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

Vanderbilt University

Status: Completed

Conditions: Fever; Anemia; HIV Positive

Study type: Observational

Funder types: Other

Identifiers

NCT01681914

U2GPS000631-05 (U.S. NIH Grant/Contract)

100803

Details and patient eligibility

About

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.

Enrollment: 492 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

492 participants in 3 patient groups

Anemia

Description:

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

Description:

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

Description:

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.