Clinical Research Directory

Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT

Sexually transmitted infections (STIs) caused by Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are increasing in France, with a significant proportion of asymptomatic infections. Standard management in sexual health clinics (called CeGIDD) relies on laboratory-based PCR tests with turnaround times of 24-72 hours, leading to frequent empirical antibiotic prescriptions, including broad-spectrum therapies. This practice contributes to antibiotic overuse and the emergence of antimicrobial resistance. The OPTIMISE study evaluates the clinical impact of implementing the cobas® Liat® CT/NG point-of-care test (POCT) in CeGIDD settings. The hypothesis is that immediate, on-site molecular testing enables: Significant reduction in unnecessary antibiotic prescriptions, particularly in asymptomatic exposed individuals, Targeted monotherapy in symptomatic patients, reducing broad-spectrum antibiotic exposure, Improved patient satisfaction and adherence through immediate diagnosis and treatment, Feasibility and acceptability of POCT integration in sexual health care pathways. The study is a prospective, single-arm, bicentric interventional RIPH2 study including approximately 700 adults consulting in CeGIDD clinics of the Hospices Civils de Lyon, either for symptomatic STI suspicion or recent sexual exposure to CT/NG. Outcomes include the proportion of avoided antibiotic prescriptions, patient and provider satisfaction, and descriptive epidemiology of non-CT/NG pathogens.

Technology-based Training Tool for PHAT Life

Youth under age 18 involved in the criminal justice system are disproportionately minorities \& affected by substance abuse, mental illness, \& HIV/STI. Most young offenders are released on community supervision without the STI, mental health, or substance use screening, diagnosis, \& treatment afforded detained youth, despite similar rates of risk behavior. Their long-term trajectory is poor, costs to society are high, \& lasting effects on community well-being \& individual employment prospects are profound. Altering this trajectory is a public health priority. Preventing HIV Among Teens (PHAT) Life is an evidence-based program that meets the need in juvenile justice to address youths' co-morbid health problems. The next step in ensuring that this decade-long line of research produces actual, real-world improvements in the lives of probation youth is to develop a PHAT Life training strategy that is effective, cost-effective, \& sustainable within juvenile justice settings. The private/public collaboration between ORBIS \& UIC will leverage existing resources \& competencies to create a commercially viable technology-based training tool for PHAT Life with great potential for sustainability \& cost-effectiveness. This Phase II uses a formative process to refine, enhance \& complete the technology-based training tool to include: (a) an interactive multimedia web browser \& mobile application, (b) dynamic multimedia presentations \& interactive queries, (c) video examples of mock intervention delivery, (d) audio narration along with scripted language, (e) brief quizzes to ensure comprehension \& knowledge acquisition, (f) opportunities to "learn more" by clicking on tabs for supplemental information, (g) targeted referrals to appendix materials, (h) games to promote engagement, \& (i) other adaptations based on Phase I feedback. The proposed technology-based training tool should be highly sustainable, because it (a) relies on "indigenous" personnel to deliver the intervention, (b) is likely to prove cost-effective since it will utilize a technology that can deliver training at scale, \& (c) will improve fidelity by leveraging technology to provide consistent training experiences to para-professionals. The training tool will be evaluated via a 2-arm RCT with 130 individuals who work with justice-involved youth. Trainees will receive the technology-based training tool.

