Implementation of a couple-based HIV prevention program: a cluster randomized trial comparing manual versus Web-based approaches

Despite the need for implementation science in HIV prevention in the United States, the number of implementation studies remains limited [1]-[4]. This may be due to the fact that while there is urgency for HIV scientists to identify, demonstrate and promote robust implementation models, the prevention field is experiencing a shift in scientific priorities [5],[6]. Shifts include movement from behavioral towards biomedical prevention approaches, promotion of behavioral couple-based models to overcome barriers in traditional, individually-based models, a recognition that efficacious multisession programs need to be briefer for sustainability in service settings [7] and that programming should target individuals living with HIV and their intimate partners [6]. Historically, the U.S. is also slowly rebounding from an economic recession. This context, in light of the traditional barriers to implementation efforts in real world HIV services agencies, may be holding back more rapid gains in HIV prevention implementation science in the U.S.

The challenge for researchers, in this time of limited HIV services agency resources, is to conceptualize and test how to more rapidly disseminate cost-effective, efficacious, practical, and sustainable prevention programs- including behavioral approaches [8]. We cannot abandon behavioral approaches because even as biomedical innovations for HIV prevention show great promise in efficacy trials, they likely cannot be fulfilled without behavioral interventions to support their adoption and dissemination [9]. Barriers evident in individual level prevention approaches have led to increased testing of couple-based strategies which are often found to be more efficacious in promoting HIV counseling and testing [10],[11] and supporting medication adherence [12], but which may require more complex implementation strategies [13],[14]. Given the promise of couple-focused approaches (e.g., balancing attention to the dyad, positive reinforcement for relationship-based behaviors, conflict management) [15], scientists have called for improved efforts at examining their dissemination [13]. Yet, couple-based services present a unique set of implementation challenges [13],[14]. How can we best balance complexity with ease of access or more rapid dissemination?

Dissemination of evidence-based HIV prevention in the U.S. has taken place largely through the Centers for Disease Control and Prevention's (CDC) Diffusion of Evidence-Based Interventions (DEBI) program in which agencies receive funding and technical assistance (TA) to deliver `packaged' programs that had been selected as `best evidence' [16],[17]. This national approach is based on best evidence from Kelly et al.[18],[19] and offers paper-based manuals, training workshops, and follow-up TA. TA may be formally or informally provided, and includes advice, assistance and training pertaining to the implementation and maintenance of the program. Since then there are a number of studies which examine the conduct and monitoring processes of agencies funded to implement CDC DEBI packages [20]-[24], but few have examined actual implementation of any DEBI program [1],[25] and none have tested alternative, scalable approaches to disseminating these packaged interventions. At the same time, computer-assisted and Internet-based prevention programs have demonstrated better short- and long-term efficacy for a range of outcomes [26]-[28] compared to manually based approaches, including HIV prevention risk reduction [29],[30]. Advantages of Web-based technologies are that they may expedite the use of effective interventions in real-world settings [30],[31] by offering the potential for time efficiency, cost-effectiveness, scalability, and enhanced learning via Internet-based approaches [32]-[35]. Scientists are calling for experiments testing computer and Internet-based dissemination formats on implementation [7],[19],[30],[36]-[41].

This clinical trial tested the adoption of an HIV prevention intervention model to clinic-based health services in neighborhoods throughout New York State. The goal of the study was to examine whether using a Web-based approach for implementation of a couple-focused HIV prevention program, Connect, yields greater implementation than a traditional, manual-based approach used by facilitators at HIV service agencies. We tested implementation of couple-based intervention modalities (manual versus Web-based) into real world settings. The study investigated how the Internet may be used to support the delivery of a behavioral `packaged' manual-based intervention and `packaged' computer based intervention in agency settings [30]. Although both manual-based and Web-based approaches require a facilitator for implementation, we hypothesized that the Web-based approach might ease the implementation process, leading to increased use. Compared to manual-based approaches, Web-based program activities may offer greater ease of access to program and re-training materials, increase the number of facilitators who could train on and use the program following an initial training, and increase rehearsal and self-efficacy for implementing activities among those facilitators who use the program [42]. We had four sets of hypotheses regarding whether more agencies (or participants) assigned to the Web-based program would implement the program (e.g., delivered sessions). We hypothesized that more agencies (or participants) assigned to implement the Web-based program would report H₁, delivering Connect with more couples; H₂, delivering more Connect sessions; H₃, delivering at least one Connect session; and H₄, delivering at least one complete Connect intervention (all six sessions) over the 18 months of follow up, compared to agencies (and staff) assigned to the manual-based approach. In addition we observed post-training use of TA and barriers to implementation.

