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STI clinical trials

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NCT ID: NCT05072093 Active, not recruiting - HIV Clinical Trials

Parrying the Pitfalls of PrEP: Project PEACH

Start date: November 20, 2021
Phase: Phase 4
Study type: Interventional

The study is a prospective cohort of young MSM who are followed for 2 years either in-person at the PRISM Health Research Clinic and/or virtually with telehealth study visits. Follow-up visits occur as frequently as every 3 months, or as appropriate to clinical needs of HIV PrEP or STI PEP. The investigators will enroll men who may decide to start or stop PrEP, change from daily oral PrEP to on-demand oral PrEP or from on-demand oral PrEP to daily PrEP, to start or stop STI PEP at any point in the study period, or injectable PrEP as an alternative to daily oral PrEP or on-demand oral PrEP. All men will be provided with the study's mobile smart phone app to support early identification of risks for PrEP discontinuation, to provide information about STI PEP and document usage patterns of on-demand oral PrEP and STI PEP, and to support easy linkage to support services for PrEP counseling and addressing concerns or questions about STI PEP and injectable PrEP.

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.

NCT ID: NCT04793841 Recruiting - STI Clinical Trials

Population Burden of STI and Implication for Intervention in Hong Kong

Start date: May 13, 2021
Phase:
Study type: Observational

This is a 5-year cross-disciplinary sexually transmitted infection (STI) project involving a) territory-wide and community-based studies (survey and specimen collection); b) simulation of STI transmission dynamics and comparison of STI intervention strategies through mathematical modelling and cost-effectiveness analysis. The aim of this project is to assess the burden and the transmission dynamics of STIs in the general population and men who have sex with men (MSM) in Hong Kong. Around 1300 sexually experienced adults and 900 MSM would be recruited, 100 participants would be invited for individual in-depth interviews. Main outcome measures include STI history and service preference, effectiveness as measured by the proportion of new STI infections (chlamydia, gonorrhoea and human papillomavirus infections) averted above base-case scenario, and incremental cost-effectiveness ratio.

NCT ID: NCT04666792 Recruiting - HIV Infections Clinical Trials

PrEParing Family Planning Clinics to Streamline Integration of HIV Prevention Services for Young Women in Kenya

Start date: March 1, 2021
Phase: Phase 4
Study type: Interventional

This a prospective, open-label implementation project to catalyze integration of HIV prevention and PrEP care services for adolescent girls and young women in family planning clinics in Kenya.

NCT ID: NCT04468724 Recruiting - HIV/AIDS Clinical Trials

MAKASI Intervention for African and Caribbean Migrants' Empowerment in Sexual Health in Paris Greater Area

MAKASI
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Background. Immigrants from Sub-Saharan Africa are the second group most affected by HIV in France. Part of these HIV infections occurred after arrival in France, in relation to social hardships. Immigrants coming from the non-French Caribbean islands face similar difficulties. Many actors strive for an easier access to healthcare services for immigrants; however the mere supply of knowledge and medicalised solutions is not enough to make persons adopt prevention behaviours. It seems necessary to act upon empowerment to bring resources to individuals and communities in order to improve their autonomy and action capacity. Civil Society Organisations and researchers join forces in the MAKASI interventional research which aims at reinforcing immigrants' empowerment in sexual health in order to reduce their exposure to sexual risks. Objectives : The MAKASI intervention consists in a unique Empowerment interview based on the principles of motivational interviewing, using an Active Referral system to social or sanitary services relevant to the person's needs. Our hypothesis is that this intervention is going to reinforce four dimensions of empowerment in sexual health among immigrants: the capacity to express their needs, competencies in sexual, self-esteem, awareness of exposure to HIV and STIs. The proposed research aims at measuring the efficacy of the intervention on these four dimensions, and at evaluating its processes and efficiency (cost-efficacy). Methods: The intervention is delivered within the mobile units of Afrique Avenir in the public spaces where African and Caribbean populations live and work. The evaluation uses integrated mixed-method approach, combining a quantitative evaluation of impact and a qualitative research on processes. The measure of impact will be done by comparing indicators on the four dimensions of empowerment in sexual health and indicators of exposure to sexual risks, between an arm where the intervention is immediate and an arm where the intervention is differed by 3 months (control arm). The qualitative evaluation of the intervention processes will be based upon an ethnographic approach of the intervention and the participants' experience. Perspectives: This project will demonstrate the efficacy and the efficiency of an innovative intervention aiming at reducing Sub-Saharan and Caribbean immigrants' exposure to risks in sexual health.

