Daniel R. Newman

Does measured behavior reflect STD risk ? : An analysis of Data from a randomized controlled Behavioral intervention study

Background: Many studies measure sex behavior to determine the efficacy of sexually transmitted disease (STD)/HIV prevention interventions. Goal: To determine how well measured behavior reflects STD incidence. Study Design: Data from a trial (Project RESPECT) were analyzed to compare behavior and incidence of STD (gonorrhea, chlamydia, syphilis, HIV) during two 6‐month intervals. Results: A total of 2879 persons had 5062 six‐monthly STD exams and interviews; 8.9% had a new STD in 6 months. Incidence was associated with demographic factors but only slightly associated with number of partners and number of unprotected sex acts with occasional partners. Many behaviors had paradoxical associations with STD incidence. After combining behavior variables to compare persons with highest and lowest risk behaviors, the STD incidence ratio was only 1.7. Conclusion: Behavioral interventions have prevented STD. We found people tend to have safe sex with risky partners and risky sex with safe partners. Therefore, it is difficult to extrapolate the disease prevention efficacy of an intervention from a measured effect on behavior alone.

Detecting Unsuspected HIV Infection With a Rapid Whole-Blood HIV Test in an Urban Emergency Department

Objective:To evaluate and compare HIV screening and provider-referred diagnostic testing as strategies for detecting undiagnosed HIV infection in an urban emergency department (ED). Methods:From January 2003 through April 2004, study staff offered HIV screening with rapid tests to ED patients regardless of risks or symptoms. ED providers could also refer patients for diagnostic testing. Patients aged 18 to 54 years without known HIV infection were eligible. Results:Of 4849 eligible patients approached for screening, 2824 (58%) accepted and were tested; 414 (95%) of 436 provider-referred patients accepted and were tested. Thirty-five (1.2%) screened patients and 48 (11.6%) provider-referred patients were infected with HIV (P < 0.001). Of these, 18 (51%) screened patients and 24 (50%) referred patients reported no traditional risk factors; 27 (77%) screened patients and 38 (79%) referred patients entered HIV care. Of HIV-infected patients with CD4 cell counts available, 14 (45%) of 31 screened patients and 37 (82%) of 45 provider-referred patients had <200 cells/μL (P < 0.001). Conclusions:ED screening detects HIV infection and links to care patients who may not be tested through risk- or symptom-based strategies. The diagnostic yield was higher among provider-referred patients, but screening detected patients earlier in the course of disease.

Incidence of herpes simplex virus type 2 infection in 5 sexually transmitted disease (STD) clinics and the effect of HIV/STD risk-reduction counseling

The seroincidence of herpes simplex virus type 2 (HSV-2) infection was determined among 1766 patients attending sexually transmitted disease (STD) clinics and enrolled in a randomized, controlled trial of human immunodeficiency virus (HIV)/STD risk-reduction counseling (RRC). Arm 1 received enhanced RRC (4 sessions); arm 2, brief RRC (2 sessions); and arm 3, the control arm, brief informational messages. The overall incidence rate was 11.7 cases/100 person-years (py). Independent predictors of incidence of HSV-2 infection included female sex; black race; residence in Newark, New Jersey; <50% condom use with an occasional partner; and, in females, incident trichomoniasis and bacterial vaginosis. Only 10.8% of new HSV-2 infections were diagnosed clinically. Incidence rates were 12.9 cases/100 py in the control arm, 11.8 cases/100 py in arm 2, and 10.3 cases/100 py in arm 1 (hazard ratio, 0.8 [95% confidence interval, 0.6-1.1], vs. controls). The possible benefit of RRC in preventing acquisition of HSV-2 infection offers encouragement that interventions more specifically tailored to genital herpes may be useful and should be an important focus of future studies.

Chlamydia trachomatis among Patients Infected with and Treated for Neisseria gonorrhoeae in Sexually Transmitted Disease Clinics in the United States

