Exploring evidence for behavioral risk compensation among participants in an HIV vaccine clinical trial.

Julia E Painter, Ralph J DiClemente, Lauren Jimenez, Theron Stuart, Jessica M Sales, Mark J Mulligan
Author Information
  1. Julia E Painter: George Mason University, Department of Global and Community Health, 4400 University Drive, Fairfax, VA 22030, United States. Electronic address: jpainte6@gmu.edu.
  2. Ralph J DiClemente: Emory University, Rollins School of Public Health, Department of Behavioral Sciences and Health Education, 1518 Clifton Road, Atlanta, GA 30322, United States. Electronic address: rdiclem@emory.edu.
  3. Lauren Jimenez: George Mason University, Department of Global and Community Health, 4400 University Drive, Fairfax, VA 22030, United States. Electronic address: ljimene4@masonlive.gmu.edu.
  4. Theron Stuart: Emory University, Emory Vaccine Center, Hope Clinic, 500 Irvin Court, Suite 200, Decatur, GA 30030, United States. Electronic address: theron.stuart@emory.edu.
  5. Jessica M Sales: Emory University, Rollins School of Public Health, Department of Behavioral Sciences and Health Education, 1518 Clifton Road, Atlanta, GA 30322, United States. Electronic address: jmcderm@emory.edu.
  6. Mark J Mulligan: Emory University, Emory Vaccine Center, Hope Clinic, 500 Irvin Court, Suite 200, Decatur, GA 30030, United States; Emory University, School of Medicine, Division of Infectious Diseases, 500 Irvin Court, Suite 200, Decatur, GA 30030, United States. Electronic address: mmulli2@emory.edu.

Abstract

BACKGROUND: HIV vaccine trial Participants may engage in behavioral risk compensation due to a false sense of protection. We conducted an ancillary study of an HIV Vaccine Trials Network (HVTN) vaccine efficacy trial to explore risk compensation among trial Participants compared to persons who were willing to participate but ineligible based on previous exposure to the Ad5+ virus (Ad5++) across three timepoints.
METHODS: Participants were drawn from the Atlanta, GA site of the HVTN 505 vaccine trial. From 2011-2013, all persons who met prescreening criteria for the clinical trial and presented for Ad5+ antibody testing were invited to participate in the ancillary study. Data were collected from vaccine trial Participants (n=51) and Ad5++ Participants (n=60) via online surveys across three timepoints: baseline, T2 (after trial Participants received 2/4 injections) and T3 (after trial Participants received 4/4 injections). Data analyses assessed demographic, psychosocial, and behavioral differences at baseline and changes at each timepoint.
RESULTS: At baseline, Ad5++ Participants were less likely to have some college education (p=0.024) or health insurance (p=0.008), and were more likely to want to participate in the vaccine trial "to feel safer having unprotected sex" (p=0.005). Among vaccine trial Participants, unprotected anal sex with a casual partner (p=0.05), HIV transmission worry (p=0.033), and perceived chance of getting HIV (p=0.027), decreased across timepoints.
CONCLUSIONS: Study findings suggest that persons with previous exposure to Ad5+ may be systematically different from their Ad5+-negative peers. Unprotected anal sex with a casual partner significantly decreased among HIV vaccine trial Participants, as did HIV worry and perceived chance of getting HIV. Findings did not support evidence of risk compensation among HIV vaccine trial Participants compared to Ad5++ Participants.

Keywords

Grants

  1. T32 AI074492/NIAID NIH HHS
  2. P30 AI050409/NIAID NIH HHS

MeSH Term

AIDS Vaccines
Adolescent
Adult
Female
HIV Infections
Health Risk Behaviors
Humans
Male
Middle Aged
Unsafe Sex
Vaccine Potency
Vaccines, Synthetic
Young Adult

Chemicals

AIDS Vaccines
Vaccines, Synthetic

Word Cloud

Created with Highcharts 10.0.0trialparticipantsHIVvaccinep=0compensationAd5+riskamongbehavioralHVTNpersonsparticipateAd5acrossbaselinemayancillarystudyVaccinecomparedpreviousexposurethreetimepoints505clinicalDatareceivedinjectionslikelyunprotectedanalsexcasualpartnerworryperceivedchancegettingdecreasedevidenceBACKGROUND:engageduefalsesenseprotectionconductedTrialsNetworkefficacyexplorewillingineligiblebasedvirusMETHODS:ParticipantsdrawnAtlantaGAsite2011-2013metprescreeningcriteriapresentedantibodytestinginvitedcollectedn=51n=60viaonlinesurveystimepoints:T22/4T34/4analysesassesseddemographicpsychosocialdifferenceschangestimepointRESULTS:lesscollegeeducation024healthinsurance008want"tofeelsafersex"005Among05transmission033027CONCLUSIONS:StudyfindingssuggestsystematicallydifferentAd5-negativepeersUnprotectedsignificantlyFindingssupportExploringBehavioraldisinhibitionRisk

Similar Articles

Cited By