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Original Study

A Randomized, Controlled Trial of inSPOT and Patient-Delivered Partner Therapy for Gonorrhea and Chlamydial Infection Among Men Who Have Sex With Men

Kerani, Roxanne Pieper PhD*†; Fleming, Mark BA*; DeYoung, Bill BA*; Golden, Matthew Robert MD*†‡

Author Information
doi: 10.1097/OLQ.0b013e318223fcbc

Erratum

The article that appears on page 941 of the October 2011 issue of the journal has an error in Table 2 for the adjusted mean and ratio of adjusted means for the number of partners notified. See below for the correction in Table 2 (in bold).

TABLE 1
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Sexually Transmitted Diseases. 40(5):432, May 2013.

Studies published over the last decade have investigated several new approaches to partner notification, including patient-delivered partner therapy (PDPT) for gonorrhea and chlamydial infection1,2 and inSPOT, a web-based partner notification service, originally developed with the goal of helping men who have sex with men (MSM) to notify partners.3 Although many persons visit internet sites like inSPOT that allow one to send e-cards to notify partners,3–5 the effect of inSPOT on partner notification is unknown. Likewise, very little data exist on the use of PDPT in MSM, and prior research and Centers for Disease Control and Prevention (CDC) expedited partner therapy guidelines raising concerns regarding the use of PDPT among MSM because of potential missed opportunities for diagnosing syphilis and human immunodeficiency virus (HIV) in this population.6,7

We undertook a randomized, controlled trial to determine whether PDPT and/or inSPOT would increase partner notification and/or treatment when compared to public health staff offering assistance to patients in notifying their sex partners (standard partner management).

METHODS

Gonorrhea and chlamydia are notifiable diseases in Washington State. In King County, WA, providers and laboratories are legally required to report cases directly to Public Health–Seattle & King County (PHSKC). The case report form submitted by reporting medical providers has a space in which the provider indicates the gender(s) of the patient's sex partners. In 2007–2008, this section of the case report form was complete in 81% of all cases of gonorrhea or chlamydial infection reported among men; however, providers reported that the gender of partners was unknown in 9% of cases, resulting in complete information on gender of partners for 72% of male cases. Because of resource limitations, PHSKC only attempts to contact MSM with gonorrhea or chlamydial infection if the provider requests PHSKC partner services or if the patient is randomly selected. Throughout the study period, we randomly selected 50% of gonorrhea and chlamydia cases among MSM to receive partner services. We have previously described PHSKC's case report-based partner services triage system.1

We attempted to enroll MSM at the time we contacted them to provide them with partner services. MSM were ineligible if they were <18 years of age, did not speak English, reported that all their partners were treated, or that they had not had sex with a man in the 60 days preceding diagnosis, the case report was received >2 weeks after the patient's treatment, or if the patient had been diagnosed with HIV or syphilis in the 90 days before their gonorrhea or chlamydia diagnosis. MSM diagnosed in our STD clinic underwent all study procedures face-to-face with staff. Potentially eligible men who were not diagnosed in the clinic underwent all study procedures through the telephone.

Participants completed the standard partner services interview (including partner enumeration) before they were randomized to a study arm. However, if patients enumerated additional partners after randomization, these data were recorded and used in study analyses. We used a computer to randomly assign participants to one of the following 4 arms after informed consent was obtained: (1) standard partner management, (2) inSPOT, (3) PDPT, and (4) inSPOT and PDPT combined (inSPOT/PDPT). In all study arms, staff attempted to develop a partner notification plan for each of a participant's sex partners from the prior 60 days and offered to directly notify each partner for whom a participant had contact information including a phone number, address, or website chat ID. Persons enrolled in the STD clinic and assigned to the inSPOT arm were given an opportunity to use inSPOT on a computer in the clinic. They also received a small printed card with the site's internet address that they could use to access the site at a later time. Study staff described the site to persons enrolled over the telephone and informed them of the site's URL. Participants assigned to receive PDPT who were in the clinic were offered prepackaged medication to give to up to 3 different sex partners. Packages included a 1-g dose of azithromycin and, if the participant had gonorrhea, a single 400 mg tablet of cefixime. The packages also included information about sexually transmitted diseases (STDs) and the importance of HIV testing, an allergy warning, an invitation to visit at no cost at our STD clinic, and condoms. Persons enrolled through the telephone could pick up similar prepackaged medication at one of several local pharmacies; we have previously described our system of distributing partner packs through pharmacies.8 MSM in the intervention arms could choose to use the interventions with some partners and not others.

