INTRODUCTION: Effective public health interventions to reduce the incidence of sexually transmitted disease (STD), including HIV, among women are urgently needed. METHODS: A randomized trial among STD clinic patients of two types of counseling regarding methods to reduce disease transmission: a 'hierarchical' message (HP), with counseling on male condoms, female condoms, diaphragms, cervical caps, and spermicides (three formulations) and a single method message (SM) covering male condoms only or female condoms only. For this analysis, 1591 subjects received one of three educational messages at the central public STD clinic in Philadelphia. Disease incidence data for up to 6 months following the index visit were extracted from the clinic's electronic database. The primary outcome was STD reinfection: laboratory-confirmed trichomonas infection and/or clinical diagnoses of at least one of four STD. Rates were based on the full sample of randomized women (full sample) and on the subset who spontaneously returned between 22 days and 183 days following their initial visit (returners). RESULTS:Rates of trichomonas infection (SM 2.5% full sample and 12.9% returners versus HP 2.4% full sample and 11.5% returners) and clinical diagnoses (SM 6.3% full sample and 39.7% returners versus HP 6.9% full sample and 41.2% returners) did not differ across the two arms of the randomized trial, both as a straight percentage and in survival analysis (P = .81). CONCLUSION: At least in this single-session intervention trial, increasing choices in protection for women did not produce a change in disease risk compared with single-method approaches.
RCT Entities:
INTRODUCTION: Effective public health interventions to reduce the incidence of sexually transmitted disease (STD), including HIV, among women are urgently needed. METHODS: A randomized trial among STD clinic patients of two types of counseling regarding methods to reduce disease transmission: a 'hierarchical' message (HP), with counseling on male condoms, female condoms, diaphragms, cervical caps, and spermicides (three formulations) and a single method message (SM) covering male condoms only or female condoms only. For this analysis, 1591 subjects received one of three educational messages at the central public STD clinic in Philadelphia. Disease incidence data for up to 6 months following the index visit were extracted from the clinic's electronic database. The primary outcome was STD reinfection: laboratory-confirmed trichomonas infection and/or clinical diagnoses of at least one of four STD. Rates were based on the full sample of randomized women (full sample) and on the subset who spontaneously returned between 22 days and 183 days following their initial visit (returners). RESULTS: Rates of trichomonas infection (SM 2.5% full sample and 12.9% returners versus HP 2.4% full sample and 11.5% returners) and clinical diagnoses (SM 6.3% full sample and 39.7% returners versus HP 6.9% full sample and 41.2% returners) did not differ across the two arms of the randomized trial, both as a straight percentage and in survival analysis (P = .81). CONCLUSION: At least in this single-session intervention trial, increasing choices in protection for women did not produce a change in disease risk compared with single-method approaches.
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