Thursday, May 3, 2012

Feedback from current/past trial volunteers on how best to collect sensitive information on potential HIV exposure and adherence

Dear Past Trial Participant:

We need your advice! 

HIV prevention researchers are trying to find better ways to collect information for future clinical trials. We want to do a better job gathering feedback around risk behaviors for HIV infection and about how consistently people are really using the products that are tested in clinical trials.
The questions below are designed to trigger your memories of clinical trial interviews but please feel free to share other ideas and thoughts you might have.  You do not have to answer all of the questions in order.

We would appreciate your thoughts in the following areas: 

1) GENERAL INFORMATION: How can we explain why the accuracy of reporting of risk behaviors and actual use of trial products is so important?

During the informed consent process, and during the trial itself, you may or may not have been told how important information about HIV risk behaviors and use of the study product is to making sure we correctly understand the results of the study.

·       In your opinion, might a more specific explanation of the critical importance of this information be useful as a standard practice? 

·       Would it help to explain how the science of the study really depends on this information? Would it help to have an explanation of the consequences of inaccurate information?

2) Environment - Internal & External: In your opinion, what type of environment works best to ensure real / accurate information is gathered?

·         What about the outside environment might be significant – for example, does it matter if the setting is a center dedicated to research or a research center combined with a treatment center?

·         What characteristics of the place in which this information is gathered matter – for example, the room location within the clinic, sound proofing, movement of people around the room, or anything else you think is important?

·         What is the single most important thing about the clinic environment that may or may not provide a sense of safety or confidence in talking about private and sensitive information?

3) STAFF: Who is best suited to gather this information?

·         Does it matter what the gender, age, race/tribe, familiarity, professional level, and language/vernacular of the interviewer is? Which aspects do you think are important? Which are not so important?

·         What is the single most important characteristic of the staff which is likely to allow study participants to be as truthful as possible about sexual risk/activity, about being able to follow the study regimen and use the product, or other related private concerns?

·         Would it be best to have two different staff do the following: one staff person to ask about potential exposures to HIV, and another staff person who would provide risk-reduction counseling? Would separating these staff functions potentially allow for more openness and truthful responses? Or might the same person be trusted to do both without influencing how people report their risk behavior and consistence of following the study procedures and using the study product?

4) METHODS/TOOLS: There are different ways in which information about sensitive behaviors is collected during a trial. These include:  self-administered surveys (the participant fills it out directly); face-to-face interviews (an interviewer asks questions and the participant responds); computer assisted (ACASI) (the participants listens to questions over headphones and enters answers into a computer); or sometimes a combination of methods are used.

·         What is your opinion on which method (or combination of methods) is best suited to have volunteers report the most real and accurate sensitive information on risk behaviors for HIV and actual use of the study product (adherence)?

·         The accuracy of some information about human behavior depends on memory. Might it be helpful to provide a question in which participants could report how confident they feel in their ability to remember these pieces of information?

5) Barriers: Based on your experiences and understanding of your community, what are the things we should avoid doing? For example,

·         In your opinion, what are the biggest obstacles to volunteers in reporting sensitive information related to risk behaviors and possible HIV exposure? What might make volunteers comfortable sharing their true experiences?

·         If you ever reported information that wasn’t accurate because of your discomfort with the way  questions were asked about your risk behaviors to HIV or about your consistent use of (adherence to) the study intervention?


·         Is there anything else you would like to share that might help us improve the quality of the sensitive information we collect from volunteers on HIV risk behaviors or adherence to product use in clinical trials?

Please share your experiences and suggestions below. If you feel comfortable, please let us know if you have even been a trial participant. Providing your name and contact information are completely optional.  You can also click here to share your thoughts in an email to HANC.   


  1. I was a participant in the VAXGEN trials some years ago. First off, while I'm sure all the compliance officers will gasp in horror when I say this, the "informed consent" protocols are WAY too long and full of entirely too much jargon. (And I say that as someone with multiple graduate degrees and a background in science research.) You've got to put that information in terms that the average participant is going to be able to understand and relate to. It would help if it could be kept down to a page or two, so that someone might actually be able to read it without holding up the intake process, and still get enough information to enable him/her to ask pertinent questions.

    Yes, you should include information about why it's important to follow the study protocols, and what might happen if participants don't. They may still not be 100% compliant, but perhaps they'll at least be motivated to mention that they forgot something--which could then be noted in the record and appropriate action taken.

    I don't think it matters much where you do this, except to say that it really should be in an individual, one-on-one situation, and absolutely not in a cubicle or a common area where there might be other people present or in a position to overhear. If you're going to be asking intimate questions, you have to give participants a safe space in which to share that information.

    I don't like the idea of splitting the questions about adherence to protocol and having someone else follow up with risk-reduction information. Over the course of the three years of the study, I developed a bond of trust with the practitioner who handled my trial. (And risk-reduction counseling was introduced into the study protocol after, I believe, the first year--so he did both with me and with the others on his case load.) That bond would be harder to establish with someone I only saw once, or maybe once a year.

    I tend to doubt you'd get better data by asking respondents to rate their confidence in the accuracy of the information they're providing. It could be harder to set up (but then again, this is the age of the smart phone, so maybe not), but you might get more accurate data (and potentially more of it) if it were possible to complete surveys through a secure web interface. Especially when it comes to matters involving sexual behavior, it's difficult to say some things out loud to another person, whereas typing on a computer allows at least the illusion of anonymity even if the responses are linked to an identifying code.

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