Assessing differential loss to follow-up and future implementation of a sexual health app intervention for men who have sex with men: a secondary survival analysis of a randomized control trial Open Access
Mancuso, Noah (Spring 2023)
Abstract
Introduction: Over the past ten years, the United States has seen an increase in sexually transmitted infections (STIs) and in HIV diagnoses among men who have sex with men (MSM) aged 25-34 and Hispanic/Latino MSM. mHealth interventions may offer a unique opportunity to provide necessary coverage of multiple primary intervention services, but there are concerns about equitable access. Studying loss to follow-up (LTFU) is important to understand potential selection bias in mHealth studies and to guide future implementation efforts of these interventions.
Methods: This is a secondary analysis of data collected from MSM in the M-Cubed trial in Atlanta, Detroit, and New York City from January 2018 to October 2019. A bias analysis was first conducted to assess potential differential LTFU in trial participants using predictors identified from the literature. An implementation assessment was then conducted among MSM who used the M-Cubed app (e.g., the intervention arm) using the e-commerce acceptance model (EAM). In both analyses, multivariate Cox regression models were used to evaluate associations with LTFU.
Results: In the bias analysis, 1,226 MSM were included with an average survival in the trial of 251 days. LTFU did not significantly differ between the intervention arm (17%, n=102) and the control group (18%, n=111). Three baseline variables were found to significantly modify the effect of randomization on survival: education level, employment status, and 3-month HIV testing history. Time-varying alcohol use also modified the association. A total of 611 MSM were included in the implementation assessment. In the final implementation model, LTFU was significantly associated with internet use, and there was significant interaction by mental health on both the relationship between internet use and LTFU and the relationship between medical mistrust and LTFU.
Discussion: mHealth interventions have the potential to improve sexual health promotion and overcome barriers to the continual engagement needed for STI and HIV prevention. To develop an unbiased understanding of the impact of these mHealth interventions, we need to assess differential LTFU in trials. To improve future uptake of mHealth technologies, researchers should focus on reducing intervention burden, improving trust in healthcare and mobile technology, and concurrently addressing alcohol abuse and mental health.
Table of Contents
Introduction............................................................................................ 1
Methods................................................................................................. 4
Results.................................................................................................... 8
Discussion............................................................................................. 12
Figure 1................................................................................................. 19
Table 1.................................................................................................. 20
Table 2.................................................................................................. 27
Figure 2................................................................................................. 33
Figure 3................................................................................................. 34
Table 3.................................................................................................. 36
Table 4.................................................................................................. 38
Table 5.................................................................................................. 45
Figure 4................................................................................................. 48
References............................................................................................ 49
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