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NCT05929482
Latinas continue to be affected disproportionally by HIV in the United States (US). Often, Latinas are not aware of their HIV status. Also, their perception of low risk for HIV interferes with condom use, HIV testing and lack of awareness, access, and use of Pre-exposure Prophylaxis (PrEP). About 60% of total HIV cases in NC occur among women of childbearing age, thus vulnerability to HIV is particularly acute among Latinas between ages 18 and 44 years old, an age group with the highest rate of new HIV infections in NC. These disparities indicate that HIV prevention among Latinas is urgent; therefore, the investigators propose an innovative intervention - a filmed dramatized story (telenovela/soap opera) Infección de Amor (IA) (Love Infection) - culturally tailored for Latinas in the US and delivered online. Infección de Amor was filmed and developed but has not been tested with the target audience. The proposed study will pilot test IA and move the intervention to online using a website that will allow individual access around the clock from any location and device, such as a smartphone, ensuring wide dissemination of the intervention in the future. This is a a two-year planning grant (R34) to prepare for an R01 efficacy trial. The aims are to: 1) Develop the intervention delivery website, conduct a website usability test, and test the feasibility and acceptability of the IA intervention (four telenovela episodes) with 10 Latinas, 2) Conduct a randomized controlled pilot study to examine change in HIV prevention behaviors (condom use; HIV testing; and PrEP awareness, access, and use) comparing intervention and control Latinas from baseline (Time 1 \[T1\], 0 months) to post-active intervention (Time 2 \[T2\], 1 month), and to six months follow-up, a period with no contact from the study staff (Time 3 \[T3, 7 months\]), and 3) Complete establishing the study infrastructure, expanding the multidisciplinary team, building the research partnerships with the community, finalize the protocol and training materials, refine recruitment and retention strategies, data collection and data management procedures, and obtain institutional review board approval in preparation for an R01 efficacy study. This study address the National Institute on Drug Abuse (NIDA) goal #4: increase NIDA research and programs' public impact. This is a novel intervention to advance HIV prevention for Latinas. This study implement a culturally durable and feasible intervention for Latinas.
NCT07209917
Cervical cancer (CC) remains one of the most common malignancies among women in India, with nearly 100,000 women diagnosed annually and over 60,000 preventable deaths annually. With high-risk human papillomavirus (HR-HPV) as the causative agent for CC, one risk factor that places women at high risk for CC is human immunodeficiency virus (HIV), as impaired immune response against Human papillomavirus (HPV) may result in persistent HR-HPV infection, a critical risk factor for progression of HPV-related cervical oncogenesis. Progression of precancerous lesions among women living with HIV (WLH) is also associated with: 1) lack of HPV screening; 2) high levels of depressive symptoms and stigma; and 3) malnutrition, which negatively impacts the activation and proliferation of immune cells. Yet programs that offer WLH with comprehensive services focused on HPV screening and psychological and nutritional support are almost non-existent, and the gap is critical. Nutrition plays an integral role in relationship to HPV/HIV co-infection, as demonstrated by an increased risk of HR-HPV associated with poor nutrition; nutritional deficiencies are likewise linked to cervical intra-epithelial neoplasia. The immunological effect of malnutrition may also be exacerbated among WLH due to elevated energy demands of chronic immune activation; worsened with HPV/HIV co-infection. Further, depressive symptoms (aka depression for brevity) partially mediate the effect of food insecurity on HIV viral suppression. In our completed ASHA-Nutrition R01 study of antiretroviral (ART) adherence, the investigators trained lay community health workers, named Accredited Social Health Activist (ASHA), to improve the health of 600 rural WLH by providing emotional support, skill-building, nutrition education, and/or protein-enriched food supplements. In that study, our intervention, co-delivered by our trained ASHA, and guided by nurses, led to increased CD4+ T cell recovery and improved anthropometric and psychosocial outcomes. The investigators found that ASHA support plus protein supplements and nutritional education were significantly associated with improved CD4 counts and increased lean mass at 18 months (P \< 0.001), as well as significant improvements in depression, ART adherence, social support and internalized stigma. In our sub study, CC screening of 598 of these WLH revealed that 13% were found to have abnormal cervical lesions and 4 (1%) had squamous CC. Preliminary evidence also revealed that nutritional supplements may be associated with a 40% reduction in the risk of abnormal cervical lesions (adjusted odds ratio \[aOR\] = 0.60), with an association between serum albumin and reduced risk of abnormal lesions (aOR= 0.39). With a focus on secondary prevention of CC, the investigators hope to mitigate the link between HR-HPV persistence and risk of CC as well as improve the health of women co-infected with HPV/HIV (W-Co-V). Our stellar team plans to build upon our prior ASHA-Nutrition intervention, using formative research to refine a nurse-led, ASHA co-delivered, nutrition-enhanced SAKHI HPV intervention, adapted for W-Co-V. This will be followed by a randomized controlled trial (RCT), assessing the efficacy of our refined comprehensive, multifaceted SAKHI HPV intervention, as compared with an enhanced Standard of Care (SOC+) (usual care + 3 sessions \[wellness, basic nutrition and HPV/HIV health promotion\]) among 348 high-risk co-infected women to prevent CC while remaining engaged in the HIV treatment cascade, and managing nutritional health. Recruited participants will be individually randomized in a 1:1 ratio into the two study arms. Our Primary outcome is HR-HPV persistence (2 positive tests for the same HR-HPV type, separated by 12-18 months). The two aims incorporating RCT interventions are as follows: Aim 2. To evaluate the efficacy of SAKHI HPV intervention among 348 W-Co-V on the primary outcome (HR-HPV persistence) as compared to the Enhanced Standard of Care (SOC+) program. H2: Compared to the SOC+ participants, SAKHI participants will have lower rates of HR-HPV persistence. Aim 3. Assess the impact of the SAKHI program secondarily on: 1) HIV indices (HIV viral load; CD4 count); 2) Nutritional index (serum albumin) at 6-, 12-, and 18-months.
