Genital infection with Chlamydia trachomatis is the most common reportable sexually transmitted disease (STD) in the United States, with more than 1 million cases reported annually.1 Serious complications of untreated chlamydial infections include pelvic inflammatory disease, infertility, and ectopic pregnancy.2 Repeat chlamydial infections, often caused by re-exposure to untreated sex partners, occur in 10% to 20% of patients within 12 months of initial infection and increase the risk of complications.3–5 Therefore, effective partner treatment strategies are needed to interrupt transmission and prevent serious health consequences.
Although the optimal partner management strategy is to bring partners in for a complete clinical evaluation, expedited partner therapy is an alternative practice by which partners of STD-infected patients are treated without an intervening medical examination.6,7 Patient-delivered partner therapy (PDPT) is the most common form of expedited partner therapy where patients deliver medication or a prescription to her/his partner. PDPT for chlamydia has been legally permissible in California since 2001 and for gonorrhea since 2007; currently over 25 other states also permit the practice of PDPT.8–10
Several randomized trials have shown that PDPT is effective in increasing partner notification and decreasing the rates of reinfection.11–13 A recent meta-analysis of 5 randomized clinical trials reported a 27% reduced risk of repeat infection in chlamydia- or gonorrhea-infected patients provided with PDPT compared with conventional partner management methods.14 Despite its demonstrated efficacy, prior studies have shown low rates of routine PDPT use by providers. Surveys conducted between 1999 and 2005 throughout the United States have demonstrated that 6% to 27% of providers reported routine use of PDPT.15–17 PDPT use appears to be more common in California, where 50% of physicians and nurse practitioners reported routinely using PDPT in 2002.18
Providers can play a pivotal role in the diagnosis, treatment, and partner management of STDs in young sexually active women who seek family planning services. However, there are no published data regarding family planning providers' usage patterns or perceptions regarding PDPT as a partner management strategy. This evaluation aimed to describe the degree to which PDPT is used for chlamydia-infected patients among California family planning providers, providers' knowledge, attitudes, and barriers regarding PDPT, and determine predictors of PDPT use. The ultimate goal of the evaluation was to apply the findings toward interventions that could improve PDPT usage among family planning providers.
MATERIALS AND METHODS
This cross-sectional survey was conducted between July and September 2007 and consisted of a self-administered, Internet-based survey of family planning providers in California. The survey covered 2 topic areas: PDPT and retesting for repeat chlamydial infection. Survey methods have been described previously in Park et al.19 Briefly, an e-mail was sent to agency directors receiving Title X federal family planning funds (n = 65) with a hyperlink to the survey and instructions to forward the e-mail to all clinicians in their agency who provide care to clients with chlamydial infections. Although we requested the exact number of clinicians recruited from each director, these data were incomplete. So as not to overestimate the response rate, only agencies that provided complete data on the number of potential respondents (40 of 65 agencies) were included in the response rate numerator and denominator. Based on these data, the response rate was calculated to be 42%. The survey participants represent a convenience sample of California family planning providers. This survey was undertaken as part of clinical quality improvement activities and program evaluation conducted by our department in the scope of routine public health practice.
The survey instrument was developed by staff at the California Department of Public Health (CDPH) STD Control Branch, the CDPH Office of Family Planning, and the California Family Health Council (CFHC). To assess the frequency of PDPT use, providers were asked “When you see female clients infected with chlamydia, how often do you provide them with medication or a prescription for medication for their male partners?” The same question was asked for female partners of male clients. Response options were presented in a 5-point Likert-type scale: never, sometimes, half of the time, usually, always. Providers who reported using PDPT were asked to describe facilitators of its use and also which methods were used.
The frequency with which providers offered PDPT for chlamydia in various situations were assessed with the use of a Likert-type scale: always, sometimes, never. Situations included: chlamydial infection confirmed with laboratory testing, presumptive diagnosis of chlamydia, repeat infection, coinfection with gonorrhea, and for partners who are unwilling/unable to come to the clinic. To assess attitudes and barriers toward PDPT, a 5-point Likert-type scale was used: strongly agree, agree, neutral, disagree, and strongly disagree. Providers were asked to rate 8 statements concerning the possible benefits and harms of PDPT, whether their medical director supported PDPT use, and potential barriers in the categories of reimbursement and medication packaging; there were also open-ended questions eliciting facilitators and barriers to PDPT use. In addition, providers were asked if they were aware of state laws allowing PDPT for chlamydia and gonorrhea and of guidelines for PDPT use. Providers were asked if they offered PDPT for any other STDs or syndromes. Finally, demographic characteristics collected included: provider type, years of family planning experience, number of chlamydia-infected patients seen per month, and hours of patient care per week.
