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

Anemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681914
• Other study ID #: 100803
• Secondary ID: U2GPS000631-05
• Status: Completed
• Phase: N/A
• First received: August 30, 2012
• Last updated: August 9, 2013
• Start date: April 2012
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Fever
• HIV Positive
• HIV Seropositivity

Locations

Country	Name	City	State
Mozambique	Inhassunge District Health Facility	Inhassunge
Mozambique	Namacurra District Health Facility	Namacurra
Mozambique	Coalane Health Facility	Quelimane

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?		6 months	No
Secondary	2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms)		6 months	No
Secondary	3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms?		6 months	No
Secondary	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?		6 months	No
Secondary	What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects?		6 months	No
Secondary	For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated.		6 months	No
Secondary	What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic?		6 months	No