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NCT ID: NCT01796613 Completed - Contraception Clinical Trials

Safety and Acceptability of Vaginal Rings That Protect Women From Unintended Pregnancy

Ring-Plus
Start date: June 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The study is a multidisciplinary research project and has two main aims: 1. To determine the safety of a contraceptive vaginal ring (CVR) in women, with an emphasis on its effect on the vaginal microenvironment after different durations of use: the vaginal microbiome, biofilm formation on epithelial cells and rings, inflammation and immune activation in the vagina 2. To investigate the feasibility, acceptability and adherence to vaginal ring use in Rwandan women, including attitudes towards a future multi-purpose vaginal ring for prevention of both pregnancy and sexually transmitted infections (STI).

NCT ID: NCT01705990 Completed - HIV Infections Clinical Trials

Safety and Immunogenicity Study of SeV-G(NP) HIV Vaccine Administered Intranasally and Ad35-GRIN HIV Vaccine Given Intramuscularly in Prime-Boost Regimens in HIV-Uninfected Volunteers

Start date: March 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.

NCT ID: NCT01618058 Completed - HIV Infections Clinical Trials

Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials

Start date: October 4, 2012
Phase:
Study type: Observational

The purpose of this trial is to determine if exposure to ARV-containing investigational products in IPM clinical trials will impact the natural history of HIV infection as measured by the virologic, immunologic and clinical outcomes of participants who become HIV-positive during the IPM 027 trial.

NCT ID: NCT01594359 Completed - Iron Deficiency Clinical Trials

Nutrition Study of Effect of High Iron Beans on Iron Status

Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether beans bred to have a high iron content are effective in improving the iron status of young women.

NCT ID: NCT01521273 Completed - Enrichment of Blood Clinical Trials

Iron Absorption From Biofortified Beans With Different Levels of Phytic Acid

Start date: March 2012
Phase: N/A
Study type: Interventional

Iron deficiency and iron deficiency anemia are among the major health problems in the developing world. Women of childbearing age as well as children are the most vulnerable population groups. In Rwanda, more than 40% of the population is estimated to be anemic. A promising approach to combat iron deficiency in Rwanda is biofortification of beans. The average consumption of beans is about 150 g per person per day in Rwanda and beans are a major staple food. Traditional plant breeding has increased the iron content of certain bean varieties from about 5 to 11 mg/100g. Iron absorption from beans however is with about 2-3% low because of high phytate and high polyphenol contents. A recently conducted study in Rwanda showed that the total amount of iron absorbed from a biofortified high iron bean was similar to the amount of iron absorbed from a control bean, which had a 50% lower iron concentration. This was surprising since the subjects had a low iron status and where therefore expected to maximize iron absorption. However, it was concluded that the additional iron bred into the bean was not bioavailable most likely due to the strong inhibitory nature of phytate in the high iron bean. To clarify that, a multiple meal study (iron absorption study) in collaboration of the Human Nutrition Laboratory of ETH Zurich and the Medical Faculty of the National University of Rwanda is planned. Subjects will receive two different bean varieties (normal iron vs. high iron) in combination with other food ingredients typical for that region. The bean varieties will be served with native phytate concentration, partially dephytinized (50%) or totally dephytinized. Subjects will be apparently healthy females of reproductive age (18-30y). Iron absorption will be determined by stable isotope techniques.

NCT ID: NCT01509573 Completed - Anxiety Clinical Trials

Pilot Feasibility Trial of the Family Strengthening Intervention in Rwanda (FSI-R)

Start date: July 2011
Phase: N/A
Study type: Interventional

The research will examine the following Specific Aims: Specific Aim 1: To adapt a U.S.-developed family-focused and strengths-based prevention program to the context of HIV/AIDS-affected families in Rwanda (the Family-Strengthening Intervention in Rwanda or "FSI-R") using prior qualitative findings and CAB input. Specific Aim 2: To deliver the intervention to a small group of families to collect preliminary data on intervention feasibility, acceptability, and to further refine the intervention manual for the FSI-R. Specific Aim 3: To conduct a pilot feasibility study of the FSI-R with 80 families. In pursuit of Specific Aim 3, this research will (a) conduct a preliminary exploratory analysis to examine the extent to which the FSI-R for HIV/AIDS-affected families is associated with improved caregiver-child relationships using measures of family connectedness, good parenting, and social support. Hypothesis 1: Participants in the FSI-R will demonstrate increases in protective processes compared to usual care controls not exposed to the FSI-R. It will also (b) conduct a preliminary exploratory analysis to determine the extent to which improved caregiver-child relationships are sustained four months after the conclusion of the FSI-R. Hypothesis 2: Four months after the conclusion of the intervention, participants in the FSI-R will demonstrate increases in protective processes compared to usual care controls not exposed to the FSI-R.

NCT ID: NCT01496989 Completed - HIV Infections Clinical Trials

Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers

Start date: December 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.

NCT ID: NCT01434628 Completed - HIV Prevention Clinical Trials

Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses

Start date: July 2011
Phase: N/A
Study type: Interventional

A range of observational and epidemiological studies have shown that the lifetime risk of HIV infection can be reduced by 70% through male circumcision. Rwanda has a national plan to offer a voluntary male circumcision (MC) program to 2 million adult men in 2 years as part of a comprehensive HIV prevention strategy. To achieve this goal, the government launched a national study, based on the WHO Framework for Evaluation of Adult MC Devices, to assess the safety, efficacy and supremacy of the PrePex™ device when compared to surgical circumcision. The PrePex device was developed to facilitate rapid scale up of non-surgical adult male circumcision in resource limited settings. Rwanda validated the aforementioned endpoints via physicians in a Safety and Efficacy Study (NCT01150370) and Randomized, Controlled Comparison Study (NCT01284088). The procedure was bloodless, required no anesthesia, no sutures and no sterile settings, with 1 AE that was managed with minimal intervention. Evidence submitted to members of WHO, USAID, UNAIDS and the Bill and Melinda Gates Foundation, and WHO audited the study site. The Safety and Efficacy study results were published in the JAIDS Journal of Acquired Immune Deficiency Syndromes, Sept 8, 2011, and presented in CROI 2011 and AUA 2011. To achieve its national "catch up" campaign with minimal burden to the overly strained health system, which lacks physicians and surgical infrastructure, Rwanda needs to task shift the procedure to nurses. This study is meant to test the Safety and Efficacy in the hands of non-surgically trained nurses from the A1 and A2 cadres.

NCT ID: NCT01424046 Completed - Type 1 Diabetes Clinical Trials

Health Care for Type 1 Diabetes in Developing World

Start date: May 2011
Phase: N/A
Study type: Interventional

This study is a pilot 2-armed, randomized, open label, clinical trial evaluating the effectiveness of a basal approach to diabetes management as compared to the current standard treatment (regular/NPH). Patients seen at the Association Rwandaise des Diabetiques (ARD) will be invited to participate in the study and consent will be obtained by the investigation team. This will continue until 40 patients have been enrolled at which time recruitment will be started at a provincial hospital, at which 10 further participants will be recruited. Participants will be consenting to 1) Randomization to basal or current insulin treatment arm and 2) Permission for use of clinical data for research.Participants will be followed every six months for a period of 24 months. The first 6 months will be a wash in period and participants will be randomised (1/1) to their treatments at the 6 month visit.

NCT ID: NCT01401335 Completed - Clinical trials for Stress Disorders, Post-Traumatic

HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

Start date: October 2009
Phase: N/A
Study type: Interventional

The investigators propose a prospective single arm pilot cohort study of 100 youth (ages 15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a district of the Southern province, in Rwanda.