The evaluation period coincided with the implementation of a free PDPT medication distribution program by CFHC, where prepackaged medication for partner treatment for chlamydia was distributed to Title X agencies throughout the state. All Title X agencies were given an equal opportunity to participate in the free medication program. Data on agency participation in the program were obtained directly from CFHC and matched to the survey data.
The primary outcome of interest for this evaluation was self-reported routine use of PDPT (“always” or “usually”) for partners of either male or female chlamydia-infected clients. Responses to attitude statements on a 5-point Likert-type scale were grouped for statistical analysis, by which “strongly agree” and “agree” were grouped together, “disagree” and “strongly disagree” were grouped together, and “neutral” remained a separate category.
The data were analyzed with the use of Stata (version 9.2, Stata Corporation, College Station, TX). The χ2 test was used to compare proportions; statistical significance was defined by a P value <0.05. Univariate logistic regression was conducted by examining the association between predictor variables (e.g., provider attitudes and knowledge regarding PDPT) and the outcome of routine PDPT usage. Associations were summarized by odds ratios and 95% confidence intervals. Multivariate logistic regression models were created to determine which variables were independently associated with routine PDPT use. Predictor variables that were significantly associated with the outcome (P < 0.05) in the univariate analyses were included in the multivariate models. Associations were summarized by adjusted odds ratios and 95% confidence intervals.
A total of 303 providers registered online and 286 of 303 (94%) completed the questions pertaining to PDPT. The respondents represented 52 of the 65 agencies (80%) and 146 of 296 clinics (49%) that receive federal Title X family planning funds in California.
Most participants were nurse practitioners or midwives (61%), had more than 5 years of experience in family planning (61%), cared for 5 to 20 chlamydia-infected clients per month (54%), and provided on average more than 20 hours per week of reproductive clinical care (62%). The characteristics of the providers who participated in the survey are presented in Table 1. Of the 52 agencies represented in this survey, 38 (73%) participated in CFHC's free PDPT medication distribution program and 232 of 286 (81%) survey respondents worked at clinics belonging to participating agencies.
The majority of providers (91%) reported having ever used PDPT for chlamydia-infected clients and 73% reported routinely providing PDPT to clients. There were no significant differences in routine PDPT usage among different provider types. However, a greater proportion of providers routinely offered PDPT to female clients versus male clients (73% vs. 53%, P < 0.0001). The most common method of PDPT delivery was providing medication directly to clients to give to his/her partner(s) (77%). This was also the most common method among providers who did not participate in CFHC's free PDPT medication distribution program (66%). Less common methods included giving clients a prescription in the partner's name (13%), writing the clients a prescription for a double dose of medication (4%), calling in a prescription to the pharmacy for the partner (1%), and other unspecified methods (5%).
The large majority of providers reported always offering PDPT to clients with laboratory-confirmed chlamydia, with a repeat infection, if the client's partner was unwilling or unable to come to the clinic, or if the partner was uninsured (Table 2). These providers were less likely to always offer PDPT to clients coinfected with gonorrhea and were least likely to offer PDPT for clients with a presumptive chlamydia diagnosis or to male clients with a pregnant partner. A majority of providers (76%) gave educational materials to clients and partners explaining PDPT medication use and side effects. In contrast, a minority of providers required a partner's signature on a form stating there were no allergies to the medication (17%), out-of-pocket payment from the client for PDPT (23%), or required that the client or partner was over 18 years of age (6% and 8%, respectively).
Finally, providers also reported offering PDPT less frequently to clients for STDs/syndromes other than chlamydia, including gonorrhea (39%), trichomoniasis (56%), pelvic inflammatory disease (25%), cervicitis (24%), and urethritis (20%).
