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

Completed

• Conditions: Anemia; Fever; HIV Positive

• Registration Number: NCT01681914
• Lead Sponsor: Vanderbilt University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-08-30
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 492

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms)	6 months
3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms?	6 months
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
What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects?	6 months
For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated.	6 months
What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic?	6 months

Trial Locations

Locations (3)

Inhassunge District Health Facility; 🇲🇿 Inhassunge, Mozambique

Namacurra District Health Facility; 🇲🇿 Namacurra, Mozambique

Coalane Health Facility; 🇲🇿 Quelimane, Mozambique