With the advent of antiretroviral therapy (ART), HIV infection has become a chronic and manageable condition. Not only does ART improve the health of persons with HIV (PWH), viral suppression through ART also substantially reduces the risk of sexual transmission of HIV. PWH who take ART as prescribed and achieve and maintain an undetectable viral load pose effectively no risk of transmitting HIV to their HIV-negative sexual partners . The critical question for HIV prevention planners is how to maximize the number of PWH who are linked to and retained in care for sustained viral suppression. In 2014, of all PWH (including persons with diagnosed and undiagnosed infection) in the United States, 62% were receiving HIV medical care, less than half were retained in care (48%) and were virally suppressed (49%) . Increasing access to care and improving health outcomes for PWH is one of the national goals in the United States . Clearly, more effective strategies that link and retain PWH to HIV care are urgently needed.
Patient navigation, a patient-centered healthcare intervention developed to reduce cancer-related disparities and barriers to care , is increasingly being applied in HIV care to assist PWH find their way through a complex and often fragmented healthcare system. Bradford et al.'s  HIV system navigation study is often cited as evidence of effectiveness for patient navigation to reduce barriers to HIV care and improve health outcomes of PWH. Bradford et al., describe patient navigation as a model of care coordination that shares some characteristics with advocacy, health education, case management, and social work. However, as reflected in the literature, the field does not appear to have a clear consensus on a standard definition of patient navigation nor what constitutes the specific duties of a navigator . As more studies of HIV patient navigation emerge, assessment of cumulative knowledge is needed to demonstrate its effectiveness. As the first attempt to systematically summarize and evaluate HIV patient navigation programs, we conducted a systematic review to identify primary research studies that examined associations between patient navigation and HIV care continuum outcomes (i.e. linkage to care, retention in care, ART uptake, medication adherence, and viral suppression); qualitatively assess whether provision of patient navigation services is positively associated with HIV care continuum outcomes, including assessment of the strength of the evidence; identify component activities or characteristics of navigation programs that may be linked to the positive associations, including the assessment of a match between target population, activities of navigators, and intended/achieved outcomes; and identify unanswered questions among these studies to pinpoint research gaps. Since healthcare systems vary by country, we focus on patient navigation implemented in the United States.
Database and search strategy
A librarian trained in systematic search methods developed database-specific search strategies using indexing terms and keywords to restrict citations to the following research areas: HIV infections, HIV seropositivity, or AIDS serodiagnosis, AND patient navigation or care coordination. See Appendix for all searches, https://links.lww.com/QAD/B344. The literature search was limited to studies published from 1 January 1996 through 23 April 2018 (last date search was performed). The automated search was performed in MEDLINE (OVID), EMBASE (OVID), PsycINFO (OVID), and CINAHL (EBSCOhost) online databases. In addition, we conducted a manual supplementary search in PubMed prepublished citations, a hand search of key journals in the HIV prevention literature, reference checks of included studies and reviews identified by the search, and search in Scopus and the New York Academy of Medicine's gray literature database (http://www.greylit.org/).
To be included in this review, studies needed to report the use of HIV patient navigation services or navigation-like services (e.g. assist PWH find their way to obtain HIV care and support services) and report quantitative data assessing an association between navigation services and an HIV care continuum outcome. Studies also needed to be conducted in the United States, be published in English language in a peer-reviewed journal, and report primary data. Reviews, unpublished materials, and conference abstracts were excluded.
Screening and data abstraction
Citations were screened in two steps. First, two coders independently screened the titles and abstracts of all citations identified from the search using the DistillerSR (Evidence Partners, Ottawa, Canada). Next for each included citation, two coders independently assessed the full report for relevancy. For each of the eligible studies, pairs of coders independently abstracted the following information using a standardized coding form developed and piloted for this review: study characteristics (e.g. location, setting, design, sample size, outcome measures, and limitations), participant characteristics, activities of patient navigators, and study findings. All discrepancies were resolved through discussion.
