Table 5.

Formative Data Themes and Quotes.

THEMES	QUOTES
Rationale and Goals for conducting Behavioral Risk Assessment Unclear	There was clear rationale but whether everyone bought into it or knew it beats me. For me there is always a concern about is this the best way to look at the question and is the question going to be used in analysis or just “interesting”. At [name] we are always asking the question, Is this data that is going to be used? We can create questions but we often wonder what expertise goes into what questions will be asked.
Unaware of behavioral risk assessment methods and measurement	We as a Network need to distinguish what kind of questions to ask and how to ask them for specific populations. Most of the members of the protocol team do not know what behavioral measures are available and what’s been validated. We often have to look at multiple resources regarding behavioral risk assessment. We look at what we wish we would have collected in previous trials, the Step data, and several other resources and pull them all together. There is a fair amount of borrowing with the idea of trying to get the best of everything.
Lack of Epidemiological data for specific populations	It would be helpful if we had specific population risk factors that we could pull from when developing the protocol. We were working mainly with sex workers and high drug use women so in the absence of epidemiological data, lots of the risk assessments and many of the questions came from the experience of the sites. Additional behavioral risk questions were added that were based on feedback from our colleagues regarding the local population.
Time restrictions and limitations	One of weaknesses is that we don’t pilot test things. People are always fussing over wording and it is hard to get consensus because multiple people have different views so we are right up against the deadline of when the protocol will open without any time for pilot testing. I have also experienced issues with translating. It would be nice if it was someone’s job to read through the final version to make sure it matches back to English. Taking the back translated version and having someone look through the final copy. What has really helped from [name] perspective is when the behavioral risk planning could start early and we could vet out all of the questions prior to when [name] officially takes off with it.
Need for face-to-face meetings	Meeting in person helped with 505 and having a clear decision making plan for the Behavioral risk assessment was good with conference calls later. What really helped is that we spent lots of hours and went to work with the team on risk assessment questions in person. It is always best when the behavioral risk assessment process begins well in advance and team meetings begin early and include face-to-face meetings.