Repeated Bacterial STIS Among Heterosexual Men
Tulane University Of Louisiana, New Orleans LA
Investigators
Linked publications, trials & patents
Abstract
DESCRIPTION (provided by investigator): Repeat infections with Chlamydia trachomatis (CT), one of the most common bacterial sexually transmitted disease, causes serious reproductive outcomes among women. While men do not experience these sequelae, they serve as a reservoir of infection for women, so effective control measures must include men. For women, expedited partner treatment (EPT) and rescreening at 3 months has been recommended, but only EPT has been recommended for men citing lack of evidence for rescreening. Our preliminary data show that, among men, 48 percent of repeated CT infections could not be attributed to sexual re-exposure to a baseline partner, suggesting that EPT alone is insufficient and that rescreening may be necessary. This research will provide the essential evidence for or against rescreening among men. The goal of the study is to examine the utility and feasibility of rescreening heterosexual men with Chlamydia Trachomatis with the ultimate goal of reducing transmission to female sexual partners in three aims: Aim 1: To determine the incidence and likely source of repeat infections of Chlamydia trachomatis (Ct) among heterosexual men. Ct positive men attending two public STD clinics will be retested at a 3 week test of cure visit and rescreened at 3 months. State-of-the-art genotyping will be supplemented with sexual histories to determine the probable source of repeat infection by 3 months (i.e. original partner, new partner or treatment failure). We hypothesize that among heterosexual men with Ct infection, 48 percent of repeat infections will not be attributed to reinfection from a baseline partner indicating a need for rescreening in addition to the provision of expedited partner treatment. Aim 2: To conduct a nested randomized controlled trial of: (arm 1) automated reminders/ return to clinic (RTC) versus (arm 2) automated reminders/choice of RTC or mail-in versus (arm 3) standard of care appointment cards/RTC for improving adherence to rescreening among heterosexual men with CT. Eligible men enrolled in aim 1, who attend the TOC visit, will be randomized to one of the three arms and followed the 3 month rescreen visit to examine adherence to the rescreening visit. We hypothesize automated reminders (i.e. text message, voicemail, or email) will be superior to the SOC and that providing a choice of rescreening venues will be superior to the RTC only option. These data will provide evidence that simple and inexpensive technology can be used to improve adherence to rescreening among heterosexual men. Aim 3: To examine barriers to adherence to expedited partner treatment and rescreening among heterosexual men. Men who did and did not adhere to their scheduled 3 month rescreening and/or to EPT will be compared using the behavioral interview data and a random sample of 120 men will undergo in-depth interviews to examine the reasons why they did or did not adhere to EPT and/or 3 month rescreening visit. This aim will provide essential barrier and facilitator data needed for the refinement of these approaches among heterosexual (mostly African American) men. PUBLIC HEALTH RELEVANCE: Among women, repeated infections with Chlamydia trachomatis (CT) are associated with serious reproductive outcomes such as pelvic inflammatory disease, ectopic pregnancy, chronic pelvic pain, and infertility. Most interventions have focused on women, but since men are the likely reservoirs of reinfection for women, they need to be targeted as well. This research will examine the utility and feasibility of rescreening men for CT.
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