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Chlamydia clinical trials

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NCT ID: NCT04553068 Completed - Clinical trials for Sexually Transmitted Diseases

Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection

EVOGUARD
Start date: October 15, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection

NCT ID: NCT04325555 Completed - Clinical trials for Sexually Transmitted Diseases

Pre-exposure Prophylaxis: A Miracle Drug or a Moral Hazard

Start date: January 20, 2020
Phase:
Study type: Observational

The investigators study the behavioral consequences of Pre-exposure Prophylaxis or PrEP on sexual health behaviors, sexual health outcomes, and partner selection preferences. The study collects observational, self-reported data on PrEP status, PrEP taking-history, PrEP adherence over the last 30 days, STD diagnosis history dating back to January 2015 up to December 2019, sexual health behaviors (e.g., positioning, number of lifetime/recent partners, condom adherence etc.), and various demographic characteristics. The survey finishes with a conjoint experiment which asks respondents to select between two potential partners, and follow-up question about each profiles. Potential partners' characteristics include recreational drug use and condom adherence. Recruitment is conducted via running an ad on Facebook in New York, London, Toronto and Sydney for comparative purposes, as these metro areas have varying levels of PrEP use and accessibility.

NCT ID: NCT03896776 Completed - HIV/AIDS Clinical Trials

A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)

Start date: October 9, 2019
Phase: N/A
Study type: Interventional

This study evaluates and compares two implementation strategies of an online HIV prevention intervention: Strategy 1 in which community-based organizations apply, and are selected, for funding to deliver Keep It Up! through current HIV testing programs; and Strategy 2 which is a "direct-to-consumer" model where centralized staff at Northwestern University recruit participants nationally through online advertising campaigns and manage engagement.

NCT ID: NCT03895320 Completed - Adolescent Behavior Clinical Trials

Protecting Our Future Generation: Promotion of Protective Sexual Health Practices Among Native American Youth and Young Adults Through an Assets-based Self-care Intervention

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

The aim of this research protocol is to test the efficacy of a self-care intervention through a randomized controlled trial (RCT), for increasing protective sexual health behaviors among youth in the participating Native American community. The investigators will randomize 450 youth and young adults ages 14-26 to the self-care intervention or a control program. Efficacy data will be collected up to 6 months post-intervention. The primary outcome will be uptake of sexually transmitted infection (STI) screening. Secondary outcomes will include: a) sexual risk and protective behaviors; and b) psychosocial assets and resources. The investigators hypothesize the self-care intervention will increase protective behaviors by: i) helping youth gain knowledge of their own sexual health risks, assets and resources; ii) motivating protection of those assets and resources; and iii) encouraging good health practices and making responsible choices.

