Completed

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)

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Blood-Borne Infections+19

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2012
See protocol details

Summary

Principal SponsorVanderbilt University
Last updated: August 13, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2012

Actual date on which the first participant was enrolled.

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
Principal SponsorVanderbilt University
Last updated: August 13, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

492 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBody Temperature ChangesCommunicable DiseasesHematologic DiseasesHemic and Lymphatic DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsAnemiaFeverHIV Seropositivity

Criteria

4 inclusion criteria required to participate
18 years old

Anemia with recorded hemoglobin level < 10 mg/dL

Fever > 37.5° C or history of fever

HIV-infected

3 exclusion criteria prevent from participating
Participants who meet algorithm-driven definitions of "danger signs" related to the condition of interest at the time of screening

Pregnant women will be excluded only if they meet the following criteria (in labor, or in need of emergency Caesarean section or dilatation and curettage)

Primary language/dialect is not spoken or understood by any member of the study team

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Inhassunge District Health Facility

Inhassunge, MozambiqueOpen Inhassunge District Health Facility in Google Maps

Namacurra District Health Facility

Namacurra, Mozambique

Coalane Health Facility

Quelimane, Mozambique
Completed3 Study Centers