Treatment Trials

21 Clinical Trials for Various Conditions

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COMPLETED
Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use Intervention
Description

A sample of 300 young (15-29) men who have sex with men (MSM) and transgender persons living in South-East Michigan's Detroit Metro Area (DMA) will be recruited through venue-based sampling and online ads to examine the efficacy of adding a substance use brief intervention (SUBI) to standard HIV prevention and care (SOC) for achieving gains in successful engagement in HIV care. The investigators will partner with Detroit-area AIDS Service Organizations (ASOs) to deliver the intervention.

COMPLETED
Couples HIV Counseling and Testing for Male Couples in the United States
Description

This is a study to determine whether testing for HIV together as a couple, as opposed to testing separately, in acceptable to men in male couples, and is a safe prevention service. Testing of couples together has been provided for decades in Africa, but has never been tested in the United States. In this study, male couples will be enrolled and randomly assigned to be tested together in the same room, or separately. At the time of testing, investigators will ask questions about how they felt about the service they received. Three months later, investigators will survey the men again, and determine whether they had any problems after the testing, like violence in the relationship or the relationship breaking up. The main outcomes are being satisfied with the testing service, and safety (lack of intimate partner violence or relationship termination). Although the study is not designed to determine if the service reduces risk behaviors for HIV transmission, investigators will examine data on risks just to explore that topic. The main hypotheses are: (1) men will be at least as satisfied with couples testing as they are with individual testing; and (2) men tested as couples will not experience higher rates of intimate partner violence or relationship dissolution, relative to men tested separately.

Conditions
TERMINATED
An Educational HIV Pre-Test Counseling Video Program for Off Hours Testing in the ED: A Randomized Control Trial
Description

This study compared the educational effectiveness of a ten-minute pre-test counseling video with the usual practice of a session with an HIV counselor.

COMPLETED
An Effective Alternative to the Standard Referral System for HIV Testing in the Emergency Department During Off Hour Tours: A Randomized Trial
Description

To compare HIV testing rates in ED patients offered video-assisted informed consent off-hours versus those referred to an HIV counselor the next business day.

COMPLETED
Pre-HIV Test Counseling Intervention to Reduce HIV Infection Risk Behavior in Men Who Are Not HIV Infected
Description

This study will evaluate the effectiveness of a single specialized pre-test counseling session in reducing HIV infection risk behavior in men who are not HIV infected.

Conditions
COMPLETED
An Accessible Digital Intervention to Promote HIV Testing/Counseling and Prevention Among Adolescents
Description

This is Phase II of a study previously registered on ClinicalTrials.gov (NCT02812329). Phase II focuses on adapting and expanding the reach of a previously developed video game aimed at HIV prevention. The game will be adapted to include web access/distribution and be evaluated using a randomized controlled trial.

Conditions
COMPLETED
HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.
Description

Project Aware is a randomized controlled clinical trial in which individuals seeking medical or health services at sexually transmitted disease (STD) clinics are recruited to participate in a multi-center HIV testing and counseling study. The investigators will assess the relative effectiveness and cost-effectiveness of (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling vs. (2) on-site HIV rapid testing with information only. The investigators will evaluate the effect of counseling on one primary outcome: STI incidence. Secondary outcomes will be reduction of sexual risk behaviors, substance use during sex (i.e., being under the influence during sex) and cost and cost effectiveness of counseling and testing. Participants will be assessed for sexually transmitted infections, HIV testing history and sexual and drug use risk behaviors at baseline and at 6-months follow-up. Approximately 5,000 individuals seeking medical or health services from approximately 9 STD clinics throughout the United States will be randomized. These individuals will be 18 years of age or older and efforts will be made to recruit a sample of study participants that reflects the proportion of minorities and gender in the STD clinic performance sites from which the investigators are recruiting.

COMPLETED
Rapid HIV Testing and Counseling in High Risk Women in Shelters
Description

This is a developmental study evaluating a new rapid HIV testing and risk prevention intervention for residents of battered women's shelters who endorse risky sexual behaviors.

