What Helps and What Hinders Participation in HIV Clinical Trials?

An Interview With Prema Menezes, Ph.D.

Prema Menezes, Ph.D.
Prema Menezes, Ph.D.

What motivates people living with HIV to enter into clinical trials? For those who have never participated in a study, what hinders their entrance? Why is it particularly important to ask these questions in the U.S. South -- home to some of the highest HIV rates and AIDS diagnoses in the nation? At ID Week 2015 in San Diego, Calif., I spoke with Prema Menezes, Ph.D., of the University of North Carolina at Chapel Hill, about her research into barriers and motivators to trial participation.

Welcome, Dr. Menezes. Please tell me about your study.

We need to continue to have clinical trials, to understand toxicity, long-term benefits and side effects of all these treatments. But it's harder and harder to recruit people into clinical trials. We really wanted to know why.

We invited 26 HIV-positive people to participate in our trial. We specifically selected for people who had participated in a trial and people who had not.

For the people who had participated, we made sure that they had participated in a trial that was at least 48 weeks in duration. For the people who had not, we asked them if they had ever been offered the opportunity to participate. If they said yes, they had been offered, but they had declined that offer, then we enrolled them in our study.

Ten were trial participants, and 16 were non-trial participants. We compared the trial to the non-trial participants, in terms of what were the facilitators and what were the barriers for participation. It was interesting, because we found that, between trial and non-trial participants, there was a difference in what they perceived as facilitators and what were barriers.

In terms of facilitators of trial participation by individual-level factors, trial participants were significantly motivated by the desire to contribute to research. In fact, one of them said, "I may never see the day that [HIV is] cured, but if part of what I did does that, then that's a good thing."

Non-trial participants did not feel that that contribution to research enabled them to enter. There's something about altruism that's different between these trial and non-trial participants.

Another reason why people participated in trials was that they improved their access to care. One said, "Being in studies, I had access to a provider at all times. We had a constant, direct link to my doctor." They felt that they got better care versus not being in a trial. But that was not something that the non-trial participants reported. So there's a big difference: 70% of trial participants, versus 12.5% of non-trial participants reported that.

In terms of barriers to clinical trial participation, we found that people didn't want to participate because they didn't want to disrupt their medication regimen. You know, we're all about you taking this medicine; you're doing fine, and then all of a sudden we're saying, "Oh, well, we want to stop this and ask you to get in a trial." They didn't want to do that. Because they felt, "You know what? I don't want to take a chance. There's really very little incentive for me to take a chance." That's what they said.

The other thing that we did find -- not huge, but pretty huge -- was a lack of provider recommendations. Non-trial participants said that this didn't have any influence on them. But trial participants said that if their doctor did not recommend the trial to them, then they did not feel enthused about joining the trial.

If the study coordinator came to them and said, "Will you join?" they didn't feel so confident. But they said having an honest heart-to-heart talk with their doctor first, versus being thrust into it with a clinical trial person, would make a big difference. They've built up trust with their doctor over all these years, and they feel that their doctor isn't going to steer them wrong. But the clinical trial person is a stranger. The study coordinator comes in and says, "Hi, I'm part of this study." They don't know this person.

Did you look into structural factors that might influence participation, such as distance from the site?

We looked at clinical trial-level factors that might actually be barriers to participation. We found that people did not participate because they were worried about transportation. So they -- especially those who live so far out -- said, "I know they compensate for time, but it would also make a difference if they compensated for gas." Now the gas rates are really low, but a couple of years ago, when the study was started and completed, gas was $3.00 a gallon, $3.50 a gallon, and on average our patients travel 50 miles one way to come to the UNCID clinic. So it was a big difference.

Another clinical trial-level factor -- it's not so much structural -- was fear of being experimented on. Non-trial participants really strongly said they didn't want to be experimented on, and they felt clinical trials were going to be experiments, so that's why they didn't participate.

What's the significance of looking at the issue of trial participation in the South?

The South is where the epidemic is growing the most. It's one of the areas in the U.S. with the highest rates of HIV, and incidence of new infections is highest. So it is an area where we really want to understand why people don't enter into clinical trials. If you do a clinical trial in the South, you have this group of people that's all living with HIV, but they're not coming to be in your trial. What is the reason? Is it because they're afraid of experiments? Do we need to increase the amount of compensation for participation? Do we need to make sure their doctor talks to them first?

That would help us get a better pool of people into our clinical trials, so our results become more generalizable. That's the bottom line: If you only get a certain group that's going to volunteer to be in your trial, that limits the generalizability of those study results. But if you get the broad group, then you can broadly generalize the study results.

Were you informed at all by the GRACE (Gender, Race and Clinical Experience) study in conducting your study?

Yes. Absolutely. That was one of the reasons for conducting the study: GRACE was designed to enroll women; they successfully enrolled women, but they did not retain women. And so, we wanted to ask these people, what are their perceptions.

This transcript has been lightly edited for clarity.