110 Clinical Trials for Various Conditions
The goal of this open-label, randomized trial is to assess the efficacy of doxycycline prophylaxis in reducing incidences of bacterial sexually transmitted infections (STIs) among adolescent and young adult females while also evaluating acceptability and antimicrobial resistance in order to inform public health policy.
The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.
The purpose of this study is to understand if taking an antibiotic called doxycycline by mouth as soon as possible after sexual contact without a condom can reduce the risk of sexually transmitted infections (STIs), including gonorrhea, chlamydia and syphilis. The study will also look at the safety of doxycycline PEP and the impact that PEP may have on the bacteria that cause STIs as well as on bacteria that normally live on the body. While doxycycline is approved by the Food and Drug Administration (FDA), taking doxycycline immediately after sexual contact to prevent infection is investigational and is not approved by the FDA for this use. Participants will take part in the study for 1 year.
The goal of this project is to collect data regarding the concentrations of doxycycline in mucosal tissues after daily dosing for 7 days in people assigned male sex at birth (AMAB) and assigned female sex at birth (AFAB) to inform future studies of doxycycline to protect against bacterial sexually transmitted infections (STIs).
This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually transmitted disease (STD) clinics and a community health center in the United States.
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.
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.
The purpose of the current study is to test a computerized HIV/STD prevention program with heterosexual African Americans. The hypothesis is that those exposed to the program will increase their correct and consistent use of condoms compared to those not exposed to the program.
In response to the increasing rates of HIV/STD infections among women over the age of 50, especially minority women, and in the attempt to reduce HIV/STD risks for over ten million older adult American women who are impacted by gray divorce and at risk for unsafe sex, the investigators will create, test, and commercialize a novel positive psychology-based "SmartWeb" intervention to promote wellbeing, HIV/STD awareness, and safe sex practices among culturally-diverse older divorced or separated women who are dating. This large end-user market for the proposed HIV/STD risk reduction intervention will greatly facilitate commercialization through advertisements, marketing research based on data mining, and in collaboration with manufacturers of condoms, and other large companies offering health products and services to older women.
Health damaging (risk) behaviors of young military personnel are reflections of health problems facing all young people in the U.S. Military life presents opportunities and challenges that may both protect against and place young troops at risk for health damaging behaviors. Challenges for maintaining a healthy armed force include high rates of sexually transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other substances. The common thread through these negative health outcomes is volitional behavior. Such behaviors do not only result in illness or injury, but also negatively impact performance of military duties and threaten military readiness. Despite military leadership in setting standards and policies regarding professional behavior and universal health care for preventing and eliminating such negative health outcomes, many health problems remain. Building on our previous military research, we will evaluate the effectiveness a cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, and victimization due to IPV in male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in Fort Jackson, SC.
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
This pilot project will evaluate the feasibility, acceptability, and preliminary effectiveness of a couples-based behavioral intervention \[COUPLES\] that augments individual evidence-based interventions with joint health education counseling for STI-affected AYA dyads within a primary care setting.
The HIV diagnosis rate among African-born Black women is the highest of all Black individuals living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis (PrEP) are two effective means of decreasing HIV risk among women, but they remain suboptimal among Black women. The specific aims of this study are: 1. To culturally adapt two widely utilized, evidence-based HIV prevention interventions originally designed for US born Black women (Sister-to-Sister (S2S) and Sisters Informing Sisters about Topics on AIDS (SISTA)) for use by African-born women 2. To conduct a randomized controlled comparative effectiveness trial (RCT) to determine the effectiveness of adapted versions of S2S versus SISTA on increasing condom use and PrEP uptake among African-born women. The adapted versions of these interventions will be given new names that resonate with the African culture. The adapted version of S2S intervention will be called "Dada Kwa Dada (DKD)" intervention while the adapted version of SISTA intervention will be called "DADA" intervention. "DADA" means "Sister" in Swahili and other languages in Eastern and Western Africa.
This digital couples-based HIV/STI prevention intervention project will determine preliminary efficacy to improve uptake of evidence-based strategies and a tailored prevention plan among cisgender male couples who are in a relationship (defined as greater than 3 months or more).
This couples-based, digital health intervention project is serostatus neutral and seeks to determine efficacy for: a) use and adherence to evidence-based HIV/STI prevention-care strategies; b) creation and adherence to a tailored prevention-care plan; c) creation and adherence to a tailored sexual agreement; and d) improvements in other relationship dynamics among male couples who are in a relationship (defined as greater than 3 months or more).
HIV and Sexually Transmitted Infection (STI) rates are increasing in rural areas including rural Colorado. Many rural residents find it difficult to access HIV and STI prevention services. In this study, an online survey on HIV and STI Prevention and best practices to provide access to prevention will be administered to rural residents in three zip 3 zones in rural Colorado. In addition to the baseline survey, study participants who are interested and medically eligible may initiate PrEP services with the University of Colorado HIV Prevention Program and receive PrEP through telemedicine visits, mailed home lab kits, and mailed medication. Persistence in PrEP care, acceptability, and feasibility of telemedicine and home lab kits will be measured.
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.
This project seeks to develop and test the acceptability, appropriateness and feasibility of uTECH, a novel social media "big data" machine learning intervention for HIV-negative substance-using sexual and gender minority people who have sex with men that aims to reduce HIV transmission risk by integrating biomedical and behavioral risk reduction strategies, including pre-exposure prophylaxis (PrEP) for HIV prevention and medication assisted treatment (MAT) for substance use harm reduction
This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection
This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail. The researchers will compare the utilization of HIV prevention and other support services between individuals who receive routine case management provided following enrollment to those who have access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support.
A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis).
The study will evaluate the use and effectiveness of mobile-messaging platforms as a public health strategy for improving sexual health outcome measures among men who have sex with men (MSM) by determining whether exposure to the message-delivery platform results in improvements in participants' self-reported sexual health and prevention behaviors, beliefs and attitudes. The study will enroll men into a randomized controlled trial. Participants randomized to the messaging intervention will have access to a smartphone-based messaging platform for three months while those assigned to the waitlist group will be offered access to the messaging platform after all follow up is complete. Participants will complete surveys at baseline, after the end of the 3 month intervention, and follow up surveys 6 and 9 months after the baseline survey.
The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual health education program, "Your Move" (YM) against a nutrition control program, "Eat Smart" (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual decisions with the ultimate goal of reducing unplanned pregnancies and STIs.
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 healthy, HIV-negative men who have sex with men and transgender women who are not taking hormones aged 18-49 years. Participant must be willing to participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.
This study is a pilot evaluation of 'Stick To It', a behavioral intervention based on the concept of gamification. The objective of the program is to encourage young men who have sex with men (MSM) to be regularly screened for HIV and sexually transmitted infections (STIs) and to adopt safer sexual behaviors, with the ultimate goal to decrease HIV and STI incidence. Gamification is the application of game elements, like points, badges, and rewards, to non-game settings.
During the formative research phase, investigators will undertake formative studies to locate, understand, and characterize high-risk social networks of African American MSM in the community; gain community participation, involvement, and input; and undertake interviews with key informants and community members to gain information needed to pilot test study recruitment procedures, measures, and intervention content. During a 4-year main outcome trial phase, the investigators will enroll 24 separate sociocentric ("bounded") social networks composed predominantly of Black MSM. Each sociocentric network will consist of the ring of friends surrounding an initial high-risk index as well as all friends surrounding persons in this second ring and then friends surrounding a successive third snowball ring of enrollees. Each 3-ring sociocentric network is expected to consist of approximately 40 unique members (n=24 networks, each with 40 members = approximately 960 individual participants). All participants will be assessed at baseline to measure sexual practices, substance use, and other risk characteristics over the past 3 months; asked to provide biological specimens to be tested for HIV and other sexually transmitted diseases (STDs); and counseled in HIV/STD risk reduction. STDs will be treated and those with HIV will be referred for treatment. The investigators will identify the individuals in intervention condition networks with the greatest number of reciprocal interconnections and the most favorable sociometric standing in the network. These individuals--expected to constitute approximately 20% of the sociocentric network and designated as network leaders--will be recruited to attend a 9-session program that provides training and guidance in how to deliver on-going, theoretically-based, and culturally tailored risk reduction advice and counseling to other members within the same network. Six and 18 months following the intervention, all participants will be reassessed on risk behavior and STD/HIV laboratory measures as well as measures of intervention exposure, with positive STD and HIV cases respectively treated or referred to care at each assessment point. Outcome analyses will test whether there is greater reduction in high-risk sexual practices, substance use associated with risky sex, and HIV/STD incidence within social networks in the intervention condition. The primary trial endpoints are reductions in prevalence and frequency of unprotected anal intercourse with nonexclusive partners, increased condom use, and lower incidence on a composite biological measure of new HIV/STD disease during the followup period.
The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision. This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.
This study is a randomized controlled trial (RCT) that will rigorously evaluate the implementation, effectiveness and cost-effectiveness of a couple-based integrated human immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with drug-involved male offenders charged with misdemeanors and their primary female sexual partners, implemented by frontline providers in Criminal Court, Community Court or probation (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.
The proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will: 1. Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV prevention intervention or a family-based General Health Promotion condition. 2. Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes over 18 months among a sample of 320 Latino parent-adolescent dyads. 3. Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in family relationships and parental monitoring/supervision over 18 months among a sample of 320 Latino parent-adolescent dyads. 4. Examine the association of other important constructs, such as religiosity, acculturation, cultural values, and sexual socialization with the primary outcomes. Based on a thorough review of the literature and preliminary data from a recent, small pilot study, the investigators hypotheses are: 1. Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to primary outcome measures of safer sexual behavior (recent sexual activity, the number of unprotected sex acts, and intentions to use condoms) and safer HIV-related attitudes. 2. Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to family relationships and parental monitoring/supervision through improved parent-child communication skills and they will mediate the intervention impact. 3. Religiosity, acculturation, cultural values, and sexual socialization will have meaningful associations with the primary outcomes and will act as moderators of intervention impact.
The purpose of this study is to evaluate the efficacy of an online pregnancy prevention intervention that was adapted from the evidence based small group intervention SiHLE.