Participants completed short baseline study interview after randomization and a follow-up interview approximately 2 weeks after enrollment. Data on how partners were notified (e.g., through telephone, in person, etc.) and whether they tested for HIV and/or syphilis were taken from the original patient (OP) interview data. Outcome data on whether partners were notified or treated were taken from data recorded by a disease intervention specialist (DIS) as part of standard partner services procedures; DIS in King County define partners as notified and treated based on either OP report or documentation of clinical evaluation or treatment obtained as part of partner services investigations. In addition to the data collected through these interviews, we used data regarding partner outcomes, gathered through partner management interviews. The main outcome of the study was participant's report that a partner was notified or treated. There was passive surveillance of adverse events to monitor adverse events; no adverse events were reported by participants during the trial.

On the basis of our partner treatment data for MSM diagnosed with gonorrhea or chlamydia, the study was originally designed to have 90% power (2-tailed α = 0.05) to detect a difference of 0.49 in the number of partners treated per index case, assuming a baseline treatment index of 0.51. We selected 0.49 as the detectable difference because we believed that we could essentially double the treatment index to 1.00. Similarly, we used a standard deviation of 1.14 based on our local partner treatment data for MSM diagnosed with gonorrhea or chlamydia. Based on the use of factorial designed and assuming 80% follow-up, this would have required enrolling a total of 363 MSM.

We used χ2 tests to test for differences between those enrolled and not enrolled, and Poisson regression with robust standard errors to determine whether PDPT or inSPOT was associated with partner outcomes. When testing to determine whether the assumptions of the Poisson regression model were met, we determined that our data were overdispersed; therefore, we applied robust standard errors to account for the overdispersion of the data. Other assumptions of Poisson regression were met. All study procedures were approved by the University of Washington Institutional Review Board.

RESULTS

Between July 1, 2007 and March 31, 2009, PHSKC received a total of 1118 case reports of gonorrhea or chlamydial infection occurring in MSM. Of these men, we attempted to offer enrollment to 548 of whom 118 (22%) were ineligible, and 37 (7%) were not contacted (Fig. 1). Of the remaining 393 eligible MSM, 75 (19%) enrolled and 318 (81%) declined enrollment. The study was halted early due to low enrollment. Enrollees were more likely than nonenrollees to be diagnosed in our STD clinic (97% of those enrolled vs. 47% of those not enrolled, P = 0.001), more likely to have gonorrhea (51% vs. 39%), and less likely to be coinfected with chlamydial infection and gonorrhea (1% vs. 9%, P = 0.003). Enrollment did not differ by race, but enrollees were slightly younger than nonenrollees (30.3 vs. 33.7 years, P = 0.004)

Figure 1.
Figure 1.:
Study enrollment.

Among the 75 enrollees, 16, 17, 24, and 18 were assigned to the PDPT, inSPOT, inSPOT/PDPT, and standard arms, respectively. Among them, 53 (71%) completed baseline and follow-up interviews. The mean age of these 53 men was 31.1 years (Table 1). Forty (76.9%) were white, 4 (7.7%) were of Asian or Pacific Islander descent, 3 (5.8%) were Latino, and 3 (5.8%) were black. Fifty-one (96.2%) were enrolled in the STD clinic, and roughly equal proportions were diagnosed with chlamydial infection (47.2%) and gonorrhea (50.9%). One participant (1.9%) was coinfected. Of these 53 men, 13, 10, 17, and 13 were assigned to the PDPT, inSPOT, inSPOT/PDPT, and standard arms, respectively. The race/ethnicity of participants and type of infection differed across study arm (P < 0.001, Table 1).