Context On the basis of studies of chlamydia and gonorrhea co-infection in the 1980s, guidelines recommend empirical treatment for chlamydia for patients receiving treatment for gonorrhea. The relevance of these recommendations to current practice is unknown. Contribution These 1995 data suggest that, in U.S. sexually transmitted disease clinics, the prevalence of Chlamydia trachomatis among patients infected with gonorrhea (20% in men, 42% in women) or treated for gonorrhea (19% in men, 35% in women) remains sufficiently high to warrant continued empirical therapy for chlamydia. Cautions These data are nearly a decade old. They may not apply in settings that are not sexually transmitted disease clinics. The Editors In the early 1980s, shortly after techniques for culturing Chlamydia trachomatis became available, program data and expert opinion suggested that C. trachomatis coexisted in up to 45% of patients infected with Neisseria gonorrhoeae (1). On the basis of these estimates, the U.S. Centers for Disease Control and Prevention (CDC) first suggested (1) and then formally recommended (2) that all patients treated for gonorrhea should also be treated for chlamydia. Presumptive chlamydia treatment in patients treated for gonorrhea (that is, co-treatment) has remained the standard of care, a recommendation recently renewed in the CDC Sexually Transmitted Diseases Treatment Guidelines, 2002 (3). Co-treatment was proposed as a strategy for chlamydia control at a time when chlamydia culture was performed only in research settings. Over the past two decades, diagnostic testing for C. trachomatis has dramatically improved (4). Nonetheless, many public clinics do not routinely test for C. trachomatis. Furthermore, even clinics that do test for chlamydia tend to use less sensitive, earlier-generation tests (enzyme immunoassay, DNA hybridization tests) (5) because the newer, more sensitive nucleic acid amplification tests (such as polymerase chain reaction [PCR]) are more expensive. To date, there are no accurate, rapid, point-of-care tests for chlamydia. Consequently, rapid testing (Gram stain, predominantly in men) is used for gonorrhea but not for chlamydia, and sensitive testing for gonorrhea remains more accessible in everyday practice than does chlamydia testing, particularly in public health settings where reimbursement for amplification tests is typically not available. The prevalence of sexually transmitted diseases (STDs) in the United States has changed notably since 1982, when co-treatment was introduced. Reported rates of gonorrhea in the United States have declined steadily from 418 per 100 000 persons in 1982 to 149 per 100 000 persons in 1995 to 129 per 100 000 persons in 2001 (6). National chlamydia trends have been difficult to determine because of increases in screening, test sensitivity, and case reporting. In regions where screening in women has been implemented for several years, rates of chlamydial infection seem to have decreased (6). If the prevalence of chlamydia among patients treated for gonorrhea has substantially decreased, co-treatment may no longer be indicated as a clinical or public health strategy. Despite the changes in testing technology and infection prevalences, few current data are available on the prevalence of chlamydia among patients treated for gonorrhea. However, over the past decade, estimates of chlamydial infection among persons infected with gonorrhea (that is, co-infection) have varied widely, ranging from 9% to 50% among men and 24% to 67% among women (7-21). Most of these studies, however, included small numbers of patients (7-12) or used less sensitive chlamydia tests (13-17). Furthermore, they addressed only the epidemiologic question of co-infection. Since treatment decisions must often be made before test results are available, the prevalence of chlamydia among patients treated for gonorrhea is more relevant than the prevalence among patients ultimately found to be infected with N. gonorrhoeae. Our analysis had two objectives. First, to investigate co-infection, we sought to determine the prevalence of chlamydia among patients at STD clinics who were infected with N. gonorrhoeae. Second, to assess the appropriateness of co-treatment, we sought to determine the prevalence of chlamydia among patients at STD clinics who were treated for gonorrhea, including those treated presumptively as sex partners of gonorrhea-infected persons. Methods Study Design We performed a cross-sectional analysis using baseline (enrollment) data collected from July 1993 through October 1995 for Project RESPECT, a randomized, controlled trial of counseling interventions (22). The trial was conducted among patients from public STD clinics in Baltimore, Maryland; Denver, Colorado; Long Beach, California; Newark, New Jersey; and San Francisco, California. All English-speaking patients at least 14 years of age who came to the clinics for an STD examination (evaluation of symptoms, screening or routine care, or contact with an infected partner) and who reported penilevaginal intercourse during the preceding 3 months were asked to participate. Participants found to be infected with HIV and men who identified themselves as homosexual or reported having a male sex partner during the preceding 12 months were excluded. All participants gave written, informed consent, and the institutional review boards at each site reviewed and approved the protocol. Overall, 43% of eligible patients agreed to participate in the 12-month intervention and follow-up. Study participants were routinely tested for gonorrhea, chlamydia, and several other STDs. Definitions For this analysis, we defined gonococcal infection as a positive culture for N. gonorrhoeae from a urethral or endocervical swab in men or women, respectively. We defined chlamydial infection as a positive PCR result from a urine specimen or endocervical swab in men or women, respectively. We included all participants with conclusive test results from both a gonorrhea culture and a chlamydia PCR. Nongonococcal urethritis was defined as the presence of at least 5 polymorphonuclear leukocytes per high-power field and absence of gram-negative intracellular diplococci on Gram stain. Mucopurulent cervicitis and pelvic inflammatory disease (PID) were defined according to the clinicians presumptive diagnosis at the initial visit. We considered patients to have been exposed to an STD if they had a referral card or reported that their partner was infected. We defined indications for treatment by categorizing men and women into mutually exclusive hierarchical groups. We used this approach to 1) distinguish treatment decisions made at the initial consultation from those based subsequently on laboratory test results and 2) exclude patients who would be treated for chlamydia anyway. This allowed us to determine the prevalence of chlamydia among patients treated for gonorrhea who would not, in the absence of co-treatment, be treated with an antimicrobial regimen effective against C. trachomatis. We considered that the following patients had other indications for chlamydia treatment: men with nongonococcal urethritis (C. trachomatis is the organism most commonly associated with this disorder [23]); women with mucopurulent cervicitis or PID (who are treated for several potential organisms, including C. trachomatis); and patients whose partners were diagnosed with chlamydia, nongonococcal urethritis, mucopurulent cervicitis, or PID. Next, we categorized men into six groups and women into five groups on the basis of treatment indication. We considered men to have treatment indications for chlamydia if they had 1) nongonococcal urethritis by Gram stain or 2) a sex partner with chlamydia, mucopurulent cervicitis, or PID. We considered the remaining men to have treatment indications for gonorrhea if they had 3) gram-negative intracellular diplococci, 4) a sex partner with gonorrhea, or 5) a positive gonorrhea culture. The final group comprised men 6) without treatment indications for either infection. We considered women to have treatment indications for chlamydia if they had 1) a sex partner with chlamydia or nongonococcal urethritis or 2) a clinical diagnosis of mucopurulent cervicitis or PID. We considered the remaining women to have treatment indications for gonorrhea if they had 3) a sex partner with gonorrhea or 4) a positive gonorrhea culture. The final group comprised women 5) without treatment indications for either infection. Statistical Analysis We compared characteristics of patients included in this analysis with those of patients enrolled in the original study. Chlamydia prevalence was determined for patients with laboratory-confirmed gonorrhea and for patients with each of the hierarchical treatment indications. For comparison between groups, we used chi-square tests and relative risks (RRs) with 95% CIs. MantelHaenszel weighted RRs were used to calculate summary RRs for stratified analyses, for which GreenlandRobins confidence limits were calculated. The large-sample population proportion method (24) was used to calculate 95% CIs for prevalences. Role of the Funding Source Project RESPECT was supported by CDC cooperative agreements. Chlamydia PCR kits were donated by Roche Pharmaceuticals, which was not involved in study design, conduct, analysis, or interpretation. Results Study Participants Of the 4328 patients enrolled in Project RESPECT, 443 were excluded from this analysis because they did not have conclusive results from both a gonorrhea culture and a chlamydia PCR. The remaining 3885 patients (90%), 2184 men and 1701 women, were included. Our sample was similar to the sample in the original study and to the clinic populations in that patients were young (median age, 25 years), were members of racial or ethnic minority groups (59% black, 16% Hispanic, 20% white, and 6% other), had low income (<