STI Screening for Women With Disabilities in Zambia

The goal of this observational study is to assess the prevalence of sexually transmitted infections (STIs), mental health disorders, and substance abuse among women with physical and psychosocial disabilities in Lusaka, Zambia, while exploring the intersectional factors that influence their access to healthcare services and health-seeking behaviors. The study targets women aged 18-49 years living with disabilities, a population historically excluded from STI surveillance and care despite facing heightened vulnerabilities. With approximately 376 million new curable STI cases occurring globally annually, women with disabilities face disproportionately higher risks due to biological vulnerabilities, socioeconomic disadvantages, and structural barriers. In sub-Saharan Africa, STI prevalence among women ranges from 8.5% to 32.7%, with evidence suggesting even higher rates among women with disabilities. In Zambia, disability prevalence is estimated at 29.9%, and women with disabilities have a 2.21-fold higher likelihood of HIV infection during antenatal care compared to the general population. Despite these statistics, a critical data gap exists regarding STI burden among Zambian women with disabilities. Existing research focuses on HIV in the general population, neglecting CT/NG, syphilis, and cervical cancer in disabled women. Women with disabilities encounter numerous barriers including physical inaccessibility, provider biases, 50% less sexual health education, higher rates of risky sexual behavior, stigma, and 3-4 times higher likelihood of sexual violence. Most health facilities lack disability-inclusive amenities, discouraging service access and leaving infection burden unknown. Target population includes women aged 18-49 years with physical and psychosocial disabilities residing in Lusaka district. Purposive sampling will recruit participants. Inclusion criteria: women aged 18+ with confirmed disability (WHO Assessment Schedule), willing to provide informed consent, sexually active within the past 12 months. Exclusion criteria: women without disabilities, cognitive disabilities, unable to provide consent, severely ill/hospitalized. Minimum sample size of 150 participants calculated at 95% CI with 5% margin of error, adjusted by 10% for nonresponse (target \~165 participants). At the end of the study, STI prevalence will be documented , providing comprehensive data on infection burden; quantification of anxiety, depression, and substance abuse prevalence with associations to STI status. Research Assistants and sign-language interpreters conduct health education at the recruitment site and assess eligibility. Women expressing interest are consented, after which the Research Assistants administer the WHODAS questionnaire collecting sociodemographic and disability-related data. Additionally, they will collect data on quality of life (EQ-5D-5L) and mental health status - anxiety, depression (PHQ-5), post traumatic stress disorders (PC-PTSD-5), and substance abuse (ASSIST). Women will then be transported to a health facility for Chlamydia and Gonorrhoea screening by collecting a vaginal swab for testing on GeneXpert™. At the same time, women will be screened for Cervical Cancer using Visual Inspection with Acetic Acid (VIA). Positive lesions may prompt same-day LEEP or cryotherapy. Women will also be tested for HIV/Syphilis using the Rapid point-of-care test (Bioquick™ HIV/Syphilis Duo) using venous blood, results in 10-20 minutes. Positive STI results will prompt same day treatment and partner referral. Women identified with severe mental health conditions will be referred for further management. Data will be collected on a tablet and submitted to a database created in RedCap with automated range/consistency checks. Data reviews will be conducted daily. Analysis includes descriptive statistics, prevalence with 95% exact confidence intervals, unadjusted prevalence ratios, and multivariable logistic regression using backward selection (significance set at 0.05). Ethical approval will be obtained from UNZABREC and NHRA. Informed consent will be provided in private settings. Participants may withdraw consent at any time. Risks are minimal (speculum discomfort, mild cramping, possible bleeding) and managed with standard protocols. Privacy will be protected through anonymization, study ID assignment, locked cabinets, and restricted access. Participants receive counseling on the importance of partner notification. Adverse events and protocol deviations will be reported per UNZABREC requirements.

Sexual Behavior and Risk Perception as Factors Associated With STI Incidence in Young Adults

This observational cross-sectional study aims to assess sexual behavior and perception of sexual risk among young adults aged 18 to 25 years in Barcelona, Spain, and to examine their association with self-reported sexually transmitted infections (STIs). The study will also explore knowledge and beliefs about STIs, protective practices such as condom use, number of sexual partners, and experiences of sexual pressure or coercion. The study will use a validated scale to assess perception of risk related to sexual behavior, together with an additional questionnaire developed for the study population.

Optimizing the Floreciendo Sexual and Reproductive Health Workshop for Latina Teens and Female Caregivers: A Pilot

Floreciendo is a sexual and reproductive health workshop for Latina teens (ages 14-18 years) and their female caregivers (e.g., mothers, sisters, grandmothers). This study involves conducting a pilot optimization trial of Floreciendo using the multiphase optimization strategy (MOST) framework. The feasibility of using a 2 x 2 x 2 factorial trial design and the acceptability of the intervention components of Floreciendo will be examined. Effectiveness and implementation outcomes will be explored. This work will be conducted in partnership with community-based organizations in the Chicagoland area.

HIV/STD Risk and PrEP Implementation Messaging Among Gay, Bisexual, and Other Men Who Have Sex With Men

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

Gathering Online for Dialogue and Discussion to Enhance Social Support

The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with up to 500 young women who are human immunodeficiency virus (HIV)-negative and who misuse alcohol. The expected outcomes are to: (1) determine the efficacy of the virtual group component in reducing alcohol use and sexual risk and increasing pre-exposure prophylaxis (PrEP) utilization; and (2) understand selected outcomes for implementation. Participants will be randomized to receive either the mHealth app or the mHealth app plus the group component, and followed up at 3- and 6-months post-enrollment.

Evaluation of the SafeSpace App Intervention

The goal of this study is to evaluate the impact of SafeSpace Sexual Health App, an innovative sexual health promotion program focused on reducing sexual risk factors and promoting sexual and reproductive health and wellbeing among young people assigned female or intersex at birth, particularly Black and/or Latine youth, LGBTQ+ youth, youth in states with high teen birth rates and youth who live in rural communities. This study utilizes a two-arm randomized control trial design to measure impacts of receiving the SafeSpace Sexual Health program compared to receiving a similar-length control app program, SafeSpace General Health that focuses on general health. The investigators will ask participants to: * Keep the SafeSpace app downloaded to their device and visit the app regularly over the course of 10 weeks. * Provide contact information. * Receive and open app push notifications for 10 weeks (up to 3 per week). * Complete 3 online surveys over a year: baseline, short-term follow-up (10 weeks after baseline), and long-term follow up (9 months after short-term follow-up). * Receive occasional text messages from the study team.