Assessment of the Effectiveness of New Clinical Guidelines for Differential Diagnosis and Management of Common HIV/AIDS-related Conditions in Mozambique
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|ClinicalTrials.gov Identifier: NCT01681914|
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : August 13, 2013
|Condition or disease|
|Anemia Fever HIV Positive|
|Study Type :||Observational|
|Actual Enrollment :||492 participants|
|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)|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
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.
- 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 ]
- 2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms) [ Time Frame: 6 months ]
- 3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms? [ Time Frame: 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? [ Time Frame: 6 months ]
- What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects? [ Time Frame: 6 months ]
- For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated. [ Time Frame: 6 months ]
- What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic? [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681914
|Inhassunge District Health Facility|
|Namacurra District Health Facility|
|Coalane Health Facility|
|Principal Investigator:||Paula E Brentlinger, MD, MPH||Friends in Global Health|
|Principal Investigator:||Troy Moon, MD, MPH||Vanderbilt University|