TABLE 1
TABLE 1:
Characteristics of Participants and Number of Sex Partners by Study Arm in a Randomized Trial of PDPT and inSPOT Among MSM With Gonorrhea and Chlamydia, King County, WA

The 53 participants who completed the study provided information about 186 partners (Table 1). Patients chose to have study staff contact 30 (16%) partners (data not shown). Staff assistance in contacting partners did not differ significantly by study arm (Table 2). Of the 27 men assigned to the inSPOT or inSPOT/PDPT arms, only 1 (4%) used inSPOT to notify a partner. Of the 30 men in the PDPT and inSPOT/PDPT arms, 24 (80%) reported giving PDPT to 1 or more partners at follow-up.

TABLE 2
TABLE 2:
Partner Management Outcomes by Study Intervention (PDPT or inSPOT) in a Randomized Trial Among MSM With Gonorrhea and Chlamydia in King County, WA
TABLE 2
TABLE 2:
(Continued)

The number of partners notified per OP was not associated with either PDPT or inSPOT (Table 2). Similarly, the method of partner notification did not vary by study assignment. Across study arms, most partners notified by patients were notified in person (38%), by telephone (34%), or by e-mail (22%). Two percent were notified through inSPOT, and 1% by text messaging.

Based on either OP report or outcomes verified by DIS, more partners were treated per OP among participants randomized to PDPT versus those not assigned to PDPT (Table 2). After adjustment for inSPOT assignment, the mean number of partners treated among participants assigned to the PDPT arms was 54% greater than those assigned to standard partner management (ratio of means = 1.54, 95% confidence interval: 1.01–2.34). Assignment to inSPOT was not associated with partner treatment.

In unadjusted analyses, fewer partners were HIV tested among participants assigned to the inSPOT arms (Table 2, ratio of means = 0.42, 95% confidence interval: 0.18–0.99). Adjusting for PDPT assignment did not change the effect of inSPOT on HIV testing, although in the adjusted model the relationship was of borderline statistical significance (P = 0.07). Similarly, the highest levels of partner syphilis testing were reported in OPs who received neither inSPOT nor PDPT, though this difference was not statistically significant (Table 2). We observed a trend toward an interaction between PDPT and inSPOT on partner syphilis testing (P for interaction term = 0.059), participants assigned to the combined PDPT/inSPOT arm reported more partners tested for syphilis per case than in the inSPOT-only and PDPT-only arms (Table 2).

DISCUSSION

The findings from this small study suggest that PDPT is acceptable to MSM and increases partner treatment in that population, that few MSM with gonorrhea or chlamydial infection are interested in using inSPOT, and that inSPOT may be associated with decreased HIV testing among partners. Our trial also raises concerns about the feasibility of conducting randomized trials of partner services in MSM, particularly if consent needs to be secured over the telephone.

Although our study is the first to evaluate the effect of PDPT on partner treatment among MSM, other studies have found that PDPT is often acceptable to MSM,9 and that PDPT increases partner treatment among heterosexuals.1,2,10 Unfortunately, our findings also lend support to concerns that PDPT could decrease syphilis and HIV testing among the sex partners of MSM with bacterial sexually transmitted infections (STIs). Although our study provides some evidence that PDPT may be effective in MSM, the decision to use or not to use PDPT remains complex. Data from Europe demonstrate that Neisseria gonorrhoeae with decreased susceptibility to oral cephalosporins is more common among MSM, and our results support the validity of concerns related to decreased HIV and syphilis testing associated with PDPT raised by the CDC national guidelines related to expedited partner therapy. On the basis of currently available evidence, we do not believe that clinicians should routinely use PDPT in MSM.

