title: A post-trial assessment of factors influencing study drug adherence in a randomized biomedical HIV-1 prevention trial.
abstract: High adherence and maintenance of blinding are critical for placebo-controlled efficacy trials of HIV-1 biomedical prevention strategies. We assessed adherence to study drug and factors affecting adherence, including perceived randomization group, in a post-trial questionnaire of participants who completed HPTN 039, a randomized, placebo-controlled trial of HSV-2 suppression with twice-daily acyclovir to reduce HIV-1 acquisition. Of the 3172 trial participants, 2003 (63%) completed the post-trial questionnaire. Of these 2003, 72% reported missing a dose of study drug less than twice a week. Study drug adherence was not compromised by perceived randomization or genital ulcer symptoms during the study. Alcohol use was cited as an adherence barrier in some populations. Assessment of study drug adherence during and at the end of trials can evaluate perceptions of randomization and adherence by randomization arm, help to better understand barriers to and motivations for adherence, and develop interventions to increase adherence for future trials.
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA, USA.
authors.forename: Shevin T
authors.initials: ST
authors.lastname: Jacob
authors.forename: Jared M
authors.initials: JM
authors.lastname: Baeten
authors.forename: James P
authors.initials: JP
authors.lastname: Hughes
authors.forename: Jesús
authors.initials: J
authors.lastname: Peinado
authors.forename: Jing
authors.initials: J
authors.lastname: Wang
authors.forename: Jorge
authors.initials: J
authors.lastname: Sanchez
authors.forename: Stewart E
authors.initials: SE
authors.lastname: Reid
authors.forename: Sinead
authors.initials: S
authors.lastname: Delany-Moretlwe
authors.forename: Frances
authors.initials: F
authors.lastname: Cowan
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Fuchs
authors.forename: Beryl
authors.initials: B
authors.lastname: Koblin
authors.forename: Sam
authors.initials: S
authors.lastname: Griffith
authors.forename: Anna
authors.initials: A
authors.lastname: Wald
authors.forename: Connie
authors.initials: C
authors.lastname: Celum
mesh_terms: D000212:Acyclovir / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D035843:Biomedical Research; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000517:prevention & control*; D015497:HIV-1 / Q000187:drug effects; D007722:Health Knowledge, Attitudes, Practice; D006558:Herpes Genitalis / Q000188:drug therapy*; D018258:Herpesvirus 2, Human / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012725:Sexual Behavior; D012959:Socioeconomic Factors; D011795:Surveys and Questionnaires; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D000998:Antiviral Agents; D000212:Acyclovir