Daily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.).
BackgroundSexually transmitted disease (STD) prevention remains a public health priority. Simple, practical interventions to reduce STD incidence that can be easily and inexpensively administered in high-volume clinical settings are needed. We evaluated whether a brief video, which contained STD prevention messages targeted to all patients in the waiting room, reduced acquisition of new infections after that clinic visit.Methods and FindingsIn a controlled trial among patients attending three publicly funded STD clinics (one in each of three US cities) from December 2003 to August 2005, all patients (n = 38,635) were systematically assigned to either a theory-based 23-min video depicting couples overcoming barriers to safer sexual behaviors, or the standard waiting room environment. Condition assignment alternated every 4 wk and was determined by which condition (intervention or control) was in place in the clinic waiting room during the patient's first visit within the study period. An intent-to-treat analysis was used to compare STD incidence between intervention and control patients. The primary endpoint was time to diagnosis of incident laboratory-confirmed infections (gonorrhea, chlamydia, trichomoniasis, syphilis, and HIV), as identified through review of medical records and county STD surveillance registries. During 14.8 mo (average) of follow-up, 2,042 patients (5.3%) were diagnosed with incident STD (4.9%, intervention condition; 5.7%, control condition). In survival analysis, patients assigned to the intervention condition had significantly fewer STDs compared with the control condition (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.84 to 0.99).ConclusionsShowing a brief video in STD clinic waiting rooms reduced new infections nearly 10% overall in three clinics. This simple, low-intensity intervention may be appropriate for adoption by clinics that serve similar patient populations.Trial registration: http://www.ClinicalTrials.gov (#NCT00137670).
Selective attrition can detract from the internal and external validity of longitudinal research. Four tests of selective attrition applicable to longitudinal prevention research were conducted on data bases from two recent studies. These tests assessed (1) differences between dropouts and stayers in terms of pretest indices of primary outcome variables (substance use), (2) differences in change scores for dropouts and stayers, (3) differences in rates of attrition among experimental conditions, and (4) differences in pretest indices for dropouts among conditions. Results of these analyses indicate that cigarette smokers, alcohol drinkers, and marijuana users are more likely to drop out than nonusers, limiting the external validity of both studies. For one project, differential rates of attrition among conditions suggested a possible attrition artifact which will interfere with interpretation of outcome results, possibly masking true program effectiveness. Recommendations for standardizing reports of attrition and for avoiding attrition through second efforts are made.
The design, logic, and results of a two-year health education study directed at improving rates of patient adherence to antituberculosis medical regimens are presented. An incentive scheme to reward positive health behaviors plus targeted educational counseling sessions was implemented in a randomized clinical controlled trial. The 205 subjects who participated in the study are categorized according to patients with active tuberculosis (n = 88) or preventive patients with no evidence of active disease (n = 117). Patients in each of these groups were randomly assigned to a special intervention (SI) group or a usual care (UC) control group and were followed monthly throughout their treatment program. While SI patients with active tuberculosis demonstrated higher levels of appointment-keeping behavior and mean percent of medication taken compared to UC patients, no statistically significant differences between the two groups were found. Preventive therapy patients assigned to the SI group, however, were significantly more likely than UC patients to remain in care during their 12-month regimen (64% vs 47%; p = .003). Furthermore, SI patients had significantly higher levels of adherence to their medical regimen compared to UC patients (68% vs 38%; p less than .001). These results demonstrate the positive effects of a structured health education program on the improvement of continuity of care and adherence behavior among patients with tuberculosis.
Men and women who receive diagnoses of C. trachomatis, N. gonorrhoeae, or T. vaginalis infections should return in 3 months for rescreening because they are at high risk for new asymptomatic sexually transmitted infections. Although single-dose therapy may adequately treat the infection, it often does not adequately treat the patient.
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