NCT ID: NCT03284541 Completed - Hiv Clinical Trials

Online HIV Prevention for Young Male Couples

2GETHER
Start date: April 5, 2018
Phase: Phase 2
Study type: Interventional

Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise. There has been a relative dearth of research dedicated to understanding these health disparities between gay/bisexual and heterosexual youth, and even less has focused on identifying factors that might promote resilience against negative health outcomes. Understanding both risk factors and processes of resilience is critical in developing efficacious interventions to improve health in this population. Through a grant from the National Institutes of Health, the investigators completed formative research with young male couples. Qualitative interviews identified preferences for couples-based intervention format and content. While coupled YMSM expressed some interest in HIV prevention, they were most interested in building relationship skills. Coupled YMSM preferred group-based interventions in order to meet and learn from other couples but had concerns about discussing personal topics in groups. Quantitative analyses found that the rate of condomless sex in couples increased from adolescence to young adulthood. Further, the influence of older partners, partner violence, and drinking before sex were strongest in emerging adulthood. Informed by these, the investigators developed 2GETHER, which aims to reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a four session program. The first two sessions are group sessions aimed at skills building, and the second two sessions are individualized couple sessions aimed at skills implementation. Modules address communication skills, coping with stress (both general and sexual minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in couples regardless of HIV status; couples learn to use behavioral and biomedical approaches to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis on the health of the couple. The investigators completed a pilot trial of 2GETHER with funding from Northwestern University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility, acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized pre-/post-test design because the goal was to evaluate feasibility, acceptability and preliminary effects in a large number of diverse couples to inform a future efficacy RCT. Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial recruited a diverse sample of couples in less than one year and each program module receive high ratings of acceptability during post-sessions evaluation and an exit interview. At the 2-week post-test, the investigators observed significant decreases in HIV risk behavior, improvements in motivation to reduce HIV risk, and improvements in relationship investment. The current study will conduct a randomized controlled trial (RCT) to test the efficacy of 2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that aims to reduce HIV transmission risk by optimizing relationship functioning. This RCT will be implemented online; both the experimental and control condition will be administered via video-conferencing technology to couples across the United States. The investigators will conduct this RCT with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER intervention or existing public health practice (PHP). PHP differs depending on the HIV status of individuals in the dyad. Couples in which both members are HIV-negative will receive the single-session Couples-Based HIV Counseling and Testing (CHCT) protocol. Couples in which both members are HIV-positive will receive the single session Life-Steps medication adherence protocol. Couples with discordant HIV statuses will receive both interventions jointly.

NCT ID: NCT03186534 Completed - Hiv Clinical Trials

Randomized Trial of an HIV Prevention and Relationship Education Program for Young Male Couples

2GETHER
Start date: August 21, 2017
Phase: Phase 2
Study type: Interventional

Young gay, bisexual, and other men who have sex with men (YMSM) are the only risk group in which rates of new HIV infections are on the rise. There has been a relative dearth of research dedicated to understanding these health disparities between gay/bisexual and heterosexual youth, and even less has focused on identifying factors that might promote resilience against negative health outcomes. Understanding both risk factors and processes of resilience is critical in developing efficacious interventions to improve health in this population. Through a grant from the National Institutes of Health, the investigators completed formative research with young male couples. Qualitative interviews identified preferences for couples-based intervention format and content. While coupled YMSM expressed some interest in HIV prevention, participants were most interested in building relationship skills. Coupled YMSM preferred group-based interventions in order to meet and learn from other couples but had concerns about discussing personal topics in groups. Quantitative analyses found that the rate of condomless sex in couples increased from adolescence to young adulthood. Further, the influence of older partners, partner violence, and drinking before sex were strongest in emerging adulthood. Informed by these, the research team developed 2GETHER, which aims to reduce HIV transmission risk in couples by enhancing relationship functioning. 2GETHER is a four session program. The first two sessions are group sessions aimed at skills building, and the second two sessions are individualized couple sessions aimed at skills implementation. Modules address communication skills, coping with stress (both general and sexual minority-specific stress), relationship sexual satisfaction, and HIV transmission risk within the dyad and with outside partners. 2GETHER was designed to address HIV transmission risk in couples regardless of HIV status; couples learn to use behavioral and biomedical approaches to prevent both HIV acquisition (e.g., HIV testing, condom use, pre-exposure prophylaxis) and transmission (e.g., medication adherence to reduce viral load), with an overarching emphasis on the health of the couple. The investigators completed a pilot trial of 2GETHER with funding from Northwestern University. The pilot trial enrolled 57 couples (N=114) and demonstrated feasibility, acceptability, and preliminary efficacy of 2GETHER. This pilot trial used a non-randomized pre-/post-test design because the goal was to evaluate feasibility, acceptability and preliminary effects in a large number of diverse couples to inform a future efficacy RCT. Post-test occurred 2 weeks post-intervention, or ~2 months post-baseline. The pilot trial recruited a diverse sample of couples in less than one year and each program module receive high ratings of acceptability during post-sessions evaluation and an exit interview. At the 2-week post-test, the investigators observed significant decreases in HIV risk behavior, improvements in motivation to reduce HIV risk, and improvements in relationship investment. The current study will conduct a randomized controlled trial (RCT) to test the efficacy of 2GETHER, a novel couples-based intervention for young men who have sex with men (YMSM) that aims to reduce HIV transmission risk by optimizing relationship functioning. The investigators will conduct an RCT with 200 dyads (total individual N=400), who will be randomized to receive the 2GETHER intervention or an attention-matched couples-based positive affect promotion program.

