Clinical Research Directory

Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care

The purpose of the study is to rigorously evaluate Next4You, an innovative, fully mobile program featuring 6 content modules, each containing 8-10 microlessons intended to reduce rates of unintended pregnancy and sexually transmitted infections (STI) and increase essential knowledge, attitudes, and skills among young people aged 16-19 currently in the foster care system in California.

Doxi-Rio: Study on the Use of Doxycycline to Prevent Sexually Transmitted Infections in Rio de Janeiro

The goal of this clinical trial is to learn if doxycycline post-exposure prophylaxis (doxy-PEP) can help prevent bacterial sexually transmitted infections (STIs) among sexual and gender minorities in Rio de Janeiro, Brazil, including men who have sex with men, transgender women, and travestis who are living with HIV or using HIV pre-exposure prophylaxis (PrEP). Bacterial STIs such as syphilis, gonorrhea, and chlamydia remain common in these populations, even with existing prevention strategies. This study aims to answer the following questions: whether doxy-PEP can reduce the number of new STIs, whether it is safe and well tolerated, whether participants use it as recommended, and whether its use may contribute to antibiotic resistance or changes in the body's natural bacteria. Doxy-PEP involves taking a dose of doxycycline, an antibiotic, shortly after sexual activity to reduce the risk of acquiring STIs. Participants will first receive information and counseling about doxy-PEP, including its possible benefits and risks, and will then choose whether or not to use this prevention strategy. Those who choose to use doxy-PEP will take doxycycline after sex as instructed and will be followed for up to 48 weeks, with clinic visits approximately every three months. During these visits, participants will be tested for STIs, monitored for side effects, and asked about medication use, sexual health, and overall well-being. Researchers will collect information on new STI diagnoses, safety, and how consistently participants use doxy-PEP. The study will also explore participants' experiences and perceptions of this strategy. The results of this study will help determine whether doxy-PEP is a practical and acceptable approach for STI prevention in Brazil and may inform future public health strategies.

Health Information Technology to Reduce Disparities in Adolescent Health Outcomes: A Pragmatic Trial

We will compare differences in sexually transmitted infection (STI) detection rates between sexual health survey (SHS)-derived electronic clinical decision support (CDS) versus usual care (e.g. no provision of CDS) using an interrupted time series design. We hypothesize that population-based STI detection rates will be higher when SHS-derived electronic CDS is provided compared to usual care. Secondary analysis will include a comparison of STI detection rates by sexual risk strata (high risk vs. at risk) and race/ethnicity.

Health-E You Efficacy Trial for Male Adolescents

This study will involve evaluating Health-E You/Salud ìTu™, a web-based, pre-visit mobile app designed to support adolescent male youth and his clinicians in discussing sexual and reproductive health (SRH) topics and care. It will test its efficacy among male patients in clinical settings using a stepped wedge cluster randomized controlled trial design.

Sexual Health Empowerment for Women's Health

The purpose of this study is to expand the reach of an existing cervical cancer literacy and prevention intervention- the Sexual Health Empowerment (SHE) Project . As a logical extension of the investigators earlier work, the objective of this renewal is to expand reach of SHE to address women's health disparities more broadly to create a sustainable model for dissemination of health promotion interventions for vulnerable populations.

Wrap It Up Rigorous Evaluation

Unintended pregnancy rates among teenagers are higher in rural counties than urban or suburban counties. Wrap It Up (WIU) is a sexual health education "booster" program for older high school students attending school in rural communities that was designed to help address this situation. Though there is preliminary evidence of the program's effectiveness, it has not yet been rigorously evaluated with a randomized controlled trial. WIU is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they move from high school into adulthood, in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections. Most students this age will have received prior SHE. WIU is a 4-to-5-hour "booster" intervention, delivered during late high school, intended to enhance the effectiveness of previous SHE. The study's primary research question is: What is the impact at 6-months post baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days? The study's secondary research questions are: * What is the impact at 6-months post baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers, peers, and partners about their sexual health? * What is the impact at 6-months post-baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services? * What is the impact at 12-months post-baseline of WIU relative to a "business as usual" comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex, or used condoms or effective birth control when they had vaginal or anal sex, in the past 90 days?

Point-of-care Tests for Vaginal Discharge in Nepal

The goal of this clinical trial is to examine if and how the implementation of point-of care-tests (POCT) for sexually transmitted infections in the management of abnormal vaginal discharge reduces the overtreatment with antibiotics in a low income country. The setting is a university hospital in a semi-rural area in Nepal and several of its rural out-reach-centers. The plan is to include 1500 women attending the gynecological outpatients with a problem of vaginal discharge over approximately a one year period. The main questions the clinical trial aims to answer are: * Does POCT guided treatment result in reduced over-treatment of antibiotics, compared to the current approach in Nepal? * What are the barriers and facilitators of the acceptability of POCTs and the resulting treatment from the perspective of both patients and health care practitioners? Participants will be randomized in three groups: * standard treatment according to current practice * POCT result based treatment * POCT result based treatment plus patient education and addressing of psycho social vulnerabilities

Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing

Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing (S-ITEST), locally known as 4 Youth by Youth (4YBY) in Nigeria, builds on the investigator's previous efforts, which are detailed in ClinicalTrial ID#: NCT04070287, NCT03874663, and NCT04710784. Many adolescents and young adults (AYA, 14-24 years old) in Nigeria have a substantial HIV risk but do not receive adequate HIV prevention services. While pre-exposure prophylaxis (PrEP), HIV self-testing, sexually transmitted infection (STI) testing, and linkage to AYA-friendly clinical services are essential, they have not been widely implemented or sustained in Nigeria. In this study, the investigators aim to 1) use participatory approaches (i.e., crowdsourcing, designathons, and participatory learning communities (PLC)) to develop sustainability strategies that sustain 4YBY in participating community sites served by recruited community-based organizations; 2) test the effects of the standard 4YBY implementation versus standard with enhanced sustainability strategy on site-level adoption and sustainability of the 4YBY intervention across 24 months in participating community sites (n=40) and community-based organizations (n=20); and 3) characterize and estimate the impact and cost-effectiveness of sustaining 4YBY over time. Guided by youth participatory action research (YPAR), the PEN-3 cultural model, Proctor's Implementation Outcomes Framework, and the Consolidated Framework for Implementation Research (CFIR), this study intends to support community-based organizations in implementing and sustaining the 4YBY intervention to increase the uptake of HIV prevention services while optimizing resource allocation to achieve sustainability in collaboration between the Washington University School of Medicine, the University of North Carolina at Chapel Hill, Georgia State University, George Washington University, Monash University, Wake Forest University School of Medicine, and the Nigerian Institute of Medical Research (NIMR).

Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters

The goal of this randomized control trial (RCT) is to assess an innovative adolescent pregnancy prevention program among youth that are at the highest risk of adolescent pregnancy, to prevent pregnancy and Sexually Transmitted Infections (STIs), including HIV/AIDS in the greater Miami area in Florida. The primary research question it aims to answer is: (RQ1a): What is the effect of adding 4.5 hours of Mind Matters trauma-coping skills curriculum to the Relationship Smarts Plus curriculum, on rates of unprotected sex among 9th and 10th graders compared to the students receiving only the 14-hour-long Relationship Smarts Plus curriculum? (RQ1b): What is the effect of the 14-hour-long Relationship Smarts Plus curriculum on rates of unprotected sex among 9th and 10th graders compared to the control group receiving only financial literacy? Participants will complete program lessons and complete surveys for data collection. The RCT will assess behavioral health outcomes and other psychological outcomes at four-time points (baseline, post-program, 3 months, and 12 months)

CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama

Pre-exposure prophylaxis (PrEP) is an important biomedical human immunodeficiency virus (HIV) prevention tool and may particularly benefit black, cis and trans-gender women, who are at an increased risk for HIV and Sexually Transmitted Infections (STIs). The purpose of this study is to use a population-based approach to create a cohort of cis and trans-gender women at risk for future HIV acquisition to better understand the factors associated with the risk of STIs and HIV diagnosis and predictors of PrEP use.

Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults

The proposed hybrid effectiveness-implementation study will systematically adapt the Informed, Motivated, Aware, Responsible Adolescent Girls and Adults (IMARA) curriculum that was previously adapted for South Africa (IMARA-SA) to use in Zambia (will be renamed Zambian Informed, Motivated, Aware, Responsible Adolescent Girls and Adults (ZAIMARA) and evaluate the impact of ZAIMARA on improving adolescent girls and young women HIV testing, HIV and STI incidence, PrEP uptake and sexual risk behaviour. The study will also assess the impact of monthly mental health screening with referral versus a monthly nutrition and exercise screening on peer leaders job retention. We will also examine implementation factors and outcomes associated with ZAIMARA across five sites.

Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: * Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? * Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? * Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk

This study will test the effectiveness, implementation outcomes, and cost effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C, and overdose risk behavior in rural Appalachia. The proposed project will take place in two counties in Appalachian Kentucky, an epicenter for the intertwined national crises of injection drug use, overdoses, and hepatitis C.

Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth

This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.

Evaluation of Parent Toolkit 2.0 (Morehouse Family Health Study)

Child Trends will conduct a randomized control trial evaluation of Parent Toolkit 2.0, an innovative intervention for parents and caregivers of middle and high school students. Child Trends will collaborate with Morehouse School of Medicine and Tressa Tucker \& Associates, LLC to implement and evaluate the program with 1,000 parent-teen pairs across Georgia. The program includes three components that will be delivered across a three-week period: (1) an online self-paced Parent Guide with information, tips, tools, and resources on adolescent health, including sexual health; (2) four videos modeling parent-teen communication around sex and contraception; and (3) two group-based sessions for parent participants to discuss program content and improve communication skills. The program aims to increase parent knowledge and parent-teen communication about adolescent health, sexual health, and relationships to help youth adopt health-promoting behaviors such as delaying sexual initiation and increasing contraceptive use.

Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth

The purpose of this study is to examine whether treatment of pregnant Malawian women with repeated doses of sulfadoxine-pyrimethamine and azithromycin antibiotics will prevent preterm deliveries and result in other health benefits both for the mother and the foetus/newborn.

Pharmacokinetic Characterization of a Single 200 mg Dose of Doxycycline in Post-exposure Prophylaxis (PEP) of Sexually Transmitted Infections in Different Biological Compartments

Post-exposure prophylaxis (PEP) using doxycycline 200 mg within 24 hours of unprotected sexual intercourse to prevent sexually transmitted infections has demonstrated a reduction in the incidence of chlamydial and syphilis infections and syphilis infection by 70% and 73% in men who have sex with men (MSM) undergoing pre-exposure prophylaxis prophylaxis (PrEP) for HIV. Other studies are underway or in development on doxycycline prophylaxis for bacterial STIs, which are particularly common in this population. Monitoring adherence to PEP is of great interest in guaranteeing the effectiveness of this strategy and to be able to assess the uptake of PEP among PrEP users. Among the many methods for assessing adherence, measuring drug concentrations is a more accurate measure of adherence than self-reporting. The therapeutic monitoring of doxycycline and the assessment of adherence have been described using plasma and hair samples, allowing estimation of intake over the last 3-4 days and 4 months, respectively. Nevertheless, these biological matrices present several limitations for application in clinical practice: reflecting the duration of exposure should be more in line with the frequency of visits (2 months), and the collection of hair samples may be difficult due to refusal or short hair. On the other hand, interpretation of the hair assay is limited by the degradation of doxycycline in this matrix, which could lead to underestimation of drug intake. By Therefore, new biological matrices are needed for more accurate assessment of doxycycline adherence in post-exposure prevention monitoring. The objective is to evaluate the pharmacokinetics of doxycycline in plasma, whole blood, dried blood spots (DBS), urine and hair after a single dose of doxycycline in men using oral doxycycline for post-exposure prophylaxis of sexually transmitted infections (syphilis or Chlamydia trachomatis) and having sex with men.

Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents

We will conduct a randomized trial to compare differences in sexually transmitted infection (STI) treatment adherence between patients receiving text messages versus those receiving usual care (e.g. no text messages). We hypothesize that STI treatment adherence will be 20% higher among patients randomized to receipt of two-way text messaging services.

Our Healthbox - Evaluating Interactive Dispensing Systems for Low-Barrier Access to HIV Testing and Harm Reduction.

When REACH Nexus at MAP Centre for Urban Solutions out of St. Michael's Hospital launched its signature program, I'm Ready in 2021, our goal was to democratize access to free HIV self-testing to reach the undiagnosed in Canada. The program, the first of its kind in Canada has been successfully rolling out 50,000 free, HIV self-tests and connecting participants via a mobile app on an iOS or Android smart phone to care. While this is an important milestone in improving access, REACH knows that more needs to be done. An estimated 20-30% of undiagnosed individuals do not have access to a phone to order the HIV self-tests, and many face multiple barriers to accessing healthcare and harm reduction support: chaotic life circumstances, addiction challenges, stigma and more. Everyone in Canada should have equitable access to the health care they need. But REACH knows that this is not the case.So, REACH is working hard to change this. hese ongoing barriers inspired us to continue creating innovative solutions, and launch our second signature program, Our Healthbox. Our Healthbox meets people where they are, with what they need for their health and well-being. This program is scaling up innovations in health technologies to reach undiagnosed individuals with HIV. These smart interactive vending machines will be strategically located across Canada. The goal is to reach people where they live to provide free and low barrier access to HIV self-testing kits, STBBI testing and other harm reduction supplies. Participation in Our Healthbox, as with I'm Ready, also gives us the opportunity to collect important data that will continue to inform and guide REACH Nexus' work to grow and scale innovative health solutions across the country.

Combination Therapy Between Doxycycline, Pentoxifylline, and Nitazoxanide in Sexually Active Men

Bacterial sexually transmitted infections (STIs) have been steadily increasing in gay, bisexual, and other men who have sex with men (MSM) over the past 2 decades. While that trend started prior to the introduction of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) in 2012, HIV PrEP has been associated with increases in sexual contacts and decreases in condom use with an resultant acceleration in the increase of bacterial STIs such as gonorrhea, syphilis, and chlamydia.

Comparing Mobile Health Strategies to Improve Pre-exposure Prophylaxis Use (PrEP) for HIV Prevention

The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV pre-exposure prophylaxis (PrEP) as directed by the clinic. PrEP is the use of a daily anti-HIV medications by HIV-negative people to help prevent HIV infection.

Vienna HIV Infection Via Sex Study

The main objective of this prospective observational cohort study is to investigate the epidemiology, the risk factors and ultimately the incidence of novel HIV infections among individuals at high risk for acquiring HIV via sex practices.