Aztreonam-avibactam synergy, a validation and comparison of diagnostic tools.

Introduction: Antimicrobial resistance is a growing problem that necessitates the development of new therapeutic options. Cefiderocol and aztreonam (AT) are often the last active β-lactams for treating metallo-β-lactamases (MBL)-producing Gram-negative bacilli. In these difficult-to-treat bacterial strains, AT resistance is frequently attributed to the co-occurrence of other resistance mechanisms.

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.

Rapid plasma reagin titer variation in the 2 weeks after syphilis therapy.

Background: Serologic tests for syphilis results at the time of diagnosis are the basis for evaluating response to syphilis therapy. After treatment, however, serologic tests for syphilis titers may continue to increase for several weeks. We evaluated rapid plasma reagin (RPR) titer variation during the 14 days after therapy using data from a recent large, prospective randomized controlled trial.

No sex for science? Formative research on the acceptability and feasibility of a true contraceptive efficacy clinical trial.

Background: Recruitment challenges and restrictions on intercourse frequency and timing have stymied previous attempts to implement true contraceptive efficacy clinical trials.

Study Design: Qualitative research was conducted in Madagascar, South Africa, and the United States to explore the acceptability of three potential true contraceptive efficacy study designs and the feasibility of recruitment for such trials, including characteristics of potential participants who may be willing to join.

Results: Participants preferred the study design with the least restrictive sex criteria: participants have sex with assigned contraceptive method/no method on days around ovulation and use condoms on other days.

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 papillomavirus and cervical neoplasia among female sex workers in Madagascar.

Introduction: Human papillomavirus (HPV) prevalence and type distribution were estimated among 90 female sex workers (FSWs) aged 18 to 58 years in Antananarivo, Madagascar.

Methods: A total of 90 FSWs aged 18 to 58 years in Antananarivo, Madagascar, were included in this study. Information on sexual and behavioral characteristics was obtained via a questionnaire.

Effect of treatment assignment on intravaginal cleansing in a randomized study of the diaphragm with candidate microbicide.

Background: Intravaginal cleansing may predispose women to adverse health outcomes and may interfere with the effectiveness and safety of female-initiated methods for preventing sexually transmitted infections (STIs). In a 4-week randomized study of 192 Malagasy sex workers, we evaluated associations between self-reported intravaginal cleansing and randomization assignment: diaphragm with viscous candidate microbicide gel (Acidform™, TOPCAD, Chicago, IL, licensed to Instead, Coppell, TX), diaphragm with placebo hydroxyethylcellulose gel (HEC, ReProtect LLC, Baltimore, MD), Acidform alone, or HEC alone.

Methods: Women were counseled to avoid intravaginal cleansing and were blinded to gel assignment.

Notifying partners of patients with early syphilis in Madagascar: case-finding effectiveness and public health implications.

Objective: To evaluate the case-finding effectiveness of a clinic-based partner notification effort for early syphilis in Madagascar.

Methods: We asked index cases who had proven early syphilis to identify and provide contact information of recent sex partners (in the past 3, 6, and 12 months for primary, secondary, and early latent syphilis, respectively). Named sex partners were contacted by index cases (patient notification) or, if approved by the index case, clinic staff members (provider notification); notified of their potential exposure to syphilis; and asked to come to the clinic for evaluation.

Predictors of unprotected sex among female sex workers in Madagascar: comparing semen biomarkers and self-reported data.

Research on the determinants of condom use and condom non-use generally has relied on self-reported data with questionable validity. We identified predictors of recent, unprotected sex among 331 female sex workers in Madagascar using two outcome measures: self-reports of unprotected sex within the past 48 h and detection of prostate-specific antigen (PSA), a biological marker of recent semen exposure. Multivariable logistic regression revealed that self-reported unprotected sex was associated with three factors: younger age, having a sipa (emotional partner) in the prior seven days, and no current use of hormonal contraception.

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.

Perceived control over condom use among sex workers in Madagascar: a cohort study.

Background: Women's perceived control over condom use has been found to be an important determinant of actual condom use in some studies. However, many existing analyses used cross-sectional data and little quantitative information exists to characterize the relationships between perceived control and actual condom use among sex worker populations.

