View clinical trials related to HIV Prevention.
Filter by:Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr. Euphemia Sibanda, Reader (Associate Professor) of Global Health and Epidemiology at Liverpool School of Tropical Medicine, UK and Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe) and Dr. Sandra McCoy, Professor of Epidemiology and Biostatistics at the University of California, Berkeley. The goal of the proposed study is to optimize, refine and pilot a pharmacy-based PrEP intervention for female sex workers (FSW) in Zimbabwe. Despite efforts to reach the most impacted and vulnerable populations with PrEP, retention rates, particularly among FSW in Africa, are very low. Relatively high levels of uptake indicate that FSW are interested in PrEP and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. Pharmacy-based PrEP has the potential to address known barriers to PrEP retention among FSW such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of PrEP.
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.
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.
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.
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.
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.
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.
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.
The primary objective of this study is to evaluate uptake and retention of long acting cabotegravir (LA-CAB) also known as Apretude versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) also known as Truvada for PrEP among high-risk women in metro-Orlando through week 48 (to also include reasons for lack of retention in PrEP care)
The overarching objective for the pilot study is to test the feasibility of using a mobile medical unit as a delivery mode combined with enhanced Pre-exposure Prophylaxis (PrEP) messaging to increase awareness of PrEP and access to PrEP medical services among women living in public housing.