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NCT ID: NCT06205368 Recruiting - HIV Infections Clinical Trials

Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men

CombineApp
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

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

NCT ID: NCT06014177 Recruiting - STI Clinical Trials

A Digital Patient Decision Aid to Increase Sexually Transmitted Infection Testing in the Emergency Department: The STIckER Study

STIckER
Start date: September 12, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05949814 Recruiting - HIV Infections Clinical Trials

Acceptability of a PrEP Program Among MSM and Transgender (TG) and Having Accepted a Targeted Screening for HIV, Hepatitis B (VHB), Hepatitis C (VHC) and STIs.

Easy-Tests
Start date: July 30, 2023
Phase:
Study type: Observational

Acceptability of a PrEP program among MSM and TG visiting a geolocated community application or a community physical place of sociability and having accepted a targeted screening for HIV, Hepatitis B, C and STIs.

NCT ID: NCT05856942 Recruiting - HIV Prevention Clinical Trials

Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program

HOT4PrEP
Start date: March 8, 2022
Phase: N/A
Study type: Interventional

The study's aim is to implement a home-based PrEP (HB-PrEP) monitoring system (self-collected blood and extragenital specimens at home and telehealth follow-up) into a large, urban sexual health clinic while also evaluating the program's clinical effectiveness. Study participants will self-collect blood specimens using Tasso devices, which are currently designated as FDA Class 2 exempt medical devices (similar to a medical lancet). This study will be integrated into King County's Ending the HIV Epidemic plan and generate data to inform refinement, adaptation and scale-up of future HB-PrEP programs. Specific research aims are to: 1. Conduct a hybrid randomized trial to compare the impact of a HB-PrEP program versus standard of care (routine in-clinic monitoring) on PrEP retention over time and use mixed-methods assessments to define the factors that influence HB-PrEP implementation. Hypothesis: HB-PrEP will increase PrEP retention rates by >10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits. 2. Perform a cost analysis of the HB-PrEP implementation strategy compared to standard care. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC. 3. Develop a qualitative tool to engage healthcare stakeholders and determine the wider scalability of HB-PrEP.

NCT ID: NCT05789134 Recruiting - STI Clinical Trials

Mycoplasma Genitalium Infection and Associated Antimicrobial Resistance Among HIV-infected Male in Hong Kong

Start date: July 24, 2023
Phase:
Study type: Observational

Worldwide, Mycoplasma genitalium (MG) is increasingly reported as an emerging cause of sexually transmitted infections. Internationally, the prevalence of MG is higher in male with urethritis and community groups especially among people living with HIV (PLHIV). While MG is treatable, antimicrobial resistance is a rising concern. This cross-sectional study aims to determine the prevalence of MG infection and the antimicrobial resistance pattern in HIV-infected male in Hong Kong. A total of 750 HIV-infected male attending HIV specialist clinic in Hong Kong would be recruited. The main outcome measures include prevalence of MG and resistance mutations to macrolide/fluoroquinolone in HIV-infected male; prevalence of MG/STI co-infections, as defined by concurrent detection of MG and one or more other bacterial STI.

NCT ID: NCT05723484 Recruiting - STI Clinical Trials

Comparing a Novel Point-of-care Cytokine Biomarker Lateral Flow Test With Nucleic Acid Amplification Tests for Detection of Sexually Transmitted Infections and Bacterial Vaginosis

GIFT
Start date: June 1, 2023
Phase:
Study type: Observational

1. To evaluate the performance of a lateral flow POC test, namely the Genital InFlammation Test (GIFT), for identifying women with inflammatory STIs and BV, who are at higher risk of HIV infection and reproductive complications; 2. To evaluate how the GIFT device can be integrated in a feasible, acceptable, and cost-effective way into routine care.

NCT ID: NCT05395754 Recruiting - Clinical trials for Sexually Transmitted Diseases

Assessing the Feasibility and Preliminary Impact of a mHealth App on Reducing STI Risk in Black MSM PrEP Users

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The study will recruit 120 Black men who have sex with men (BMSM) from the local area, New Orleans. The main purpose of this research study is to test the effect of a new smartphone application, "PCheck," on reducing the incidence of STIs, compared to routine care through the LSU-Crescent Care Sexual Health/PrEP Clinic.

NCT ID: NCT05125380 Recruiting - Cervical Cancer Clinical Trials

Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC). Specific aims are the following: - To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV. - To evaluate the prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and other STIs in the cohort. - To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN). - To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer

NCT ID: NCT04921618 Recruiting - Hiv Clinical Trials

Partner Notification of Sexually Transmitted Infections (STIs) in Testing Centers

Not'IST
Start date: July 12, 2021
Phase:
Study type: Observational

Since the 2000s, the incidence of bacterial STIs increases, mainly among men who have sex with men but also among heterosexual men and women with multiple sexual partners. A partner notification (PN) approach could break transmission chains and curb STI epidemics. PN brings together a set of interventions to help people diagnosed with STIs to inform their partners, encourage them to get tested, so that they can access treatment or prevention. A PN approach, systematically offered at STI diagnosis, has not yet been implemented in France and needs to be evaluated. In 2018, the Conseil National du Sida (French National AIDS Council) stated in favor of a formalized PN approach, particularly in testing centers, which carry out a large part of STI diagnoses. The aim of our research project is to build interventions facilitating information, testing and treatment of partners of people diagnosed with STIs in testing centers and sexual health clinics. Step 1: A cross-sectional study Primary objective To describe the PN practices of people diagnosed with an STI in testing centers and sexual health clinics without any intervention Secondary objectives - To describe the profiles of people diagnosed with an STI in testing centers or sexual health clinics and therefore likely to receive an intervention to help them notify their partners; - To describe the profiles of people notified by their partners and who attend testing centers or sexual health clinics for STI testing; - To describe the notification received by these notified partners and identify the facilitators of testing use following notification. Step 2: A qualitative study Objectives - To evaluate the acceptability of testing center staff for an STI notification program in general and discuss the feasibility of interventions pre-identified by a literature review; - In a collaborative (researchers and staffs) approach, to adapt these interventions to (1) the testing centers working and (2) the needs of their users identified in the cross-sectional study. Expected results This study is the first step in implementation of a PN program as part of a comprehensive management of STI diagnoses in France.

NCT ID: NCT04832477 Recruiting - Substance Use Clinical Trials

Assessing the PrEP Care Cascade Among Black Men and Transwomen in the Southeastern US

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

The proposed research aims to assess the multiple forms and paths of stigma and substance use as they relate to pre-exposure prophylaxis (PrEP) use for HIV prevention. How stigma and an evolving public health landscape impact PrEP use among Black sexual minorit men who use substances is unknown. The current application focuses on addressing critical and novel questions to improving the essential building blocks of biomedical prevention approaches by providing crucial information for enhancing interventions to lower HIV prevalence among substance using Black sexual minority men.