NCT ID: NCT04429061 Completed - HIV Infections Clinical Trials

Reaching 90 90 90 in Adolescents in Zambia: Using All Our SKILLZ

SKILLZ
Start date: February 1, 2020
Phase: N/A
Study type: Interventional

"SKILLZ," is a mixed methods evaluation of the Grassroots Soccer (GRS) SKILLZ Package based in Lusaka, Zambia. The package is made up of three football-based programs: (1) SKILLZ-Girl - implemented in schools as part of a 10-week program culminating in a tournament event; (2) SKILLZ-Club - implemented as an ongoing extra-curricular activity after the completion of SKILLZ-Girl; (3) SKILLZ-Plus - a clinic based football group targeted at girls that are HIV-positive. The programs work together to build a continued support system which encourages uptake of Sexual Reproductive Health (SRH) and HIV services, while facilitating ART adherence (for HV-positive participants) and continued engagement with health services over the long-term (whether to contraceptive methods, HIV prevention services, HIV repeat testing, and/or HIV treatment and care). The study team has developed an enhanced SKILLZ-Girl offering, which will include a comprehensive module on HIVST, contraceptives and PrEP, access to a nurse during the implementation of sessions and the additional offering of HIVST and contraceptive services at the event along with ongoing engagement through the SKILLZ-Club program (Enhanced Arm) , The central hypothesis is that this enhanced curriculum will increase HIV testing and contraceptive uptake compared to the standard SKILLZ curriculum & standard event (SOC Arm). The investigators further hypothesize that the intervention in the enhanced arm will positively and directly affect a number of mediating factors including attendance at soccer events where community-based SRH services are offered, SRH knowledge, empowerment, self-confidence, and perceptions of gender balance, and (reduced) stigma. For girls found to be HIV-positive, the follow-on SKILLZ intervention (SKILLZ-Plus) has been designed to facilitate linkage to HIV care and treatment, reduce HIV-related stigma, increase disclosure to family and partners, increase feelings of social support, empowerment, self-efficacy, and ultimately adherence to ARVs, viral load suppression (VLS) and retention in HIV care and treatment. This study will be conducted in up to 32 secondary schools that GRS currently serves in the Lusaka Urban District.

NCT ID: NCT04378439 Recruiting - HIV/AIDS Clinical Trials

Appalachian Partnership to Reduce Disparities (Aim 2)

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

By combining two strategies (i.e., peer navigation and mHealth) into a complete, culturally compatible, bilingual intervention to increase the use of needed HIV, STI, and HCV prevention and care services among racially/ethnically diverse GBMSM and transgender women in rural Appalachia. Study Investigators anticipate that participants in the intervention group, relative to counterparts in the delayed-intervention group, will demonstrate increased HIV, STI, and HCV testing.

NCT ID: NCT04222504 Recruiting - Contraceptive Usage Clinical Trials

Community-based Venues for Delivery of Healthcare Services: Proof of Concept Pilot

Start date: February 8, 2021
Phase: N/A
Study type: Interventional

The investigators propose to offer a package of evidence-based health services to women in three hair salons in the Umlazi township of Durban. Based on community feedback in previous survey and qualitative work, the package has been designed to include daily PrEP, family planning/contraceptives, and STI screening. Interested salon clients at intervention salons will elect which services to use. An additional three salons will serve as controls, offering no health services to clients. Surveys will be conducted in both salon groups. Attendance at follow-up visits for monitoring and medication refill will be encouraged using text message reminders, WhatsApp support groups, and lottery-based incentives for free salon services. Recruitment in intervention salons will conclude when 200 clients uptake PrEP. Two hundred participants will be recruited in control salons.

NCT ID: NCT03897049 Completed - HIV/AIDS Clinical Trials

Evaluation of the Trans Women Connected Mobile App for Changes in Sexual Health-related Behavior Among Transgender Women

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

The study is a 2-arm cluster randomized controlled trial to be conducted with 450 trans women to assess the effectiveness of the Trans Women Connected mobile app. Those in the treatment arm will be provided with the Trans Women Connected app, to be downloaded to their own device, and asked to use it during a month period. Those in the control arm will be asked to download a general health app and use it during a month period. Participants will complete brief online surveys at baseline, immediately following the app-use period (1-month post baseline), and at 3- and 6-months following baseline. The baseline and follow-up assessments will collect data on demographic characteristics, measures related to our primary and secondary outcomes, and psychosocial measures. The primary outcome measures are self-reported sexually transmitted infection (STI)/HIV testing and sex without a condom, with secondary measures including sexual risk behaviors, health care visits, perceived social support/connectedness, pre-exposure prophylaxis (PrEP) use, self-efficacy in negotiation/communication, and comfort with gender identity and appearance. In addition, process data, such as forum content, and usage data will be collected and analyzed.