Assessment of study quality
We used the Quality Assessment Tool for Quantitative Studies developed by the Effective Public Health Practice Project  to assess study quality. Each study was rated by a pair of coders for selection bias, study design, confounders, blinding, data collection methods, and withdrawals/dropout. Based on the number of components rated as ‘weak’ (criteria defined by the tool), each study was rated as strong (no ‘weak’ ratings), moderate (one ‘weak’ rating), and weak (two or more ‘weak’ ratings).
Determination of study finding per outcome
Due to the heterogeneity across studies in study designs, outcome measures, analytic approaches, and presentation of statistical results, we conducted a qualitative synthesis rather than a meta-analysis. The evidence of a positive association was determined by a statistically significant (P < 0.05) association between patient navigation and an outcome. When no statistical test was reported, we determined the evidence by the direction of association (i.e. positive association). When unadjusted and adjusted findings were both reported, adjusted findings were used.
Eight studies reported more than one finding per specific outcome (average 2, minimum–maximum: 2–4 findings) as they used equally valid multiple measures [8–12] or multiple types of contrasts [5,13,14]. For these cases, we designated the evidence as a ‘positive association’ if more than 50% of the results showed statistically significant (P < 0.05) positive associations between HIV patient navigation and the outcome; a ‘mixed result’ if 50% of the results showed statistically significant positive associations; and a ‘null association’ if less than 50% of the results showed statistically significant positive associations. With these decision rules, we had one finding per outcome for each study. We qualitatively summarized the findings.
Of 789 unique citations identified through electronic and hand searches, 20 studies were included in this review. (See Fig. 1 for detailed selection process.) Table 1 presents these studies’ characteristics. Studies were published from 2005 to 2018. Study locations were primarily large cities in the United States with high HIV prevalence. Study settings were mostly clinics (n = 13) or community-based organizations (n = 6), but a few studies were conducted in jail settings (n = 5) [11,15–17]. Five (25%) [10,11,13,15,18] were randomized controlled trials (RCTs) and 10 (50%) used either a prepost one-group design or a non-RCT with a comparison group. Twelve (60%) were rated as of weak study quality.
Target populations were primarily PWH who had challenges being engaged in HIV care. Examples include PWH with a history of incarceration (n = 8) [11,14–17,19–21], with recent/new HIV diagnosis (n = 5) [10,14,18,20–21], with comorbid conditions such as substance use and mental health problems (n = 4) [10,13,19,22], and those who were veterans (n = 1) , women (n = 1) , or racial minorities (n = 1) .
Patient navigators engaged in a range of activities that can be summarized with the categorization used in Bradford et al., that is, accompanying HIV-positive clients to appointments, coordinating their clients’ appointments, providing nonclinical services (e.g. transportation, food, clothing), providing HIV information, referring clients to HIV care or other health services, and relationship building. Five studies [10–12,15,20] indicated that the navigators were ‘peers’ (e.g. being PWH and/or having similar sociodemographic characteristics as the clients), three studies [8,19,23] indicated that the navigators had professional degrees such as nursing or clinical social work, and three studies [5,14,16] indicated that the navigators had Bachelors’ degrees. In some studies there was no clear boundary between the roles of patient navigators and case managers (e.g. case management was part of the navigator's duty or the case manager performed patient navigation [11,13,14,16–18]), while others had a clear separation of roles between them or reflected the idea that patient navigation and case management are two separate strategies [5,9,10,12,15,20,24,25] (data not shown in the table). Six studies assessed patient navigation-related associations with linkage to care, 11 with retention, four with ART uptake, four with medication adherence, and 15 with viral suppression. Studies did not uniformly report information on the duration or intensity of contacts between the patient navigator and their clients. The two studies that provided the most comprehensive information were Cabral et al. and Cunningham et al. (see Table 1).
Studies with any positive associations
Seventeen out of the 20 studies (85%) [5,8,9,11,12,14–21,23–26] reported any positive associations between patient navigation and any HIV care continuum outcome. Except for the three studies that did not provide statistical tests [14,16,20], all of the positive associations were statistically significant.
