285 Clinical Trials for Various Conditions
National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for sexually active young women under the age of 25. Despite these recommendations, many young women are not being screened for STDs, with some estimates that less than 50% of women receiving health care are screened for chlamydia. Untreated STDs can lead to important sequelae to women's reproductive health including pelvic inflammatory disease, infertility and ectopic pregnancy. One of the most important barriers to widespread STD screening is provider failure to recognize an opportunity for STD screening. The goal of this study is to determine whether offering STD screening (chlamydia and gonorrhea) by a non-physician member of the medical practice (who receives an automated alert indicating STD screening should be offered) will be associated with a higher rate of STD screening in young women attending primary care practices compared to usual care (where a physician offers screening with no electronic alert). This study will be performed in UPMC-affiliated primary care practices (Family Practice, Internal Medicine, OB/GYN, Pediatrics). Practices will be assigned to the intervention or usual care. The intervention will be an auto-task in the electronic medical record to the non-physician/NP/PA medical staff (medical assistants, LPNs, RNs) to offer chlamydia and gonorrhea screening via urine or self-collected vaginal sampling, in an opt-out manner, to eligible women. Practices assigned to the usual care group will not have the intervention. STD screening rates (# women undergoing STD screening/# eligible women) will be compared between the to groups (intervention practices and control practices). Results of this study may be important to guide national STD screening recommendations and will address critical barriers to widespread STD screening.
Project Aware is a randomized controlled clinical trial in which individuals seeking medical or health services at sexually transmitted disease (STD) clinics are recruited to participate in a multi-center HIV testing and counseling study. The investigators will assess the relative effectiveness and cost-effectiveness of (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information only. The investigators will evaluate the effect of counseling on one primary outcome: STI incidence. Secondary outcomes will be reduction of sexual risk behaviors, substance use during sex (i.e., being under the influence during sex) and cost and cost effectiveness of counseling and testing. Participants will be assessed for sexually transmitted infections, HIV testing history and sexual and drug use risk behaviors at baseline and at 6-months follow-up. Approximately 5,000 individuals seeking medical or health services from approximately 9 STD clinics throughout the United States will be randomized. These individuals will be 18 years of age or older and efforts will be made to recruit a sample of study participants that reflects the proportion of minorities and gender in the STD clinic performance sites from which the investigators are recruiting.
This study will determine whether showing an educational DVD to people at sexually transmitted infection clinics can reduce incidence of new infections and risky sexual behaviors and improve overall health.
This study will evaluate the effectiveness of a sexual risk reduction intervention in reducing sexual risk behavior in HIV uninfected, heterosexual people who use methamphetamine.
This study will evaluate the effectiveness of a tailored interactive online risk reduction program versus a standard online risk reduction program in reducing the risk of Sexually Transmitted Diseases (STD) infection in young adults.
This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).
The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also evaluating acceptability and antimicrobial resistance in order to inform public health policy.
The goal of this project is to collect data regarding the concentrations of doxycycline in mucosal tissues after daily dosing for 7 days in people assigned male sex at birth (AMAB) and assigned female sex at birth (AFAB) to inform future studies of doxycycline to protect against bacterial sexually transmitted infections (STIs).
This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG).
The goal of this clinical trial is to test the efficacy of a mobile app, Combine, to increase the uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP) over 24 months and to assess the effects of different implementation strategies on intervention maintenance among GBMSM in rural southern United States. The main aims of the study are: * To assess the relative effects of three treatment conditions on gains in engagement in HIV prevention compared to a modified standard of care control condition * Measure and assess secondary factors affecting app implementation * Refine implementation strategies and coordinate with potential funders Participants will download an HIV prevention smartphone app and be randomly assigned to one of four groups: * Control: App access only * Self-testing: App access + ability to order HIV and STI self-test kits * Motivational interview: App access + motivational interview to develop plans to use app effectively. * Self-testing + motivational interview: App access + ability to order HIV and STI self-test kits + motivational interview to develop plans to use app effectively. Researchers will compare each of the latter three groups to the control condition to see if HIV and STI testing increase in these groups
The goal of this observational study is to learn about awareness around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors in men having sex with men. The main objective is to study a prospective cohort of MSM in Atlanta, Chicago, and San Diego to understand men's strategies to prevent HIV/Sexually Transmissible Infections (STIs), including PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors Participants will complete: * Quantitative surveys quarterly * HIV/ STI testing every 6 months * Qualitative assessments: focus group discussions and in-depth interviews
In the United States (US), gay and bisexual men living with human immunodeficiency virus (HIV) bear a heavy burden of bacterial sexually transmitted infections (STIs) such as gonorrhea, chlamydia, and syphilis. It is important to diagnose and treat STIs in a timely manner to prevent health complications and reduce transmissions. The purpose of this study is to understand whether gay and bisexual men living with HIV are willing to collect and return specimens for bacterial STI testing when combined with live audio/video (AV) conferencing support.
