View clinical trials related to HIV/AIDS.
Filter by:The study uses a repeated measures, single group pretest-posttest design methodology to examine the feasibility, acceptability, and preliminary effectiveness of the FASTLANE II intervention aimed at decreasing risky sex behaviors among active methamphetamine using women. The study's methodology consists of two phases: 1) The feasibility and evaluation of recruitment capability and intervention effectiveness, and 2) qualitative acceptability interviews.
Educational workshops are an efficacious strategy to increase healthcare providers' ability to provide gender-affirming care for transgender (trans) people. This strategy may also reduce healthcare providers' stigma towards trans people and people living with HIV. There is less evidence, however, of educational workshops that address HIV prevention and care among trans women. This protocol details the development and pilot testing of the TEACHH: Transgender Education for Affirmative and Competent HIV and Healthcare intervention that aims to increase gender-affirming HIV care competency among healthcare providers.This community-based research (CBR) project involves intervention development and implementation of a non-randomized multi-site pilot study with pre- post-test design. First, the investigators will conduct a qualitative formative phase involving focus groups with 30 trans women and individual interviews with 12 providers to understand HIV care access barriers for trans women and elicit feedback on a proposed workshop. Second, the investigators will pilot test the intervention with 90-150 providers (n=30-50x3 in-person settings). Primary outcomes include feasibility (e.g., completion rate), workshop satisfaction, and willingness to attend another workshop. Secondary pre- and post-intervention outcomes, assessed directly preceding and following the workshop, include perceived competency, intention to provide gender-affirming HIV care, and attitudes/biases towards trans women with HIV. Primary outcomes will be summarized as frequencies and proportions (categorical variables) and means and standard deviations (continuous variables). The investigators will conduct paired-sample t tests to assess pre- and post-intervention differences for secondary outcomes.
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented. The project has the following important specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. Investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.
To address the critical scientific gaps in PrEP safety for transgender youth and to plan for appropriate implementation of PrEP in transgender youth communities, the study will be conducted in 3 integrated phases. In Phase 1, a pharmacokinetic (PK) study exploring the interactions of cs-HT for both TW and TM youth on TDF/FTC will be conducted. Simultaneously, in Phase 2, ethnographic data via focus groups (FGs) and in-depth interviews (IDIs) to inform the development of a tailored intervention to improve uptake and adherence to PrEP for transgender youth will be collected. In Phase 3, a small demonstration trial of PrEP use in transgender youth, utilizing the ethnographically developed intervention to improve uptake and adherence, while also monitoring renal and bone safety outcomes will be implemented. The project has the following important specific aims: Aim 1: To evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among 24 TW taking estradiol and 24 TM taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily adherence and maximize drug exposure. Aim 2: To develop a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth that is grounded in theory (Information-Motivation-Behavioral Skills Model of Behavior Change, Gender Affirmation, Empowerment Theory) and incorporates the PK data from Aim 1. Investigators will conduct FGs with young TW (N=20-30) and TM (N=20-30) and conduct IDIs with participants from the PK study (Total N=10-14). Investigators will solicit continuous input and feedback from TW and TM on the project's Youth Advisory Board. Aim 3: To conduct a small randomized controlled trial within a PrEP demonstration project comparing the newly developed intervention with standard of care (SOC) in TW (N=50) and TM (N=50) ages 15-24 years.
The I-TEST study builds upon two participatory approaches, open challenge contests and entrepreneurship training. The study utilizes open challenge contest to generate youth-driven interventions on strategies to promote HIV self-testing and other testing for other sexually transmitted infections (STIs) among young people in Nigeria. Open challenge contests involves leveraging on the knowledge and strengths of the crowd (in this case young people) to generate solutions to an issue. Following completion of one of the open challenge contest, was the Designathon contest where young people in Nigeria collaborated to develop new services and products for promoting self-testing for HIV and other sexually transmitted diseases, guided by human-centered, design thinking framework. After which, six teams from the Designathon were selected to move onto an Innovation bootcamp. The Innovation bootcamp was a 4-week long accelerated training program for young people to delve into the world of entrepreneurial and innovation management skills, while applying basic research principles. At the end of the course, 5 finalist teams were selected to pilot test their innovation plan in the community for a duration of 6 months, beginning July 2019. This study is focused on evaluating the effectiveness of these five youth participatory interventions on HIV testing and other key prevention among at risk youth (14-24 years old in Nigeria).This research study will involve undertaking a prospective one-year assessment of these five pilot interventions.
Premised on the National AIDS Strategy's focus on identifying new HIV infections through increased HIV testing, the purpose of this formative pilot study is to develop and test an integrated HIV self-testing strategy that utilizes a simplicity-model approach to HIV self-testing in emerging adult sexual minority men of color.
The investigators propose to develop, implement, and evaluate a theory-driven parental disclosure intervention to assist parents living with HIV (PLH) to make a planned, developmentally appropriate disclosure of their HIV status to their uninfected children or, for PLH with younger children, to articulate a clear plan for disclosure to their children when developmentally appropriate. The majority of the 33.4 million individuals living with HIV worldwide reside in low-resource settings and are also of reproductive and child-rearing age. It is therefore important to the field of public health to develop an evidence-based parental disclosure intervention that can be effectively delivered to parents by a broad range of paraprofessionals. The investigators hypothesize that the proposed intervention will demonstrate efficacy in helping PLH to make developmentally appropriate disclosure to children or make a developmentally appropriate plan of disclosure and will demonstrate short, medium, and long-term efficacy in improving the well-being of parents, children, and families. The proposed scientifically rigorous evaluation includes mixed methods of data collection, a cluster randomized controlled trial, multiple data sources, and a 36-month longitudinal follow-up involving a large sample of parents, children, and providers. The intervention program to be developed and the evaluation data to be collected in the current study will inform the practice and clinic guidelines aimed at improving both parental HIV disclosure and the well-being of PLH, children and families in China and other low-and middle-income countries (LMICs).
This study aims to help young Latino gay and bisexual men access sexual health information, including PrEP. Participants will be randomly assigned to either the patient navigation or the usual care condition and followed for 6 months. The study will recruit self-identified Latino men between the ages of 18 and 29 who also identify as gay, bisexual, and/or have sex with other men, and report CDC defined HIV risk behaviors.
The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.
This study assesses the feasibility and acceptability of the APPEAL program, a 3-session intervention designed to promote positive affect among men and women living with HIV infection. Forty participants will be randomly assigned to receive the APPEAL program, and another 40 will receive standard of care. All participants will complete self-reported assessments at baseline and at 3 and 6 months, and will have their HIV antiretroviral medication adherence monitored as part of study participation.