The results of the START Study, a randomized controlled trial of interventions to reduce HIV/STD risk behaviors among 522 young men being released from prison in four states (California, Mississippi, Rhode Island and Wisconsin), were recently published in the American Journal of Public Health. IDCR Chief Editor, Dr. David Wohl, spoke with Dr. Richard Wolitski, lead author of the study, which was supported by the Centers for Disease Control and Prevention (CDC). Dr. Wolitski is the Acting Deputy Director for Behavioral and Social Sciences in the CDC's Division of HIV/AIDS Prevention.
David Wohl (DW): You led what many consider to be a very important and unique study looking at reducing HIV and STD risk behaviors among young men released from prison. Could describe the two interventions that were studied?
Richard Wolitski (RW): The Project START intervention was collaboratively developed by researchers at the four sites and CDC. It compared the relative efficacy of two different interventions. The first intervention was a single-session intervention that was conducted before participants were released from prison. The single-session intervention was based on a brief HIV risk assessment and risk-reduction planning intervention developed by Grinstead and colleagues that had previously been shown to reduce risk in this population. We compared the effects of the single-session intervention with those of the six-session enhanced intervention.
The enhanced intervention was meant to provide a bridge between incarceration and then reintegration into the community. The enhanced intervention had two sessions that were conducted before participants were released. The first of these was identical to the single-session intervention, and the second session focused more broadly on the individual participant's needs after release. It included an assessment of needs and planning for housing, employment, financial problems, social relationships, and avoiding reincarceration. Then participants had four additional scheduled interventions after release. These interventions were client-centered and adopted elements of prevention case management and motivational interviewing.
DW: When I think about that kind of case management and a client-driven approach, I would think that there might be some variability in the frequency with which case managers, following release, would interact with participants. Was there any freedom on the part of the case managers in the enhanced intervention or were they restricted to only four sessions with the participant after release?
RW: All the participants were scheduled to receive four scheduled interventions, but we also made it possible for the participants to receive additional sessions as needed during the three-month intervention period following release. There weren't that many people who received additional sessions. There were a total of just 91 additional enhanced intervention sessions that were delivered to 49 participants, and most of those, 61%, received only one additional session.
DW: What were the main results of the study?
RW: The enhanced intervention was associated with a significant overall reduction in sexual risk behaviors 24 weeks after release. More specifically, we found that men who received the enhanced intervention were significantly less likely to report unprotected sex the last time they had sex and during the full recall period. Although there was a significant overall reduction in sexual risk, this reduction was due almost entirely to reductions in risk with the participants' main or primary partners.
DW: There are few studies that have shown positive changes in risk behavior in general, and certainly there remains very limited data about interventions for an incarcerated or recently incarcerated population. However, I was surprised that we did not see greater differences at week 12 -- at the end of the enhanced intervention. The only significant difference was seen at week 24, which is three months after the intervention was completed. Any thoughts about why you saw a greater effect after the intervention ceases?
RW: That's a really good question. One thing that's important to keep in mind is that at the 12-week interview, the participants were asked about their risk behavior since their first week of release from prison. The period of time that participants are reporting on includes a time period where enhanced intervention participants had received very little of the intervention, so it's really only at the 24-week assessment that we can look at behavior change after participants had a chance to receive the full intervention.
DW: You mentioned that the enhanced intervention seemed to motivate participants to practice safer sex with their main partners, more so than non-main partners, and studies of HIV-infected releasees have shown that HIV-infected former inmates are more likely to practice unsafe sex with their main partner, with whom they may feel more comfortable with than casual partners. The finding that the intervention seemed to work more so with the main partners seems particularly significant.
RW: One of the things to understand about this population is that many of the men had already reduced their risk with their non-main partners and that the highest levels of risk were observed with main partners. So, I think in part what's happening here is that the enhanced intervention sensitized men to the potential risks of contracting HIV or another sexually transmitted infection from their main partners or also sensitized them to the possibility that they might be putting their main partner at risk. Many of these main partners were also at risk --- one third of the men who had a main partner believed that this partner had one or more risk factors for HIV, hepatitis or other sexually transmitted infection.
