Active clinical trials for "HIV Infections"

Breastfeeding remains the optimal mode of feeding for infants younger than six months. Exclusive Breast Feeding (EBF) among HIV-infected mothers has been shown to be associated with a sustained and significant reduction in HIV transmission and has the potential to reduce infant and under-five mortality. Given the considerable authority among men as decision makers in sub-Saharan African, we may be witnessing a missed opportunity to engage men in the education, awareness, and decision-making for EBF. Understanding the role and impact of male partners on this decision-making process require further examination to inform the development of effective and sustainable evidence-based interventions to support the initiation and sustainment of EBF.

The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients. The objectives are to measure patient retention, virological suppression, provider and patient costs, cost-effectiveness, and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models, and to compare these to patients who receive ART directly from the clinic at three month intervals. Methods A prospective, parallel, cluster-randomized non-inferiority trial with three study arms will be conducted. 30 Clusters (sites) will be randomized in strata according to geographic location (urban and rural) to the 3 study arms as follows: Control arm: sites at which patients will receive three monthly ART supply at the facility (arm 3MF). Intervention arm 1: sites at which patients will receive three monthly ART supply in CAGs (arm 3MC) Intervention arm 2: sites at which patients will receive six monthly ART supply in the community by a healthcare worker (arm 6MCD). The study population will consist of stable, HIV-infected adults who have received first-line ART for at least six months, who have a viral load <1000 copies/ml at baseline, and who provide informed consent for inclusion in the study. An average of 192 participants from each study site will be included, with a total sample size of approximately 5760 participants. The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment, with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm. Retention in care will also be compared between the three arms after 24 months. The secondary outcomes are: Viral suppression: defined as the proportion of patients with virological suppression (<1000 copies/ml) 12 and 24 months after study enrolment; Cost of providing ART: defined as the cost per patient of providing ART in each of the three arms (from a provider perspective); Cost of retaining a patient: defined as the provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms, and the incremental cost-effectiveness ratio for the comparative arms.

Many older adults in rural South Africa still lack knowledge of their HIV status despite a high probability of infection. Older adults tend to test less for HIV because most HIV testing and prevention programs have been targeted at younger age groups. Other reasons for failure to test for HIV include frailty and lack of financial resources to travel to HIV testing centers. Home-based testing is a powerful approach to bring HIV testing services -- and HIV status knowledge -- to older adults. In real-life health systems, community health workers, such as the South African community care givers, could potentially provide home-based HIV testing on a routine basis. In this study, the investigators are trying to establish the best 'form' for the 'function' home-based HIV testing. Specifically, the investigators aim to Establish the comparative effectiveness of three home-based HIV testing options among older adults in rural South Africa Identify spill-over effects of the different home-based HIV testing options to other adults in the households and communities of the older adults receiving the testing options Determine the comparative cost-effectiveness of the three home-based HIV testing options among older adults.

The investigators hypothesize that a strategy of establishing facility-based mother support groups (MSGs) for HIV-positive mothers will result in increased retention rates of HIV-exposed infants in clinic-based PMTCT follow-up systems twelve months post-delivery compared to clinics that lack MSGs. The study will be conducted in health facilities in rural Mutare and Makoni health districts in Manicaland province, Zimbabwe. A two-arm cluster controlled study design will be used in 30 rural clinics randomly assigned to either arm to compare the effectiveness of MSGs. Arm 1 of the study consists of standard of care whilst arm 2 consists of standard of care together with facility-based MSGs.

This study evaluates the effects of praise message phone calls on antiretroviral therapy (ART) initiation, adherence, and prescription refills. The investigators will use randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs) in Ethiopia to a praise message phone call study arm or to a standard of care control study arm.

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 proposed study aims to develop an intervention that is strategic in that it will 1) be a focused on an approach that combines an in-person session with post-session, two-way text messaging to continue the intervention and reinforce the gains from the in-person session and 2) ultimately find HIV+ Black men who have sex with men who have left HIV care where they are likely to present (e.g., city and county health clinics, community-based organizations, emergency rooms).

This study will estimate the impact of a suite of clinical decision-support tools on structural, process, and clinical outcomes related to HIV care. The "enhanced EMR" package under investigation will include EMR monitoring tools, data quality control procedures and support, patient reports, alerts, and reminders about patient care. This intervention will be delivered by the Ministry of Health and Rwanda Biomedical Centre and monitored by the study team led by University of Rwanda's School of Public Health and Brown University.

The main objective of this study is to qualify and quantify, by microscopy techniques, CD4+ lymphocyte abnormalities during HIV infection in 7 patients who are naive to any ARV (antiretroviral ) treatment and secondarily to follow the kinetics of reversion of the observed abnormalities, as well as the evolution of the levels of PLA2G1B and its cofactor gp41 in 8 patients under ARV treatment

The Mediational Interventions for Sensitizing Caregivers (MISC) model developed by Professor Pnina Klein is to enhance the cognitive and social development of children throughout the developing world . Although MISC has proven effective in a longitudinal study in two poorer communities of Addis Ababa, Ethiopia , it has not been used with HIV households or in the Ugandan context where there is desperate need for enhanced caregiving in HIV-affected families. We propose to work with community leaders, healthcare workers, and parents/caregivers in adapting MISC to the Ugandan cultural and social context in Kayunga. For intervention families, MISC training will be added to an ongoing home health care visit (HHCV) program already in place for HIV children in Kayunga district. We will then evaluate whether MISC parent/caregiver training improves cognitive and psychosocial development in their children, and whether clinical stability of the HIV child is an important modifier for MISC training benefit.