Kathleen Van Damme

Prostate-specific antigen to ascertain reliability of self-reported coital exposure to semen

Objective: The objective of this study was to assess the validity of women’s reports of recent unprotected sex by testing for prostate-specific antigen (PSA) in vaginal samples. Study Design: The authors conducted prospective research with 332 female sex workers attending 2 public dispensaries in Madagascar. Results: Among women who reported no sex or protected sex only within the past 48 hours, 21% and 39%, respectively, tested positive for PSA. Among those testing positive for PSA, no differences in PSA concentrations were found among those reporting no sex, protected sex only, or at least one unprotected act. Conclusions: The substantial disagreement between self-reports and measurement of a biologic marker of semen exposure in vaginal specimens substantiates that self-reports of sexual behavior cannot be assumed to be valid measures. Future sexually transmitted infection/HIV and pregnancy prevention studies should confirm the validity of self-reports or use end points that do not rely on self-reported data.

A Phase III Equivalence Trial of Azithromycin versus Benzathine Penicillin for Treatment of Early Syphilis

BACKGROUND Syphilis remains an important source of morbidity worldwide. Long-acting penicillin is the only therapy currently recommended for syphilis in much of the world. Because of hesitation to use penicillin for fear of anaphylaxis, there is a need for an effective, well-tolerated alternative to penicillin for syphilis therapy. METHODS This multicenter, randomized clinical trial was conducted in clinics for the treatment of persons with sexually transmitted diseases. We compared serological cure rates for human immunodeficiency virus (HIV)-negative persons with early syphilis treated with azithromycin at a dosage of 2.0 g administered orally as a single dose with cure rates for those treated with benzathine penicillin G at a dosage of 2.4 million units administered intramuscularly. RESULTS A total of 517 participants were enrolled in the trial. In the intention-to-treat analysis, after 6 months of follow-up, serological cure was observed in 180 (77.6%) of 232 azithromycin recipients and 186 (78.5%) of 237 penicillin recipients (1-sided lower bound 95% confidence interval, 7.2%). Nonserious adverse events were more common among azithromycin recipients than they were among penicillin recipients (61.5% vs 46.3%), and such adverse events were accounted for, in large part, by self-limited gastrointestinal complaints. CONCLUSIONS In this trial, the efficacy of azithromycin at a dosage of 2.0 g administered orally was equivalent to that of benzathine penicillin G for the treatment of early syphilis in persons without HIV infection.

Evaluation of azithromycin resistance in Treponema pallidum specimens from madagascar

Treponema pallidum resistance to azithromycin has been documented in the US, Canada, and Ireland. We found no evidence of resistance to azithromycin in specimens from 141 patients with syphilitic lesions in Madagascar suggesting resistance is geographically isolated and supporting use of azithromycin as alternative treatment for early syphilis in Madagascar.

Evidence-based treatment guidelines for sexually transmitted infections developed with and for female sex workers

background  Sex work is frequently one of the few options women in low‐income countries have to generate income for themselves and their families. Treating and preventing sexually transmitted infections (STIs) among sex workers (SWs) is critical to protect the health of the women and their communities; it is also a cost‐effective way to slow the spread of HIV. Outside occasional research settings however, SWs in low‐income countries rarely have access to effective STI diagnosis.

Predictors of Serological Cure and Serofast State After Treatment in HIV-Negative Persons With Early Syphilis

BACKGROUND Syphilis management requires serological monitoring after therapy. We compared factors associated with serological response after treatment of early (ie, primary, secondary, or early latent) syphilis. METHODS We performed secondary analyses of data from a prospective, randomized syphilis trial conducted in the United States and Madagascar. Human immunodeficiency virus (HIV)-negative participants aged ≥ 18 years with early syphilis were enrolled from 2000-2009. Serological testing was performed at baseline and at 3 and 6 months after treatment. At 6 months, serological cure was defined as a negative rapid plasma reagin (RPR) test or a ≥4-fold decreased titer, and serofast status was defined as a ≤ 2-fold decreased titer or persistent titers that did not meet criteria for treatment failure. RESULTS Data were available from 465 participants, of whom 369 (79%) achieved serological cure and 96 (21%) were serofast. In bivariate analysis, serological cure was associated with younger age, fewer sex partners, higher baseline RPR titers, and earlier syphilis stage (P ≤ .008). There was a less significant association with Jarisch-Herxheimer reaction after treatment (P = .08). Multivariate analysis revealed interactions between log-transformed baseline titer with syphilis stage, in which the likelihood of cure was associated with increased titers among participants with primary syphilis (adjusted odds ratio [AOR] for 1 unit change in log(2) titer, 1.83; 95% confidence interval [CI], 1.25-2.70), secondary syphilis (AOR, 3.15; 95% CI, 2.14-4.65), and early latent syphilis (AOR, 1.86; 95% CI, 1.44-2.40). CONCLUSIONS Serological cure at 6 months after early syphilis treatment is associated with age, number of sex partners, Jarisch-Herxheimer reaction, and an interaction between syphilis stage and baseline RPR titer.