The HIV diagnosis rate among African-born Black women is the highest of all Black individuals living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis (PrEP) are two effective means of decreasing HIV risk among women, but they remain suboptimal among Black women. The specific aims of this study are: 1. To culturally adapt two widely utilized, evidence-based HIV prevention interventions originally designed for US born Black women (Sister-to-Sister (S2S) and Sisters Informing Sisters about Topics on AIDS (SISTA)) for use by African-born women 2. To conduct a randomized controlled comparative effectiveness trial (RCT) to determine the effectiveness of adapted versions of S2S versus SISTA on increasing condom use and PrEP uptake among African-born women. The adapted versions of these interventions will be given new names that resonate with the African culture. The adapted version of S2S intervention will be called "Dada Kwa Dada (DKD)" intervention while the adapted version of SISTA intervention will be called "DADA" intervention. "DADA" means "Sister" in Swahili and other languages in Eastern and Western Africa.
This study is a pilot randomized trial of STIckER in which 40 providers (20 trained in using the STIckER decision aid and 20 providing standard care) will enroll a total of 140 sexually active young Emergency Department (ED) patients over six months in a pediatric and adult ED setting. The primary goal is to determine if sexually active young individuals who use STIckER are more likely to undergo STI testing. By developing an effective automated digital tool to increase STI testing, the investigators aim to improve evidence-based sexual health education, reduce STI rates, and enhance the health outcomes of young individuals nationwide.
Primary objective: - To evaluate the efficacy of oral reparixin versus standard care alone in limiting disease progression in adult patients hospitalised for infectious pneumonia acquired in the community (CAP), including COVID-19. Secondary objectives: - To determine the effect of reparixin on several disease severity/progression measures including recovery, ventilatory free days and mortality. Safety objectives: - To evaluate the safety of oral reparixin versus placebo in the specific clinical setting.
Demonstration project to implement penicillin allergy testing in STD outpatients using a questionnaire and pen allergy testing
Background: STDG3 is an inherited eye disease. Currently there is no treatment for STDG3. Past studies of STDG3 have largely looked at members of large families at a single time point. Researchers want to learn more about the disease at an individual level. Objective: To understand the natural history of changes in the retina that occur in people with STDG3. Eligibility: People ages 10 and older with STDG3 due to a variant in the ELOVL4 gene. Design: Participants will have 6 visits. First they will have a screening visit, followed by a baseline visit. Then they will have a visit 6 months later. Then they will have a visit 1, 2, and 3 years after the first visit. Visits will last 4 to 8 hours. Visits will include the following: Medical history and physical exam. Complete eye exam. Participants' eye pressure and ability to see letters on a vision chart will be tested. Their pupils will be dilated with eye drops. Pictures will be taken of the retina and the inside of the eye. Questions about participants' family history, especially the presence of eye disease. Visual field test. Participants will be seated in front of a large dome and asked to press a button when they see a light within the dome. Electroretinogram. Participants will sit in the dark with their eyes patched for 30 minutes. Then they will wear special contact lenses and watch flashing lights. Optical coherence tomography. Cross-sectional pictures will be taken of participants' retinas. Fundus autofluorescence. Blue light will be shone into participants eyes to assess the health of the retina....
