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. 2022 Aug 27;29:100985. doi: 10.1016/j.conctc.2022.100985

Table 1.

Detailed Description of Procedures in the RCT comparing iPrEP to Usual Care.

Procedures Details
UT-HEARTS referral
  • Prior to enrollment, individuals are screened in-person and are offered a referral to the UT-HEARTS program. Questions assessing eligibility for the study are imbedded within the screening form.

  • Women who accepted the referral were contacted by a UT-HEARTS coordinator following the initial study visit.

Pre-test
  • The pre-test assesses:
    • Socio-demographics (age, education level, sexual orientation, income level, and employment status)
    • Behaviors (sexual activity and substance use) – based on the risk assessment battery (RAB)
    • Predictive data (risk perception and willingness for PrEP uptake)
  • Study data includes phone numbers, physical and email addresses for follow-up

RCT assignment
  • Intervention Group:

  • Women will receive the iPrEP intervention on a tablet device

  • iPrEP uses qualitative themes

  • iPrEP is divided into sections addressing factors with historical success at increasing PrEP adherence [42]

  • Scales chosen to measure themes and sections are retained from the original HPTN 073 instrument

  • Scales are modified (in some cases) for cultural competency and tailoring to women

Control Group:
  • Women will receive usual care
    • An assessment visit with an ED-assigned social worker who specializes in substance use
    • Social worker will offer a list of substance abuse treatment referral agencies, but no intervention
    • Study procedures will not interfere with the protocol for social workers
Post-test
  • Women who are randomized will complete a post-test after the RCT.

  • The post-test will assess predictive data in two areas risk perception and willingness for PrEP uptake.

Outcomes
  • Primary:

  • Increased willingness for PrEP uptake post intervention and at follow-up assessments (1, 3, and 6 months).

  • Stimulate an initial PrEP clinic visit within a 6-month period.

  • Secondary:

  • Decrease high risk sex 6-months post intervention measured by TLFB [38,39], RAB [[35], [36], [37]]

  • Decrease in substance use [[43], [44], [45], [46], [47]] measured by TLFB, and self-report

  • STI outcome, confirmed via EMR and/or self-report [48,49]

  • HIV seroconversion within 6 months, confirmed via self-report

  • Perception of whether the intervention informed decision making (Yes/No format)