View clinical trials related to HIV/AIDS.
Filter by:Adherence to antiretroviral therapy (ART) drops sharply after prison release. Effective medication adherence training immediately before and after prison release may improve health outcomes and limit transmission of Human Immunodeficiency Virus (HIV). ATHENA (Adherence Through Home Education and Nursing Assessment) is an evidence-based medication adherence intervention, which is delivered in the patient's home by nurses and peer educators working in teams. In this study, researchers will examine the acceptability and feasibility of the ATHENA intervention through a 2-arm randomized controlled trial conducted with HIV-infected prisoners in Indonesia. Eligible subjects will be >18 years of age, HIV-infected, and may be treatment-experienced or treatment-naive. Subjects randomized to the intervention arm will participate in monthly medication adherence counseling sessions within prison and home visits up to four months after prison release. Subjects randomized to the control arm will receive standard care, which includes a referral for HIV care after prison release. The primary endpoint is the proportion of subjects demonstrating ART adherence >90% at 3 months after prison release. Secondary endpoints are: 1) retention in HIV care, 2) ART initiation, 3) HIV- RNA viral load, 4) CD4+ T-cell count, 5) quality of life, 6) hospitalization, 6) substance use and sexual risk behaviors at 3 months after prison release.
In natural HIV disease, a small fraction (1-2%) of infected individuals develops exceptionally high titres of HIV-1 neutralizing serum activity. Antibodies isolated from these individuals have been shown to be highly active against a broad range of different HIV strains and are therefore called broadly neutralizing antibodies (bNAbs). These antibodies are in fact able to prevent (S)HIV infection in animal models and therefore of great interest for the development of an HIV vaccine. Information of neutralizing antibodies in patients from Africa is still scarce and would be of great value in the development of adapted HIV vaccine strategies in these regions. This study aims to investigate African HIV-infected individuals, who have developed neutralizing antibodies using highly specialized laboratory methodologies.
This is a multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program at selected outpatient HIV clinics (OPCs) and network laboratories in Vietnam.
This study aims to evaluate the effectiveness of two strategies for multi-month dispensing (MMD) of ART in Community ART Refill Groups (CARGs) on retention, virologic suppression, and cost compared to standard of care. This study is a three-arm cluster-randomized controlled trial conducted among 5,760 stable HIV-positive patients) in Zimbabwe to compare outcomes of three antiretroviral therapy (ART) dispensing models. Outcomes of retention in care, virologic suppression, and cost effectiveness will be investigated in 30 purposively selected clusters (facilities) which are randomized into three arms; standard of care (3 months dispensing at facilities), three-month dispensing in CARGs, and six-month dispensing in CARGs. Each study arm will have 10 clusters stratified into 2 urban and 8 rural. Study participants will be followed, and outcomes will be measured at 12 months and 24 months. Qualitative research will be conducted at baseline, 12 months, and 24 months (20 participant Focus Group Discussion (FGDs) and 20 provider Key Informant Interview (KII) at each interval) to understand patient and health provider acceptability of multi-month dispensing of ART within CARGs. Other outcomes of interest include measuring gains of facility decongestion and feasibility of multi-month dispensing of ART within CARGs. Cost analysis will include comparisons of patient level costs, cost per patient outcomes and cost effectiveness across the three study arms.
The CHAIN Network aims to identify modifiable biomedical and social factors driving the greatly increased risk of mortality among young undernourished children admitted to hospital with acute illness, as inpatients and after discharge. The study will inform priorities, risks and targeting for multi-faceted interventional trials. CHAIN is a multi-centre cohort study with a nested case control analysis of stored biological samples. Study sites are located in Africa and South Asia. Children will be recruited at admission to hospital, stratified by nutritional status. Exposures will be assessed at admission, during hospitalisation, at discharge, and at two time points after discharge. The main outcomes of interest are mortality, re-admission to hospital and failure of nutritional recovery up to 180 days after discharge. To determine community health norms, an additional sample of children living in the same communities will be enrolled and assessed at one time point only.
Emerging evidence from high-income countries suggests that diabetes mellitus is become a major health problem among HIV-infected patients. However, due to differences in social, environmental, and genetic factors data from high-income countries can not be extrapolated directly to low-income countries. This study investigates HIV, ART, inflammation, and body composition changes as risk factors for diabetes mellitus among HIV-infected patients in Tanzania.
