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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01681914

Enrollment

492

Registered

2012-09-10

Start date

2012-04-30

Completion date

2012-09-30

Last updated

2013-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Fever, HIV Positive

Keywords

adult HIV positive patients

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms)	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
What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects?	6 months

Countries

Mozambique

Outcome results