Among these 17 studies, three (18%) used an RCT design, 10 (59%) used either a prepost one-group design or a non-RCT with a comparison group, and four (23%) were from observational, correlational, or program evaluation studies. As for study quality, two of the 17 (12%) were rated as strong, four (23%) as moderate, and 11 (65%) as weak. Among these 17 studies, five reported positive associations with linkage, that is, 83% of the six total studies that assessed the association between navigation and linkage. Ten reported a positive association with retention (i.e. 91% of the 11 total that assessed this association), one with ART uptake (i.e. 25% of the four total), two with medication adherence (i.e. 50% of the four total), and 11 with viral suppression (i.e. 73% of the 15 total). Of these 17 citations, only three [9,11,15] reported any null associations (none reported negative associations) between patient navigation and HIV care continuum outcomes.
As for the specific activities conducted by the patient navigator of these 17 studies, 12 (71%) reported accompaniment to appointments and 10 (59%) reported appointment coordination. Service provision (e.g. transportation) was reported by almost half (n = 8, 47%) of the citations, followed by relationship building (n = 7, 41%), provision of HIV information (n = 6, 35%), and service coordination (n = 6, 35%). Referral to HIV care or other health services was reported by almost a third (n = 5, 29%).
Among these 17 studies, there was a considerable match between the target population, intended and achieved outcomes, and the activities of the patient navigators to address these outcomes. For example, a study by Gardner et al. specifically targeted recently diagnosed PWH. The study aimed at and was successful in improving linkage and retention in HIV care via relationship building, addressing barriers to healthcare, encouraging contact with a clinic, and sometimes accompaniment to a clinic visit. Recognizing that PWH generally receive HIV care in jails but fail to do so after being released into the community, studies that solely targeted PWH who were released from jails aimed at and were successful in linking them into HIV care or promoting ART uptake after release [11,16,17], retaining them in care after release [11,15] and reducing vial load or maintaining viral suppression after release [15,17]. Addressing a host of postrelease issues (e.g. lack of transportation, housing, employment, social stigma, and discrimination) and accompaniment to the initial primary care visit upon release to ensure linkage were common across these programs.
Studies that included PWH with poor engagement in care as evidenced by, for example, lapse in documented HIV care, aimed to and successfully re-linked and/or retained them in HIV care [5,8,9,14,20,24–26]. Many of these programs also reported significant positive associations with viral suppression [5,12,14,19–21,23–25]. Outreach to those who are out of care, assisting with scheduling appointments, appointment reminders, assistance with transportation, and accompaniment to a clinic visit were common across these programs.
Studies that did not find any positive associations
Three [10,13,22] out of the 20 studies did not find any positive associations between patient navigation and HIV care continuum outcomes. Two of the three studies used an RCT design [10,13] and the other was an observational study. With respect to study quality, two were rated as of strong study quality [10,13] and one as weak ,
The target populations of these studies were those with comorbid conditions such as substance use and mental health/behavioral health issues. Two of these studies [10,13] reported accompaniment to appointments, appointment coordination, concrete service provision, and provision of HIV information. In addition, Cabral et al. reported relationship building (e.g. connecting the patient with social networks) and Metsch et al. reported referral to non-HIV health services and accompaniment to the first substance disorders treatment appointment.
Only 20 out of 789 unique citations identified by systematic search have examined associations between patient navigation and HIV care continuum outcomes. Among these 20 studies, 17 (85%) found one or more positive associations, showing some evidence supporting patient navigation as a potentially effective strategy to enhance engagement in care among PWH. However, only three of the 17 studies were RCTs, and many of them (65%) were rated as being of weak study quality. On the other hand, two of the three studies that reported no positive findings were RCTs and one was rated as of weak quality. Taken together, these data suggests that positive findings were more likely to be found in studies with weaker study designs/quality. It is clear that more studies with rigorous design are needed to establish a solid evidence base.
