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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.
JMIR Res Protoc. 2018 Dec 18; 7(12):e10448.JR

Abstract

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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03320512; https://clinicaltrials.gov/ct2/show/NCT03320512 (Archived by WebCite at http://www.webcitation.org/74OVZkICl).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)

DERR1-10.2196/10448.

Authors+Show Affiliations

Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Durham, NC, United States.Behavior and Technology Lab, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.Behavior and Technology Lab, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.Behavior and Technology Lab, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States. Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30563818

Citation

LeGrand, Sara, et al. "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." JMIR Research Protocols, vol. 7, no. 12, 2018, pp. e10448.
LeGrand S, Knudtson K, Benkeser D, et al. 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. JMIR Res Protoc. 2018;7(12):e10448.
LeGrand, S., Knudtson, K., Benkeser, D., Muessig, K., Mcgee, A., Sullivan, P. S., & Hightow-Weidman, L. (2018). 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. JMIR Research Protocols, 7(12), e10448. https://doi.org/10.2196/10448
LeGrand S, et al. 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. JMIR Res Protoc. 2018 Dec 18;7(12):e10448. PubMed PMID: 30563818.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - LeGrand,Sara, AU - Knudtson,Kelly, AU - Benkeser,David, AU - Muessig,Kathryn, AU - Mcgee,Andrew, AU - Sullivan,Patrick S, AU - Hightow-Weidman,Lisa, Y1 - 2018/12/18/ PY - 2018/03/19/received PY - 2018/08/07/accepted PY - 2018/07/01/revised PY - 2018/12/20/entrez PY - 2018/12/20/pubmed PY - 2018/12/20/medline KW - HIV KW - men who have sex with men KW - mobile apps KW - mobile phone KW - pre-exposure prophylaxis KW - transgender women KW - youth SP - e10448 EP - e10448 JF - JMIR research protocols JO - JMIR Res Protoc VL - 7 IS - 12 N2 - 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03320512; https://clinicaltrials.gov/ct2/show/NCT03320512 (Archived by WebCite at http://www.webcitation.org/74OVZkICl). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/10448. SN - 1929-0748 UR - https://www.unboundmedicine.com/medline/citation/30563818/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_ L2 - https://www.researchprotocols.org/2018/12/e10448/ DB - PRIME DP - Unbound Medicine ER -
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