Addressing Alcohol/HIV Consequences in Substance Dependence - Boston ARCH Cohort
The purpose of this study is to expand and continue a cohort of HIV-infected adults to establish the longitudinal Boston ARCH Cohort of 250 HIV-infected men and women with current substance dependence or ever injection drug use that have a spectrum of alcohol use; and to determine the effect of alcohol consumption on changes in bone health prospectively in the Cohort.
NCT01740115 — HIV Infection
Status: Completed
http://inclinicaltrials.com/hiv-infection/NCT01740115/
Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS in resource-constrained settings is the failure of ART-eligible patients to complete the steps required to initiate treatment. The high rate of loss to care of patients who are treatment-eligible at HIV diagnosis may be due in part to the large number of steps required between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In South Africa, these steps usually require approximately four clinic visits over a period of 2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses among those eligible for ART is to simplify and condense the steps required for starting treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and tuberculosis (TB) diagnosis are available. These technologies can be combined with changes to clinic schedules to allow all steps required for ART initiation under South African guidelines (lab tests, physical exam, education) to take place on the day the patient presents for an HIV test. This study is a randomized strategy evaluation of the feasibility, effectiveness, and cost-effectiveness of rapid ART initiation. Outpatient, non-pregnant, HIV-positive adults who come to a South African clinic for an HIV test, consent to study participation, and are eligible for ART will be randomized 1:1 to rapid ART initiation or to standard care. Those who are assigned to rapid ART initiation will have the possibility of receiving their first dose of ARVs as early as the same day, while those who are assigned to standard care will follow the clinic's usual procedures for starting ART. Rapid ART initiation for HIV-positive pregnant women, which has recently become the standard of care in South Africa, will also be assessed in a programmatic evaluation conducted alongside the randomized evaluation, with a retrospective comparison group. The primary study outcome for non-pregnant adults will be remaining alive, in care and virally suppressed 10 months after having a positive HIV test at the study site or making a first HIV-related visit. The primary study outcome for pregnant women will be adherence to ART until delivery. The cost effectiveness of the rapid initiation strategy will be assessed as the cost per patient achieving the primary outcome for each population.
NCT01710397 — HIV
Status: Completed
http://inclinicaltrials.com/hiv/NCT01710397/
A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral therapy (HAART) has greatly improved survival rates and changed the leading causes of death, from AIDS-related diseases to cardiovascular disease and lung cancer. Rates of tobacco use among individuals with HIV/AIDS are very high and varenicline may be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS. Through this trial, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The investigators hypothesize that 1) varenicline and counseling will significantly increase end-of-treatment (week 12) and 24-week biochemically-confirmed abstinence, versus placebo and counseling; 2) quality of life will be rated higher in the varenicline and counseling group versus the placebo and counseling group, and there will be no significant differences between treatment arms in terms of the frequency of severe varenicline-related side effects; and 3) improved affect and reduced cognitive impairment will mediate the effect of varenicline therapy on quit rates.
NCT01710137 — Nicotine Dependence
Status: Completed
http://inclinicaltrials.com/nicotine-dependence/NCT01710137/
Phase IIa Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)
This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk of HIV infection. In addition, the effect of different intervals of the prime-boost will be studied.
NCT01705223 — AIDS
Status: Completed
http://inclinicaltrials.com/aids/NCT01705223/
Enabling People Living With HIV/AIDS (PHA) to Serve as Change Agents for HIV Prevention
The Appreciative Inquiry Change Agents (CA) program (NAMWEZA) intends to address broad societal issues by engaging HIV-positive leaders as 'change agents' in their communities. In this study, the CAs will be recruited from an HIV Care and Treatment Centre in Dar es Salaam. The Namweza program has the potential to address structural issues related to HIV risk, such as access to limited resources, through an entrepreneurial component of the program. A positive, or appreciative, focus promotes CAs to examine assets in themselves and in their networks, encourages strengthening of relationships, and facilitates planning for a positive future for themselves, their families, and their communities. A stepped wedge randomized trial will be performed to evaluate the effectiveness of the program for the following primary outcomes: uptake of HIV services among network members of the CAs; rate of unprotected sex and frequency of concurrent relationships among CAs and their social networks; and levels of self-esteem, general self efficacy, and risk of intimate partner violence in the CAs. Secondary outcomes include: depressive symptoms, hopefulness, and HIV-related stigma (among CAs); social support and quality of relationships (among CAs); and HIV knowledge, attitudes and self-efficacy in preventing HIV transmission or re-infection (CAs and their networks). The following are primary hypotheses that will be tested through this stepped wedge randomized trial evaluation: 1. Uptake of HIV services will increase among individuals in the network of the HIV-positive Change Agents related to the intervention; 2. Levels of self-esteem and general self-efficacy will increase in trained Change Agents; 3. Rate of unprotected sex and number of concurrent partners will decrease (among network of Change Agents as well as Change Agents themselves; i.e. the 'study population'); and 4. Prevalence of intimate partner violence (IPV) will decrease in Change Agents. Secondary hypotheses are: 5. Prevalence of depressive symptoms and HIV-related stigma will decrease and level of hopefulness will increase in trained Change Agents; 6. Levels of HIV knowledge, attitudes and self-efficacy in preventing HIV transmission and re-infection among CA and their networks will increase; and 7. Degree of social support and quality of relationships will improve among CA. If the proposed intervention is found to be effective, linkages with the Tanzanian Ministry of Health and other stakeholders will enable scale-up of the program throughout the country.
