Active clinical trials for "HIV Infections"

The purpose of this research study is to understand why certain HIV medication regimens (called anti-retroviral or ARV medications) cause more weight gain than others. In this research, the investigators will compare micro-RNA profiles of people who take Symtuza(darunavir(D)/cobicistat(C)/emtricitabine(F)/tenofovir alafenamide (TAF))[D/C/F/TAF] with those who take Biktarvy(bictegravir(B)/emtricitabine(F)/tenofovir alafenamide (TAF))[B/F/TAF] and try to correlate this with the change in body weight and BMI over a course of 48 weeks. The investigators will also attempt to monitor the calorie intake of the participants in the two groups and correlate it with treatment-induced weight gain. Micro-RNAs are small molecules that are produced naturally in the human body, and which are responsible for modifying the expressions of genes. They have the potential to be used in diagnostic and therapeutic medicine and their putative role has been explored in many diseases across many clinical trials. By doing this research, the investigators hope to learn more about their role in HIV disease and its correlation with treatment-induced weight gain.

Integrase-strand-transfer-inhibitors (INSTIs) based regimens have been associated with body weight gain and increase in total body adipose tissue (AT). Whereas there is by now no clear understanding of the mechanisms that induce these changes, we have observed modifications of AT in vitro, in animals models or in vivo in obese patients with raltegravir (RAL) and dolutegravir (DTG) with the presence of increased peri-adipocyte fibrosis and high levels of collagen VI that have been associated with poor metabolic prognoses together with cellular insulin resistance and decreased adiponectin secretion. One major clinical question is whether such AT abnormalities are reversible. Doravirine (DOR), the most recent available Non-Nucleosidic Reverse Transcriptase Inhibitor (NNRTI) drug, has an excellent metabolic profile and as a NNRTI is expected to induce neither changes in fat tissue distribution nor changes in body weight. Tenofovir disoproxil fumarate (TDF) is associated with a protective lipid profile and, unlike tenofovir alafenamide (TAF) which seems to potentiate weight gain in combination with INSTI, has not been associated with weight gain. One major clinical question is whether such AT abnormalities are reversible. Doravirine, the most recent available NNRTI drug, has an excellent metabolic profile and as a NNRTI is expected to induce neither changes in fat tissue distribution nor changes in body weight. Tenofovir DF is associated with a protective lipid profile and, unlike TAF which seems to potentiate weight gain in combination with INSTI, has not been associated with weight gain. We hypothesized that modifications in morphology and function of the adipose tissue in patients with significant weight gain under an INSTI-based regimen could be improved after switching to the triple drug TDF/Emtricitabine/DOR and that fat increase and body weight will be stopped or reversed. This pathogenesis study aimed to evaluate potential changes in adipose tissue after switching from an INSTI-based regimen (Raltegravir or Dolutegravir or Bictegravir) to TDF/Emtricitabine/DOR. Each patient will be evaluated with an adipose tissue biopsy performed before (D0) and after a 48 week switch (W48) from an INSTI-based regimen to the non INSTI-based regimen combining TDF/3TC/Doravirine. With a number of 22 patients at D0, a total of 20 patients with paired adipose tissue biopsies are expected at W48. The antiretroviral therapy with TDF/emtricitabine/Doravirine will be used as routine practice recommends.

Having health workers assist HIV-infected persons with the recruitment and testing of their sexual contacts and biological children is an effective and efficient way of identifying additional HIV-infected persons in need of HIV treatment and HIV-uninfected persons in need of HIV prevention. However, in Malawi, a country with a generalized HIV epidemic, health workers lack the counseling and coordination skills to routinely assist their HIV-infected clients with these services. This study will determine how to help health workers to effectively and efficiently provide these services to their patients through a set of digital capacity-building tools.

This research study uses a cluster randomized controlled trial design to evaluate the effectiveness of Treatment Text (TXTXT) intervention on adherence and viral load suppression at 3- and 6- months post intervention initiation for youth and young adults with HIV. A total of 12 clinics will be randomized into one of the following two conditions: Comparison Arm (n=6 clinics)- Clinics randomized to the comparison arm will have participants receive the standard of care for 3 months, followed by a 3-month intervention period. Intervention Arm (n=6 clinics)- Clinics randomized to the intervention arm will have participants receive the TXTXT intervention for 6 months.

A community-based Phase III, cluster randomized trial that seeks to determine the 24 week survival with retention in care of point of care CD4 testing with visitect and an enhanced package of screening and prophylaxis for opportunistic infections among patients with advanced HIV disease.

To address the significant barriers to pre-exposure prophylaxis (PrEP) implementation for cisgender women and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is the second part (Aim 2) of a multi-component project and involves a patient- and clinic-level intervention in a public health family planning clinic in Duval County Florida, where most patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed 1) a tablet-based decision support tool (DST) that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV, and 2) clinic-wide trainings regarding shared decision making and trauma informed care. In Aim 1 (previously completed), participants were randomized to viewing an HIV prevention DST in a clinic that had not received clinic-wide trainings. In Aim 2 (the present study), there will be two phases. In the first phase, participants will receive care at the clinic following training; the DST will not be used. In the second phase, in addition to being seen at a clinic-site that has experienced the training, participants will use the DST before their visit. Participants will be surveyed about experiences with HIV prevention counseling, intentions about using HIV prevention, and DST use (among those in the active arm in the second phase). A subset of participants, individuals who self-identify as Black or Latinx, will also complete a post-clinic visit interview. The investigators will assess whether participants initiated an HIV prevention method three months following their initial visit. The main outcomes will include a quantitative and qualitative assessment of PrEP or other HIV prevention use, decisional certainty, and satisfaction with information about HIV prevention options.

The objective of this study is to understand the effects of HIV cure strategies on the virus and immune cells that reside within the gastrointestinal tract. Subjects receiving therapies with the potential for HIV cure will undergo a colonoscopy to obtain gastrointestinal tissue for research assays. This study will test whether receiving these therapies will induce changes in the immune cells in the gastrointestinal tract and reduce the tissue-associated HIV viral levels.

A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (< 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone/text-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).

The goal of the study is to evaluate Malkia Klabu ("Queen Club") in Tanzania, a loyalty program intervention that creates adolescent girls and young women (AGYW)-friendly drug shops where AGYW can access HIV prevention services and contraception.

The goal of this study is to improve HIV care outcomes for people who inject drugs (PWID) in India. The study will implement a two-phase trial to evaluate whether HIV treatment outcomes (HIV viral suppression) in HIV infected PWID can be improved with three different interventions: i) by offering a faster treatment start time (same-day antiretroviral therapy [ART] initiation vs. standard), ii) by provided community-based HIV care in PWID-focused centers (vs. centralized government-based HIV care) and, iii) providing an enhanced adherence support to participants who experience treatment failure at six months (vs. routine adherence support). The investigators hypothesize that faster access to ART and HIV treatment in PWID-focused community sites will lead to higher levels of initiation and retention to ART compared with standard care; and use of enhanced navigation and psychosocial support to patients who experience treatment failure at six months will lead to improved viral suppression compared with routine adherence support.