In May 2013, a revised and updated version of the Centers for Disease Control and Prevention/National Institutes of Health/HIV Medicine Association Guidelines for Prevention and Treatment of ...Opportunistic Infections in HIV-Infected Adults and Adolescents was released online. These guidelines, since their inception in 1989, have been widely accessed in the United States and abroad. These guidelines have focused on the management of HIV/AIDS-related opportunistic infections that occur in the United States. In other parts of the world, the spectrum of complications may be different and the resources available for diagnosis and management may not be identical to those in the United States. The sections that have been most extensively updated are those on immune reconstitution inflammatory syndrome, tuberculosis, hepatitis B, hepatitis C, human papillomavirus, and immunizations. The guidelines will not be published in hard copy form. This document will be revised as needed throughout each year as new data become available.
Expedited partner therapy (EPT), the practice of treating the sex partners of persons with sexually transmitted infections without their medical evaluation, increases partner treatment and decreases ...gonorrhea and chlamydia reinfection rates. We conducted a stepped-wedge, community-level randomized trial to determine whether a public health intervention promoting EPT could increase its use and decrease chlamydia test positivity and gonorrhea incidence in women.
The trial randomly assigned local health jurisdictions (LHJs) in Washington State, US, into four study waves. Waves instituted the intervention in randomly assigned order at intervals of 6-8 mo. Of the state's 25 LHJs, 24 were eligible and 23 participated. Heterosexual individuals with gonorrhea or chlamydial infection were eligible for the intervention. The study made free patient-delivered partner therapy (PDPT) available to clinicians, and provided public health partner services based on clinician referral. The main study outcomes were chlamydia test positivity among women ages 14-25 y in 219 sentinel clinics, and incidence of reported gonorrhea in women, both measured at the community level. Receipt of PDPT from clinicians was evaluated among randomly selected patients. 23 and 22 LHJs provided data on gonorrhea and chlamydia outcomes, respectively. The intervention increased the percentage of persons receiving PDPT from clinicians (from 18% to 34%, p < 0.001) and the percentage receiving partner services (from 25% to 45%, p < 0.001). Chlamydia test positivity and gonorrhea incidence in women decreased over the study period, from 8.2% to 6.5% and from 59.6 to 26.4 per 100,000, respectively. After adjusting for temporal trends, the intervention was associated with an approximately 10% reduction in both chlamydia positivity and gonorrhea incidence, though the confidence bounds on these outcomes both crossed one (chlamydia positivity prevalence ratio = 0.89, 95% CI 0.77-1.04, p = 0.15; gonorrhea incidence rate ratio = 0.91, 95% CI .71-1.16, p = 0.45). Study findings were potentially limited by inadequate statistical power, by the institution of some aspects of the study intervention outside of the research randomization sequence, and by the fact that LHJs did not constitute truly isolated sexual networks.
A public health intervention promoting the use of free PDPT substantially increased its use and may have resulted in decreased chlamydial and gonococcal infections at the population level.
ClinicalTrials.gov NCT01665690.
Since the site of human subjects research has public health, regulatory, ethical, economic, and social implications, we sought to determine the global distribution and migration of clinical research ...using an open-access trial registry.
We obtained individual clinical trial data including location of trial sites, dates of operation, funding source (United States government, pharmaceutical industry, or organization), and clinical study phase (1, 1/2, 2, 2/3, or 3) from ClinicalTrials.gov. We used the World Bank's classification of each country's economic development status "High Income and a Member of the Organization for Economic Co-operation and Development (OECD)", "High Income and Non-Member of the OECD", "Upper-Middle Income", "Lower-Middle Income", or "Low Income" and United Nations Populations Division data for country-specific population estimates. We analyzed data from calendar year 2006 through 2012 by number of clinical trial sites, cumulative trial site-years, trial density (trial site-years/106 population), and annual growth rate (%) for each country, and by development category, funding source, and clinical study phase.