Attitudes, Barriers, Facilitators, and Knowledge
Most providers reported favorable attitudes toward the practice of PDPT (Table 3). More than 90% of the providers reported that PDPT helped them provide better care for clients with chlamydia, that it was well-received by clients, and that it protected clients from reinfection. The proportion with positive attitudes toward PDPT was significantly higher for providers who routinely use PDPT compared with providers who did not routinely use PDPT (P < 0.02 for each positive attitude). The most common concerns were that PDPT resulted in missed counseling opportunities (51%) and incomplete care for the partner (42%). Nonroutine PDPT users and nonusers were significantly more likely to have concerns over partner care than routine PDPT users (P < 0.05 for each concern).
The barrier most often identified was lack of reimbursement by either public or private insurance programs (41%). Specifically, 34% identified the lack of coverage by MediCal (California's Medicaid program) or California Family Planning, Access, Care, and Treatment (PACT) program (state family planning services program for low-income residents), and 32% identified the lack of private insurance coverage (Table 3); however, this barrier was not significantly associated with routine use of PDPT. Not having prepackaged single doses of medication at the clinic site was also identified as a barrier (13%). A minority of providers (5%) reported that PDPT was not supported by their medical director. Among 90 providers who responded to open-ended questions about other barriers to providing PDPT, 15 commented that patient's refusal or lack of compliance with delivering the medication was a barrier.
Knowledge about legislation and guidelines concerning PDPT for chlamydia was high: 89% of providers were aware of the 2001 state law allowing PDPT for clients diagnosed with chlamydia and 75% of providers were aware of the existence of state PDPT guidelines. Knowledge about PDPT laws and guidelines were not significantly associated with routine use of PDPT for chlamydia. However, less than half of providers (46%) were aware of a 2007 law allowing PDPT for partners of gonorrhea-infected clients. Awareness of the 2007 law permitting PDPT was associated with higher PDPT use for gonorrhea (73% vs. 10%, P < 0.0001).
Predictors of Routine PDPT Use for Chlamydia
Variables significantly associated with routine use of PDPT in univariate logistic regression analysis included the 8 attitude variables described in the section earlier, as well as volume of chlamydia-infected clients, hours of patient care, agency participation in CFHC's free PDPT medication distribution program, and medical director support. Model 1 adjusted for variables that were significant in univariate analyses (excluding the attitude variables) and demonstrated that participation in CFHC's free PDPT medication distribution program, high monthly volume of chlamydia-infected clients (5–20 per month), and having a medical director who is supportive of PDPT were independently associated with routine PDPT use (Table 4). Model 2 consisted of the 8 attitude variables alone and only 1 attitude statement (PDPT was a missed counseling opportunity) was independently predictive against routine PDPT use (data not shown). However, when all variables were combined into a third model, none of the attitude variables were significant independent predictors and the direction and magnitude of the adjusted odds ratios for the significant predictors from Model 1 changed minimally (data not shown).
In our evaluation, we were able to describe the frequency of PDPT use as well as identify key attitudes and concerns about PDPT among California family planning providers. Specifically, nearly three-fourths of providers routinely used PDPT to treat partners of chlamydia-infected patients and believed that PDPT helped them provide better care and reduced chlamydia reinfections. However, concerns still existed that PDPT may compromise the quality of care for the patient's sex partner(s).
Despite substantial differences in the populations surveyed and study methodologies, PDPT use in our survey appears higher than that reported by Packel et al in a 2002 study of California physicians and nurse practitioners, where 50 reported routine PDPT use.18 Given that family planning clinicians provide care to a large volume of women seeking reproductive health services including STD testing and treatment in California, the results of our evaluation may give some indication that PDPT use has increased since 2002. Increasing PDPT use may reflect increasing acceptability and decreasing concerns over safety and liability surrounding PDPT following the initial passage of the law permitting PDPT for chlamydia in 2001.
Although concerns about PDPT appear to have decreased over time, fear that PDPT results in incomplete care for the partner was still a major concern. Indeed, without a clinical examination, partners would not be tested for HIV, other STDs, assessed for complications, or counseled about risk-reduction behavior. Studies of STD coinfection rates among partners of chlamydia-infected patients have demonstrated between 3 and 17 prevalence of other STDs (i.e., gonorrhea or trichomoniasis).20,21 The risk of missing concurrent STDs/HIV and undertreating complicated infections in partners may be mitigated by providing educational materials that emphasize the need to seek comprehensive STD care as soon as possible, even if symptoms resolve after PDPT use.22
The lack of reimbursement for PDPT medication by both public and private insurance carriers was the most common barrier identified by providers. Currently, most private insurers do not cover medication costs for PDPT unless the partner is also an enrolled member. Although the provision of free, prepackaged medication for PDPT currently addresses this barrier among participating agencies in California, private insurers would also need to reimburse for PDPT if this practice is to be sustained over the longer term.
