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HIV Prevention clinical trials

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NCT ID: NCT05365958 Completed - HIV Prevention Clinical Trials

Podcasting HIV Prevention Within African American Communities

Start date: February 11, 2022
Phase: N/A
Study type: Interventional

Given the continued impact of HIV among African Americans, there is still an urgent need to expand prevention efforts and HIV testing in African American communities. Heterosexual individuals may acquire and spread infection directly through heterosexual contact, bi-sexual sexual contact, and/or indirectly through homosexual sexual contact. Evidence-based interventions (EBIs) have been shown to increase consistent condom use, decrease sexual partners, and increase HIV testing; however, traditionally-implemented EBIs may not be accessible to communities given the resources and expertise needed to implement them. This project seeks to: 1) assess feasibility for the development of two theory- based, video podcast-delivered, HIV prevention interventions for self-identified heterosexual African American males and females; and 2) evaluate their feasibility & effectiveness (pilot). The investigators will develop the two (male and female) video podcasts that maintain the theoretical integrity of two established Centers for Disease Control evidence-based behavioral HIV prevention interventions. The assessment phase will consist of leveraging African American community stakeholders and experts in the development of the podcast content. The effectiveness phase will consist of broadcasting the podcasts for participants and evaluating psychosocial factors related to HIV prevention at 1 and 3 month follow-ups. This intervention is the first of its kind and has the potential to increase HIV protective behaviors in this hard-to-reach and medically underserved population. The resulting interventions are expected to be easily disseminated throughout the African American communities, with the potential to reduce HIV- related disparities within this population. This study will impact and advance the field by demonstrating feasibility and effectiveness for a novel mode of intervention engagement within HIV prevention science, serve as valuable preliminary data for a larger R01 trial, and foster HIV prevention awareness within the African American community.

NCT ID: NCT05338996 Completed - HIV Prevention Clinical Trials

Addressing Health Disparities in Engagement, Retention, and Utilization of PrEP Among South Florida Women of Color

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Women of color (WOC) in South Florida, the region with the highest HIV rates in the U.S., experience significant barriers to accessibility, uptake, and utilization of Pre-exposure prophylaxis (PrEP) for HIV prevention, despite FDA approval since 2012. The purpose of this study is to use a Community-Based Participatory Research (CBPR) approach to finalize, and pilot-test a multi-component evidence-based intervention to reduce health disparities in engagement, utilization, and retention in PrEP care, with the goal of improving HIV prevention outcomes for the target population of WOC in S. Florida, primarily African American, Latina, and Haitian women in 3 designated Ending the HIV Epidemic (EHE) counties: Miami-Dade, Broward, and Palm Beach counties.

NCT ID: NCT05087927 Completed - HIV Prevention Clinical Trials

Study for IFE4PrEP Intervention on PrEP Uptake by Southern African American Women

IFE4PrEP
Start date: April 18, 2023
Phase:
Study type: Observational

Purpose: This study is partnering with communities to identify the best ways to provide HIV prevention communication and services for women living in public housing who have been disproportionately affected by HIV but underserved by current HIV prevention programs. The investigators want to work with community members to develop and design the delivery of a program to promote awareness of and access to pre-exposure prophylaxis (PrEP) for HIV prevention among women living in public housing. Participants: Up to 248 cisgender females who are 18 years of age or older and currently reside in Durham Housing Authority (DHA) housing will be enrolled in this study at UNC. Procedures (methods): Data collection for this formative study will consist of 4 focus groups of up to 12 women in each focus group living in DHA as well as a survey of 200 women living in DHA.

NCT ID: NCT04868383 Completed - HIV Prevention Clinical Trials

Using Smart Phone Technology to Support PrEP Uptake and Adherence

prep'd
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

This is a single arm pilot study of a new smartphone app to support adherence to PrEP medication for HIV prevention in public clinics in Virginia.

NCT ID: NCT04791007 Completed - HIV Prevention Clinical Trials

OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults

Start date: October 5, 2019
Phase: Early Phase 1
Study type: Interventional

This is a monocentric phase I study in open-label and randomized, double-blind, placebo-controlled cohorts of HIV-1 seronegative adults to evaluate the safety, acceptability, and pharmacokinetic of OB-002H Gel administrated vaginally and rectally.

