Active clinical trials for "Acquired Immunodeficiency Syndrome"

Though HAV is mainly transmitted through the fecal-oral route, infection by sexual intercourse and blood transfusion is also possible. Injection drug users (IDUs) and men who have sex with men (MSM) have a higher risk of acquiring HAV due to their behaviors. Reemerging threat of hepatitis A among MSM in Taiwan has been reported recently. Based on the guidelines for the diagnosis and treatment of HIV/AIDS and the Advisory Committee on Immunization Practices (ACIP), Taiwan, vaccination of individuals against HAV with any of the following indications is recommended: HIV patients, adults with chronic hepatic disease, hemophilia, liver transplantation, occupational exposure, MSM, persons who use injection or noninjection illicit drugs, or persons traveling to or working in countries that have endemicity of HAV. In HIV-infected patients, the immunogenicity to HAV vaccination is sub-optimal in HIV-infected patients and the seroconversion rate is estimated 68-90% after administration of 2 or 3 doses of HAV vaccine. Furthermore, the antibody titers of HIV-infected patients following HAV vaccination are significantly lower compared to those of HIV-uninfected persons. The sub-optimal response among HIV-infected subjects remains an unresolved problem. In this study, the investigators aim to determine the to conduct a randomized clinical trial to compare the immunogenicity of 2 different doses of HAV vaccination (1 dose versus 2 doses) in HIV-infected patients who failed to achieve serologic response in the primary vaccination. This proposal will provide the solid evidence to elucidate the role of booster HAV vaccination in HIV-infected patients without response to primary HAV vaccination.

To compare the effect of different PrEP drugs (FTC-TDF and FTC-TAF), doses and timing of doses on p24 antigen level in resected foreskin tissue following HIV exposure ex vivo challenge.

Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years. Studies in various countries show that both out of school and in school adolescents and youth are engaged in risky sexual behaviors. Peer-based interventions have become a common method to effect important health-related behavior changes and address the HIV/AIDS pandemic. This study therefore aimed to evaluate the effectiveness of peer education in improving HIV knowledge, attitude, and preventive practices among in-school adolescents

Parental illness and death from HIV/AIDS has a profound and lasting impact on a child's psychosocial well-being, potentially challenging the basic needs for survival and compromising the child's future. Therefore, the impact of parental HIV/AIDS on children needs to be treated from both a public health and a developmental perspective. However, to date the role of a resilience-based approach among children affected by HIV is hypothesized but not evidence-based. In this application, we propose to develop a theory-guided, resilience-based, multimodal intervention by culturally adapting and integrating components from three SAMHSA model programs which show strong evidence in promoting protective factors among young children. The multimodal intervention will include three approach levels: the individual child (peer-group activities), the family (caregiver parenting skill training), and the local community (community advocacy). The short, medium, and long-term efficacy of the Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention to improve health and psychosocial well-being of children will be evaluated over 36 months through a cluster randomized controlled trial. About 800 HIV/AIDS-affected children (8 to 11 years of age) and their primary caregivers will be recruited from central China where we have built a strong research infrastructure and community collaboration during our previous study. The primary outcome measures for the children will include physical health, mental health, growth and development, school performance, and a biological indicator of neurobiological stress response (salivary cortisol). The outcome measures at caregiver level will include parenting style, parental engagement, and mental health well-being. The changes at the community level will be measured using children's and caregivers' perceptions of social support and HIV-related public stigma. We will also examine the potential mechanism through which the ChildCARE intervention is exerting its impact by identifying improvement in protective factors and other individual and contextual factors that potentially mediate or moderate the intervention effect. This proposed project will examine whether the multilevel protective factors we identified in our initial project are amenable to intervention and whether their hypothesized changes explain improvement in children outcomes.