Methods: We assessed the association between measures of perceived condom use control and self-reported use of male condoms employing data from a longitudinal pilot study among 192 sex workers in Madagascar.

Promoting continuous use as a strategy for achieving adherence in a trial of the diaphragm with candidate microbicide.

Women need more choices for protection from HIV and other sexually transmitted infections (STIs). We conducted a randomized 4-week study in Madagascar in preparation for a Phase III randomized controlled trial (RCT) of the diaphragm with a candidate microbicide for STI prevention. All participants completed quantitative surveys; half participated in a qualitative interview.

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.

Predictors of adherent use of diaphragms and microbicide gel in a four-arm, randomized pilot study among female sex workers in Madagascar.

Background: Participants' protocol adherence may influence assessments of the effectiveness of new female-controlled methods for sexually transmitted infection prevention.

Methods: In 2005 we conducted a randomized pilot study among female sex workers (FSWs) in Madagascar in preparation for sexually transmitted infection prevention trial of diaphragms and a vaginal microbicide. Participants (n = 192) were randomized into 4 arms: diaphragm plus microbicide (Acidform), diaphragm plus placebo gel hydroxyethyl cellulose (HEC), Acidform alone, or HEC alone.

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.

Unmet need for contraception among sex workers in Madagascar.

Background: The study was conducted to investigate past and future pregnancy preferences and contraceptive need among Malagasy sex workers.

Study Design: We analyzed data on pregnancy and contraceptive use collected during the baseline visit of a randomized, prospective formative trial which assessed diaphragm and microbicide acceptability among sex workers. To be eligible, women could not be pregnant or planning pregnancy for the next 2 months.

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

Background: In preparation for a randomized controlled trial (RCT), we conducted a pilot RCT of the acceptability and feasibility of diaphragms and candidate vaginal microbicide for sexually transmitted infection prevention among high-risk women in Madagascar.

Methods: Participants were randomized to four arms: (1) diaphragm (worn continuously) with Acidform applied in the dome; (2) diaphragm (worn continuously) with placebo gel hydroxyethylcellulose (HEC) in the dome; (3) HEC applied intravaginally before sex; (4) Acidform applied intravaginally before sex. All women were given condoms.

Barriers to the use of modern contraceptives and implications for woman-controlled prevention of sexually transmitted infections in Madagascar.

Globally, unplanned pregnancies and sexually transmitted infections (STIs) persist as significant threats to women's reproductive health. Barriers to the use of modern contraceptives by women might inhibit uptake of novel woman-controlled methods for preventing STIs/HIV. Use of modern contraceptives and perceptions and attitudes towards contraceptive use were investigated among women in Antananarivo, Madagascar, using qualitative research.

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.

Pregnancy among sex workers participating in a condom intervention trial highlights the need for dual protection.

Background: Little is known about pregnancy rates among sex workers (SWs) or the factors that predispose SWs to this risk. We aimed to estimate the pregnancy incidence rate among Madagascar SWs participating in an intervention trial promoting use of male and female condoms and assess the influence of various predictive factors on pregnancy risk.

Methods: SWs from two study clinics in Madagascar participated in a randomized trial to assess the effect of peer education and clinic-based counseling on use of male and female condoms and prevalence of sexually transmitted infections (STIs).

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.

Cost-effectiveness of treatment strategies for cervical infection among women at high risk in Madagascar.

Background: According to the national guidelines developed in 2001, a woman at high risk of gonorrhea and chlamydia in Madagascar is treated presumptively at her first sexually transmitted infection clinic visit; risk-based treatment (RB) is subsequently used at 3-month visits.

Objectives: To compare health and economic outcomes for a 2-stage Markov process with the following 3 cervical infection treatment policies at baseline and at 3-month follow-up visit: presumptive treatment (PT), RB, and an interim laboratory/risk-based policy.

Study Design: Cost-effectiveness analysis was used to compare the 9 treatment strategies.

Increased risk of chlamydial and gonococcal infection in adolescent sex workers in Madagascar.

Goal: To examine and compare young sex workers' risk of acquisition of sexually transmitted infections (STIs) with the risk among their older counterparts.

Objective: To evaluate the effect of young age--16-19 years vs. 20 years and older--on risk of incident infection with Neisseria gonorrhoeae (GC) or Chlamydia trachomatis (CT).

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.