Over a 7-year period, 89,647 clinical trials operated 784,585 trial sites in 175 countries, contributing 2,443,850 trial site-years. Among those, 652,200 trial sites (83%) were in 25 high-income OECD countries, while 37,195 sites (5%) were in 91 lower-middle or low-income countries. Trial density (trial site-years/106 population) was 540 in the United States, 202 among other high-income OECD countries (excluding the United States), 81 among high-income non-OECD countries, 41 among upper-middle income countries, 5 among lower-middle income countries, and 2 among low-income countries. Annual compound growth rate was positive (ranging from 0.8% among low-income countries to 14.7% among lower-middle income countries) among all economic groups, except the United States (-0.5%). Overall, 29,191 trials (33%) were funded by industry, 4,059 (5%) were funded by the United States government, and 56,397 (63%) were funded by organizations. Countries with emerging economies (low- and middle-income) operated 19% of phase 3 trial sites, as compared to only 6% of phase 1 trial sites.
Human clinical research remains concentrated in high-income countries, but operational clinical trial sites, particularly for phase 3 trials, may be migrating to low- and middle-income countries with emerging economies.
In June 2000, the United States National Institutes of Health (NIH) organized a review of the scientific evidence on the effectiveness of condoms in preventing sexually transmitted infections (STIs). ...The review concluded that condoms were effective in protecting against transmission of HIV to women and men and in reducing the risk of men becoming infected with gonorrhoea. Evidence for the effectiveness of condoms in preventing other STIs was considered to be insufficient. We review the findings of prospective studies published after June 2000 that evaluated the effectiveness of condoms in preventing STIs. We searched Medline for publications in English and included other articles, reports, and abstracts of which we were aware. These prospective studies, published since June 2000, show that condom use is associated with statistically significant protection of men and women against several other types of STIs, including chlamydial infection, gonorrhoea, herpes simplex virus type 2, and syphilis. Condoms may also be associated with protecting women against trichomoniasis. While no published prospective study has found protection against genital human papillomavirus (HPV) infection, two studies reported that condom use was associated with higher rates of regression of cervical intraepithelial neoplasia and clearance of cervical HPV infection in women and with regression of HPV-associated penile lesions in men. Research findings available since the NIH review add considerably to the evidence of the effectiveness of condoms against STIs. Although condoms are not 100% effective, partial protection can substantially reduce the spread of STIs within populations.
In this prospective study of female university students, investigators from Seattle demonstrate that the consistent use of condoms by male partners from the initiation of female sexual activity ...decreases the incidence of female human papillomavirus (HPV) infection. The incidence of genital HPV decreased from 89.3 per 100 patient-years (for 5 percent condom use) to 37.8 per 100 patient-years (for 100 percent condom use).
The consistent use of condoms by male partners from the initiation of female sexual activity decreases the incidence of female HPV infection. The incidence of genital HPV decreased from 89.3 per 100 patient-years (for 5 percent condom use) to 37.8 per 100 patient-years (for 100 percent condom use).
Genital human papillomavirus (HPV) infections are common in sexually active young women,
1
–
4
and certain types of HPV are causally related to anogenital cancers
5
and warts.
6
Although evidence demonstrates that the use of condoms by men substantially reduces the risk of genital transmission of human immunodeficiency virus in women,
7
data on the effectiveness of condoms in reducing the incidence of other sexually transmitted infections are more limited.
8
,
9
In particular, several studies have found that condom use by men does not reduce the risk of HPV infection in women,
1
,
4
,
10
–
13
and recent congressional hearings have addressed changing Food . . .
Patients being treated for gonorrhea or chlamydia were offered medication to give to their sexual partners or standard referral of partners. There was a lower rate of recurrent or persistent ...gonorrhea among the patients with expedited treatment of partners than among those with standard referral of partners (10 percent vs. 13 percent). This strategy had a smaller effect on recurrent chlamydial infection than on recurrent gonorrhea.
