Active clinical trials for "Gonorrhea"

The proposed study is a randomized controlled trial (RCT) that will rigorously evaluate the effectiveness and cost-effectiveness of delivering a multimedia evidence-based intervention (WORTH) and streamlined HIV testing to prevent human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) with Black/African-American (hereafter referred to as Black) women drug users in probation sites in New York City (NYC), compared to streamlined HIV testing alone. Repeated assessments will occur at baseline and 3, 6, and 12-months post intervention. The primary outcomes will be to reduce cumulative incidence of biologically confirmed STIs (i.e., Chlamydia, gonorrhea and trichomonas and the number of unprotected sex acts.

Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent gonorrhea and chlamydia infection in heterosexual patients, but has not been evaluated for use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner management with heterosexual patients, but note the absence of evidence necessary to make an equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess the impact of EPT on partner notification, treatment, and STI re-infection among MSM are critical to the development of evidence-based partner management guidelines. Recent data from urban Peru has identified prevalences of rectal and pharyngeal gonorrhea and chlamydia ranging from 5-20%. The elevated burden of disease among MSM in Peru suggests that frequent transmission of undiagnosed gonorrhea and chlamydia through MSM sexual networks may be a factor contributing to the persistently high incidence of HIV infection among MSM in the region. The investigators propose a pilot evaluation of the effect of EPT on partner notification and treatment among MSM in Peru diagnosed with gonorrhea or chlamydia at any anatomic site. Specific Aim 1: To explore the social norms and structural factors influencing partner notification and treatment among MSM in Peru. Specific Aim 2: To determine the effect of EPT on anticipated and actual partner notification among MSM diagnosed with gonorrhea or chlamydia infection. Specific Aim 3: To develop preliminary data on rates of gonococcal and chlamydial re-infection among MSM randomized to receive EPT compared with standard partner notification counseling. The proposed study will provide pilot data on the use of EPT with MSM diagnosed with gonorrhea or chlamydia and form the basis for a subsequent Phase III clinical trial of EPT as an STI control method among MSM in Latin America.

To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620 eligible African American men who have sex with men (MSM) will be conducted. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a free bag of condoms and water-based lubricants. This two-arm trial will test four hypotheses: Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STD incidence and risk of HIV acquisition/transmission among young African American men (15-29 years old) having sex with men and presenting for STD testing. H1. Men randomized to receive the intervention will have a lower incidence rate of laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving the control condition. H2. Men randomized to receive the intervention will report significantly fewer acts of unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments compared to those receiving the control condition. H3. Men randomized to receive the intervention will report having significantly fewer unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between follow-up assessments compared to those receiving the control condition. H4. Men randomized to receive the intervention will report having significantly fewer negative experiences with condom use between follow-up assessments compared to those receiving the control condition. H5. Men randomized to receive the intervention will demonstrate significantly greater improvement in condom application skills, throughout the 12-month study, compared to those receiving the control condition.

Non-professional community leaders may be at a great advantage in reaching otherwise hard to reach populations for the purpose of advising on sexually transmitted disease (STD) prevention (lay health advisors), health care access, and model health behavior. Latino migrant farm workers are at increased risk for STD and might benefit from such lay health advisors. The study will examine whether this strategy is a useful one for STD prevention in Latino migrant farm workers in rural and small town areas of North Carolina.

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.

The investigators propose to develop and pilot an HIV prevention intervention based on rectal STI testing, counseling, and treatment for MSM in Peru. The investigators will use nucleic acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological outcomes including changes in levels of inflammatory cytokines following rectal STI. The intervention is based on three interrelated objectives: 1) To use periodic rectal STI nucleic acid testing to identify the members of the MSM population at greatest short-term risk for HIV infection; 2) To provide single-dose antibiotic treatment to control the immune activation and mucosal inflammation caused by rectal GC/CT infection that increase cellular risk for HIV transmission; and 3) To use Personal Cognitive Counseling (PCC) to understand and modify recent high-risk sexual practices that led to rectal STI acquisition and that increase future HIV risk. The investigators propose to screen 750 behaviorally high-risk MSM for rectal GC/CT infection to enroll 100 GC/CT-positive individuals (using a conservative 15% prevalence estimate) and 50 GC/CT-negative controls (matched by age and baseline frequency of URAI). GC/CT-infected participants will be given single-dose antibiotic therapy and randomized to receive single-session PCC (n=50) or standard post-test counseling (n=50). The primary outcome will be the impact of PCC on self-reported sexual risk behavior (URAI). Secondary outcomes will assess: 1) Feasibility/Acceptability of the STI screening program; 2) Impact of GC/CT infection and treatment on levels of inflammatory cytokines (IL-6, IL-8, TNF-αand IL-1β) in rectal mucosa; 3) Prevalence of persistent/recurrent rectal GC/CT; and 4) HIV incidence in GC/CT-infected and -uninfected MSM.

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

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.

This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of up to eight of the participating sites in the United States. Subjects who have untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract identified by a positive culture or Nucleic Acid Amplification Test (NAAT) conducted at a prior visit will be offered enrollment in the study. They will receive one dose of directly observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study will receive treatment per local standard of care. The duration of the study for each subject will be approximately 11 through 14 days. The primary objective of this study is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype.

To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).