Dataset Information

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.

ABSTRACT: 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.

SUBMITTER: Rouffiac AE

PROVIDER: S-EPMC7059079 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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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.

Rouffiac Anne-Emilie AE Whiteley Laura L Brown Larry L Mena Leandro L Craker Lacey L Healy Meredith M Haubrick Kayla K

JMIR research protocols 20200220 2

<h4>Background</h4>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, ...[more]

PMID: 32130196

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Project description:Pre-exposure prophylaxis (PrEP) provides a strong preventative benefit to individuals at risk for HIV. While PrEP adherence is highly correlated with its efficacy, adherence rates are variable both across and within persons.The objective of this study was to develop and pilot-test a smartphone-based intervention, known as mSMART, that targets PrEP adherence. mSMART provides contingency management in the form of monetary incentives for daily PrEP adherence based on a real-time adherence assessment using a camera-based medication event-monitoring tool as well as medication reminders, PrEP education, individualized behavioral strategies to address PrEP adherence barriers, and medication adherence feedback.This was a 4-week open-label, phase I trial in a community sample of young men who have sex with men already on PrEP (N=10).Although adherence composite scores corresponding to PrEP biomarkers indicated that 90% (9/10) of the sample already had an acceptable baseline adherence in the protective range, by the end of the 4-week period, the scores improved for 30% (3/10) of the sample-adherence did not worsen for any participants. Participants reported mean PrEP adherence rates of 91% via daily entries in mSMART. At the end of the 4-week period, participants indicated acceptable ratings of satisfaction, usability, and willingness to recommend mSMART to others. There were no technical difficulties associated with smartphone compatibility, user misunderstandings about mSMART features that interfered with daily use, or study attrition.This study is the first to apply contingency management to PrEP adherence. Findings indicated that mSMART is feasible and acceptable. Such an adherence intervention administered via a user-friendly smartphone app can allow for widespread dissemination. Future efficacy trials are needed.ClinicalTrials.gov NCT02895893; https://clinicaltrials.gov/ct2/show/NCT02895893 (Accessed by Webcite at http://www.webcitation.org/72JskjDJq).

Project description:BackgroundMultilevel interventions are necessary to address the complex social contributors to health that limit pre-exposure prophylaxis use among Black women, including medical distrust, pre-exposure prophylaxis stigma, and access to equitable health care. Strategies to improve knowledge, awareness, and uptake of pre-exposure prophylaxis among Black women will be more successful if information-sharing and implementation take place within trusted environments. Providing women with information through trusted cultural and social channels can effectively support informed decision-making about pre-exposure prophylaxis for themselves and members of their social networks who are eligible for pre-exposure prophylaxis.ObjectiveThe goal of this project is to improve knowledge, awareness, uptake, and trust of pre-exposure prophylaxis, as well as reduce pre-exposure prophylaxis stigma, among Black women living in the US South.MethodsThis multilevel, mixed methods study uses a community-engagement approach to develop and pilot test a salon-based intervention. There are three components of this intervention: (1) stylist training, (2) women-focused entertainment videos and modules, and (3) engagement of a pre-exposure prophylaxis navigator. First, stylist training will be provided through two 2-hour training sessions delivered over 2 consecutive weeks. We will use a pre- and posttest design to examine knowledge and awareness improvement of pre-exposure prophylaxis among the stylists. Upon full completion of training, the stylists will receive a certificate of completion and "Ask Me about PrEP" signage for their beauty salons. Second, together with the community, we have codeveloped a 4-part entertainment series (The Wright Place) that uses culturally and socially relevant stories to highlight key messages about (1) HIV, (2) pre-exposure prophylaxis, and (3) Black women's social contributors to health. Quantitative and qualitative measures will be used in a pre- and posttest design to examine pre-exposure prophylaxis knowledge, awareness, risk, stigma, trust, intentions, and women's perceptions of the usability and acceptability of the overall intervention and its implementation strategies. A video blog will be provided after each video. Third, participants will have access through an email or text message link to a pre-exposure prophylaxis navigator, who will respond to them privately to answer questions or make referrals for pre-exposure prophylaxis as requested.ResultsThis project was funded in October 2020 by Gilead Sciences and was approved by the Duke University School of Nursing institutional review board in April 2021 (Pro00106307). Intervention components were developed in partnership with community partners in the first year. Data collection for phase 1 began in April 2022. Data collection for phase 2 began in May 2022. The study will be complete by October 2022.ConclusionsMultilevel interventions that consider the assets of the community have promise for promoting health among Black women who have influence within their social networks. The findings of this study have the potential to be generalizable to other populations.International registered report identifier (irrid)PRR1-10.2196/34556.

Project description:BACKGROUND:HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM. OBJECTIVE:The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app. METHODS:This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY. RESULTS:App refinement is underway. Enrollment for the pilot RCT began in October 2018. CONCLUSIONS:MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/10694.

Project description: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:The aim of this study will be 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 began 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.

Dataset Information

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.

Publications

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.

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