Table 1.
Outcomes and measures for MyChoices pilot randomized controlled trial.
| Domain | Description or scale | ||
| Primary outcomes | |||
|
|
App acceptability | System Usability Scale [28,32] | |
|
|
App feasibility | Proportion using the app ≥1 time | |
| Secondary outcomes | |||
|
|
HIV testing | Proportion testing at least once during study | |
|
|
PrEPa uptake | Proportion of those with a behavioral indication for PrEP who are prescribed and utilize PrEP | |
| Social cognitive theory model constructs outcomes | |||
|
|
Self-regulation | Frequency of use of relevant app components, perceived HIV or STIb risk [33] | |
|
|
Self-efficacy | HIV testing self-efficacy [34], PrEP use self-efficacy [35], condom use self-efficacy [36] | |
|
|
Goal setting | Frequency of use of HIV testing plan | |
|
|
Environmental influences | Frequency of use of reminders, frequency of testing due to geofencing technology | |
| Covariates (based on ecosocial model) [37] | |||
|
|
Individual | ||
|
|
|
Demographics, socioeconomic position | Age, race or ethnicity, student status, education, income, family structure, employment, insurance status |
|
|
|
Sexual behavior (# sex partners, condom use, partner selection) | Adapted from the AIDS Risk Behavior Assessment [38] |
|
|
|
Drug use behavior (ie, alcohol, cocaine, meth) | Alcohol, Smoking, and Substance Involvement Screening Test [39] |
|
|
|
Mental health (depression, anxiety) | Personal Health Questionnaire Depression 8-Item Scale [40], Generalized Anxiety Disorder 7-Item Scale [41], sexual minority stress [42] |
|
|
|
Trauma and abuse | Startle, Physically Upset, Anger, and Numbness Posttraumatic Stress Scale [43] |
|
|
Social | ||
|
|
|
Social support | Patient-Reported Outcomes Measurement Information System [44] |
|
|
|
Peer norms for condom use | Questions regarding peer’s use and perceptions for condoms [45,46] |
|
|
Structural | ||
|
|
|
SRVc or city | Geographic location of study participant |
|
|
|
Incarceration history | Recent history and frequency |
|
|
|
Structural discrimination | External homophobia [42], racism [47] |
|
|
|
Stigma | HIV-related, PrEP-related |
| Other covariates |
|
||
|
|
Mobile phone and technology use | Pew research technology use questionnaire [48,49] | |
|
|
Mobile app use over the study period | Log in attempts, HIV testing and PrEP use, proportion complete HIV testing plans, proportion requesting HIV or STI home-test kits | |
|
|
HIV Negative Cascade | HIV or STI testing history, PrEP awareness, barriers to PrEP uptake, PrEP adherence [50], barriers to PrEP use | |
aPrEP: pre-exposure prophylaxis.
bSTI: sexually transmitted infection.
cSRV: subject recruitment venues.