NCT ID: NCT03090802 Completed - Clinical trials for Human Immunodeficiency Virus

MAMAS: Mentoring Adolescent Mothers at School

MAMAS
Start date: June 26, 2017
Phase: N/A
Study type: Interventional

This study aims to evaluate the efficacy of an intervention designed to reduce STI/HIV incidence by increasing the number of adolescent mothers who re-enroll and remain in school. The objective of the intervention is to have older mentor mothers, who themselves were pregnant adolescents, to mentor younger adolescent mothers. Mentor mothers will provide ongoing psychosocial support, help navigate re-admission to school, and help facilitate access to an existing State-sponsored cash transfer, the child support grant (CSG), in the early postpartum period. Our combination social protection program will enhance resilience of young adolescent mothers to facilitate their return to school and thereby reduce HIV risk. The investigators will evaluate the efficacy of the intervention using a pre-test post-test randomized controlled trial design. Participants in the intervention will receive the Mentoring Adolescent Mothers At School (MAMAS) intervention and standard postpartum care. Those in the control arm will receive standard postpartum care. Additionally, for those participants randomized to the intervention arm, mentor mothers will use participatory visual methods (e.g., photovoice, cell-films, drawings) as part of the intervention itself. Last, among those participants randomized to the intervention arm and who return for their 9-month assessment, the investigators will conduct 20 in-depth interviews to understand the process of resilience development from their perspective. Primary outcomes: School outcomes (initial outcomes) HYP 1.1: Program participation will increase school enrollment HYP 1.2: Program participation will increase school engagement HIV risk outcomes (intermediate outcomes) HYP 2.1: Program participation will reduce number of sexual partners HYP 2.2: Program participation will reduce inconsistent condom use HYP 2.3: Program participation will reduce intimate partner violence HYP 2.4: Program participation will decrease HIV/STI infection HYP 2.5 (for HIV+): Program participation will increase retention in care Secondary outcomes: HYP 5: Program participation will increase peer support HYP 6: Program participation will increase familial support HYP 7: Program participation will increase school re-admission HYP 8: Program participation will increase application to the child support grant HYP 9: Program participation will increase receipt of the child support grant

NCT ID: NCT02513225 Completed - Drug Use Clinical Trials

Trial of an Adapted STD Screening and Risk Reduction Intervention

Start date: July 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02493647 Completed - HIV Clinical Trials

Love, Sex & Choices: A Web Series on Mobile Devices to Reduce Black Women's HIV Risk

LSC
Start date: September 2015
Phase: N/A
Study type: Interventional

This study tests a 12-episode Internet-based, guide enhanced Love, Sex, & Choices (LSC) HIV prevention soap opera video series for smartphones or computers, in a randomized clinical trial among predominately at-risk African American urban women. The following hypotheses are to be tested: 1) The LSC treatment arm will show lower unprotected sex risk, meaning lower frequency of unprotected sex (vaginal + anal) with high risk partners at 6 months post intervention compared to an attention control arm 2) The LSC treatment arm will show higher participation in HIV testing at 6 months post intervention compared to the control. If effective, this video intervention could be rapidly implemented and brought to scale at low cost via the Internet, widely reaching young urban women with the goal of reducing HIV risk behavior and increasing HIV testing.

NCT ID: NCT02447484 Completed - HIV Clinical Trials

Texting Intervention to Sustain HIV Prevention in Women in High-drug-use Contexts

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a program of regular, theory-based text messages that encourages the message recipient to continue practicing safer sex (i.e., using condoms with sex partners) is effective in maintaining positive behavior change in women who have completed a brief safer-sex training.