Skip to main content
OpenTrials
Completed

NCT Number: NCT01681914

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia Blood-Borne Infections Body Temperature Changes Communicable Diseases Fever Genital Diseases HIV Infections HIV Positive HIV Seropositivity Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inhassunge District Health Facility, Inhassunge, Mozambique

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms)

    Time frame: 6 months

  2. 3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms?

    Time frame: 6 months

  3. 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

  4. What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects?

    Time frame: 6 months

  5. For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated.

    Time frame: 6 months

  6. What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic?

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 10, 2012
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.