Overall, fewer studies assessed ART uptake and adherence than assessed linkage to care, retention in care and viral suppression. Keeping the above caveat in mind, patient navigation was more likely to be positively associated with linkage (five out of the six studies that assessed associations between patient navigation and linkage to care found positive associations), retention (10 out of 11), and viral suppression (11 out of 15) than with ART uptake (one out of four) or ART adherence (two out of four). Positive associations with linkage to and retention in care suggest that patient navigation may be successful in moving PWH through the complexities of the medical system and keep them from falling out of care. Associations with viral suppression are a welcome finding. Achieving viral suppression is the ultimate clinical goal, but is often considered a distal outcome that may not necessarily be achieved even when earlier steps in the continuum are reached. These findings may support the notion that the key to increasing the proportion of PWH who are virally suppressed is to get them and keep them in HIV care. Appointment accompaniment and appointment coordination were the most frequently reported activities of patient navigators in the programs that had positive associations but the nature of the data did not allow us to determine if outcomes could be directly attributed to any of these or other specific navigational activities.
Few included studies reported the characteristics of patient navigators, for example, whether they were paid staff vs. volunteers, whether they met educational and other training requirements, or whether they were demographically matched with their clients. It should be noted that a few recently published studies specifically did mention whether the patient navigators were peers [10–12,15,20] or professionals (i.e. nurse or clinical social worker) [8,19,23]. All of those that utilized ‘professional’ navigators found positive associations with HIV care continuum outcomes, but four out of the five that utilized peer navigators [11,12,15,20] also found positive associations. At this point, the number of studies is still too small to make a conclusive statement about effectiveness of certain types of navigators. More studies with additional focus on navigator's characteristics will help answer important implementation questions such as whether it is equally effective to use peer vs. professional or paid vs. unpaid patient navigators, what are the most critical components of patient navigator training, and how important is it to match demographic characteristics, such as race and gender of patient navigators and clients. We also found that some patient navigation programs had navigators performing case management [11,13,14,18] while other programs had a clear separation of roles between navigators and case managers [5,9,10,12,15,20,24,25], but it is still unknown which of these models is more effective. These findings suggest that HIV patient navigation requires a standard definition for it to be implemented and evaluated consistently. In addition, very few studies provided comprehensive information about the duration/frequencies of contact between patient navigators and clients. Such information would help inform the cost and cost effectiveness of a patient navigation program, and again, is an important consideration for the field to implement this strategy to scale.
Most of the participants in the reviewed studies were PWH who were out of care or at risk for falling out of care. Few studies had specific focus on participant's characteristics such as race, gender identity, and mode of HIV acquisition, and asked the question of whether patient navigation is a particularly important strategy among certain demographic groups. Among the ones that did, the results are inconclusive. For example, Cunningham et al. found that the navigation program was most effective among the homeless while Cabral et al. found a ‘suggestive’ (nonsignificant) positive effect among the stably housed. Irvine et al.[24,25] found improvements in the outcomes in almost all the subgroups including those with lower mental functioning, unstable housing, or hard drug use. Clearly, more research is warranted to tackle this question.
In the studies with any positive associations between patient navigation and HIV care continuum outcomes, we observed a considerable match between how patient navigators’ activities (e.g. providing transportation, accompanying the postrelease initial primary care visit) addressed the purpose and intended outcomes (e.g. to promote postrelease linkage to care) for a specific target population (e.g. PWH being released from jails). It is noteworthy that all four studies that solely targeted PWH who were released from jails [11,15–17] reported positive findings. On the other hand, the three studies with no positive associations [10,13,22] specifically targeted PWH with comorbid conditions such as substance use and mental health/behavioral health issues. The patient navigators in these studies did provide many of the same activities as those with any positive associations, suggesting that PWH with comorbidities may need additional strategies to improve their outcomes.