Genetic Typing of the Porin Protein of Neisseria gonorrhoeae from Clinical Noncultured Samples for Strain Characterization and Identification of Mixed Gonococcal Infections

ABSTRACT Molecular methods that characterize the Neisseria gonorrhoeae porin protein Por are needed to study gonococcal pathogenesis in the natural host and to classify strains from direct clinical samples used with nucleic acid amplification-based tests. We have defined the capabilities of por variable region (VR) typing and determined suitable conditions to apply the method to direct clinical specimens. Nested PCR from spiked urine samples detected 1 to 10 copies of template DNA; freezing spiked whole urine greatly reduced the ability to amplify porB. In a laboratory model of mixed gonococcal infections, the por type of one strain could be determined in the presence of a 100-fold excess of another. por VR typing was used to examine clinical samples from women enrolled in studies conducted in Baltimore, Md., and Madagascar. por type was determined from 100% of paired cervical swab and wick samples from 20 culture-positive women from Baltimore; results for eight individuals (40%) suggested infection with more than one strain. In frozen urine samples from Madagascar, porB was amplified and typed from 60 of 126 samples from ligase chain reaction (LCR)-positive women and 3 samples from LCR-negative women. The por VR types of 13 samples (21%) suggested the presence of more than one gonococcal strain. Five por types, identified in >45% of women with typed samples, were common to both geographic areas. Molecular typing is an important adjunct to nucleic acid amplification-based diagnostics. Methods that utilize direct clinical samples and can identify mixed infections may contribute significantly to studies of host immunity, gonococcal epidemiology, and pathogenesis.

Response to therapy following retreatment of serofast early syphilis patients with benzathine penicillin

Persistent nontreponemal titers after treatment are common among patients with early syphilis. We retreated 82 human immunodeficiency virus-negative early syphilis participants who were serofast at 6 months using benzathine penicillin. Only 27% exhibited serological response after retreatment and after an additional 6 months of follow-up.

Effect of consistent condom use on 6-month prevalence of bacterial vaginosis varies by baseline BV status.

Objectives  Bacterial vaginosis (BV) is a condition characterized by a disturbed vaginal ecosystem which fluctuates in response to extrinsic and intrinsic factors. BV recurrence is common. To explore whether consistent condom use was associated with BV occurrence or recurrence, we compared the effect of condom use on BV prevalence after 6 months, among women with and without BV at baseline.

Randomised controlled trial of alternative male and female condom promotion strategies targeting sex workers in Madagascar

Objectives: To assess whether individual clinic-based counselling as a supplement to peer education for male and female condom promotion leads to greater use of protection and lower STI prevalence among sex workers in Madagascar already exposed to intensive male condom promotion. Methods: In two public dispensaries in Madagascar, a total of 901 sex workers were randomly allocated between two alternative male and female condom promotion interventions: peer education only, or peer education supplemented with individual clinic-based counselling. Participants were followed for 12 months. Every 2 months they made clinic visits, where they were interviewed on condom use. Peer educators counselled all participants on condom use as they accompanied their assigned participants to study visits. Participants assigned to receive the supplemental intervention were counselled by a trained clinician following study interviews. Participants were tested and treated for chlamydia, gonorrhoea and trichomoniasis every 6 months. We used logistic regression to assess whether the more intensive intervention was associated with reduced STI prevalence. Use of protection with clients and non-paying partners was assessed by study arm, site, and visit. Results: There was no statistically significant association between study arm and aggregated STI prevalence. No substantial differences in levels of reported protection were noted between study groups. Conclusions: This study found little evidence for gains from more thorough clinical counselling on male and female condom use. These findings suggest that less clinically intensive interventions such as peer education could be suitable for male and female condom promotion in populations already exposed to barrier method promotion.

Evidence-based planning of a randomized controlled trial on diaphragm use for prevention of sexually transmitted infections

Objectives: We conducted formative research to evaluate the acceptability and feasibility of continuous diaphragm use among low-income women highly exposed to sexually transmitted infections (STIs) in Madagascar. Goal: To identify potential obstacles to researching the effectiveness of diaphragm use for STI prevention in a randomized controlled trial. Study Design: Mixed methods to collect complex information. In a quantitative pilot study, women were asked to use diaphragms continuously (removing once daily for cleaning) for 8 weeks and promote consistent male condom use; they were interviewed and examined clinically during follow-up. Focus group discussions (FGDs) were conducted pre-/postpilot study. Audiotaped FGDs were transcribed, translated, coded, and analyzed. Results: Ninety-three women participated in prepilot FGDs, 91 in the pilot study, and 82 in postpilot FGDs. Diaphragm use was acceptable and feasible, but participants reported lower condom use in FGDs than during interviews. Most participants reported in interviews that they used their diaphragms continuously, but FGDs revealed that extensive intravaginal hygiene practices may impede effective continuous diaphragm use. Despite counseling by study staff, FGDs revealed that participants believed the diaphragm provided effective protection against STIs and pregnancy. Conclusions: Mixed methods formative research generated information that the prospective pilot study alone could not provide and revealed contradictory findings. Results have methodological and ethical implications that affect trial design including provision of free hormonal contraceptives, and additional instructions for vaginal hygiene to avoid displacing the diaphragm. Mixed methods formative research should be encouraged to promote evidence-based study design and implementation.