Was a conceptual or theoretical framework used? If yes, critique how it was used. If not, critique the lack of its use in a study

Was a conceptual or theoretical framework used? If yes, critique how it was used. If not, critique the lack of its use in a study – if absent, should one have been used with this study design? The study was an open label two-arm, pilot randomized controlled trial of MSM presenting for PrEP at Fenway Health, the largest clinic providing primary care for sexual and gender minority patients in New England [31]. Enrolled participants were equally randomized to either: (1) ”Life-Steps for PrEP”, a nurse-delivered, CBT-oriented PrEP adherence intervention, or (2) a time and sessionmatched comparison condition. Recruitment Participants were recruited by community outreach by the staff of Fenway Health, a Boston community health center with expertise in sexual and gender minority health. Participants were recruited via advertisements on social media, including several sites where MSM meet sexual partners, and flyers posted within the waiting areas of Fenway Health’s clinical care sites. Inclusion/Exclusion Criteria Eligible participants were those assigned male sex at birth, 18 years of age or older, HIV-uninfected at screening (confirmed via HIV blood test), and at high risk for HIV acquisition, defined by having condomless anal sex (insertive or receptive) with an HIV-infected partner at least once