Currently, 12 million children in Sub-Saharan Africa and 1.9 million children in South Africa (SA) are orphaned by HIV/AIDS. Research addressing what can be done to support these children has been limited, clustered and of variable quality. Our prior work showed that an important support structure for care of HIV affected children (orphans) in SA is through Community Based Organizations (CBOs). Currently, no evidence-based CBO intervention exist. CBO careworkers report low efficacy in addressing the mental health and cognitive developmental needs of children. There is therefore a critical need to empower frontline CBO careworkers to be trained in addressing the mental health and cognitive developmental needs of orphans. The Mediational Intervention for Sensitizing Caregivers (MISC) used in our previous work with parents in Uganda holds promise. The objective in this application is to use a mixed methods approach (observations, focus groups, questionnaires) to test the acceptability and feasibility of adapting MISC to be used by CBO careworkers instead of parents (MISC-CBO), and to assess preliminary outcomes. Guided by the Mathews and Hudson's framework for evaluating caregiver-child training programs, our approach will consist of three phases: Adapt, Process evaluation, Outcome evaluation. In Phase 1 (Adapt, Year 1) we will conduct formative research (qualitative interviews and focus groups) with community stakeholders, a Community Advisory Board and children to ascertain feasibility and acceptability of MISC-CBO in the SA cultural context with 7-11 year old AIDS orphans. In Phase 2 (Implementation and process evaluation, Year 2) we will recruit 80 AIDS orphans through 4 CBOs (20 children and 4 careworkers from each CBO). Two CBOs will be allocated to MISC-CBO and 2 will be allocated to treatment as usual (TAU of comparable contact hours). One year of bi-weekly (every 2 weeks) intervention sessions will be conducted. Process evaluation will include individual interviews, observations, focus groups and questionnaire-based assessment of MISC-CBO feasibility, adherence and fidelity. In Phase 3 (Outcomes assessment, Years 2 & 3) the effects of MISC-CBO to promote mental health and cognitive development through the mechanism of improved quality of caregiving by CBO careworkers will be assessed through mental health and cognitive assessments at baseline (beginning of Year 2), 6, 12 and 18 months compared to TAU in the children and careworkers recruited in Phase 2. At the end of this formative RO1 that transforms a parent intervention into a CBO careworker intervention, we will have established the foundational assessments and intervention to apply for an RO1 to evaluate a randomized controlled trial designed to fully test the efficacy of MISC-CBO during the critical developmental window of at-risk HIV affected children aging into adolescence. This project will make possible the only culture-appropriate and sustainable evidence-based CBO intervention that can be readily and effectively implemented globally in low-resource settings with children generally at risk from disease, malnutrition and neglect.

This study aims to test if small incentives promote linkage to care and 6-month viral suppression among individuals recently tested for HIV at selected sites within Johannesburg, South Africa. Individuals who obtain a reactive HIV test result will be randomized to receive either the standard of care (SOC) for linkage to care or to receive financial incentives for confirmatory testing, linkage to care and viral suppression.

This is a randomized controlled trial to test a combination behavioral and biomedical interventions to improve the HIV prevention and care cascades in a population of mobile men in a high priority setting (fishermen in Kenya). The intervention strategy is to recruit and train highly socially-connected men to distribute HIV self-tests and provide linkage support to men in their close social networks. The study will determine whether this social network-based approach along with small financial incentives in the form of transport vouchers can increase men's self-testing, linkage to and uptake of ART and PrEP after self-testing, virologic suppression at 6 months (for those initiating ART) and PrEP adherence (for those initiating PrEP) at 6 months. The study includes a longitudinal qualitative and mixed methods (quantitative and qualitative assessments) to identify the pathways of intervention action, and understand how the social network-based approach with support for linkage affects testing and ART and PrEP uptake and retention in men.

The purpose of this project is to compare the effect of a family-based HIV prevention program to the effect of an adolescent-only health promotion program on adolescent HIV risk and marijuana use among adolescents enrolled in the Juvenile Drug Court (JDC) of the Rhode Island Family Court.

The purpose of this study is to assess the safety and tolerability of intravaginal administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1 will receive up to 7mg of P2G12, or placebo. Three subjects in Group 2 will receive up to 14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or placebo. A safety review will take place before subjects in Groups 2 and 3 receive study drug to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical inspections will be performed to determine what effect, if any, the study drug has had on the site of administration. Adverse event data will be collected throughout the trial.

This study involves conducting formative research to develop a culturally appropriate secondary prevention intervention for HIV-positive Black young men who have sex with men (B-YMSM). The intervention draws upon the principles of Critical Consciousness Theory (CCT). The formative research includes reviewing data and findings from relevant ATN protocols (i.e., 070, 068, and 073) and existing health promotion interventions targeting young men of color (i.e., the Young Warriors program, Hermanos de Luna y Sol [HLS]) and conducting focus groups with up to 32 HIV- positive B-YMSM.