Our results related to inSPOT contrast with prior evaluations documenting that many people visit the inSPOT site,3 that many MSM find internet partner notification sites acceptable,11,12 and that approximately 6% of MSM with access to inSPOT send e-cards to someone.4 We found that virtually no MSM wanted to use inSPOT, even though using e-mail to notify partners was common. Prior studies, which have found that many e-cards are sent for relatively rare infections such as crabs and scabies,3 suggest that many e-cards are probably sent for reasons other than true partner notification. However, it seems likely that many other e-cards are sent to sex partners exposed to STIs. Perhaps, most concerning is our finding that fewer partners of participants assigned to inSPOT were tested for HIV, and possibly syphilis, when compared to the partners of other participants. This finding should be interpreted with caution, given the very limited use of inSPOT among those assigned to it. The circumstances of our trial, in which DIS advised persons with STDs about inSPOT, were different from how most people probably find out about the internet site, and consequently may not accurately reflect the site's real world effect. However, our findings, like another recent report,13 highlight the limitations of what we know about inSPOT and other similar sites, as well as our uncertainty about whether inSPOT has a positive, negative, or no effect on partner treatment and STI control.

Another concerning finding in our study was the difficulty we encountered in enrolling MSM in our trial. To our knowledge, no recent randomized trials of partner services have enrolled substantial numbers of MSM, though studies performed many years ago did enroll such men,14,15 and more recent studies among MSM indicate acceptance of the concept of partner notification.16 Our experience calls into question the contemporary feasibility of conducting such trials in this critically important population. In particular, we were unable to enroll almost any MSM diagnosed outside of our STD clinic. This experience contrasts sharply with our success enrolling heterosexuals through the telephone in a similar study conducted in the late 1990s.1,8 In comparison to this previous effort, we are uncertain whether our failure to enroll subjects reflects differences in the studies' target populations, differences in the staffing models we employed, or variances in study procedures. In general, MSM with STDs in King County have more sex partners than their heterosexual counterparts. Among both MSM and heterosexuals, people are more likely to ensure the treatment of their regular partners.17,18 PDPT requires a substantial effort by OPs to help in ensuring their partners' treatment, and the intervention may not have been very attractive to some MSM, who may have been unwilling or unable to deliver PDPT to their partners. This hypothesis is consistent with survey data suggesting that MSM are less willing to accept PDPT from a partner or deliver it to a partner than heterosexuals.19 Our MSM study employed PHSKC DIS to interview patients, whereas our trial in heterosexuals, which was funded through National Institutes of Health and CDC, had dedicated study staff. These dedicated staff may have been more skilled in research procedures than public health DIS, fostering the success of prior study. However, the DIS involved in this trial have successfully recruited participants for other studies, suggesting that staffing alone was probably not the cause of our inability to enroll participants in this study.20 Finally, the informed consent procedures used in this trial were substantially more time consuming than those we used in the 1990s, and this may have negatively affected enrollment. We believe that future studies of partner notification and treatment services in MSM that involve informed consent should be preceded by formative work addressing why MSM choose to enroll or not to enroll in such studies. However, investigators should also consider designing such studies to meet criteria for waivers of consent. Such an approach should be feasible when undertaking the public health research investigating alternative, widely employed standards of care.

In reporting the mean numbers of partners notified, treated, and tested for HIV and syphilis, our study is somewhat different from other trials of partner management strategies, which have primarily reported the percentage of partners with the outcome of interest. We believe that comparing partner indices (mean number of partners with an outcome per case) is a better way to evaluate partner outcomes, because, in some cases, randomization to a partner management strategy may increase or decrease the elicitation of partners, thereby affecting the denominator used to calculate the percent of partners with a given outcome. Randomizing study subjects after partner elicitation interviews, as we did in our trial, will eliminate this concern. However, in practice, some persons will acknowledge additional partners after randomization, and these partners need to be included in study outcomes.

In conclusion, although we observed increased partner treatment among participants randomized to PDPT, our study raises concerns about whether either PDPT or inSPOT is a useful approach to partner management for STD among MSM. Given the small size of our study, our findings are not definitive. However, they highlight how little we know about the utility of these interventions in MSM, and the challenges of studying partner services in this critically important population.