This study is the first to examine implementation of a couple-based HIV prevention intervention, and the first to test competing modalities for implementation of a behaviorally- based HIV prevention program (in this case, a CDC DEBI) among HIV services agencies. Findings did not support our hypotheses, demonstrating instead that whether measured at the level of the agency or the participants, staff trained on the Web-based program did not demonstrate significantly higher implementation compared to those trained on the manual-based approach. Agency level outcomes did demonstrate higher mean number of couples with whom staff at manual-based agencies worked compared to Web-based agencies, however, these findings were not significant at the individual level. Findings also show overall low rates of implementation, but implementation rates that are consistent with the landmark study on which the CDC DEBI approach is based [18]. Our discussion therefore focuses on potential explanations for these findings and recommendations for future research on couple-based program implementation.

As a dissemination trial, commitment from agencies to implement Connect was not an eligibility criterion. Furthermore, we did not offer additional resources or incentives for implementation. Our goal was to observe how agencies managed the process of manual or Web-based implementation with their clients post-training and TA. We did observe implementation: staff at 33% of Web-based and 48% of traditional agencies implemented sessions over 18 months; 17% of participants assigned to Web-based agencies and 26% of staff assigned to traditional agencies implemented sessions over 18 months. A smaller number implemented multiple sessions and cycles and was able to sustain use at low levels. The economic recession that began in 2008 had a devastating effect on HIV services agencies in New York State—some lost as much as 30% of their funding within three to six months. Because most participants reported their agencies were already implementing at least one DEBI, absent additional incentives or funding, more staff may have felt more comfortable implementing the traditional version of Connect, which did not require access to a computer or wireless Internet. Of note is that these low percentages are consistent with and only slightly lower than those reported in Kelly et al. [18],[19], showing `adoption' or `offers of service' rates of between 36% and 60% of agencies participating in an implementation trial for another DEBI, the Peer Opinion Leader (POL) model. In this prior study the outcome was defined as `offers of service' and not actual implementation, leaving us unable to examine whether actual rates of program `use' are comparable.

The expected benefits of a Web-based program notwithstanding, implementation rates may reflect a time of low or dwindling resources or of considerable organizational disruption in services provision due to the recession and related cuts. Examination of data related to changes in organizational budgets over time may further inform interpretation of findings. During the study period four agencies (three manual-based and one Web-based) chose to incorporate Connect into competing grant renewals from New York State or the CDC to continue implementation. These were successful and post 18-month follow-up, these agencies continue implementation. Future trials may consider ways to offer short term resources in support of implementation or increase time spent during training sessions to how best to integrate new programs into existing service delivery or reimbursement mechanisms.

Our expectation that facilitators would use a Web-based strategy and facilitate a couple-based intervention at once may have been unrealistic and may also explain the low usage of the Web-based Connect among our agency participants. With few exceptions, the facilitators had never worked with couples. Enthusiasm during program trainings to implement a couple-based program suggested individual level commitment to implement the program. However, many expressed concerns about how they would manage couple-related interventions at their agencies. While Connect activities are simplified for easy implementation and are intended to be delivered by a wide range of facilitators, implementing a couple-based intervention presents a unique set of challenges [13],[14]. Staff may have felt unduly challenged by the simultaneous demands of attending to both the new elements of a Web-based intervention and the needs of the dyad. We did not include adequate measures to examine this interpretation, so strongly recommend that future implementation trials incorporate measures sensitive to both the innovation of the program and the approach to implementation. Given the increasing attention to both couple-based and Web-based HIV prevention and the potential advantages cited [13],[14] though not borne out in this study, future implementation trials might incorporate additional training and supervision for any new or novel component of implementation, particularly in the beginning stages.

