Clinical trial NCT01681914: Assessment of the Effectiveness of New Clinical Guidelines for Differential Diagnosis and Management of Common HIV/AIDS-related Conditions in Mozambique
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Fever
HIV Positive
Keywords: adult HIV positive patients
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of HIV-infected adult Mozambicans (age 18 years or over) who receive ambulatory care at the Centro de Saúde (Health Center) of the 3 participating health districts (Inhassunge, Namacurra and Maganja da Costa) in Zambézia Province. All 3 health centers have been providing ART for more than three years.

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.


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)

Primary outcomes:
measure: 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?
timeFrame: 6 months
Secondary outcomes:
measure: 2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms)
timeFrame: 6 months
measure: 3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms?
timeFrame: 6 months
measure: 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?
timeFrame: 6 months
measure: What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects?
timeFrame: 6 months
measure: For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated.
timeFrame: 6 months
measure: What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic?
timeFrame: 6 months
Other outcomes:
Locations:
city: Inhassunge
country: Mozambique
facility: Inhassunge District Health Facility
city: Namacurra
country: Mozambique
facility: Namacurra District Health Facility
city: Quelimane
country: Mozambique
facility: Coalane Health Facility
Study officials:
affiliation: Friends in Global Health
name: Paula E Brentlinger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Troy Moon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.