This review is subject to some limitations. Although we conducted a comprehensive search, we may have missed studies that evaluated navigation services, but did not use the term navigation to describe their interventions or programs. To address this situation, we broadened our search terms to be more inclusive of navigation-like studies, but we may have introduced some bias by including studies that might not be considered patient navigation by some. This highlights the need for a standardized definition of patient navigation in the research literature. Another limitation is our method to determine the evidence per study outcome for each study. We used a statistically significant positive finding(s) as the evidence of a positive association when a statistical test was conducted and the direction of association when no statistical test was conducted in a given study, but we may have inflated the number of positive findings for the three studies [14,16,20] that did not provide statistical tests. Reflecting the state of the science in the published literature on the topic of HIV patient navigation in the United States, this review presents a broad qualitative overview of effectiveness. As the field matures with more publications of studies with stronger study designs, meta-analysis of RCTs, for example, to determine the impact of patient navigation on HIV care continuum outcomes should be a next step. Lastly, we did have many more positive findings than null findings, indicating that there could be some publication bias of papers (i.e. null results may not have been published and thus were not captured in our review.)
This review suggests that overall, patient navigation, as is presented by the included studies, is positively associated with HIV care continuum outcomes, particularly linkage to and retention in HIV care and viral suppression. However, 65% of the studies that found any associations were of weak quality, and it is still unknown if there is a causal association between patient navigation and HIV care continuum outcomes because only three of the studies that found any positive associations used an RCT design. More research studies with rigorous designs, and that compare patient navigators with different characteristics across different patient populations are warranted in order to increase the confidence in patient navigation as an effective tool to improve HIV care continuum outcomes.
Authorship: Y.M. and L.J.K. conceptualized the overall navigation project; Y.M. conceptualized the systematic review and analysis with assistance from D.H.H., C.A.L., and K.B.R., analyzed and interpreted the data, and drafted the manuscript. Y.M., D.H.H., C.A.L., K.B.R., and L.J.K. screened and coded the studies. J.B.D. undertook the comprehensive literature search and contributed to the review methodology. All authors contributed to data interpretation and edited the manuscript for important intellectual content.
Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Centers for Disease Control and Prevention.
Conflicts of interest
The authors declare no conflicts of interest.
1. Centers for Disease Control and Prevention. Evidence of HIV treatment and viral suppression in preventing the sexual transmission of HIV. https://www.cdc.gov/hiv/pdf/risk/art/cdc-hiv-art-viral-suppression.pdf
. Published December 2017. [Accessed 13 March 2018]
2. Centers for Disease Control and Prevention. Understanding the HIV care continuum. Fact sheet. https://www.cdc.gov/hiv/pdf/library/factsheets/cdc-hiv-care-continuum.pdf
. Published July 2017. [Accessed 29 May 2018]
3. National HIV/AIDS strategy for the United States: updated to 2020. http://www.hiv.gov/federal-response/national-hiv-aids-strategy/nhas-update
. Published July 2015. [Accessed 12 March 12, 2018]
4. Freeman HP, Rodriguez RL. The history and principles of patient navigation
2011; 117 (15 Suppl):3539–3542.
5. Bradford JD, Coleman S, Cunningham W. HIV system navigation: an emerging model to improve HIV care access
. AIDS Patient Care and STDs
2007; 21 (suppl 1):S49–S58.
6. Koester KA, Morewitz M, Pearson C, Weeks J, Packard R, Estes M, et al. Patient navigation facilitates medical and social services engagement among HIV-infected individuals leaving jails and returning to the community
. AID Patient Care STDs
7. Effective Public Health Practice Project. Quality assessment tools for quantitative studies. Hamilton, ON: Effective Public Health Practice Project. Effective Public Health Practice Project; 1998.