Male Circumcision and Risk of HIV Infection among Heterosexual African American Men Attending Baltimore Sexually Transmitted Disease Clinics

5000/y in 43%), and were approximately equally distribute

Chlamydia screening in a Health Plan before and after a national performance measure introduction.

BACKGROUND Male circumcision has received international attention as an intervention for reducing HIV infection among high-risk heterosexual men; however, few US studies have evaluated its association with the risk of HIV infection. METHODS We analyzed visit records for heterosexual African American men who underwent HIV testing while attending sexually transmitted disease (STD) clinics in Baltimore, Maryland, from 1993 to 2000. We used multivariable binomial regression to evaluate associations between circumcision and the risk of HIV infection among visits by patients with known and unknown HIV exposure. RESULTS Overall, 1096 (2.7%) of 40,571 clinic visits yielded positive HIV test results. Among 394 visits by patients with known HIV exposure, circumcision was significantly associated with lower HIV prevalence (10.2% vs. 22.0%; adjusted prevalence rate ratio [PRR], 0.49 [95% confidence interval [CI], 0.26-0.93]). Conversely, among 40,177 visits by patients with unknown HIV exposure, circumcision was not associated with reduced HIV prevalence (2.5% vs. 3.3%; adjusted PRR, 1.00 [95% CI, 0.86-1.15]), and age >or=25 years old and diagnosis of ulcerative STD were associated with increased prevalence. CONCLUSIONS Circumcision was associated with substantially reduced HIV risk in patients with known HIV exposure, suggesting that results of other studies demonstrating reduced HIV risk for circumcision among heterosexual men likely can be generalized to the US context.

