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Study
Documents
The Explore study has made available its
most important study documents in order that they may serve as sources of
information for researchers, participants, or anyone who may be interested
in the workings of the study.
Study Protocols
The Explore study has gone through four versions of its study protocol, with each one incorporating some changes,
such as, for example, adopting a process for maintaining the participation
of volunteers if they move away from their study site.
Template Informed Consent Form
Below is the template informed consent form
for the Explore study, protocol version 4.0. This is only the TEMPLATE
form. This form was provided to sites as a "guide" for their own
consent forms, which must contain site-specific information and policies.
Due to the need to include site-specific information, each site's forms
differed somewhat, but all were based on the template.
Risk Assessment
At their screening visits and at all semiannual visits following that, Explore participants completed an extensive questionnaire inquiring about sexual acts, substance use, and other behaviors. That questionnaire, the "risk assessment," is available below in PDF format. Please note that there are three versions of the risk assessment. The first version was used during the screening, or baseline visit. The second was used during the Months 6 and 12 visits, and then was revised to include more questions regarding drug use starting at the 18-month mark. The revised risk assessment was used from the 18-month visit through the rest of each participant's study participation.
Explore Counseling Materials
The materials below represent the content
of and instructions for the Explore counseling regimen. Both of the
counseling conditions – "standard" and
"intervention" – are covered in these materials. The Explore
counseling materials were developed by the Center for AIDS Prevention
Studies (CAPS) at the University of California, San Francisco.
- Explore
Counseling Delivery Manual: This is the counseling
that was provided to Explore participants during their study visits.
- Explore
Counseling Delivery Manual Guide: The Delivery Manual
Guide provides instructions on how to deliver the counseling. This
document was used to train the Explore counselors and serve as a
reference after the training period.
- Counseling
Special Topics[zip file]: During the course of the study, CAPS
produced "special topics" addendums to the counseling manual
as the need arose. Usually, these additional counseling protocols
attempted to address a condition or phenomenon that had risen to
prominence recently among MSM, but was not prominent at the time when
the intervention was written.
- Counseling
Worksheets[zip file]: These documents were produced to aid the
counseling process by providing ways for participants to track their
thoughts or progress over the course of a counseling session or over
multiple sessions.
Participant Feedback Survey
The participant feedback survey was
administered at the end of each participant's Explore involvement to
ascertain the nature of their experience with the study. The survey
contains both closed-ended and open-ended questions. Once they are
completed, analyses of the feedback survey will appear on the Explore Research
page.
Explore Directory
The Explore
Directory contains contact information for the study
co-chairs, principal investigators, statisticians, and assorted other
staff.
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