Abstract #267  -  The evolving standard of behavioral HIV prevention interventions: Lessons learned from the CPOL trial
Authors:   Presenting Author:   Dr. Daniel Montano - Batelle
Additional Authors:  Dr. Danuta Kasprzyk,
Aim: New standards in HIV prevention intervention research trails are evolving. I will discuss two issues with respect to these standards. First, such trials must now include a minimal intervention package in the control arm for ethical reasons, without a pure ‘no intervention’ control group. Second, it is a challenge to synergistically promote multiple prevention strategies with respect to new combination prevention expectations. We use the NIMH 5-country Community Popular Opinion Leader (CPOL) Intervention randomized control trial (RCT) to illustrate the dilemmas and concerns associated with these issues.
Method / Issue: We implemented the RCT to test the CPOL prevention intervention in 30 rural sites in Zimbabwe, with 15 sites serving as intervention venues, and 15 as comparison ones. The CPOL Ethics Workgroup determined that implementation should include a minimal prevention package in comparison sites, with the CPOL intervention to be implemented over and above this minimal package in intervention sites. Thus, a combination package of services for all sites was developed with behavioral and biomedical approaches. During the assessment, participants were asked detailed sexual history questions about HIV and STD risks and other behavioral risks (i.e., alcohol use), provided pre-test counseling, STD and HIV testing, provided results with post-test counseling, and treatment of lab diagnosed bacterial STDs. The CPOL behavioral intervention was an added component in half the study sites. The CPOL intervention targeted multiple prevention behaviors and their underlying beliefs and normative perceptions.
Results / Comments: Baseline, 12- and 24-month data were collected from a cohort of 5543 people aged 18-30 in study sites. Outcomes were then contrasted between intervention and comparison group sites. Results showed an equal reduction in behavioral risk and in STD/HIV acquisition between intervention and comparison sites. The intervention package considered as a minimal standard was as effective as the package with the CPOL intervention added to it. Additionally, some of the behaviors targeted by the CPOL intervention may be viewed as mutually exclusive – e.g, using condoms vs. sticking to one partner and avoiding sex workers. Thus, the beliefs promoted for one behavior may decrease the likelihood of another behavior.
Discussion: Prevention intervention results are affected by the fact that control and comparison arms have intensive public health prevention interventions implemented along-side planned behavioral interventions. Thus, detecting an effect for behavioral interventions over and above a minimal package of services will be difficult, especially if prevention services include components such as risk assessment, STD testing and treatment and risk reduction counseling. Prevention intervention trails will need alternative study designs to establish effects. Additionally, combination prevention, particularly involving both biomedical and behavioral approaches, may target competing underlying beliefs and behaviors possibly having opposite effects on behaviors. For example, promoting beliefs to increase uptake of male circumcision may have the effect of decreasing condom use or sticking to one partner (disinhibition). There is a critical need for research to design behavior change strategies that will synergistically promote multiple prevention behaviors.
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