Evaluation of an Ultrasensitive p24 Antigen Assay as a Potential Alternative to Human Immunodeficiency Virus Type 1 RNA Viral Load Assay in Resource-Limited Settings

Objective: To evaluate chlamydia-screening policies, testing practices, and the proportion testing positive in response to the new Health Plan Employer Data and Information Set (HEDIS) chlamydia-screening performance measure in a large commercial health plan. Methods: We interviewed health plan specialty departmental chiefs to describe interventions used to increase chlamydia screening and examined electronic medical records of 15- to 26-year-old female patients—37,438 from 1998 to 1999 and 37,237 from 2000 to 2001—who were classified as sexually active by HEDIS specifications to estimate chlamydia testing and positive tests 2 years before and after the HEDIS measure introduction. Results: In January 2000, the obstetrics and gynecology department instituted a policy to collect chlamydia tests at the time of routine Pap tests on all females 26 years old or younger by placing chlamydia swabs next to Pap test collection materials. Other primary care departments provided screening recommendations and provider training. During 1998–1999, 57% of eligible female patients seen by obstetrics and gynecology exclusively and 63% who were also seen by primary care were tested for chlamydia; in 2000–2001 the proportions tested increased to 81% (P < .001) and 84% (P < .001). Proportions tested by other primary care specialists did not increase substantially: 30% in 1998–1999 to 32% in 2000–2001. The proportion of females testing positive remained high after testing rates increased: 8% during 1998–1999 and 7% during 2000–2001, and the number of newly diagnosed females increased 10%. Conclusion: After the obstetrics and gynecology department introduced a simple systems-level change in response to the HEDIS measure, the proportion of females chlamydia-tested and number of newly diagnosed females increased. Level of Evidence: II-2

Structure of outcome beliefs in condom use

ABSTRACT An inexpensive enzyme-linked immunosorbent assay method for human immunodeficiency virus type 1 quantitation, ultrasensitive p24 antigen assay (Up24), was compared with RNA viral load assay (VL). Up24 had 100% sensitivity of detection at a viral load of ≥30,000, with sensitivity of 46.4% at a viral load of <30,000 (232 specimens from 65 seropositive subjects). The assay was highly reproducible, with excellent correlation between duplicates and among three laboratories.

Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY Jelly used with a diaphragm

To study the structure of beliefs about condom use outcomes, the authors derived and tested 4 psychosocial hypothetical models: (a) a 2-factor model of the personal and social outcomes of condom use; (b) a 2-factor model of the pros and cons of the behavior; (c) a 3-factor model (i.e., physical, self-evaluative, and social) of outcome expectancies; and (d) a thematic 4-factor model of the protection, self-concept, pleasure, and interaction implications of the behavior. All 4 models were studied with a confirmatory factor analysis approach in a multisite study of 4,638 participants, and the thematic solution was consistently the most plausible. Self-concept and pleasure were most strongly associated with attitudes toward using condoms, intentions to use condoms, and actual condom use, whereas protection and interaction generally had little influence.

Vaginal microbicide and diaphragm use for sexually transmitted infection prevention: a randomized acceptability and feasibility study among high-risk women in Madagascar.

Objectives: To assess the safety and acceptability of 2 vaginal microbicide gels (Acidform and BufferGel) used with a diaphragm compared to KY Jelly used with a diaphragm among low-risk, sexually abstinent women. Study Design: Eighty-one women enrolled in a randomized, masked, phase I safety study using a diaphragm with Acidform, BufferGel, or KY Jelly for 6 to 10 hours nightly for 14 nights. Physical examination, colposcopy, and lab studies were performed after 1 and 2 weeks of use. Diaries and questionnaires were used to assess user acceptability. Results: Sixty-nine participants (85%) completed the study. Safety and acceptability appeared similar among the 3 study groups and no serious adverse events related to the study products were reported. Adverse events were mild and anticipated. Conclusions: Acidform and BufferGel compared to KY Jelly, when used with diaphragm daily for 14 days, appeared to be safe and acceptable in a small study of low-risk abstinent women.