Conditions
COMPLETED
Video-based Counseling & Rapid HIV Testing for Teens
Description

This study evaluated the educational effectiveness of a youth-friendly pre-test video (derived from a previous qualitative study) and compared it with in-person HIV pre-test counseling. A convenience sample of 200 medically stable individuals between the ages of 15 and 21 presenting to an urban ED were recruited to participate in this study and randomized into 2 groups. Individuals were eligible if they were English-speaking, sexually active and able to consent. All participants completed a sexual risk factor and demographic survey. Group 1 completed a validated pre-test knowledge measure, viewed the HIV education video then completed a post-test knowledge measure. Group 2 completed the same knowledge measures, but received pre-test HIV counseling from a trained public health advocate. HIV testing was optional

COMPLETED
Rapid HIV Testing and Counseling in Drug Abuse Treatment
Description

This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV risk behaviors.

COMPLETED
Stigma and Online Counseling to Increase HIV/STI Testing
Description

The alarmingly high rates of HIV/STI (sexually transmitted infections) observed among Black men who have sex with men (BMSM) necessitate a new model for engaging BMSM. New approaches include addressing stigma related concerns and structural barriers in order to increase HIV/STI testing uptake. This research includes a 2 x 2 factorial design to test an intervention that is aimed at increasing HIV/STI testing uptake among BMSM; this design includes testing HIV/STI stigma focused counseling, and online HIV/STI test counseling with at-home, self-administered HIV and STI test kits.

Conditions
COMPLETED
Evaluating Post-test HIV Counseling Videos for Teens
Description

The design of this randomized controlled trial (RCT) is to test the effectiveness of a post-test behavioral video in educating adolescents about HIV transmission and affecting their intentions to engage in risk-reduction behavior.

COMPLETED
Providing Online Counseling for Home-Based HIV Testing With Transgender Youth
Description

This research study will recruit 200 transgender youths between the ages of 15-24. There are two arms to the research study: the control and the intervention arm. Each eligible participant will be randomized into either arm. The control arm participants receive an OraQuick HIV testing kit sent to an address of their choice and instructions of how to conduct the test. They will enter their results on the research study website and complete surveys at 3 month intervals until an entire year has passed. Participants in the intervention arm will receive an OraQuick HIV testing kit sent to them and will receive video-based counseling called Motivational Interviewing and Certified Testing and Referral. After this counseling session, the results from the OraQuick HIV test will be logged by study staff. Then, participants in the intervention arm will fill out surveys at 3 month intervals until a year has passed.

COMPLETED
Project Nexus: Providing Online Counseling for Home-Based HIV Testing
Description

The proposed research aims to address the question: Compared to the current standard of care for home-based HIV tests, in which persons conduct and interpret HIV tests without counseling, does the addition of video conferencing with a remote counselor increase health-enhancing, protective behaviors among male-male couples and facilitate linkage to care for those who test positive?

Conditions
COMPLETED
Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)
Description

The purpose of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South Africa.

Conditions
COMPLETED
Improving HIV Screening With Nurse-Based Rapid Testing/Streamlined Counseling
Description

Background: HIV testing is cost-effective in unselected general medical populations, yet testing rates among those at-risk remain low, even among those with regular primary care. HIV rapid testing is effective in many healthcare settings but scant research has been done within primary care settings, nor within the US Department of Veteran's Affairs Healthcare System. Objectives: We evaluated three methods proven effective in other diseases/settings: Nurse standing orders for testing, streamlined counseling, and HIV rapid testing. Design: Randomized, controlled trial with three intervention models: Model A (traditional counseling/testing); Model B (nurse-initiated screening, traditional counseling/testing); Model C (nurse-initiated screening, streamlined counseling/rapid testing). Participants: 251 patients with primary/urgent care appointments in two VA clinics in the same city (one large urban hospital, one freestanding outpatient clinic in a high HIV prevalence area) Measurements: Rates of HIV testing and receipt of results; sexual risk reduction; HIV knowledge improvement. Results: Testing rates were 40.2% (Model A), 84.5% (Model B), and 89.3% (Model C) (p=\<.01). Test receipt rates were 14.6% (Model A), 31.0% (Model B), 79.8% (Model C) (all p=\<.01). Sexual risk reduction and knowledge improvement did not differ significantly between counseling methods. Conclusions: Streamlined counseling with rapid testing significantly increased testing and receipt rates over current practice without changes in risk behavior or post-test knowledge. Increased testing and receipt of results could lead to earlier disease identification, increased treatment and reduced morbidity/mortality. Policymakers should consider streamlined counseling/rapid testing when implementing routine HIV testing into primary/urgent care.

COMPLETED
Brief Intervention to Reduce STDs in ER Drug Users
Description

The goal of the proposed project is to determine the effectiveness of a brief motivational intervention among Emergency Department (ED) patients who use cocaine and/or heroin to prevent Sexually Transmitted Infections (STIs) and Human Immunodeficiency Virus (HIV) by comparing cumulative incidence and frequency of safe sex behavior between intervention and standard voluntary counseling, testing and referral to substance abuse treatment (control) groups over a one year follow-up period.

COMPLETED
The Self-Collection Study: a Study of Self-collected HPV Testing and Results Counseling
Description

Cervical cancer is the second most common type of cancer among women worldwide. Women with human immunodeficiency virus (HIV) bear a disproportionate burden of cervical cancer and its precursor, cervical intraepithelial neoplasia (CIN), that result from persistent high-risk Human Papillomavirus (HPV) infection. HIV clinical practice guidelines recommend two Pap tests in the year following diagnosis, and if both are normal, yearly thereafter. Nationally, only 25% of women meet this recommendation. The mean annual Pap testing rate for federally funded HIV centers is only 55.7%. In 2009, quality improvement statistics from the Johns Hopkins Hospital Moore Clinic, a large urban HIV center, revealed an annual Pap testing rate of 59%. This occurred despite interventions to address adherence issues were implemented, including nurse case management, co-location of HIV and gynecology services, flexible scheduling, and continuity of care. Women keep their appointments for HIV primary care more often than for gynecology care in the Moore Clinic, so an intervention that takes place during a primary care visit could improve cervical cancer screening rates. The availability of HPV testing provides a unique opportunity to increase perceived susceptibility to and severity of cervical cancer among women with HIV, and to encourage follow-up Pap testing. HPV testing involves analyzing a sample of cervicovaginal cells for the presence of high-risk HPV strains. Detection of high-risk strains of the virus indicates a high risk for high grade CIN and cancer, while a negative HPV test predicts a less than 2% risk of developing CIN. HPV testing can be easily conducted by women themselves through self-collection in a primary care visit. Studies of women without HIV who do not have regular Pap testing have demonstrated that self-collected HPV testing and results counseling increases the overall screening rate, and women who test positive for HPV have a high rate of follow-up Pap testing. Self-collected HPV testing and results counseling could be utilized in the HIV primary care setting to promote Pap testing among women with HIV.

Conditions
COMPLETED
Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing
Description

This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing.

Conditions
COMPLETED
Evaluating Methods to Increase HIV Testing, Access to HIV Care, and HIV Prevention Strategies
Description

This is a five-part study that will take place in the Bronx, New York (NY), and Washington, District of Columbia (DC). The different components of the study will focus on increasing the number of people being tested for HIV, evaluating ways to link HIV-infected people to HIV care sites, evaluating methods to reinforce antiretroviral therapy (ART) adherence, and evaluating a counseling program that focuses on HIV prevention. (Details for only three components of this study are included in ClinicalTrials.gov (Linkage-to-Care, Viral Suppression and Prevention for Positives) because they are the only ones that were randomized and had prescriptive interventions.)

Conditions
WITHDRAWN
Project TEACH-Kenya
Description

Public health programs and policies have utilized the "combination prevention" model of bringing together tailored, proven interventions in order to reduce the global impact of HIV. Project TEACH-Kenya adapts two effective HIV interventions, Project BRIEF (Behavioral intervention, Rapid HIV test, Innovative video, Efficient cost and health care savings, Facilitated seamless care) and STEP (Skill-based Teenage Education Program for HIV prevention) to increase HIV testing and counseling rates, implement proven risk reduction programs, and improve rates of linkage to care and ART initiation among adolescents in Kenya. The collaboration with St. Francis Community Hospital and input from the Kasarani community will increase the breadth, reach, and impact of this HIV prevention intervention in Kenya.

Conditions