The purpose of this study is to conduct empiric studies of tuberculosis (TB) among people in prison with and without a history of opioid dependence. This includes: a) comprehensive TB diagnostic study (symptom screening, chest x-ray, tuberculin skin test, acid-fast bacilli smear, Gene Xpert, and sputum culture) to determine best practices for screening HIV+ and HIV- prisoners; b) A RCT of latent TB infection prevention strategies among HIV+ and HIV- prisoners with high prevalence of hepatitis C (HCV) using standard 40-week daily isoniazid (40H) vs short-course weekly isoniazid + rifapentine (12HR); and c) a 2-arm preference trial comparing post-release TB treatment completion in patients on opioid agonist treatment (methadone) vs no opioid agonist treatment in patients being treated for active or latent TB, or patients with no TB, who are transitioning to the community. Investigators will also use this data, and publicly available data to complete agent-based modeling for comparative and cost-effectiveness of various TB screening and treatment strategies among prisoners, and upon community transition post-release from prison.
This study aims at assessing the effect of a demand-creation intervention on couples' HIV counseling and testing (couples' HCT) uptake among married couples who have never tested together as a couple. The study is being implemented in 12 clusters; six intervention and six comparison clusters. A total of 1,538 couples will be enrolled into the study; 769 couples per arm. Couples in the intervention communities are invited to participate in small group, couple-focused or men-only, interactive sessions lasting 3-4 hours in which the advantages and fears associated with couples' HCT are discussed with invited couples to motivate them to consider testing together as a couple. The meetings are reinforced with testimonies from previously tested couples. At the end of the sessions, couples or men receive invitation coupons which they present to a designated health facility to receive couples' HCT services (couples are free to receive individual HCT or not to honor the invitation, if they are not interested in taking the HCT offer). In the comparison communities, standard of care health education activities including general adult community sessions are held but couples do not receive any invitations to test as a couple. Nevertheless, couples in the comparison communities have unlimited access to HIV counseling and testing services that are offered by the Rakai Health Sciences Program within the study communities. The investigators hypothesize that couples in the intervention arm will be more likely to test together than those in the comparison arm. The study objectives include: a) exploring the motivations for and barriers to couples' HCT uptake; b) assessing the effect of a demand-creation intervention on couples' HCT uptake among married couples with no prior couples' HCT experience, and c) exploring the effect of couples' HCT vs. individual HCT on linkage to and retention in HIV care.
The purpose of this study is to determine if treatment with pegylated interferon alpha 2b (peg-IFN-α2b) will reduce the amount of integrated HIV DNA in peripheral blood cells and tissues of individuals with chronic HIV infection receiving antiretroviral treatment (ART). A reduction and/or clearance of the latent viral reservoir (i.e.: virus that remains dormant in HIV-infected subjects receiving suppressive treatment ) is considered essential for HIV eradication. By measuring the changes in integrated proviral HIV DNA, which is considered a surrogate measure of the latent reservoir, the investigators will establish if peg-IFN-α2b treatment should be considered as a component of future viral eradication strategies.
The aim of this study is to investigate the benefits of ARV treatment to patients, to the family members of patients on ARV treatment, and to communities at large. The study also aims to investigate the impact of a peer adherence support and a nutritional intervention on measures of treatment success. To this end, 648 patients who had commenced ARV treatment in the past month at twelve selected health care facilities will be recruited into the study. In addition, 204 randomly sampled households from the communities served by the twelve selected clinics will be recruited into the study. Trained enumerators will at baseline conduct semi-structured interviews with patients and households. Following the baseline survey, patients recruited into the study will be randomly assigned to one of three groups: - Patients receiving ARV treatment and the associated support currently provided in the public sector ARV treatment programme. - Patients receiving (a) plus bi-weekly visits by an experienced ARV patient who has been trained as a peer adherence supporter - Patients receiving (a) and (b) plus a weekly nutritional supplement in the form of two 400g cans of meatballs and spaghetti in tomato sauce The group of 'comparison' households comprises the fourth group. Trained enumerators will conduct follow-up interviews with all patients and households at approximately six- and at twelve-months respectively. In addition, the ARV coordinator and other providers working in the ARV treatment programme at each of the twelve selected health care facilities will be interviewed by trained enumerators, at baseline and again at six- and at twelve-months. Clinical data will be obtained from patient files at baseline and at completion of the study. Using these data, various outcomes of importance to the study will be compared between the four study groups, using experimental and non-experimental methods.