. The secondary objectives were to compare medication adherence, health-related quality of life, self-efficacy, and healthcare resource use between groups. The third objective was to assess the feasibility of the study protocol and the acceptability of the intervention. METHODS This was a randomized controlled trial with blinding of outcome assessors. We recruited 76 patients with ACS from St. Paul’s Hospital in Vancouver, Canada and randomized them to one of two groups within seven days of discharge. The Txt2Prevent program included automated one-way text messages about follow-up care, self-management and healthy living. Data was collected during the index admission and at 60-days after randomization. The primary outcome was measured with the Health Education Impact Questionnaire (heiQ). Other outcomes included the EQ-5D-5L, EQ visual analogue scale, Sullivan Cardiac Self-Efficacy Scale, Morisky Medication Adherence Scale and self-reported healthcare resource use. Analyses of covariance were used to test the effect of group assignment on follow-up scores (controlling for baseline) and were considered exploratory in nature. Feasibility was assessed with descriptive characteristics of the study protocol. Acceptability was assessed with two survey questions and semi-structured interviews. RESULTS There were no statistically significant differences between the groups for the heiQ domains (adjusted mean difference: health directed activity: –0.13 [95% confidence interval (CI): –0.39-0.13]; positive and active engagement in life: 0.03 [95% CI: –0.19-0.25]; emotional distress: 0.04 [95% CI: –0.22-0.29]; self-monitoring and insight: 0.14 [95% CI: –0.33-0.05]; constructive attitudes and approaches: –0.10 [95% CI: –0.36- 0.17]; skill technique and acquisition: 0.05 [95% CI: –0.18-0.27]; social integration and support: –0.12 [95% CI: –0.34-0.19]; health services navigation: –0.05 [95% CI: –0.29-0.19]). For the secondary outcomes, there were no statistically significant differences in adjusted analyses except in one self-efficacy domain (‘Total Plus’), where the Txt2Prevent group had lower scores (mean difference: –0.36 [95% CI: –0.66 to -0.50]). The study protocol was feasible although recruitment took longer than expected. Over 90% of participants reported they were satisfied with the program. CONCLUSIONS The Txt2Prevent study was feasible to implement; however, although exploratory, there were no differences between the two groups in adjusted analyses except for one self-efficacy domain. As the intervention appeared acceptable, there is potential in using text messages in this context. The design of the intervention may need to be reconsidered to have more impact on outcome measures. CLINICALTRIAL ClinicalTrials.gov NCT02336919 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.6968

scholarly journals mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam (Preprint)

2021 ◽  
Author(s):  
Celine Larkin ◽  
Jessica Wijesundara ◽  
Hoa L Nguyen ◽  
Duc Anh Ha ◽  
Anh Vuong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Text Messaging ◽  
Health Workers ◽  
Controlled Trial ◽  
Text Messages ◽  
Community Based ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled

BACKGROUND Tobacco kills more than 8 million people each year, mostly in low- and middle-income countries. In Vietnam, 1 in every 2 male adults smokes tobacco. Vietnam has set up telephone Quitline counseling that is available to all smokers, but it is underused. We previously developed an automated and effective motivational text messaging system to support smoking cessation among US smokers. OBJECTIVE The aim of this study is to adapt the aforementioned system for rural Vietnamese smokers to promote cessation of tobacco use, both directly and by increasing the use of telephone Quitline counseling services and nicotine replacement therapy. Moreover, we seek to enhance research and health service capacity in Vietnam. METHODS We are testing the effectiveness of our culturally adapted motivational text messaging system by using a community-based randomized controlled trial design (N=600). Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months. Trial recruitment took place in four communes in the Hung Yen province in the Red River Delta region of Vietnam. Recruitment events were advertised to the local community, facilitated by community health workers, and occurred in the commune health center. We are assessing the impact of the texting system on 6-month self-reported and biochemically verified smoking cessation, as well as smoking self-efficacy, uptake of the Quitline, and use of nicotine replacement therapy. In addition to conducting the trial, the research team also provided ongoing training and consultation with the Quitline during the study period. RESULTS Site preparation, staff training, intervention adaptation, participant recruitment, and baseline data collection were completed. The study was funded in August 2017; it was reviewed and approved by the University of Massachusetts Medical School Institutional Review Board in 2017. Recruitment began in November 2018. A total of 750 participants were recruited from four communes, and 700 (93.3%) participants completed follow-up by March 2021. An analysis of the trial results is in progress; results are expected to be published in late 2022. CONCLUSIONS This study examines the effectiveness of mobile health interventions for smoking in rural areas in low- and middle-income countries, which can be implemented nationwide if proven effective. In addition, it also facilitates significant collaboration and capacity building among a variety of international partners, including researchers, policy makers, Quitline counselors, and community health workers. CLINICALTRIAL ClinicalTrials.gov NCT03567993; https://clinicaltrials.gov/ct2/show/NCT03567993. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30947

scholarly journals One-Way and Two-Way Mobile Phone Text Messages for Treatment Adherence Among Patients With HIV: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Dickson Shey Nsagha ◽  
Vincent Verla Siysi ◽  
Same Ekobo ◽  
Thomas Obinchemti Egbe ◽  
Odette Dzemo Kibu
Keyword(s):  
Quality Of Life ◽  
Data Collection ◽  
Text Messaging ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Randomized Controlled ◽  
The Impact ◽  
Sms Text Messaging