There was a lower rate of recurrent or persistent gonorrhea among the patients with expedited treatment of partners than among those with standard referral of partners.
Partner notification, the process of informing and treating the sex partners of patients with sexually transmitted infections, has been a centerpiece of U.S. efforts to control sexually transmitted infections since the 1940s.
1
However, in areas with the highest rates of sexually transmitted infections in the United States, public health departments provide partner-notification services for less than 20 percent of patients with gonorrhea or chlamydial infection, leaving most patients to arrange their partners' treatment without assistance.
2
,
3
Many, and perhaps most, such partners do not receive treatment after their partner's diagnosis,
4
–
8
and reinfection and further transmission are common.
6
,
9
– . . .
Timely diagnosis of infant HIV infection is essential for antiretroviral therapy (ART) initiation. In a randomized controlled trial, we found the Texting Improves Testing (TextIT) intervention (a ...theory-based text messaging system) to be efficacious for improving infant HIV testing rates and maternal retention in prevention of mother-to-child HIV transmission (PMTCT) programs. Using an implementation science approach, we aimed to evaluate real-world effectiveness of the intervention.
In a pragmatic, cluster-randomized, stepped-wedge trial with 2 time periods of observation, we randomly allocated 10 clinics to begin implementing the intervention immediately and 10 clinics to begin implementing 6 months later. To approximate real-world conditions, inclusion criteria were broad. Women at clinics implementing the intervention received up to 14 text messages during pregnancy and after delivery and had the option to respond to text messages, call, or send inquiry text messages to a designated clinic phone. The primary outcomes were infant HIV testing and maternal retention in care during the first 8 weeks after delivery. We used modified Poisson regression with robust variance estimation to estimate the relative risk and 95% confidence intervals (CIs). Generalized estimating equations were applied on individual-level data to account for clustering by site. Between February 2015 and December 2016, 4,681 women were assessed for study participation, and 2,515 were included. Participant characteristics at enrollment did not differ by study arm. Overall median age was 27 years (interquartile range IQR 23-30), median gestational age was 30 weeks (IQR 28-34), 99% were receiving ART, and 87% who enrolled during intervention phases owned a phone. Of 2,326 infants analyzed, 1,466 of 1,613 (90.9%) in the intervention group and 609 of 713 (85.4%) in the control group met the primary outcome of HIV virologic testing performed before 8 weeks after birth (adjusted relative risk aRR 1.03; 95% CI 0.97-1.10; P = 0.3). Of 2,472 women analyzed, 1,548 of 1,725 (90%) in the intervention group and 571 of 747 (76%) in the control group met the primary outcome of retention in care during the first 8 weeks after delivery (aRR 1.12; 95% CI 0.97-1.30; P = 0.1). This study had two main limitations. Staff at all facilities were aware of ongoing observation, which may have contributed to increased rates of infant HIV testing and maternal retention in care at both intervention and control facilities, and programmatic initiatives to improve maternal and infant retention in care were ongoing at all facilities at the time of this study, which likely limited the ability to demonstrate effectiveness of the trial intervention.
In this study, a larger proportion of infants in the intervention group received HIV testing compared with the control group, but the difference was small and not statistically significant. There was also a nonsignificant increase in maternal postpartum retention in the intervention periods. Despite the lack of a significant effect of the intervention, key lessons emerged, both for strengthening PMTCT and for implementation research in general. Perhaps most important, improving the implementation of usual care may have been sufficient to substantially improve infant HIV testing rates.
ClinicalTrials.gov Trial Number NCT02350140.
