HIV Vaccine Clinical Trial Timeliness and Retention: HighRisk DrugUsing Women

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HIV Vaccine Clinical Trial Timeliness and
Retention High-Risk Drug-Using Women

University of Pennsylvania HIV Prevention
Research Division PENN Prevention CTU
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Overview

• Methods and characteristics of those enrolled in
  Philadelphia
• Retention strategies and outcomes
• Summary of analyses of timeliness and retention

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AIDS cases by race/ethnicity and date of diagnosis
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AIDS cases by mode of transmission and date of
diagnosis
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Target population

• Women
• Sexually active in prior three months
• Multiple male partners
• Use of crack cocaine in prior three months
• Residing in high prevalence neighborhoods
• Willingness to participate in vaccine trial

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Strategies Used to Recruit and Enroll High Risk
Participants

• Epidemiologic and geographic data used to
  identify target areas
• Ethnographic data identifies specific locations
  and high risk networks
• Mobile pre-screening
• Refer potentially eligible for study screening
  visit to clinical site

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Prescreening (894), Screening (231), and
Enrollment (124)
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Socio-demographic characteristics
124 Women Enrolled Race 91
Black Average (SD) Age 37 (5.8) HS Diploma
52 Unstable Living Arrangement 20
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Sex risk characteristics of enrolled
participants (prior three months)
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Drug use characteristics of enrolled participants
(prior three months)
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Retention strategies

• All appointments scheduled at time of enrollment
  (day of visit window opening)
• Use of Participantfile database to maintain
  current contact information and document
  retention efforts
• Participants assigned to three person retention
  team
• Weekly hotlist of scheduled and missed
  appointments
• Provide tokens or minivan service
• Toll free telephone contact
• Freely distribute prevention supplies
• Risk reduction counseling and referral

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All retention efforts..

• Protect confidentiality
• Done with prior permission of participant and
  community
• Demonstrate respect for participants
• Documented in database
• Compensated participants for their time

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Scheduled Visit
-2 WEEKS
-1 WEEK
-1 day
Visit window
Reminder letter sent
Reminder phone call
Weekly hot list
If no Contact
Visit Contacts Primary Secondary
Continue visits Continue calls Visit
hangouts Send letters
Check Jails Check Rehab Search death registry
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Visit completion
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Summary of timeliness and loss
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Socio-demographic characteristics by visit
timeliness
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Drug use behaviors during three months prior to
enrollment by visit timeliness
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Mean number of sex risk events during three
months prior to enrollment by visit timeliness
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Conclusions

• Heterosexual drug using women can be recruited
  and retained at levels acceptable for clinical
  trials of HIV preventive vaccines
• Risk behaviors of participants were not
  associated with timeliness or loss
• Retention is critical particlarly\ when trials
  have unexpected findings
• Risk behaviors of participants are necessary but
  not sufficient to predict HIV incidence

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The Penn HVTU
Ian Frank Michael Lanier Deb
Dunbar Kevin Trimel-Jones Dana
Brown Arthur Thornton Anne Colon Amanda
Rodriguez Mack Taylor Monique Mobert Helen
Navaline Chelsea Voyteck Annet Davis-Vogel
Winston Smith Melissa Cherico Joy St.
Louis Joanne Williams Julie Becker Marlene
Eisenberg Peter Smith Anthony Dixon Robert
Frederick Linette Fontroy
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Ignorance
Poverty
Sexism
Access To Care
Discrimin- ation
Disem- powered Women
Stigma- tization
Human Rights Abuses
Prejudice
Denial
High Risk Behavior
Complacency
Courtesy of Jim Hoxie