8. Andersen M, Hockman E, Smereck G, Tinsley J, Milfort D, Wilcox R, et al. Retaining women in HIV medical care
. J Assoc Nurses AIDS Care
9. Bove JM, Golden MR, Dhanireddy S, Harrington RD, Dombrowski JC. Outcomes of a clinic-based surveillance-informed intervention to relink patients to HIV care
. J Acquir Immune Defic Syndr
10. Cabral HJ, Davis-Plourde K, Sarango M, Fox J, Palmisano J, Rajabiun S. Peer support and the HIV continuum of care: results from a multisite randomized clinical trial in three urban clinics in the United States
. AIDS Behav
11. Myers JJ, Dufour MK, Koester KA, Morewitz M, Packard R, Klein KM, et al. The effects of patient navigation on the likelihood of engagement in clinical care for HIV-infected individuals leaving jail
. Am J Public Health
12. Shacham E, Lopez JD, Brown TM, Tippit K, Ritz A. Enhancing adherence to care in the HIV care continuum: the Barrier Elimination And Care Navigation (BEACON) Project evaluation
. AIDS Behav
13. Metsch LR, Feastser DJ, Gooden L, Matheson T, Stitzer M, Das M, et al. Effects of patient navigation with or without financial incentives on viral suppression among hospitalized patients with HIV infection and substance use
14. Wohl AR, Dierst-Davies R, Victoroff A, James S, Bendetson J, Bailey J, et al. The Navigation Program: an intervention to reengage lost patients at 7 HIV clinics in Los Angeles County, 2012-2014
. J Acquir Immune Defic Syndr
15. Cunningham WE, Weiss RE, Nakazono T, Malek MA, Shoptaw SJ, Ettner SL, et al. Effectiveness of a peer navigation intervention to sustain viral suppression among HIV-positive men and transgender women release from jail. The LINK LA randomized clinical trial
. JAMA Intern Med
16. Jordan AO, Cohen LR, Harriman G, Teixeira PA, Cruzado-Quinones J, Venters H. Transitional care coordination in New York City Jails: Facilitating linkage to care for people with HIV returning home from Rikers Island
. AIDS Behav
2013; 17 (17 Suppl 2):S212–S219.
17. Teixeira PA, Jordan AO, Zaller N, Shah D, Venters H. Health outcomes for HIV-infected persons released from the New York City jail system with a transitional care-coordination plan
. Am J Public Health
18. Gardner LI, Metsch LR, Anderson-Mahoney P, Loughlin AM, del Rio C, Strathdee S, et al. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care
19. Kral AH, Lambdin BH, Comfort M, Powers C, Chen H, Lopez AM, et al. A strength-based case management intervention to reduce HIV viral load among people who use drugs
. AID Behav
20. Charles V, Kingsky S, Riordan M, Jain K, Holtgrave D. Maulsby C, The Positive Charge Intervention Team. Positive Charge: filling the gaps in the U.S. HIV continuum of care
. AIDS Behav
21. Wohl AR, Ludwig-Barron N, Dierst-Davies R, Kulkarni S, Bendetson J, Jordan W, et al. Project Engage: Snowball sampling and direct recruitment to identify and link hard-to-reach HIV-infected persons who are out of care
. J Acquir Immune Defic Syndr
22. Brennan-Ing M, Seidel L, Rodgers L, Ernst J, Wirth D, Tietz D, et al. The impact of comprehensive case management on HIV client outcomes
. PLOS One
23. Hemmy Asamsama O, Squires L, Tessema A, Rae E, Hall K, Williams R, et al. HIV nurse navigation: charting the course to improve engagement in care and HIV virologic suppression
. J Int Assoc Provid AIDS Care
24. Irvine MK, Chamberlin SA, Robbins RS, Myers JE, Braunstein SL, Mitts BJ, et al. Improvements in HIV care engagement and viral load suppression following enrollment in a comprehensive HIV care coordination program
. Clin Infect Dis
25. Irvine MK, Chamberlin SA, Robbins RS, Kulkarni SG, Robertson MM, Nash D. Come as you are: improving care engagement and viral load suppression among HIV care coordination clients with lower mental health functioning, unstable housing, and hard drug use
. AIDS Behav
26. Cabral HJ, Tobias C, Rajabuin S, Sohler N, Cunningham C, Wong M, et al. Outreach program contacts: do they increase the likelihood of engagement and retention in HIV primary care for hard-to-reach patients?
. AIDS Patient Care and STDs
2007; 21 (suppl 1):S59–S67.