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. 2025 May 23;14:e64961. doi: 10.2196/64961

Table 1.

Overview of phase-wide data collection methods and measures-Harris County, Texas (2021-2025).

Construct Measure Study week Source
Eligibility

SUDa
  • Substance use and co-occurring mental health diagnoses (Mini International Neuropsychiatric Interview)

0 SUD intake records
PrEP knowledge and attitudes (based on barriers identified in aim 1)

PrEPb knowledge
  • PrEP knowledge questionnaire [62]

0, 4, 10, 16 REDCapc survey

PrEP attitudes
  • PrEP Attitudes Measure [63]

0, 4, 10, 16 REDCap survey

PrEP stigma
  • PrEP Anticipated Stigma Scale (PASS) [64]

0, 4, 10, 16 REDCap survey

PrEP adherence self-efficacy
  • Adherence Starts with Knowledge (ASK-20) [65]

0, 4, 10, 16 REDCap survey

HIV risk behaviors
  • Risk Assessment Battery [66]

0, 4, 10, 16 REDCap survey

HIV risk perceptions
  • Perceived Risk of HIV Scale [67]

0, 4, 10, 16 REDCap survey
Initial efficacy (aim 3)

PrEP eligibility
  • HIV screening, viral hepatitis screening, pregnancy screening, screening for sexually transmitted diseases, and behavioral risk factors

4, 16, 4 Laboratory results
Nurse interview

PrEP uptake (primary outcome)
  • PrEP prescription filled and self-reported initial dose of PrEP taken

10, 16 Self-report

PrEP adherence (behavioral)
  • Video-confirmed dose (intervention, daily oral PrEP)

  • Video-confirmed dose (intervention, long-acting injectable [LAI] PrEP, and initial oral cabotegravir)

  • Follow-up injection (intervention LAI)

  • Self-reported dose daily oral PrEP (intervention and standard treatment)

5-16 n/a and 5-16 Scene health reports, study records, study records, and weekly online survey

PrEP adherence (laboratory-confirmed)
  • Tenofovir concentrations (>1000 ng/mL)

16 Laboratory results
Feasibility measures (aim 3)

Enrollment rate
  • Proportion screened who are eligible

  • Proportion eligible who consent

d Study records

Session attendance
  • Proportion of motivational enhancement sessions attended

Study records

Use of Scene Health app
  • Proportion of medication adherence videos uploaded

Scene Health reports

Study retention
  • Proportion of participants who remain in the study at 12-week follow-up

Study records
Acceptability measures (aim 3)

Client satisfaction
  • Client satisfaction questionnaire

4, 16 REDCap survey
Other covariates

Substance use severity
  • NIDA-Modified Alcohol, Smoking, and Substance Involvement Screening Test [68]

0, 4, 10, 16 REDCap survey

Alcohol
  • Alcohol Use Disorders Identification Test [69]

0, 4, 10, 16 REDCap survey

Health literacy
  • Calgary Charter on Health Literacy Scale [70]

0 REDCap survey

Medical mistrust
  • Group Based Medical Mistrust Scale [71]

0, 4, 10, 16 REDCap survey

Trauma
  • Life Events Checklist/PTSDe Checklist for DSM-5f [72,73]

0, 4, 10, 16 REDCap survey

Depression
  • Patient Health Questionnaire-9 [74]

0, 4, 10, 16 REDCap survey

SUD treatment attendance
  • Number of substance use disorder therapy sessions attended

16 Study records

aSUD: Substance use disorder.

bPrEP: pre-exposure prophylaxis.

cREDCap: Research Electronic Data Capture.

dNot applicable.

ePTSD: posttraumatic stress disorder.

fDSM-5: Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition).