88 Clinical Trials for Various Conditions
The proposed study will be a 24-week intervention with a 12-month follow-up period to evaluate the impact of contingency management with stepped care to pre-exposure prophylaxis (PrEP) adherence and support services (CoMPASS) to promote HIV prevention among individuals with opioid use disorder who have injected drugs in their lifetime. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .
YMHP is a counseling intervention program for which the goals are to better understand HIV-prevention focused self-management behaviors among HIV-negative YMSM, and to study the implementation of YMHP to improve portability and scalability. The clinic sites will help investigators to assess and address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce HIV infection among YMSM that reflects the complexities of real world adolescent HIV clinics.
This study will conduct an effectiveness trial of the 4-session evidence-based YMHP intervention for young men who have sex with men (YMSM) of color ages 15-29 at two CBOs in New York City, compared to usual care.
African Americans have considerably higher rates of HIV infections than do White, Hispanic, Asian, and Native Americans. African Americans accounted for 59% of all diagnoses of HIV infection among youth (13-24 years of age) in the United States. Young African Americans also have disproportionately high rates of other sexually transmitted infections (STIs). Therefore, the broad, long-term objective of this research is to identify interventions to reduce the risk of HIV and other STIs among young African Americans. Entertainment-education refers to narrative interventions designed to change behavior while providing entertainment. Several studies have evaluated the impact of media content on HIV risk behavior. One study found that exposure to an entertainment-education based HIV testing campaign was associated with increases in HIV testing among sexually active teens 12 months post exposure. Similarly, a radio soap opera called "Twende na Wakati" became the most popular television show in Tanzania and was highly successful in reducing the number of sexual partners and increasing condom use. A narrative video intervention study in STI clinic waiting rooms in three U.S. cities found a significant reduction in STI re-infection among patients visiting during months when the video was shown compared with patients visiting during months when it was not shown. Although these studies show that entertainment-education can be a promising medium for behavior change, none of them evaluated the efficacy of a tailored online entertainment-education intervention specifically designed for African American youth. To address this gap in the literature, this study tested the preliminary efficacy of an innovative, theory-based HIV risk-reduction serial drama intervention, Reality Check, specifically tailored to young African Americans. We used a randomized controlled trial, allocating African Americans 18 to 24 years of age to Reality Check, or an attention-control intervention promoting physical activity. Each intervention was delivered as a series of videos streamed online and accessible via any Internet-capable device. Participants completed surveys online at baseline, immediately post intervention, and 3 months post intervention. We hypothesized that, Reality Check would reduce condomless sex during the 3-month post-intervention period compared with the attention-matched control group, adjusting for baseline of the criterion.
The purpose of the Texas Christian University (TCU) Disease Risk Reduction (DRR2) Project is to develop and test a self-administered tablet computer app, StaySafe, for probationers under community supervision that is designed to improve decision-making skills around health risk behaviors, especially involving HIV and hepatitis B \& C risks. StaySafe utilizes materials and concepts adapted from an earlier, group-based curriculum, WaySafe, designed to increase positive decision-making skills for offenders in the last phase of their prison-based substance abuse treatment before transitioning back to the community.
Smartphone applications and mobile technologies offer users the potential to access critical information (e.g., proper condom use, directions to testing sites, and other sexual and reproductive health services) when it is needed most. Relevant findings will identify areas where existing interventions may be leveraged and adapted to work among young women of color in an urban setting and their networks. As SRH smartphone apps continue to proliferate, this study will expand researchers', developers', and health educators' limited knowledge about the feasibility, acceptability and preliminary efficacy of a sexual health educational app tailored with and for young Black and Latino women, aged 18-25 in NYC, including whether this app acts as a gateway to sexual health educators, clinical and other service providers. If proven effective, findings from this study will identify areas where existing interventions may be leveraged and adapted to work among a YBLW and their networks, and potentially adapted for other high needs communities.
The incidence of HIV/AIDS among African American men who have sex with men (MSM) is alarming, and the public health response to this urgent situation has been hampered by a lack of sexual risk reduction interventions with solid evidence of efficacy in this population. Accordingly, the broad, long-term objective of the proposed research is to identify interventions to reduce the risk of sexually transmitted infection (STI) among African American MSM. This application seeks funds to develop and test the efficacy of a theory-based, contextually appropriate behavioral intervention to reduce sexual risk behavior among African American MSM. Intervention development will be guided by social cognitive theory, the theory of planned behavior, qualitative information from focus groups, and findings from a longitudinal survey of men from the study population. A one-on-one intervention will be utilized to address the specific prevention needs of each man and to allay participants' concerns about revealing their sexual involvement with men by virtue of participating in a group or workshop intervention. The study will utilize a randomized controlled trial design, with baseline, immediate post intervention, and 6 and 12 months post intervention assessments. The participants will be African American MSM who will be randomized to a one-on-one sexual risk reduction intervention or a one-on-one health promotion intervention that will serve as the control condition. The primary outcome is consistent condom use during anal and vaginal intercourse. The study will test whether the intervention increases the consistent use of condoms during anal intercourse, the primary outcome, whether it decreases other sexual risk behaviors, and whether social cognitive theory variables mediate the effects of the intervention on consistent condom use. This study will provide an urgently needed intervention to reduce the risk of HIV and other STIs in one of the highest risk populations in the United States.
The purpose of this study is to develop and evaluate an HIV risk reduction intervention for women with a history of abuse.
The purpose of this study is to evaluate the effectiveness of the Making Employment Needs (MEN) Count intervention, an HIV intervention and prevention program for heterosexual Black men. The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period. MEN Count was developed and pilot tested using a Community-based participatory research (CBPR) approach via funding from a National Institutes of Health (NIH) R21, in Boston, Massachusetts. A more larger scale, two-armed quasi-experimental controlled trial design will be used to test MEN Count among Black men recruited/enrolled from an STD clinic and other community-recruitment methods in Washington, DC. Study participants (N=504) will be Black men reporting heterosexual risk for HIV \[unprotected sex with a woman and 2+ female sex partners in the past 6 months\] and either current unemployment or homeless in the past 6 months. To evaluate the effectiveness of MEN Count, a two-armed quasi-experimental design will be conducted in which participants will receive either MEN Count or an attention comparison program similar to MEN Count in structure. We will assess program impact on reduction in number of unprotected sex episodes and incident cases of STI (Chlamydia, gonorrhea, syphilis) via survey and STI testing, respectively, at baseline and 6 and 12 month follow-ups. Additionally, quality assurance and process evaluation efforts will be conducted to ensure high quality program adherence and delivery, as well as to support program replication should the model prove effective.
The goal of this study is to develop and test a program to help Black men who have sex with men and women reduce their chances of getting or giving HIV infection to their sex partners. The program is designed to be delivered via the internet so that it would be available to more men. Men who agree to participate in the study will be assigned by chance to receive the POWER intervention or a similar program that is focused on general health called POWER-HEALTH. They will also complete a computer administered interview when they first enroll in the study, 2 weeks following the last session of the program and 3 months after that. Participants will receive a small compensation for their time and effort.
The purpose of this study is to research a new behavioral treatment to reduce sexual risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal meth), and are at risk for HIV acquisition. This study proposes using a treatment based on our original pilot study that incorporates risk reduction and behavioral activation therapy. In order to help learn what types of treatment programs best help individuals who abuse crystal meth and engage in sexual risk-taking, we will compare our treatment to a control group. The treatment group will receive therapy incorporating behavioral risk reduction counseling with behavioral activation therapy to treat depression, helping individuals reengage in their life. The control group will receive the risk reduction counseling without the behavioral activation therapy. The current study hopes to explore the efficacy of this previous developed treatment in a two-arm pilot randomized controlled trial.
The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction intervention for currently or recently incarcerated adolescents who report problematic substance use.
This project assesses the efficacy of an HIV prevention program with adolescent females incarcerated in the Mississippi training school for girls. Participants in both the health education control group and the HIV prevention group will increase health knowledge as a result of their participation in the health classes while incarcerated. However, participants in the HIV prevention group will increase their condom application, assertiveness, and communication skills relative to girls in the health education only group. In addition, after release from the training school, participants in the HIV prevention group will report lower sexual risk behaviors and will have lower rates of infection with chlamydia and gonorrhea during the 12-month follow-up period than participants in the health education only group.
This study will examine whether pairing a grade 6 in-school HIV education program and a parent training program will reduce prevalence of behaviors that present high risk of HIV infection in youth in the Bahamas. In a continuation of this study, we shall examine whether an in-school HIV prevention program delivered to grade 10 students reduces HIV risk behavior and the impact of both the grade 6 intervention and the grade 10 intervention compared to the grade 6 intervention alone.
A randomized clinical trial evaluating the reduction of HIV risk behaviors and drug use when providing integrated behavioral drug and HIV risk reduction counseling (BDRC) along with methadone maintenance treatment in Wuhan, China
The purpose of this study to conduct a small randomized control trial to compare the relative effectiveness of a single-session of HIV testing and counseling risk reduction intervention (HCT-only) to an enhanced intervention that includes the standard HCT intervention plus a theory-based and culturally-tailored group-level intervention designed to reduce or eliminate HIV and STI risk behaviors (HCT-plus) among African-American men who have sex with men (AA-MSM).
This study will develop and evaluate the effectiveness of culturally appropriate HIV/sexually transmitted disease risk-reduction interventions in reducing sexual risk behavior among young African-American adolescents.
The planned research will adapt an intervention of known efficacy to target a new outcome of significant importance to public health. Specifically the Community Reinforcement and Family Training (CRAFT) procedures will be adapted, from reinforcing treatment entry, to reinforcing treatment retention and HIV risk behavior reduction in persons with opioid dependence who receive a Buprenorphine taper detoxification. The research plan includes three phases: 1) development of a manual guided therapy, 2) development of therapist training and fidelity measures and 3) a randomized pilot evaluation with 52 patients receiving either the new CRAFT treatment or treatment as usual.
A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran.
A randomized clinical trial comparing drug abuse and HIV risk reduction counseling (DC-HIV) alone, DC-HIV combined with naltrexone maintenance, and DC-HIV combined with buprenorphine maintenance for the treatment of heroin addicts in Malaysia.
To determine the efficacy of an enhanced HIV risk reduction intervention delivered concurrently with a vaccination schedule to reduce the number of unprotected vaginal and anal sex acts among HIV-negative, high-risk non-injection drug-using (NIDU) women. To determine the efficacy of an enhanced vaccine education intervention delivered at baseline to increase vaccine knowledge and understanding of a potential HIV vaccine among HIV-negative, high-risk NIDU women.
The decision to disclose one's serostatus to family members creates considerable emotional strain for people living with HIV (PLWH), regardless of gender and sexual orientation. While disclosure to family members has been linked to positive outcomes including increased social support, improved health outcomes (i.e., sexual, physical, mental), reduced loneliness and stress, and improved HIV disease management, the decision not to disclose can also lead to positive outcomes. To date, most research about serostatus disclosure has focused on the act of disclosing - the who, what, where, and when of disclosing - rather than the decision process involved. The investigator's long-range goal is to further refine and evaluate an intervention designed to enhance HIV disclosure decision-making among PLWH. To reach this goal, the investigators are proposing a course of study with the following specific aims: Specific Aim 1. Assess the effectiveness of the intervention relative to an attention-control condition on a variety of primary outcomes related to disclosure and health. Specific Aim 2: Examine the effects of the intervention over time. Specific Aim 3: Explore the potential mediating effects of disclosure decision making on the primary outcomes. Specific Aim 4: Explore potential moderating effects of participant demographics (e.g., gender, age), relationship characteristics (i.e., relationship satisfaction, proximity, importance of disclosure), and contextual variables related to family (e.g., adaptability, problem-solving) on intervention effectiveness. Specific Aim 5: Evaluate the effects of treatment engagement, retention and expectations on outcomes.
The purpose of the study is to test the feasibility, acceptability, and efficacy of an adapted intervention that is theoretically and empirically guided by the Information-Motivation-Behavioral skills model (IMB) and aims at reducing sexual risk behavior among women who have experienced Intimate Partner Violence (IPV), as well as such an intervention.
The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM). The study will also explore the most effective ways to support participants in continuing their PrEP use over time. The main questions it aims to answer are: * Does the C4 program help participants take PrEP more regularly? * Does adding the 3MV intervention to C4 provide additional support for adherence? Researchers will compare two intervention strategies to see if they result in better PrEP adherence: * C4 Intervention: A program focused on individualized care coordination and addressing structural needs. * C4 + 3MV Intervention: A combination of care coordination with additional behavioral change sessions. Participants will: * Participate in PrEP education and counseling sessions. * Have their PrEP use monitored through dried blood spot (DBS) tests. * Complete questionnaires about their experiences and challenges with PrEP. Receive support sessions tailored to address individual barriers to PrEP adherence.
The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.
The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is time to take their medication, and uses motion-sensing technology to visually and automatically confirm the pill was swallowed. The goal of this study is to assess the impact of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.
The researchers are working with a technology company, AiCure, to develop a smartphone app, DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is time to take their medication, and uses motion-sensing technology to visually and automatically confirm the pill was swallowed. The goal of this study is to understand people's experiences using this new app while taking HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.
This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.
The Stay Study is a multi-site, open-label HIV pre-exposure prophylaxis (PrEP) demonstration project for advancing PrEP delivery in the San Francisco Bay Area Transgender Community. Approximately 188 HIV-uninfected participants will be enrolled at 4 sites in San Francisco and Fremont and will be provided Truvada to take orally once daily as PrEP.
Efforts to help syringe exchange registrants employ additional HIV risk reduction strategies are often thwarted by strong social networks that reinforce substance use and other risky injection use and sexual behaviors. The proposed study addresses this important problem by evaluating the feasibility and efficacy of a novel Community Supported Risk Reduction group. This structured intervention works with injection drug users and at least one drug-free family or friend to mobilize social support, teach HIV risk reduction skills, develop treatment readiness, and support participation in community activities designed to expand drug-free social networks.