The proposed study involves conducting a larger-scale study exploring Game Plan's effects among MSM in the real-world, alongside innovative approaches for expanding HIV testing. Using a hybrid 1 effectiveness-implementation approach, the investigators will recruit up to 360 high-risk, heavy drinking MSM online from several high-incidence areas in the US to participate in a program providing home-based HIV/STI self-tests in the mail at regular intervals over a year (baseline, 6 months, 12 months). Participants will be randomly assigned to receive access to either (1) a 24-hour helpline for counseling/referrals, or (2) the helpline plus Game Plan. Investigators will test whether those who use Game Plan show lower rates of heavy drinking, any STIs, and high-risk CAS events compared to those receiving access to the helpline alone.
This study will evaluate the referral to harm reduction services (HRS) including syringe services, naloxone overdose prevention, substance use treatment referral, HIV, HCV, and STD testing and referral and linkage to care through capacity building of existing programs through client services data.
The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including gonorrhea, chlamydia and syphilis. The study will also look at the safety of doxycycline PEP and the impact that PEP may have on the bacteria that cause STIs as well as on bacteria that normally live on the body. While doxycycline is approved by the Food and Drug Administration (FDA), taking doxycycline immediately after sexual contact to prevent infection is investigational and is not approved by the FDA for this use. Participants will take part in the study for 1 year.
The purpose of this research study is to compare two specimen collection techniques (vaginal vs. endocervical swab) to screen for sexually transmitted infections in pregnant women. Either a physician or the patient may collect the vaginal specimen; the physician will collect the endocervical specimen during a standard-of-care pelvic exam. Each technique utilizes a specialized swab for specimen collection. We will used the Hologic Aptima C. trachomatis and N. gonorrhoeae detection assay to analyze both specimens. We hypothesize that the results from the physician-collected vaginal specimen will have equivalent outcomes those from the physician-collected endocervical specimen. If the techniques are equivalent for detecting infection, there may be an opportunity for cost saving and increased patient satisfaction with the vaginal technique, especially using patient-collected vaginal specimen collection.
This proposed study is to test whether Health Check-up for Expectant Moms (HCEM), a computer-delivered screening and brief intervention (SBI) that simultaneously targets sexually transmitted infection (STI) risk and alcohol/drug use during pregnancy, reduces antenatal and postpartum risk more than an attention, time, and information matched control condition among pregnant women seeking prenatal care.
In response to the increasing rates of HIV/STD infections among women over the age of 50, especially minority women, and in the attempt to reduce HIV/STD risks for over ten million older adult American women who are impacted by gray divorce and at risk for unsafe sex, the investigators will create, test, and commercialize a novel positive psychology-based "SmartWeb" intervention to promote wellbeing, HIV/STD awareness, and safe sex practices among culturally-diverse older divorced or separated women who are dating. This large end-user market for the proposed HIV/STD risk reduction intervention will greatly facilitate commercialization through advertisements, marketing research based on data mining, and in collaboration with manufacturers of condoms, and other large companies offering health products and services to older women.
Sexually transmitted infections (STIs) are highly prevalent among adolescents. Clinical practices related to screening, diagnosis, treatment, and prevention of STIs among adolescents are suboptimal. There is a need to expand our screening programs to nontraditional healthcare settings such as emergency departments (ED) and to determine the most efficient and cost-effective method for providing this screening. The goal of this study is to leverage our recent insights obtained from single center ED-based adolescent GC/CT screening research and apply them across a national pediatric ED research network to determine the most clinically effective and cost-effective screening approach for adolescents when implemented into a real-world clinical setting through a pragmatic trial. This will be accomplished through a network of children's hospital EDs with a track record of robust research collaboration (Pediatric Emergency Care Applied Research Network or PECARN). This intervention will rely on an innovative approach that electronically integrates patient-reported data to guide clinical decision support. The investigators will apply human factors modeling methods to perform ED workflow evaluations at each participating pediatric ED to determine the most efficient way to integrate the screening process into clinical care. The investigators will then conduct a comparative effectiveness pragmatic trial of targeted STI screening versus universally offered STI screening through electronic integration of patient reported data for provision of clinical decision support. The investigators will develop decision analytic models to evaluate the cost-effectiveness of targeted screening compared to universally offered screening.