During the training for the Web-based Connect, many participants asked about the security of the program. Although we discussed the steps taken to ensure confidentiality of all program data, participating staff cited Health Information Portability and Accountability Act (HIPAA)-related concerns regarding access to the information gathered on couples engaged in the Web-based program activities. The program did not save identifiable data, rendering HIPAA concerns unwarranted. Future research should provide follow-up—with support from agency administrative staff—to clarify with staff that any programming adopted at the agency provides adequate protection of client confidentiality.

Despite limitations, the study makes critical contributions to HIV prevention implementation science. Findings show the feasibility of training on and implementing both a manual-based and a Web-based version of a couple-based DEBI (or other evidence-based, manualized, behavioral intervention), and the enthusiasm of HIV services organizations and their staff to participate in implementation trials in the absence of strong economic incentives. In particular, agencies embraced the opportunity to expand service provision to include couple-based and Web-based programming. Couples-based approaches for HIV testing and counseling, as well as for more intensive primary and secondary prevention efforts are increasing. Implementation methods must be identified to best bring them to scale. Increasing interest in both of these areas of HIV prevention efficacy studies suggest the need for more careful study to inform rapid and efficient implementation of efficacious programs.

Study findings raise questions regarding the implementation of such programming in the absence of dedicated funding, however, and of barriers. Our interpretation of findings suggest that either a very poor economy, which rapidly reduced resources at participating agencies and led to low overall implementation, and (for one outcome) higher manual-based implementation; or else the combined challenge of using both a web-based curriculum and also implementing couple-based programming for the first time, may have contributed to the lack of hypothesized outcomes. Findings point to several important issues for future implementation research in HIV prevention, with couple-based programs, and/or with Web-based programming. Web-based programming should be built to support a range of browsers and beta-tested thoroughly prior to trial initiation. During trials, participants should receive more frequent proactive TA to ensure movement from the pre-implementation to implementation stages, and more time and assistance to agencies to integrate new programs into their existing program structure and reimbursement mechanisms. This should enhance support from administrators and smooth transitions for line workers managing multiple responsibilities. Support to agencies in identifying external funding for new program implementation should further reduce barriers to implementation. Future dissemination studies should also consider not only a comparison of mediums, but also the features of Web-based programming that can best support facilitators [72],[73]. The task ahead is to strengthen trainings for implementation to include not just information regarding the innovation or program, but the implementation procedures and expectations (including access to resources) to best prepare agencies for the transition to couple- and Web-based approaches and ongoing support, and to identify whether, how, and when it may be efficient to use human-delivered and Web-based components of programming to achieve implementation. Future work may also consider hybrid interventions introduced in face-to-face single sessions by medical and mental health practitioners, and followed by self-administered, Web-based sessions accessed by participants or clients and their partners or other family members. Such approaches are likely given the present state of the economy, healthcare reform and changes in reimbursement for healthcare in the United States. In the end, the key factors barring most agencies post-training from successfully implementing the program remain unclear. We hope these may be borne out in ongoing analysis of the dataset, including qualitative data from agency site visits.

In the years since the initiation of this trial, the policy and best practice of HIV prevention and the use of digital technologies have changed dramatically. Interventions are being shortened to one or two sessions in the name of feasibility, economy, and practical dissemination [7]. Interventions are also now primarily targeted to individuals living with HIV and their intimate partners [6]. The Web-based program developed and implemented in this trial is the prototype for a number of HIV prevention programs currently being tested for efficacy and effectiveness [74],[75]. The program's software `backbone' can be repurposed for future use in the dissemination of similar, activity-based, multi-session programs. Web-based programming will take on even more importance with the continuing economic challenges to agencies and reduced time for prevention services. Building on small successes and lessons learned here should strengthen future efforts.

SSW and NE conceived of the study and study design. SSW was responsible for study leadership, including protocols development, implementation and manuscript preparation. EW, MC and SSW were responsible for data analysis. JR, EW, SSW and RK were responsible for development of multimedia content. TH developed training and site visit protocols. KP coordinated the study. All authors (EW, KP, TH, LG, MC, RH, JR, RK, SSW, NE) contributed to the conduct of the study and read and approved the final manuscript.