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.

• Protocol v4.0
• Protocol v3.0
• Protocol v2.0
• Protocol v1.0

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.

• Template Informed Consent Form

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.

• Risk Assessment 1: Screening (baseline) visit
• Risk Assessment 2: Months 6 and 12 visits
• Risk Assessment 3: 18-month visit onward

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 Participant Feedback Survey

Explore Directory

The Explore Directory contains contact information for the study co-chairs, principal investigators, statisticians, and assorted other staff.