A significant factor in the routine use of PDPT was the availability of free prepackaged medication. In narrative statements, providers wrote that the CFHC PDPT medication program made PDPT use “easy and affordable” because medication was “free, prepackaged, included instructions, and was available on-site.” Although we did not design our survey as a formal evaluation of the medication distribution program, our data demonstrate that the program facilitated the use of PDPT among participating family planning providers. Since our evaluation was conducted, the number of agencies participating in the PDPT medication distribution program increased from 40 to 51; future evaluation efforts may also focus on examining how increasing agency participation rates have affected PDPT usage. Given that having a supportive medical director was also significantly associated with routine PDPT use, targeted outreach to medical directors may be warranted in order to assess and address their barriers to PDPT use.
A minority of respondents (18) used pharmacies to dispense PDPT medications by writing or calling in prescriptions for partners of CT-infected patients. This is in contrast to the United Kingdom, where a common method of accelerated partner therapy (APT) involves using pharmacists who conduct consultations and dispense medication without a prescription from a clinician. The use of community pharmacists to dispense APT was recently evaluated in a nonrandomized trial by Estcourt et al, and was found to be more effective at getting partners treated than traditional partner referral methods.23
Although California state guidelines only routinely recommend PDPT for chlamydia or gonorrhea, it is notable that 56 of providers in our survey also reported routine use of PDPT for trichomoniasis. Given the cross sectional nature of our study, we were not able to ascertain whether passage of the PDPT law for chlamydia may have encouraged use of PDPT for other STDs, including trichomoniasis. Another hypothesis is that providers were already using PDPT for trichomonas rather than asking male partners to come to clinic for diagnosis; at the time of our evaluation, there no readily available sensitive diagnostic assays for detecting trichomonas in men. A recent trial demonstrated that PDPT for trichomoniasis reduced repeat infections compared with health department investigation and field-delivered therapy, with similar reinfection rates to traditional partner referral.24 Given that trichomonas infection in men is usually asymptomatic, PDPT for trichomoniasis may be a viable option for male partners who are unlikely to seek care.
Despite passage of state laws permitting PDPT for gonorrhea in January 2007, most providers were not aware of the law and did not routinely use PDPT for gonorrhea. Because awareness of the law was significantly associated with PDPT use, continuing efforts are needed to increase awareness of the law and existence of state and national guidelines for PDPT use. Currently, free PDPT medication distribution programs statewide are being expanded to include gonorrhea partner treatment, which may also increase PDPT use.
There are several limitations to this evaluation. The target population for this evaluation was California family planning providers and our findings may not be generalizable to other clinical settings. Although we attempted to reach all eligible family planning providers by having the survey distributed by all California Title X-funded agency directors, one-third of directors did not provide us with the number of providers to whom the survey was sent, despite multiple attempts at retrieving this information. Beacuse only those agencies that provided complete data on potential respondents were included in the response rate calculation, our results may underestimate or overestimate the true response rate. Though a large majority of Title X agencies had at least 1 provider respond to our survey (80), we did note that nonresponding agencies were less likely to participate in the free PDPT medication program than agencies with provider responses (23 vs. 73). Agency directors who were not supportive of PDPT may have been less likely to forward the survey to providers, and our findings may be biased towards agencies in favor of PDPT. However, we conducted an analyses of nonresponding agencies and determined approximately 0.1 of chlamydia cases reported statewide were from these agencies, thus these agencies do not care for a disproportionate number of chlamydia cases in California. Another potential limitation is that provider self-report of clinical practices may not accurately reflect his/her true use of PDPT. Finally, agency-level participation in CFHC's free PDPT medication distribution program may not equate to clinic participation since agencies controlled distribution.
In conclusion, a majority of California family planning providers in this sample reported routine use of PDPT for treating partners of chlamydia-infected clients; however, there are still key concerns and barriers that need to be addressed. Based on our findings, future efforts to facilitate PDPT use should focus on continued provision of free or low-cost prepackaged medication to clinic sites, with consideration to expanding programs to include partner treatment for gonorrhea. Structural-level changes such as implementing clinic policies that support PDPT and encouraging public and private insurers to provide reimbursement for this practice will also likely be beneficial.
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