Learning from Broader Randomized Clinical Trials

The larger, more extensive, randomized clinical trial was conducted at a large STD clinic in
New York City. The interventions to be tested included the original Let’s Do Something Different video for African Americans, along with the new video, Porque Si, for Latinos. In addition to testing the video alone, the study also looked at whether videos supplemented by small group discussions would result in even greater improvements in patient knowledge, attitudes, and healthy behaviors, and decreases in subsequent STDs.

Over a 1-year period in 1992, with the assistance of the NYC Department of Health, San Doval and Duran worked closely and patiently with clinic staff and clients to encourage participation in the study. “There is a big difference between going into a clinic and saying, ‘I have something I want to try and see if it will work,’ versus going in and saying, ‘I worked in this field and I’ve seen what you’re up against and I’d like to spend some time watching and working with you,’ and doing it in such a way that neutral development of a program addresses everybody’s needs, rather than walking in like an outside expert,” says Duran. “It was a very roll-up-your-sleeves kind of approach,” says San Doval.

Remarkably, they recruited 98% of the patients that they asked to participate, enrolling a total of 3,348 clients at Morrisania STD Clinic into the study. “Without Alexi and Richard’s knowledge of the system and how the clinics operate, we could not have collected anywhere near the amount of data that we did,” O’Donnell says. “We needed to adhere
to a very rigorous study protocol.We had to have people who are committed to doing that and be able both to supervise and to be there. They needed to be able to understand
the workings of those systems to be able to see the project through,” she adds.

At the Morrisania clinic, one of the largest clinics in the city (serving about 8,000 patients a year), participants were assigned to one of three groups:

• Control group, in which the client experienced a typical clinic visit
• Video group, in which the client viewed a video
• Video-plus group, in which the client viewed a videoand participated in a small-group session led by a trained facilitator

The Human Touch Before coming to HHD, Richard Duran spent years counseling drug addicts and STD patients. He had managed clinics, taken phone calls, and checked patients in. He knew first-hand how overworked clinic staff were.And he knew that the clinic trial must not interfere with getting patients seen and treated as efficiently as possible, and that clinic staff often resent the presence of researchers. “There were a lot of behind-the-scenes, day-to-day things that you have to work out with the staff.We touched everybody’s work in the clinic, from the registration person to the nurses to doctors.We tried to see how we could do our job without interfering with their job,” says Duran, recalling that they declined an invitation to occupy one of the nicer offices, opting instead for an out-of-the-way cubicle that wouldn’t displace clinic staff. Working with patients also required sensitivity. Privacy and confidentiality were paramount, and the videos helped people discuss touchy issues as they affected the characters in the vignettes. Duran also ran some of the groups of patients participating in the study. It helped people in an embarrassing situation to open up, Duran says.“Each group was new. It’s live.You don’t know what the next person is going to say, and what’s going to happen in the group. Part of the human condition is that misery does love company. It’s nice when you walk into a room and you’re feeling really bad about your life now and you say,‘ Wow, there are six other people here who feel just like me. I just feel like I have some support here.’ ”

Those assigned to the video-plus group discussed and role-played realistic scenarios involving talking about condom use with partners. They also learned about a variety of
condoms and selected three types at no cost.

The intervention was evaluated in several ways. First, researchers examined whether, compared to controls, patients who participated in either of the interventions had
greater understanding of the risks of HIV and other STDs, more positive attitudes about discussing and using condoms with partners, and greater intentions to do so. Second, all
participants were given a coupon to redeem for three more free condoms at a pharmacy several blocks from the clinic. Again, the team monitored whether those who participated
in the interventions were more likely to redeem their coupons than those who received only regular clinic services. Third, with the help of staff at the NYC Department of
Health surveillance system, they monitored whether those in the interventions were less likely to get a new STD infection subsequent to their clinic visit. Staff tracked new
STD infections among clinic clients for an average of 17 months following the initial clinic visit.

Clinical Trial Results
HHD scientists looked at self-reports of HIV/STD knowledge and two different indicators of behavior change: condom acquisition and repeat STD infections.When compared to adults receiving routine clinic services, clients who participated in the video interventions demonstrated the following:

- Fewer repeat STD infections, indicating adoption of safer behaviors and reducing
their exposure to HIV (new infections in the control group: 27 percent; new infections in
the intervention group: 23 percent).

- Greater likelihood of redeeming coupons to get condoms and intending to
use them regularly. Further, the results were most dramatic for those patients who
saw the video and participated in the small group discussion: Forty-one percent of the
video-plus group redeemed coupons, compared to 22 percent of the control group.
Participants’ perceived risk of their chances of acquiring HIV and other STDs was the
strongest psychosocial predictor of condom acquisition.

- Increased motivation to change behaviors that place them at risk.

- Increased knowledge about HIV and other STDs and how they are
transmitted; greater understanding of the HIV and STD risks they face.

In addition, feasibility and cost-effectiveness, when targeted to STD clinic clients at high risk of contracting and transmitting infections, indicated that this strategy should be considered for inclusion in HIV prevention programming.

“ We were able to demonstrate that this intervention significantly reduced STD re-infection rates, especially among men and women who have a higher incidence of STDs and are more at risk for spreading STDs, and perhaps HIV because they have multiple sex partners and unprotected sex,” says Dr. Carl O’Donnell, senior methodologist.“ Prior to this finding, the conventional wisdom was that brief interventions didn’t work and they especially
didn’t work among high-risk populations.We found the opposite — this intervention not only worked, but it worked particularly well in high-risk populations.”