NCT ID: NCT04686279 Completed - HIV/AIDS Clinical Trials

Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)

Start date: April 1, 2021
Phase: Phase 1
Study type: Interventional

ATN DREAM is an early phase-1, open label study to examine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a one-dose tenofovir (TFV) medicated douche. The overall goal is to inform the design of an extended safety study of an on-demand and behaviorally congruent TFV douche to confer protection from HIV acquisition in an outpatient pre-RAI context

NCT ID: NCT04558554 Completed - HIV Prevention Clinical Trials

Pharmacy Delivery to Expand the Reach of PrEP in Kenya

Start date: November 26, 2020
Phase: N/A
Study type: Interventional

3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.

NCT ID: NCT04550221 Completed - HIV Prevention Clinical Trials

The Shauriana Intervention for GBMSM in Kenya

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

The Shauriana intervention, developed from qualitative work using a community-based participatory approach, aims to integrate PrEP, sexual health, and mental health support for gay, bisexual, and other men who have sex with men in Kenya. This study consists of a brief pilot test phase with 10 participants, followed by a randomized, controlled trial with 60 participants.

NCT ID: NCT04532307 Completed - HIV Prevention Clinical Trials

Isisekelo Sempilo Trial to Optimize Peer (Thetha Nami) Delivery of HIV Prevention to Young People in Rural KwaZulu-Natal

Start date: March 12, 2020
Phase: N/A
Study type: Interventional

Despite advances in efficacious, efficient and safe biomedical tools to reduce HIV transmission and acquisition the HIV epidemic in South Africa(SA) remains an intractable problem, with the lifetime risk of infection approaching 70% for a 15-year-old girl currently living in northern KwaZulu-Natal, the Africa Health Research Institute(AHRI) research setting. This is in part due to the difficulty in engaging adolescents and youth in HIV interventions. We build on formative work to develop and tailor the interventions to young people's needs. Our findings suggested that young people want to focus on sexual and reproductive health(SRH) and value health-promotion from people of their own age and background (peer-support). In a 2016 population-based study of 15-24-year-olds in the study area we found that one in five had a curable Sexually Transmitted Infection(STI) of which three quarters of did not report any symptoms and would not have been cured with current syndromic management. We also found that home-based self-sampling and treatment for STIs was acceptable and desirable to young people. Based on this we developed and conducted a 6-month pilot of the Isisekelo Sempilo adolescent and youth friendly clinics. These are mobile and fixed clinics that are linked to existing primary care services. The clinics deliver nurse-led HIV-testing, prevention and care integrated with SRH. To date n=337 of those referred from the community(~10%) have attended the clinic. In our setting >85% of school-leavers are unemployed; there are high levels of common mental disorders which increase with age (rising to 32% of those aged 20-22). Systematic reviews have found that community-based delivery of HIV care and peers are effective in supporting HIV care, adherence and virologic suppression. However, none of these interventions have been tested for HIV-prevention and in youth. Based on this we developed and piloted Thetha Nami, an area-based peer-navigator intervention promoting psychosocial well-being in addition to HIV-prevention to young people aged 15-29. Over a four-month period 24-pairs of peer navigators approached 5872, 15-29-year-old men and women, of which 5272 (90%) accepted the needs assessment. We aim to use advances in intervention design and evaluation to answer the question, "will these tailored HIV-prevention interventions developed in partnership with young people arrest the HIV epidemic and improve well-being?"

NCT ID: NCT04195776 Completed - HIV/AIDS Clinical Trials

Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse

DREAM-02
Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

DREAM-02 is a phase 1, open label study to evaluate different sequences of tap water douching and simulated receptive anal intercourse (sRAI) in the presence of a tenofovir douche designed to confer protection from Human Immunodeficiency Virus (HIV) acquisition. DREAM-02 will assess the safety and pharmacokinetics (PK) of different sequences of administration of tap water (H2O) and rectal tenofovir (TFV) douches to more accurately represent the community practice of commonly using cleansing douches prior to RAI, and occasionally after RAI. DREAM-02 results are essential to gain understanding of Tenofovir diphosphate (TFV-DP) concentrations at various anatomic distances in the colon, and how those concentrations may be modified by sRAI, seminal fluid, and sequence of cleansing tap water douches.