REFERENCES

1. Golden MR, Whittington WL, Handsfield HH, et al. Effect of expedited treatment of sex partners on recurrent or persistent gonorrhea or chlamydial infection. N Engl J Med 2005; 352:676–685.
2. Schillinger JA, Kissinger P, Calvet H, et al. Patient-delivered partner treatment with azithromycin to prevent repeated Chlamydia trachomatis infection among women: A randomized, controlled trial. Sex Transm Dis 2003; 30:49–56.
3. Levine D, Woodruff AJ, Mocello AR, et al. inSPOT: The first online STD partner notification system using electronic postcards. PLoS Med 2008; 5:e213.
4. Kachur R, McFarlane M, Smith A, et al. Use of electronic partner notification services among online US men who have sex with men. Presented at The International STD Research Meeting; P2.23. London, United Kingdom; June 28–July 1, 2009.
5. Stephens SC, Bernstein KT, Katz MH, et al. The effectiveness of patient-delivered partner therapy and chlamydial and gonococcal reinfection in San Francisco. Sex Transm Dis 2010; 37:525–529.
6. Stekler J, Bachmann L, Brotman RM, et al. Concurrent sexually transmitted infections (STIs) in sex partners of patients with selected STIs: Implications for patient-delivered partner therapy. Clin Infect Dis 2005;40:787–793.
7. Centers for Disease Control and Prevention. Expedited Partner Therapy in the Management of Sexually Transmitted Diseases. Atlanta, GA: US Department of Health and Human Services, 2006.
8. Golden MR, Whittington WL, Handsfield HH, et al. Partner management for gonococcal and chlamydial infection: Expansion of public health services to the private sector and expedited sex partner treatment through a partnership with commercial pharmacies. Sex Transm Dis 2001; 28:658–665.
9. Klausner JD, Chaw JK. Patient-delivered therapy for chlamydia: putting research into practice. Sex Transm Dis 2003; 30:509–511.
10. Kissinger P, Mohammed H, Richardson-Alston G, et al. Patient-delivered partner treatment for male urethritis: a randomized, controlled trial. Clin Infect Dis 2005; 41:623–629.
11. Mimiaga MJ, Fair AD, Tetu AM, et al. Acceptability of an internet-based partner notification system for sexually transmitted infection exposure among men who have sex with men. Am J Public Health 2008; 98:1009–1011.
12. Mimiaga MJ, Tetu AM, Gortmaker S, et al. HIV and STD status among MSM and attitudes about Internet partner notification for STD exposure. Sex Transm Dis 2008; 35:111–116.
13. Rietmeijer CA, Westergaard B, Mickiwicz TA, et al. Evaluation of an Online Partner Notification Program. Sex Transm Dis 2011; 38:359–364.
14. Landis SE, Schoenbach VJ, Weber DJ, et al. Results of a randomized trial of partner notification in cases of HIV infection in North Carolina. N Engl J Med 1992; 326:101–106.
15. Cleveland JQ. A cost-effective study of alternate methods for gonorrhea contact referral and rescreening. Dade County, FL: Dade County Department of Public Health.
16. Mimiaga MJ, Reisner SL, Tetu AM, et al. Partner notification after STD and HIV exposures and infections: Knowledge, attitudes, and experiences of Massachusetts men who have sex with men. Public Health Rep 2009; 124:111–119.
17. Menza TW, De Lore JS, Fleming M, et al. Partner notification for gonococcal and chlamydial infections in men who have sex with men: Success is underestimated by traditional disposition codes. Sex Transm Dis 2008; 35:84–90.
18. Shiely F, Hayes K, Thomas KK, et al. Expedited partner therapy: A robust intervention. Sex Transm Dis 2010; 37:602–607.
19. Coyne KM, Cohen CE, Smith NA, et al. Patient-delivered partner medication in the UK: An unlawful but popular choice. Int J STD AIDS 2007; 18:829–831.
20. Golden MR, Gift TL, Brewer DD, et al. Peer referral for HIV case-finding among men who have sex with men. AIDS 2006; 20:1961–1968.
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