DW: Are there any plans to evaluate longer-term differences between the study arms, beyond week 24?
RW: At this time, we don't have any plans to do that. However, the CDC is supporting the packaging of the Project START intervention for dissemination to the CDC's prevention partners. This means that there will be additional opportunities to evaluate the effectiveness of this intervention as it is being delivered by local agencies.
DW: Do you think, given what you now know from looking closely at the results, that a three-month post-release intervention is sufficient?
RW: A three-month post-intervention follow-up is an acceptable standard in the field, and this follow-up is longer than others that have been used in HIV prevention studies with incarcerated men. Certainly, having a longer follow-up is better, but it requires additional resources that were not available for this study. It's possible that, given the comprehensive nature of this intervention, some of the participants established a stable pattern of behaviors that allowed them to maintain reduced risk behaviors over time. But we really don't know that at this point in time.
DW: The results that you found at week 24 after release were significant, but 68% of those receiving the enhanced intervention reported unsafe risk behaviors, albeit versus 78% of those in the single session arm. How could anyone get excited about over two thirds of the people in the enhanced intervention still practicing risky behavior?
RW: We have to be realistic about what any one intervention can accomplish. A lot of people would have thought that it would be difficult or impossible to see any risk reduction in this population. As you know, incarcerated men are sometimes viewed as people who really don't care about their own health or the health of their partners, and this study demonstrates that it is actually possible to motivate these men to reduce their risk behavior. It does indicate, though, that there is a need for additional intervention for some men, or perhaps different types of intervention for men who did not respond to this particular intervention.
DW: Your study concentrated on people following release, and a common misperception, is that HIV-infected people in prison acquire their infection during incarceration. The CDC took a lead with a study of an outbreak of acute or transmitted HIV within a correctional system in Georgia. Your study focused on people getting out of prison, versus an intervention to try to reduce acquisition of HIV within a correctional system. Why?
RW: One thing that is important to keep in mind is that incarcerated men continue to be part of the communities that they came from, and that most men who are incarcerated will be re-released back into the community. Addressing this period of transition from incarceration to release is really critical for public health. We chose to focus on this period after release in part because we wanted to design an intervention that would be feasible for health departments or community-based organizations to implement in collaboration with local correctional facilities. So our primary interest here was driven by the types of organizations that we thought might be implementing this intervention in the future.
DW: Right. In your conclusion to the paper you call upon community-based organizations and health departments to work in tandem with correctional institutions to improve the well-being of people such as those who enrolled in your study. Given what you've learned and your experience, what do you see as being obstacles to that kind of cooperation and how your results might help us to overcome them?
RW: The most important thing that this study shows is that this type of intervention is feasible and can be efficacious in reducing risk behavior among incarcerated young men. There are a number of challenges that people face when coming from outside correctional settings and trying to conduct this type of intervention, and one of the biggest challenges is gaining entry into the facilities. What we hope is that this paper and this study will give health departments and community-based organizations that are interested in establishing those relationships with correctional facilities a model that they can show to local correctional facilities to show that this can work.
DW: You mentioned earlier that the intervention is going to be packaged and become more accessible. Any details about how those who are interested in learning more about the program can get the materials to actually start to implement their version?
RW: Probably the best thing that I could do is to refer people to the CDC website (www.cdc.gov/hiv/PROJECTS/ProjectSTART), where there is additional information that is online about the study. The actual intervention package will not be available for another year or two, from the CDC. Some of the local researchers may be willing to provide additional information in the interim, but readers would have to contact them directly. The contact information for all principal investigators is listed on the Project START website.
DW: So, summing-up, the take-home lessons from the START Study seem to be that, even in this difficult-to-reach and difficult-to-change population, you can see some change in risky behavior in a positive direction, and while this is encouraging, the results certainly points to the need for further development of interventions to complement this one. Is that fair to say? Is there anything more you'd say to expand upon that?
RW: I think that's a good summarization of the study, and I would say that Project START can be an important part of a comprehensive strategy for reducing HIV transmission among incarcerated men and their sex partners. Other elements of that approach include HIV testing upon entry and release from prison, as well as interventions that are designed specifically for persons living with HIV and AIDS.