This study implemented and evaluated a multi-level intervention to improve PLWHA‘s knowledge of HCV and encourage them to find out their HCV status. The intervention had multiple components across the intrapersonal, interpersonal, community, and institutional levels of the Socioecological Framework, which posits that desired outcomes are most likely to occur when targeted across multiple levels. Study results suggest that our primary outcome, accurate HCV knowledge among patients with HIV, was higher during the intervention phase than pre-intervention phase. Thus, our intervention successfully achieved our primary goal. Interestingly, accurate HCV knowledge was decreasing during both pre-intervention and intervention time periods, though at a much reduced rate during the intervention phase. It is hard to explain why accurate knowledge would decrease prior to the intervention, although it is possible that the act of garnering partners and initiating the study—even pre-intervention—led some providers to share HCV information with their patients early on, and then taper off until the intervention was launched. Post-intervention, it is plausible that patients who had attended a community health class later forgot new HCV learnings. It may be particularly difficult for PLWHA, who know so much about HIV, to retain knowledge about HCV transmission which is similar, but not identical, to that of HIV. Future studies may wish to develop brief review materials that can be posted in the clinic or the community, and also to encourage patients to attend refresher health classes. The deterioration we saw in HCV knowledge may also be related to the fact that we trained the clinic‘s HIV medical providers early in the study but did not offer additional, future trainings. Consequently, we did not reach any new HIV providers, including medical fellows who turnover frequently. Also, it may be that providers decreased their HCV efforts with the elapsing of time since their training. In the future, it may be wise to institute routine prompts, such as prompts in an electronic medical record system, for providers to discuss HCV with at-risk patients. This is consistent with recommendations from the Centers for Disease Control and Prevention (CDC) HCV National Prevention Strategy for Health Professionals [35
The number of participants who reported ever having been tested for HCV evidenced a significant increase 3 months after implementation of the intervention. In addition, immediately following the start of the intervention, a previously downward trend in the prevalence of patients knowing their HCV test results was reversed, and the prevalence of patients talking with their medical providers about HCV was higher during the intervention phase. We hypothesized that the intervention would lead PLWHA to test for HCV or ask their providers about whether they had ever previously been tested for HCV, enabling them to know their HCV status. We also hypothesized that HIV medical providers would test for HCV more frequently. Based on patient report, the findings indicate an increase in HCV testing and, perhaps more importantly, knowledge of one‘s HCV status. Knowing one‘s HCV status allows people to seek treatment for HCV and to take steps to prevent transmitting HCV.
We also tested intermediate outcomes such as awareness of HCV and patient-provider discussion about HCV. Participant awareness of HCV was significantly higher 3 months after implementation of the intervention. Because our intervention activities were spread out across the 17-month intervention period, it may be that a minimum threshold of intervention implementation had to be reached before awareness measurably increased. Admittedly, it is possible that the research interviews rather than the intervention raised HCV awareness; however, HCV awareness is a precursor to seeking HCV testing and accurate HCV knowledge, and so is important to demonstrate. Participants further reported more HCV discussions with their providers during the intervention phase. This finding lends validity to our primary outcome of more accurate HCV knowledge. Improvements in HCV knowledge may have occurred through our efforts to educate providers who, in turn, communicated with patients. Alternatively, more accurate HCV knowledge may have resulted directly through our community education efforts.
Intervention effects were found for different outcomes at a variety of times (e.g., immediately after the stated intervention date, three months later) and in both abrupt and slope changes. This may be because our intervention began on the date we indicate as the intervention date, but continued over time. The trend in significant findings for multiple outcomes is likely more meaningful than when outcomes were found. We conclude that overall, the intervention met its goals and is worthy of replication. However, it should also be refined in an attempt to improve HCV knowledge and testing further, both of which evidenced room for improvement even during the intervention phase.
We examined a number of covariates, and notably, the intervention was equally effective across race, gender, age, education, employment status, and HIV status. The findings suggest that the intervention was appropriately targeted to participants with a history of injection drug use, who were significantly more likely to report having had an HCV discussion with a medical provider, getting tested for HCV, and knowing their HCV status. Although parenteral transmission through injection drug use more commonly leads to HCV transmission than sexual risk behaviors, rates of current injection drug use in our sample were extremely low. It is therefore unsurprising that our data also suggest that medical providers talked about HCV more often to participants with at least one sexual partner, because sexual risk behavior rather than injection drug use is more common in our population of PLWHA. However, it also appears that medical providers did not necessarily test participants with more sexual partners for HCV. This, too, may be appropriate, because studies indicate that risk for HCV is predicted by many sexual partners, such as more than 20 partners [4
], and not just one or two.