NCT07335289
PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating: * Same-day initiation based on rapid HIV testing, and * Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP. The primary hypothesis is that giving participants choice in follow-up location will improve PrEP persistence compared to a clinic-only model. Secondary analyses will evaluate safety of rapid testing, acceptability, and participant costs. Exploratory analyses will assess HIV incidence and resistance. Findings from PrEP4U will provide essential evidence to guide scalable, equitable, person-centered delivery models for lenacapavir PrEP in the U.S. and globally.
NCT05484895
This 5-year project will test an mobile health approach to improve HIV self-testing (HST) and linkage to HIV-related care among high-risk men in China. HIV-negative men who have sex with men (MSM) will be randomly assigned to an intervention group: access to WeTest-WeLink (a mobile application-based HIV testing health promotion and risk reduction program), or a control group. Participant HST and sexual risk behaviors will be evaluated at baseline and at 6, 12, and 18 months post-baseline.
NCT07663149
This study aims to evaluate the effectiveness of continuous phenylephrine infusion at 50 mcg/min in preventing shivering after spinal anesthesia in cesarean section. This study was an open-label randomized clinical trial involving patients undergoing cesarean section under spinal anesthesia. Subjects were allocated into two groups: without phenylephrine and continuous phenylephrine infusion at 50 mcg/min. The primary outcome was the incidence of shivering during observation, assessed using the Crossley and Mahajan scale. Secondary outcomes included hypotension, ephedrine requirement, hemodynamic adverse events, and nausea vomiting.
NCT06853314
(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report/medical records, recent adherence and longer-term adherence by self-report/medical records over the 6-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks. (Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race/ethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.
NCT07392372
This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels. The main goals of this study are: * To learn about the safety of BNT351 and check for side effects. * To measure the amount of BNT351 antibody in blood over time. * To test the amount of HIV in the blood at different times after treatment with BNT351 in people living with HIV.
NCT04946994
The purpose of this randomized clinical trial is to characterize the effects of two exercise interventions, high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME), on sleep and inflammation in older people living with HIV (PWH). This study is a sub-study associated with The High Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults with HIV (HEALTH-HIV; NCT04550676). The investigators propose the following aims: Aim 1. Compare the effectiveness of HIIT and CME exercise interventions on sleep in older PWH. Aim 2. Quantify inflammation markers associated with sleep quality (self-report surveys) in older PWH at baseline, between (week 8) and after exercise interventions (HIIT and CME) (week 16). The investigators hypothesize HIIT will lead to greater improvement in sleep quality (duration and quality) compared to CME and older PWH who experience poor sleep quality and the CME intervention will have increased inflammation markers compared to older PWH who experience better sleep quality and the HIIT intervention. The intervention is being delivered by research personnel at the University of Washington associated with the HEALTH-HIV study (NCT04550676). Data for this study will only be collected at the University of Washington site of the HEALTH-HIV study.
NCT07388394
Since the advent of antiretroviral treatments, the life expectancy of people living with HIV (PLHIV) has increased significantly. In France, more than 30% of PLHIV are now over 50 years old. This population is exposed to high multimorbidity, leading to frequent polypharmacy, defined as the regular use of at least five medications. Polypharmacy also has a qualitative dimension, including potentially inappropriate prescriptions. It increases the risk of adverse effects and drug interactions and impairs quality of life. A coordinated geriatric approach is therefore essential to optimize care. Healthy aging, promoted by the WHO, aims to improve the lives of older people. In this context, a study will be conducted at the Nice University Hospital among PLHIV aged 75 and over. It will collect quantitative data, the results of which will enable us to consider, if necessary, adapting the care pathways of these patients whose needs are complex.