NCT01693458 — HIV Infection
Status: Completed
http://inclinicaltrials.com/hiv-infection/NCT01693458/
Assessment of the Effectiveness of New Clinical Guidelines for Differential Diagnosis and Management of Common HIV/AIDS-related Conditions in Mozambique: A Country-specific Public Health Evaluation." (CDC)
Utilizing funding through the President´s Emergency Plan for AIDS Relief (PEPFAR) this project seeks to assess the effectiveness of a subset of the new Mozambican clinical guidelines for the diagnosis, initial management, and follow-up ( >1 follow-up visit to determine response to initial and/or second-line therapy) of common signs and symptoms in HIV-infected adult patients as used under field conditions by Mozambique-based clinicians in MOH health facilities in Zambézia province, Mozambique. The operational feasibility of the new guidelines will be described; they will be compared to the previous standard of care for the problem(s) of interest, and the clinical importance of differences between guidelines designed for Mozambican non-physician clinicians and new guidelines (also issued in late 2009) for Mozambican physicians will be described. The subset of guidelines to be addressed in the current phase of this 2-year project includes algorithms for diagnosis and management of acute fever, persistent fever, and anemia.
NCT01681914 — Anemia
Status: Completed
http://inclinicaltrials.com/anemia/NCT01681914/
Beyond the Physical: Enhancing Psychosocial Functioning in Parkinson's Disease
This project will investigate the feasibility and preliminary effectiveness of an intensive and focused working memory training program for patients in the early stages of PD receiving dopaminergic therapy. The investigators hypothesize that working memory training will be an effective method of improving working memory and related cognitive and behavioural functions in PD patients.
NCT01647698 — Parkinson Disease
Status: Active, not recruiting
http://inclinicaltrials.com/parkinson-disease/NCT01647698/
The Thai Red Cross AIDS Research Centre
Objectives 1. To determine the impact of MSM-targeted multidisciplinary services on uptake of HIV voluntary counseling and testing (VCT) 2. To determine the impact of MSM-targeted multidisciplinary services on the enrollment into care and retention of HIV-positive MSM Subject population: HIV-negative and HIV-positive MSM clients, age ≥18 years old, of the Thai Red Cross Anonymous Clinic (TRC-AC) in Bangkok Thailand, the Cipto Mangunkusumo Hospital in Jakarta, and the Sanglah Hospital in Bali, Indonesia Number of participants: 200 HIV-negative and 150 HIV-positive MSM participants
NCT01637324 — HIV Testing
Status: Completed
http://inclinicaltrials.com/hiv-testing/NCT01637324/
The Thai Red Cross AIDS Research Centre
The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV) types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.
NCT01637298 — Anal Intraepithelial Neoplasia
Status: Completed
http://inclinicaltrials.com/anal-intraepithelial-neoplasia/NCT01637298/
Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy
The purpose of this study is to advance the evidence base regarding methods for facilitating informed decisions among patients with knee and hip osteoarthritis by comparing DVD and online formats of decision aids for these conditions. The project will assess how these different formats impact key outcomes including: patient knowledge about treatment options, decisional conflict, preparation for decision making, decision self-efficacy, stage of decision making, and acceptability and usability of the decision aids.
NCT01618097 — Osteoarthritis
Status: Completed
http://inclinicaltrials.com/osteoarthritis/NCT01618097/