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Assessment of the Effectiveness of New Clinical Guidelines for Differential Diagnosis and Management of Common HIV/AIDS-related Conditions in Mozambique

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Troy Moon, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01681914
First received: August 30, 2012
Last updated: August 9, 2013
Last verified: April 2013
  Purpose

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.


Condition
Anemia
Fever
HIV Positive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 1. What proportion of HIV-infected adult patients with common signs and symptoms can be assigned specific, potentially treatable diagnoses or syndromic classifications when evaluated in conformity with new Mozambican algorithms? [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms? [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • What proportion of HIV-infected adult patients with common signs and symptoms improve clinically when evaluated and managed in conformity with new Mozambican algorithms for técnicos de medicina? [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects? [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic? [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 492
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Anemia
Ambulatory, HIV-infected adult patients with hemoglobin <10 g/dL will be evaluated and managed in accordance with Mozambique's new anemia guideline for non-physician clinicians. The basic steps recommended by the guideline are: screen for danger signs and stabilize or admit if indicated; perform rapid malaria antigen test (and/or peripheral blood smear) and treat if indicated; evaluate for adverse drug reactions and manage per Mozambican national guidelines; consider nutritional deficiencies and intestinal parasites; evaluate response to therapy at <=1 month.
Fever or History of Fever
Ambulatory, HIV-infected adult patients with measured axillary temperature >=37.5 C or history of fever within the past 24 hours will be evaluated and managed in accordance with Mozambique's new fever guideline for non-physician clinicians. The basic steps of the fever guideline are: screen for danger signs and stabilize or admit if indicated; perform rapid malaria antigen test (and/or peripheral smear) and treat if indicated; treat any other cause of fever identified through history and physical examination; re-evaluate at next scheduled clinical visit (sooner if worse or if not improving within 48 hours of initiating treatment). Although blood cultures are seldom performed in Mozambican health centers, venipuncture specimens will also be cultured for bacterial pathogens at the first study visit.
Anemia and Fever/History of Fever
Patients who meet eligibility criteria for both the anemia and fever arms will be evaluated and managed using both the new Mozambican anemia guideline and the new Mozambican fever guideline, as above.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of HIV-infected adult Mozambicans (age 18 years or over) who receive ambulatory care at the Centro de Saúde (Health Center) of the 3 participating health districts (Inhassunge, Namacurra and Maganja da Costa) in Zambézia Province. All 3 health centers have been providing ART for more than three years.

Criteria

Inclusion Criteria:

  • > 18 years old
  • HIV-infected
  • Fever > 37.5° C or history of fever
  • Anemia with recorded hemoglobin level <10 mg/dL

Exclusion Criteria:

  • Primary language/dialect is not spoken or understood by any member of the study team.
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681914

Locations
Mozambique
Inhassunge District Health Facility
Inhassunge, Mozambique
Namacurra District Health Facility
Namacurra, Mozambique
Coalane Health Facility
Quelimane, Mozambique
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Paula E Brentlinger, MD, MPH Friends in Global Health
Principal Investigator: Troy Moon, MD, MPH Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Troy Moon, Assistant Professor Department of Pediatric Infectious Diseases, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01681914     History of Changes
Other Study ID Numbers: 100803, U2GPS000631-05
Study First Received: August 30, 2012
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
adult HIV positive patients

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014