Through provider interviews, we discovered several barriers to HCV testing and provider-patient discussions about HCV, despite the fact that guidelines for HIV management include testing for HCV [36
]. In particular, many HIV providers indicated that they are more worried about chronic diseases such as diabetes and heart disease in their patients than they are about liver disease. In addition, like other researchers [37
], we found that some HIV providers were reluctant to test their patients for HCV, due to the belief that HIV management is more important than HCV management, or that the side effects for antiviral treatment of HCV are too onerous to put patients through. These side effects include fatigue, thyroid abnormalities, bone marrow suppression, and depression [9
]. Because of these concerns, we held testing contests in the clinic to bring attention to HCV testing. It is notable that we found trends in HCV testing and patient knowledge despite the reluctance of some providers. We recommend addressing these concerns head-on in future interventions.
It should be noted that this intervention addressed some, but not all, of the principle components of the CDC‘s National HCV Prevention Strategy [35
]. In particular, it attempted to educate health care professionals on HCV identification, management, and treatment, and to educate people at risk for HCV about risk factors and testing. The intervention also sought to educate community-based program staff on HCV prevention and to encourage them to identify people who need testing for HCV. The intervention did not address the National HCV Prevention Strategy‘s principle component of surveillance of disease trends, although we did, as recommended, engage in research evaluation of this particular intervention. In addition, HCV prevention initiatives, especially among PLWHA, should include harm reduction strategies in the form of needle and syringe exchange programs, as well as substance abuse treatment, including opioid substitution treatment [38
]. Although we offered substance abuse treatment, we did not offer these other harm reduction activities, in part because our particular population had low rates of injection drug use. However, these components are recommended alongside HCV awareness and testing initiatives to create combination approaches for optimal prevention of HCV infection [39
A rather unique feature of this study is its use of the ITS design. Although researchers have called for ITS to be used in the evaluation of community-level interventions, such use of ITS is still relatively rare [30
]. In this study, we devoted at least one full day to data collection every two weeks for two years, a process that was both time-intensive and required significant partnership with the clinics. The result, however, was a stronger research design that provides greater confidence in the causal intervention effects than a case-control design would have offered because it addresses several threats to validity. In this study, for example, we were able to test for any pre-existing trend and rule it out as a rival theory for the observed intervention effect. ITS designs are vulnerable to their own threats to validity, which we controlled for carefully in this study. For example, we rigorously tested for changes in the study population through comparison of participants during the pre-intervention and intervention phases, with only one significant difference (race) resulting. We then conducted sensitivity analyses to ensure that our findings were not a mere byproduct of changes in the study population but rather an intervention effect. As such, this study illustrates how the ITS design can be used effectively in community research given real-life administrative constraints.
This study has several limitations. First, it is limited by its use of patient report rather than medical record abstraction for HCV testing. Also, the intervention itself was extensive and multi-level, requiring ample staff and time resources. Even so, it lacked needle and syringe exchange activities, which future researchers and interventionists would be wise to incorporate. We are unable to tease apart which aspects of the intervention were most impactful on outcomes, even though such information would be useful. In addition, we collected data only before and during intervention activities, such that we are not able to examine whether removal of the intervention led to any decay in outcomes. Finally, despite the strength that ITS offers for internal validity, the ITS design is often limited in its external validity. In this particular study, our conclusions are known only to be generalizable to patients at the ID clinic where the study occurred. This study‘s findings may be generalizable to other clinics and patients, based on the extent to which they are similar to ours. Our sample had a very low self-reported current injection drug use rate, had a mean age of 43, and had known their HIV status on average 9 years, all of which may be different from other clinic populations.
In conclusion, this is the only intervention study to promote HCV knowledge and testing among PLWHA of which we are aware. The high co-morbidity of HIV-HCV combined with the increasing liver-related mortality among PLWHA makes HCV prevention, testing, and treatment a priority for the over 1 million people in the US infected with HIV. Additional interventions paired with rigorous evaluation are needed.