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HIV Prevention clinical trials

View clinical trials related to HIV Prevention.

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NCT ID: NCT06158126 Not yet recruiting - Pregnancy Related Clinical Trials

UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

PrIMO
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is: - Do composite adverse pregnancy events, maternal health outcomes, and/or infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA? Women receiving PrEP at the time of pregnancy diagnosis or initiating PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP at the start of the study and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period. In addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.

NCT ID: NCT06094634 Not yet recruiting - HIV Prevention Clinical Trials

IGHID 12219 - A Brief Alcohol Intervention for PrEP Use Among MSM in Vietnam

BPrEP
Start date: April 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of a brief alcohol intervention (BAI) vs. standard of care (SOC) to improve pre-exposure prophylaxis (PrEP) use among men who have sex with men (MSM) with unhealthy alcohol use initiating or re-initiating PrEP in Vietnam.

NCT ID: NCT06056544 Not yet recruiting - HIV Prevention Clinical Trials

Client-Centered Care Coordination for Black Men Who Have Sex With Men

Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM). The main aims of the study are: 1. Determine the efficacy of C4 for increasing PrEP adherence among Black MSM. 2. Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence. 3. Describe the acceptability and feasibility of C4 implementation in community settings. Participants in the clinical trial will be randomized to receive the intervention or standard of care for PrEP in two sites. Researchers will compare administration of C4 to standard of care to see if C4 improves adherence to PrEP. C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). The intervention pulls from the Centers for Disease Control and Prevention (CDC) Comprehensive Risk Counseling and Services (CRCS) and Self-Determination Theory (SDT) to support client-identified HIV prevention goals to promote, adopt, and maintain PrEP use. CRCS is a public health strategy to assist persons in developing behavioral goals to reduce HIV acquisition and transmission. In this intervention, the HIV prevention plan element of CRCS will be the foundation of the C4 intervention. After the initial prevention plan is developed, elements of SDT will be used to implement a client-centered care approach to assist in addressing issues which many arise which impede successful PrEP adherence.

NCT ID: NCT06030856 Recruiting - HIV Prevention Clinical Trials

PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk

PALESA
Start date: July 5, 2023
Phase: N/A
Study type: Interventional

This is a pilot randomized trial among 50 AGYW (aged ≥16≤18 years), who discontinued PrEP use within the past 6 months, assigned in a 1:1 ratio to receive: 1) STI self-test kits (Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)) with in-person instruction at enrolment and telephone/video-based instructions for home use coupled with self-administered behavioural risk assessment or 2) self-administered behavioural risk assessment only (standard of care). All participants will receive comprehensive sexual and reproductive health (SRH) services during their study visits including choice of family planning method initiation and support, and behavioural HIV/STI risk reduction counselling.

NCT ID: NCT06030557 Recruiting - Hiv Prevention Clinical Trials

PrEPared-RN, CAN Nurse-Led Management of High-risk Patients for Pre-Exposure Prophylaxis (PrEP)

Prep-RN
Start date: April 16, 2023
Phase:
Study type: Observational

During the initial encounter, the nurses will complete program enrollment forms (consents and disclosures as approved by IRB), medical history, and risk assessment. If needed, the RN will facilitate a 4th generation rapid HIV test or draw HIV serology. A general review of systems, focused physical exam with emphasis on sexually transmitted infections and signs of seroconversion is provided, including identifying signs of genitourinary infection. The nurse will order labs per standing order and performs blood draw. Pre-test and Post-test counseling with HIV and STI testing is provided at this time. Upon receipt of a negative HIV rapid or serology test, PrEP-RN provides a 7-14 day supply of samples with a 30-day prescription of FTC/TDF (Truvada) or a 30-day prescription of FTC/TAF (Descovy) per standing order. At each follow-up visit, client's self-efficacy, attitudes/beliefs about PrEP, general health indicators, and social determinants of health, such as access to transportation and housing status, are recorded. Process evaluation will be performed to determine relationships of these variables and PrEP adherence, implementation (12 months), and continuation/dissemination (year 2) phases of the study.

NCT ID: NCT05968755 Not yet recruiting - HIV Prevention Clinical Trials

Leveraging Chatbot to Improve PrEP in the Southern United States

Start date: March 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.

NCT ID: NCT05937698 Recruiting - HIV Prevention Clinical Trials

The CATALYST Study

Start date: May 30, 2023
Phase:
Study type: Observational

The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at PEPFAR sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe.

NCT ID: NCT05889533 Recruiting - HIV Prevention Clinical Trials

Eswatini Ring Study: Increasing PrEP Options for Women

Start date: May 9, 2023
Phase:
Study type: Observational [Patient Registry]

The study will deliver PrEP choice between oral PrEP and the PrEP ring for women in PEPFAR/USAID public health service delivery sites, building on the existing PrEP service delivery models at each site and in accordance with national guidelines for PrEP service delivery in Eswatini. The overall goal of the study is to characterize and assess the feasibility, acceptability, uptake, patterns of use, and clinical outcomes of an enhanced service delivery package providing fully informed choice of oral PrEP and the PrEP ring among women, especially adolescent girls and young women, in Eswatini.

NCT ID: NCT05856942 Recruiting - HIV Prevention Clinical Trials

Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program

HOT4PrEP
Start date: March 8, 2022
Phase: N/A
Study type: Interventional

The study's aim is to implement a home-based PrEP (HB-PrEP) monitoring system (self-collected blood and extragenital specimens at home and telehealth follow-up) into a large, urban sexual health clinic while also evaluating the program's clinical effectiveness. Study participants will self-collect blood specimens using Tasso devices, which are currently designated as FDA Class 2 exempt medical devices (similar to a medical lancet). This study will be integrated into King County's Ending the HIV Epidemic plan and generate data to inform refinement, adaptation and scale-up of future HB-PrEP programs. Specific research aims are to: 1. Conduct a hybrid randomized trial to compare the impact of a HB-PrEP program versus standard of care (routine in-clinic monitoring) on PrEP retention over time and use mixed-methods assessments to define the factors that influence HB-PrEP implementation. Hypothesis: HB-PrEP will increase PrEP retention rates by >10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits. 2. Perform a cost analysis of the HB-PrEP implementation strategy compared to standard care. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC. 3. Develop a qualitative tool to engage healthcare stakeholders and determine the wider scalability of HB-PrEP.

NCT ID: NCT05804461 Recruiting - HIV Prevention Clinical Trials

Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

To develop, assess and compare the effectiveness of a Motivational Interviewing Intervention for increasing Pre-Exposure Prophylaxis (PrEP) uptake among Latino Men Who Have Sex With Men (MSM) in Puerto Rico.