NCT07656077
The study aims to better characterize intestinal tissue-resident memory T cells (TRM) in people living with HIV-1 receiving suppressive antiretroviral therapy (ART). TRM cells are key components of tissue immunity and may contribute to HIV-1 persistence within the intestinal mucosa, a major viral reservoir. The phenotypic, transcriptomic, and functional characteristics of intestinal CD4+ and CD8+ TRM cells, their susceptibility to HIV-1 infection, and their potential role as viral reservoirs will be investigated. Blood samples and additional colonic biopsies obtained during routine clinically indicated colonoscopy will be collected from HIV-1-infected participants and HIV-seronegative controls.
NCT06444360
The use of behavioral intervention to reduce stimulant use and concurrent HIV sexual transmission risk.
NCT07637877
This study focuses on people with HIV who experience incomplete immune reconstitution despite suppressive antiretroviral therapy (ART), characterized by persistently low CD4⁺ T cell counts and residual inflammation. The underlying cause is largely attributed to the persistent HIV latent reservoir. Recent evidence indicates that rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) commonly used in ART, has an immunomodulatory function beyond its antiviral activity. It activates the CARD8 inflammasome - an intracellular "kill switch" - triggering pyroptosis selectively in HIV-infected cells. In this study, rilpivirine will be added to suppressive ART in patients with incomplete immune reconstitution. The investigators hypothesize that this strategy will reduce the latent reservoir, restore CD4⁺ T cell counts and function, attenuate excessive immune activation, and ultimately improve long-term clinical outcomes.
NCT06333808
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
NCT07643948
The study aims to determine the prevalence of drug resistance mutation (DRM) in virally suppressed HIV infection, and the impacts of regimen change and the presence of low level viremia. Adults living with HIV infection on antiretroviral therapy (ART) with full viral suppression would be recruited. Cases are patients planning for regimen switch, while controls are those with and without low level viraemia (LLV) not planned for switch. Blood samples would be collected before and after switch. Sequencing would be performed to identify DRM present in HIV-1 proviral DNA.
NCT07644546
Seasonal influenza causes morbidity in people with impaired immunity, including adults with elder ages and other comorbidities \[1\]. Standard-dose inactivated influenza vaccines (IIV) may induce lower hemagglutination inhibition (HAI) titers and more rapid waning in these groups. High-dose IIV could generate higher and more durable serological responses, including HAI, B-cell activation and antibody magnitude, which was demonstrated in randomized trials \[2,3\]. MF59-adjuvanted IIV further enhances innate immune activation and antigen presentation, potentially broadening and strengthening responses, particularly during antigenic drift seasons \[4\]. These enhanced platforms represent biologically distinct strategies to overcome reduced vaccine responsiveness. Influenza A/H3N2 was reported as the predominant circulating strain in Taiwan. Initial antigenic characterization suggested suboptimal match between some circulating A/H3N2 viruses (the subclade K variant) and the vaccine reference strain, whereas A/H1N1 viruses appeared consistency with the circulating and vaccine-containing strain \[5\]. As of February 2026, approximately 2,300 cases of severe influenza had been confirmed during the 2025-2026 season, representing the largest epidemic in the post-COVID-19 era. In the meanwhile, both MF59-adjuvanted and high-dose influenza vaccine were firstly introduced in Taiwan for elderly people \[5\]. Previous study had demonstrated that people living HIV (PWH) might have lower humoral immune responses compared with people without HIV, even among PWH with relatively higher (defined as ≥ 350 cells/mm3) CD4 counts \[6\]. In spite of the broad use of these novel influenza vaccines in older adults and other population with immunocompromised status such as the recipient of solid organ transplantation \[7\], evidence gap exists in PWH, where vaccine responses vary by CD4 count, viral suppression, immune activation, comorbidities, and prior vaccination history. High-dose influenza vaccination has shown improved serologic outcomes versus standard dose in PWH in randomized trials \[2\], while data of MF59-adjuvanted vaccines used for PWH are lacking. Moreover, comparative serological responses, durability or effectiveness between the two vaccines (MF59 adjuvant vs high-dose) was only conducted among participants with elder age, which showed that the seroconversion rate for H3N2 among those receiving MF59-adjuvanted vaccines did not meet noninferiority criteria compared with those receiving high-dose vaccines \[8\]. Nevertheless, such data on PWH remains unclear. In this study, we aimed to compare toe immunogenicity among PWH undergoing MF59-adjuvanted or high-dose seasonal influenza vaccine.
NCT07645378
Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030.
NCT06373952
The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for men who have sex with men (MSM) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like MSM, and allows immediate engagement in the post-test linkage process to prevention or treatment services.
NCT05929911
People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.
NCT06951542
The overall aim of this study is to assess the acceptability, feasibility, fidelity, and effectiveness of a depression treatment intervention augmented with counseling to address stigma. Using a multiple-baseline design, 200 depressed adults living with HIV will be enrolled in the trial. Participant surveys and abstracted clinical data related to HIV and depression care will assess the effectiveness of the intervention.
NCT07044297
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it