Active clinical trials for "Acquired Immunodeficiency Syndrome"

Retention in care and persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. Alcohol use is known to impede the health care and health outcomes of people living with HIV. The proposed comparative effectiveness study will evaluate the outcomes as well as the facilitators and barriers to implementing a theory-based alcohol counseling intervention that objectively monitors HIV treatment adherence with corrective feedback and increases care engagement delivered by cell phone in resource limited clinical settings.

Sub-Saharan Africa (SSA) is home to 85% of the adolescents and young people living with HIV (AYPLHIV) globally and they are heavily affected by the HIV/AIDS epidemic: AYPLHIV in SSA are the only population group for whom HIV-related mortality continues to increase, and they have overall poorer outcomes than all other age groups. Lesotho with worldwide the second-highest HIV prevalence shows a viral suppression rate among AYPLHIV of only 49%. In order to address the multiple barriers in the adolescent HIV care cascade and their unique needs, multicomponent packages of differentiated service delivery (DSD) are a promising approach. In close collaboration with different local stakeholders, the researchers designed a DSD model specifically for AYPLHIV, called the PEBRA model. In the PEBRA model the peer-educator (PE) plays a pivotal role, by coordinating the ART refill/care according to the patient's preferences using a tablet-based application, called PEBRApp (https://github.com/chrisly-bear/PEBRApp). The PEBRApp helps the PE to assess each participant's preference, to adapt the ART refill according to these preferences in a feasible manner, to keep track of the ART refill, and to ensure regular contact between the PE and the participant. The model includes key innovative options such as individualized automatic SMS notifications and decentralized ART delivery. The PEBRApp was developed with ❤️ by Technify Maseru, Lesotho (www.technifyls.com) & Christoph Schwizer Zurich, Switzerland (www.christophschwizer.ch).

The most commonly used illicit stimulant in HIV-infected individuals is methamphetamine (MA). Prior studies demonstrate strong evidence that MA promotes increased HIV transcription as well as immune dysregulation. A challenge in achieving worldwide HIV eradication is targeting specific marginalized populations who are most likely to benefit from an HIV cure but possess poorer immune responses. For this study, HIV+ infected ART-suppressed individuals with no prior history of MA use disorder will be administered oral methamphetamine (the maximum FDA approved daily dose for the treatment of childhood obesity) to determine the effects of short-term MA exposure on residual virus production, gene expression, and inflammation. Measures of MA exposure in urine and serum will then be associated with residual virus production, gene expression, cell surface immune marker protein expression, and systemic markers of inflammation. The clinical trial data will generate advanced gene expression and immunologic data to identify potential novel targets for reversing HIV latency, reducing inflammation, and personalizing future therapies in HIV+ individuals who use MA.

The HIV/AIDS crisis in Sub-Saharan Africa has left millions of children orphaned. These children, who are potentially infected with HIV themselves, are highly vulnerable and face some serious risks to their health and overall well-being. A variety of health and economic interventions to help orphans and vulnerable children (OVCs) (and the households in which they live) are being carried out in Mozambique by World Education Inc./Bantwana (WEI/B), funded by USAID. The program is known in Portuguese as Força à Comunidade e Crianças or FCC (in English, "Strengthening Family and Communities"). This study will collect survey and administrative data to assess the impact of the FCC program on OVCs and the households in which they live. A baseline survey was administered to define a sample of households and individuals to follow over time through the upcoming follow-up survey and to measure baseline household characteristics. Follow-up data collection will begin in March 2019. It has several components: Household survey The follow-up survey will provide measurements of the rich set of intermediate and final outcomes for the estimation of treatment effects of the FCC program. Data collection on HIV testing and school attendance This study will supplement survey-reported HIV testing rates with an objective, administrative measure of HIV testing at health clinics. At the time of the follow-up survey, the survey team will recommend that eligible individuals in the household be tested for HIV at a specified local health clinic. To allow tracking of those who follow through with testing, consenting individuals will be given coupons redeemable for a small financial incentive once they have completed an HIV test. In addition to self-reported data on school participation by children, this study will also measure school participation directly. Both school enrollment (presence in school registration records) and school attendance (physical presence of children in school during unannounced school visits by research staff) will be measured. Project staff will visit schools in study communities to check attendance rates of specific school-aged children who were listed in the baseline survey in their community. Informational treatments aimed at raising HIV testing rates To allow insight into the mechanisms through which the FCC program has its effects, this study will provide additional simple treatments in the context of the follow-up survey to explore possible FCC mechanisms: stigma reduction, HIV/AIDS information, and HIV treatment (antiretroviral therapy, or ART) information.

In the US, fewer than 6% of all youth living with HIV (YLWH) achieve HIV viral suppression. However, health disparities among youth extend across the entire HIV care continuum in that there is a strong association between younger age and later HIV diagnosis, lower engagement in care, lower levels of antiretroviral therapy (ART) adherence, and worse HIV clinical outcomes. In response to this critical public health dilemma, the investigators propose to develop a novel mobile health application ("app") to improve engagement in health care and ART adherence and to pilot test this mobile health app in 18-29-year-old YLWH residing in San Francisco. The aims of this study are to: Aim 1: Build on a theory-guided model and formative work to complete the development of a novel personalized mobile health app for improved HIV clinical outcomes among YLWH (includes field test of initial release to ensure adequate usability and engagement). Aim 2: Conduct a six-month single arm pilot study to examine WYZ feasibility and acceptability among YLWH ( N = 76) living in the San Francisco Bay Area. Finally, the investigators will conduct in-depth qualitative interviews with a subset of participants (N = 20) and clinical team members (N = 10) whose patients participated in the pilot study. The investigators hypothesize that this mobile health app will be feasible and acceptable and will result in improved HIV clinical outcomes. Upon completion, the investigators will be ready to test the efficacy of this app in a subsequent large-scale randomized control trial among a population that is disproportionately impacted by HIV and at elevated risk for poor clinical outcomes.

This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant and breastfeeding women with HIV infection.

The overall goal of this project is to implement and test the efficacy of an enhanced comprehensive multidisciplinary early palliative care (EPC) package that includes four motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance care planning in a cost effective manner and could promote engagement and retention in HIV care. If successful, it could serve as a model of early palliative care for persons with AIDS in the US.

This study will be a phase I, open label, three period, fixed sequence crossover study to evaluate the effect of Carbamazepine (CBZ) on the steady-state pharmacokinetics of Dolutegravir (DTG) and on the safety and tolerability of DTG. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There is no washout between treatment periods.

The purpose of this study is to determine the safety, pharmacology and bioactivity of disulfiram in antiretroviral treated HIV-infected adults. The investigators primary hypothesis is that 3 days of disulfiram will result in an increase in HIV transcription in CD4+ T-cells in patients on suppressive antiretroviral therapy (ART).

This study is a Phase 1, open label, non-randomized, single dose study to determine pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral administration in healthy Japanese subjects. A total of 10 healthy Japanese subjects will be enrolled in this study to receive a 50 mg single dose of DTG. Subjects will have a screening visit within 30 days prior to the administration of study drug, a treatment visit, and a follow-up visit 7-14 days after the administration of study drug.