BACKGROUND Incomplete adherence to antiretroviral therapy (ART) is one of the factors that contribute to HIV drug resistance, and it is a major problem for the public health system in controlling the HIV pandemic. There is emerging evidence that SMS can play an important role in health care delivery among patients with HIV on ART, especially in resource-limited settings. OBJECTIVE This paper aims to assess the impact of two-way and one-way SMS text messaging on adherence to HIV treatment. We hypothesized that sending weekly text messages through the one-way and two-way SMS text messaging approach will improve adherence to ART among patients with HIV and improve associated clinical outcomes (quality of life). METHODS A randomized controlled trial is being carried out among participants with HIV who have been on ART for at least one month from an accredited treatment center, namely the Buea Regional Hospital and Kumba District Hospital of South West Region, Cameroon. Participants with HIV, both male and female, aged 21 years and older make up a sample size of 207. The interventions involved the use of mobile phone text messages. Before commencing the intervention, a focus group discussion was carried out among the participants to understand their perception about the use of SMS-based interventions to improve adherence. A total of 246 participants were randomized to receive either a one-way text message (SMS sent to a recipient without recipient sending a reply) or two-way text message (SMS sent to a recipient and recipient sends a reply) or the control (no SMS, only standard care). Data on adherence and quality of life were collected at baseline and after 6 months and will be analyzed using SPSS version 21, while qualitative data will be analyzed using Atlas.ti 7.5. RESULTS Data collection began in September 2019 with focus group discussions and baseline data collection. After 1 month of baseline data collection, the intervention began in October 2019, and postintervention data were collected after 6 months (March 2020). At the end of the study, we will be able to understand the perception of patients toward SMS text messaging–based interventions and also assess the impact of one-way and two-way SMS text messages on treatment adherence among patients with HIV and on associated clinical outcomes (quality of life). CONCLUSIONS The impact of SMS text messaging varies across different settings. The results from this study will determine the perception of patients toward an SMS text messaging–based intervention and its impact on adherence to ART. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16127

scholarly journals Protocol Development for HMU! (HIV Prevention for Methamphetamine Users), a Study of Peer Navigation and Text Messaging to Promote Pre-Exposure Prophylaxis Adherence and Persistence Among People Who Use Methamphetamine: Qualitative Focus Group and Interview Study (Preprint)

2020 ◽  
Author(s):  
Vanessa M McMahan ◽  
Noah Frank ◽  
Smitty Buckler ◽  
Lauren R Violette ◽  
Jared M Baeten ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Focus Groups ◽  
Text Messaging ◽  
Text Messages ◽  
Transgender People ◽  
Protocol Development ◽  
Sex With Men ◽  
Peer Navigation ◽  
Hiv Acquisition ◽  
Exposure Prophylaxis

BACKGROUND Cisgender men who have sex with men (MSM) and transgender people (TGP) who use methamphetamine are disproportionately impacted by HIV acquisition. Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV, and interventions that support PrEP persistence and adherence should be evaluated among MSM and TGP who use methamphetamine. OBJECTIVE We conducted formative work to inform the development of text messaging and peer navigation interventions to support PrEP persistence and adherence among MSM and TGP who use methamphetamine. In this paper, we describe how the findings from these focus groups and interviews were used to refine the study interventions and protocol for the Hit Me Up! study (HMU!; HIV Prevention in Methamphetamine Users). METHODS Between October 2017 and March 2018, we conducted two focus groups and three in-depth interviews with MSM and TGP who use methamphetamine or who have worked with people who use methamphetamine. During these formative activities, we asked participants about their opinions on the proposed interventions, education and recruitment materials, and study design. We focused on how we could develop peer navigation and text messaging interventions that would be culturally appropriate and acceptable to MSM and TGP who use methamphetamine. Transcripts were reviewed by two authors who performed a retrospective content analysis to describe which specific opinions and recommendations influenced protocol development and the refinement of the interventions. RESULTS Overall, participants thought that MSM and TGP would be interested in participating in the study, although they expected recruitment and retention to be challenging. Participants thought that the peer navigator should be someone who is nonjudgmental, has experience with people who use methamphetamine, and is patient and flexible. There was consensus that three text messages per day were appropriate, adherence reminders should be straightforward, all messages should be nonjudgmental, and participants should be able to tailor the timing and content of the text messages. These suggestions were incorporated into the study interventions via the hiring and training process and into the development of the text library, platform selection, and customizability of messages. CONCLUSIONS It is important to include the opinions and insights of populations most impacted by HIV to develop PrEP interventions with the greatest chance of success. Our formative work generated several recommendations that were incorporated into the interventions and protocol development for our ongoing study. CLINICALTRIAL ClinicalTrials.gov NCT03584282; https://clinicaltrials.gov/ct2/show/NCT03584282

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