EXPLORE: A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV among Men who have Sex with Men (MSM)
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.
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.
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.
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.
The Explore Directory contains contact information for the study co-chairs, principal investigators, statisticians, and assorted other staff.