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

Abstract

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

Theories of change for e-health interventions targeting HIV/STIs and sexual risk, substance use and mental ill health amongst men who have sex with men: systematic review and synthesis

“… At part of the systematic ‘intervention mapping’ process for intervention development, researchers searched the literature for behaviour change methods that could address programme objectives; drew on existing theory; and, in consultation with experts in MSM, chatting, e-dating and the Internet, selected theoretically informed strategies to achieve programme objectives. Transtheoretical model and social cognitive theory Not stated HealthMindr Smartphone/ mobile app Sullivan [ 84 ] Jones [ 66 ] Features of this mobile app included the following: risk assessments used to provide tailored prevention suggestions, with customisable assessment reminders; screeners assessing eligibility for PrEP and PEP; tailored recommendations for HIV testing frequency; identification of HIV testing options tailored to participant preferences and testing location details and map; an HIV test planner with customisable reminders; test kit, condom and lubricant ordering; substance use/mental health screening; service directory and a feature allowing users to submit questions to study staff. Based on social cognitive theory, risk assessments are theorised to lead to feedback and self-regulation, and for each of several targeted health behaviours app features were designed to promote four mechanisms of change: goal-setting, self-efficacy, outcome expectations and self-regulation.…”

“…Quality varied notably across theory reports and clustered towards low and medium quality, with 14 reports (42%) meeting none or one of the assessed criteria [ 61 , 63 – 65 , 76 , 77 , 79 – 82 , 84 , 86 – 88 ]; 14 (42%) meeting two or three criteria [ 56 , 58 , 59 , 62 , 66 – 68 , 71 – 75 , 78 , 83 ] and only five (15%) meeting four or five criteria [ 55 , 60 , 69 , 70 , 85 ].…”

“…Interventions often drew on more than one existing scientific theory. The information-motivation-behavioural skills (IMB) model and social cognitive theory were the most commonly cited, with the former informing seven interventions [ 55 , 56 , 60 , 61 , 64 , 68 , 70 , 77 – 80 , 83 , 87 ] and the latter informing eight [ 62 , 63 , 66 , 67 , 69 , 72 , 73 , 76 , 81 , 84 ]. The former was initially developed to inform HIV prevention but has since been advanced as a model for conceptualising individual and social determinants of health behaviours more broadly [ 90 ], and the latter incorporates individual, social and structural factors shaping, and techniques for changing, health behaviours [ 91 ].…”

“…2 ) [ 55 , 56 , 59 – 61 , 63 – 68 , 70 – 73 , 77 – 79 , 83 , 84 , 87 , 88 ]. Ten of the 13 theories of change in this grouping referenced social cognitive theory [ 56 , 63 , 66 , 67 , 72 , 73 , 83 , 84 , 87 ] and/or the IMB model [ 55 , 56 , 60 , 61 , 64 , 67 , 68 , 70 , 71 , 77 – 80 , 83 , 87 ], often in combination with other scientific theories. Three referenced the theory of planned behaviour [ 59 , 70 , 88 ] and one referenced no existing scientific theories but shared key constructs with other theories of change in this grouping [ 65 ].…”

A Decision Analytics Model to Optimize Investment in Interventions Targeting the HIV PrEP Cascade of Care

“…In our model, MSM who were indicated for but not using PrEP were eligible to start Healthmindr, with a range of app initiation probabilities that translated to different levels of Healthmindr capacity ( Table 1 ). MSM on Healthmindr then had an additional PrEP initiation probability (elevating the baseline probability) that corresponded to the intervention efficacy, which was based on power analyses for the study protocol [7]. MSM dropped off the intervention when indications lapsed, but they could reenter Healthmindr upon new indications.…”