This pilot project will evaluate the feasibility, acceptability, and preliminary effectiveness of a couples-based behavioral intervention \[COUPLES\] that augments individual evidence-based interventions with joint health education counseling for STI-affected AYA dyads within a primary care setting.
The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen for patients with locally advanced HER2-negative breast cancer. The primary efficacy objective is to determine if the immunotherapy increases the presence and percentage of tumor and/or stromal area of infiltrating lymphocytes prior to initiation of standard neoadjuvant chemotherapy. At enrollment, patients will be assigned to one of 2 cohorts based on hormone receptor status. * Cohort A - patients with HER2-negative, hormone receptor-negative breast cancer (defined as both ER and PgR with \< 10% positive staining on IHC) Note: before beginning standard neoadjuvant chemotherapy, patients in Cohort A may be reassigned to Cohort A2 to receive extended pembrolizumab as part of new standard neoadjuvant and postoperative adjuvant therapy. * Cohort B - patients with HER2-negative, hormone receptor-positive breast cancer (defined as either ER or PgR with ≥ 10% positive staining on IHC)
The overall goal is to develop new clinical approaches to restore limb function after spinal cord injury (SCI). Corticospinal tract (CST) axons are involved in controlling limb function. Paired pulse induced spike-timing dependent plasticity (STDP) enhances synaptic strength between residual CST axons and spinal motoneurons (SMNs) resulting in temporary improvements in limb function in humans with incomplete SCI. Motor training will be combined with paired-pulse STDP stimulation to further enhance plasticity and behavioral recovery.
African American men have by far the highest rates of HIV in the US, but there are few randomized controlled trials (RCTs) of interventions to dissuade heterosexually active African American men from engaging sexual risk behavior. This research seeks to address this gap in the behavioral intervention literature. That self-initiated behavior change, as well as intervention-induced behavior change, is often short-lived, eroding over time, is widely known; accordingly, this research also seeks to test a strategy to sustain intervention efficacy. In a RCT, African American men 18 to 45 years reporting recent unprotected intercourse with a woman will be randomized to the Steering Together in a New Direction (STAND) HIV Risk Reduction Intervention or a No-Intervention Control Condition. To test a strategy to sustain intervention effects, the men also will be randomized to receive or not receive individually tailored text messages. The theoretical basis of the interventions is social cognitive theory and the reasoned action approach, which is an extension of the theory of planned behavior and the theory of reasoned action. Men will complete self-report measures via audio computer-assisted self-interviewing at baseline and immediately post and 6 and 12 months post-intervention. The trial will test whether the STAND HIV Risk Reduction Intervention as compared with the No-Intervention Control Condition, increases consistent condom use, the primary outcome. Secondary outcomes include unprotected intercourse, multiple sexual partners, insertive anal intercourse, and proportion condom-protected intercourse. The trial will also test whether STAND's efficacy is greater among men in the Text Messaging Intervention compared with men not receiving text messages. This will provide information on the utility of a low-cost strategy to extend an intervention's efficacy. Finally, the study will test for mediation of intervention effects: the hypothesis that STAND affects outcome expectancies and self-efficacy, which, in turn, affect consistent condom use.
The goal of this research study is to evaluate the impact of a paraprofessional-delivered, culturally adapted, evidence-based intervention (EBI) on sexually transmitted disease (STD), substance use and poor mental/emotional health among American Indians (AI) through a Randomized Controlled Trial (RCT). These intertwining risks have produced marked disparities and have unique cultural and social determinants in Native communities. If aims are achieved, scientific knowledge and community-based practice will be advanced in areas vital to AI communities, and to STD and drug prevention science. Prior to this study, the investigators applied findings from research protocol (IRB#00005929) and adapted a brief intervention to reduce risk and increase protective behaviors for STDs, HIV/AIDS, substance use and poor mental/emotional health, and to promote STD screening. The specific aim of the current study is to compare the efficacy of the adapted brief intervention vs. a comparison condition on participants' condom use, STD screening and treatment-seeking behaviors, substance use and emotional/mental health outcomes at 3 and 6 months post-intervention.