View clinical trials related to HIV.
Filter by:The purpose of this study is to compare two models of substance abuse treatment in Vietnam, and how they each affect HIV care. In Vietnam, the current model for treating people with HIV who are also dependent on opioids is to refer them to methadone maintenance treatment centers. The new model the protocol will study is treatment of HIV and opioid dependence with buprenorphine/naloxone and counseling in the HIV clinic.
Nigeria has significant challenges in the delivery and coverage of PMTCT (Prevention of mother-to-child transmission of HIV) services. Only 30% of pregnant women living with HIV are provided anti-retroviral drugs for PMTCT. Less than 10% of HIV-exposed infants receive HIV testing for early diagnosis by age 2 months. Furthermore, an unacceptably high number of women with HIV who are enrolled in PMTCT programs do not complete them. In other words, uptake and retention in PMTCT programs in Nigeria is not adequate. Ultimately, mother-to-child transmission of HIV is high, resulting in a high number of new child HIV infections. Mentor Mothers (MMs) are women living with HIV who provide peer support to other HIV-positive women. MM programs have been incorporated into PMTCT programs in several African countries with some success, but with varying levels of MM training and program structure. The MoMent (MOther MENTor) study investigates whether highly-structured MM programs will further improve uptake and successful completion of PMTCT services (eg testing and appointments) in Nigeria. The study also evaluates the impact of structured MM programs on other outcomes, including facility deliveries, new infant HIV infections, infant survival and maternal viral suppression. Rural areas are the focus of this study because of their particularly poor performance in PMTCT coverage and outcomes.
To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.
The goal of this study is to conduct an HIV prevention intervention to train HIV seropositive drug users to be peer health educators.
The purpose of this study is to understand how to improve health care services for HIV-positive women during their pregnancy and after delivery. The study's aim is to compare two different ways of providing antiretroviral therapy for pregnant women with HIV. The study is to be conducted at the Gugulethu Midwife Obstetric Unit (MOU) in Cape Town. There are three phases of the study: Phase 1 is a cross-sectional evaluation of consecutive HIV-infected pregnant women attending their first antenatal clinic visit (n=1600); Phase 2 is an observational cohort that will follow women from Phase 1 who are eligible for ART (n=600) from the second antenatal clinic visit until the first postpartum visit; Phase 3 is a randomized trial of women from Phase 2 who are breastfeeding and will compare two different service models for delivering ART to women after they delivery their babies (n=480). For Phase 3, women who are taking ART will randomly be assigned to either (1) referral to receive ART at the nearest adult clinic at 4-8 weeks after delivery (this is currently how all women receive care in this setting) or (2) to continue to come to the antenatal clinic for ART services until the end of breastfeeding. All women will received the standard local ART services (with identical medications and medical treatment); they are different because some women will stay longer in care at the antenatal clinic. All women participating in Phase 3 will be followed through at least 2 months after they deliver.
Purpose: To compare the effectiveness of a combination intervention strategy (CIS), consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and accelerated ART initiation for eligible participants delivered by facility personnel, and cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on linkage to and retention in HIV care at 12 months among adults testing positive for HIV in Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+ non-cash financial incentives (FI) compared to CIS without FI on study outcomes.
The purpose of this study is to assess the utility of the Theory of Planned Behavior in predicting condom use among men who have sex with men. It also aims to assess the utility of two interventions, one known as "implementation intentions", the other involves the practice of a planning task known as "the tower of Hanoi", in increasing condom use in this population.
The purpose of the ENRICH study is to evaluate a combination intervention package (CIP) designed to improve implementation of Isoniazid Preventive Therapy (IPT) among people living with HIV (PLWH) in Ethiopia. The study is a two-arm cluster randomized trial, randomized at the HIV clinic level, which includes 10 HIV clinics in Dire Dawa and Harari, Ethiopia. Clinics are randomized to deliver the combination intervention package (CIP) or standard of care (SOC), with stratification by facility size (<80 or >80 patients enrolled in HIV care per year). The experimental intervention will be delivered to all patients in HIV clinics randomly assigned to CIP who initiated HIV care at the CIP site on or after January 1, 2013 and initiated IPT on or after date of study initiation, July 1, 2013. In HIV clinics assigned to SOC, usual care procedures for provision of IPT will be delivered. Study Aims and Hypotheses Aim 1. Characterize and compare the effectiveness of a combination intervention package with standard of care for IPT provision in Ethiopia. Hypothesis 1.1: IPT initiation for new patients enrolling in HIV care at CIP clinics will be higher than that for newly enrolled patients at SOC clinics. Hypothesis 1.2: Adherence to and completion of IPT for participants initiating IPT at CIP clinics will be higher than that for those initiating IPT at SOC clinics. Aim 1a. Assess acceptability of CIP among participants enrolled in HIV care and healthcare providers at CIP clinics. Acceptability will include: 1) perceived barriers and facilitators of uptake and delivery of the intervention package among healthcare providers, and 2) acceptability and utilization of intervention components as well as the overall intervention package among IPT initiators and non-initiators. Aim 2. Assess the impact of CIP compared with SOC on HIV-related outcomes. Hypothesis 2: HIV-related outcomes for participants receiving IPT at CIP clinics will be superior to outcomes in participants receiving care at SOC clinics. HIV-related outcomes to be assessed include retention in care and, among those participants receiving antiretroviral therapy (ART), adherence to ART and CD4+ count. Aim 3. Assess the safety and tolerability of IPT among HIV-infected individuals under routine program conditions in Ethiopia. Aim 4. Identify patient and program characteristics associated with IPT adherence and completion at SOC sites. Hypothesis 4.1: IPT adherence and completion will be associated with modifiable patient characteristics, including ART status; knowledge and attitudes about IPT; and social support. Hypothesis 4.2: IPT adherence and completion will be associated with modifiable program characteristics, including provider/patient ratio, patient tracking, and patient support groups.
Response-guided triple-therapy with boceprevir (BOC) in combination with pegylated interferon (PEGIFN) and ribavirin (RBV) is the current standard of care for HIV-negative patients infected with hepatitis C genotype (HCV-GT) 1. In contrast, in HIV-positive patients, a fixed treatment duration of 48 weeks is used. The aim of this study is to assess efficacy and safety of response-guided triple-therapy with BOC in combination with PEGIFN and RBV in HIV-positive patients. Thus, treatment duration will be individualized based on HCV-RNA negativity at treatment week 8 (W8). All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at W8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks, while patients with detectable HCV-RNA at W8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks.
Tuberculosis (TB) is the most common opportunistic infection amongst HIV-infected patients starting antiretroviral therapy (ART) in developing countries and thus the most frequent form of immune reconstitution inflammatory syndrome (IRIS). Paradoxical TB-IRIS occurs in 8- 43% of patients starting ART while on TB treatment and results in morbidity, hospitalisation, consumes health care resources and TB-IRIS may be fatal. We have previously demonstrated in a clinical trial that prednisone reduces morbidity when used for treatment of paradoxical TB-IRIS. This trial is a double-blind placebo-controlled trial of prophylactic prednisone (40mg/day for 2 weeks followed by 20mg/day for 2 weeks, started on the same day as ART) in patients with TB who are identified as being at high risk for paradoxical TB-IRIS (starting ART within 30 days of initiating TB treatment and CD4 < 100/μL). The trial will enroll 240 participants, randomised 1:1 (prednisone:placebo). The primary endpoint is development of paradoxical TB-IRIS, defined using international consensus case definitions. Secondary endpoints include time to IRIS event, severity of IRIS, quality of life assessment, mortality and corticosteroids adverse events. The trial is powered to determine a reduction in TB-IRIS events.