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

NCT ID: NCT01681914

Last Updated: 2013-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 492 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-09-30

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.

Conditions

Anemia; Fever; HIV Positive

Keywords

adult HIV positive patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Anemia

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Troy Moon

Assistant Professor Department of Pediatric Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paula E Brentlinger, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Friends in Global Health

Troy Moon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Inhassunge District Health Facility

Inhassunge, , Mozambique

Namacurra District Health Facility

Namacurra, , Mozambique

Coalane Health Facility

Quelimane, , Mozambique

Countries

Mozambique

References

Moon TD, Silva WP, Buene M, Morais L, Valverde E, Vermund SH, Brentlinger PE. Bacteremia as a cause of fever in ambulatory, HIV-infected Mozambican adults: results and policy implications from a prospective observational study. PLoS One. 2013 Dec 30;8(12):e83591. doi: 10.1371/journal.pone.0083591. eCollection 2013.

Reference Type: DERIVED

PMID: 24386229 (View on PubMed)

Other Identifiers

U2GPS000631-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

100803

Identifier Type: -

Identifier Source: org_study_id