To evaluate methods for detection of genital human papillomavirus (HPV) DNA in men, samples were obtained from 3 consecutive groups of 10 men attending a sexually transmitted disease clinic by use of ...(1) a salinewetted Dacron swab alone, (2) a saline-wetted cytobrush, or (3) emery paper (600A-grit Wetordry Tri-M-ite; 3M) abrasion followed by a saline-wetted Dacron swab. By use of a polymerase chain reaction-based assay, 45% of emery-paper samples were found to be positive for β-globin, compared with 23% of swab-alone and 0% of cytobrush samples. Subsequently, emery paper and saline-wetted Dacron swabs were used to obtain penile shaft, glans, foreskin, and scrotum samples from 318 male university students. Urine samples were also obtained. Of 1323 samples tested, 1288 (97%) were found to be positive for β-globin. HPV DNA was detected in samples from 104 men (33%): 24% from the penile shaft, 16% from the glans, 28% from the foreskin, 17% from the scrotum, and 6% in urine. The HPV prevalence was similar for circumcised and uncircumcised men. Testing multiple sites increased the number of men for whom HPV DNA was detected.
Gonorrhea treatment has been complicated by antimicrobial resistance in Neisseria gonorrhoeae. Gonococcal fluoroquinolone resistance emerged more rapidly among men who have sex with men (MSM) than ...men who have sex exclusively with women (MSW).
To determine whether N. gonorrhoeae urethral isolates from MSM were more likely than isolates from MSW to exhibit resistance to or elevated minimum inhibitory concentrations (MICs) of antimicrobials used to treat gonorrhea.
6 years of surveillance data from the Gonococcal Isolate Surveillance Project.
Publicly funded sexually transmitted disease clinics in 30 U.S. cities.
Men with a total of 34 600 episodes of symptomatic urethral gonorrhea.
Percentage of isolates exhibiting resistance or elevated MICs and adjusted odds ratios for resistance or elevated MICs among isolates from MSM compared with isolates from MSW.
In all U.S. regions except the West, isolates from MSM were significantly more likely to exhibit elevated MICs of ceftriaxone and azithromycin than isolates from MSW (P < 0.050). Isolates from MSM had a high prevalence of resistance to ciprofloxacin, penicillin, and tetracycline and were significantly more likely to exhibit antimicrobial resistance than isolates from MSW (P < 0.001).
Sentinel surveillance may not be representative of all patients with gonorrhea. HIV status, travel history, and antimicrobial use data were missing for some patients.
Men who have sex with men are vulnerable to the emerging threat of antimicrobial-resistant N. gonorrhoeae. Because antimicrobial susceptibility testing is not routinely done in clinical practice, clinicians should monitor for treatment failures among MSM diagnosed with gonorrhea. Strengthened prevention strategies for MSM and new antimicrobial treatment options are needed.
Following male circumcision for HIV prevention, a high proportion of men fail to return for their scheduled seven-day post-operative visit. We evaluated the effect of short message service (SMS) text ...messages on attendance at this important visit.
We enrolled 1200 participants >18 years old in a two-arm, parallel, randomized controlled trial at 12 sites in Nyanza province, Kenya. Participants received daily SMS text messages for seven days (n = 600) or usual care (n = 600). The primary outcome was attendance at the scheduled seven-day post-operative visit. The primary analysis was by intention-to-treat.
Of participants receiving SMS, 387/592 (65.4%) returned, compared to 356/596 (59.7%) in the control group (relative risk RR = 1.09, 95% confidence interval CI 1.00-1.20; p = 0.04). Men who paid more than US$1.25 to travel to clinic were at higher risk for failure to return compared to those who spent ≤ US$1.25 (adjusted relative risk aRR 1.35, 95% CI 1.15-1.58; p<0.001). Men with secondary or higher education had a lower risk of failure to return compared to those with primary or less education (aRR 0.87, 95% CI 0.74-1.01; p = 0.07).
Text messaging resulted in a modest improvement in attendance at the 7-day post-operative clinic visit following adult male circumcision. Factors associated with failure to return were mainly structural, and included transportation costs and low educational level.
ClinicalTrials.govNCT01186575.
PDF
