AnemiaNCT01681914
Assessment of the Effectiveness of New Clinical Guidelines for Differential Diagnosis and Management of Common HIV/AIDS-related Conditions in Mozambique
An observational study of Anemia and Fever, run by Vanderbilt University at 3 sites in Mozambique.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Fever, HIV Positive
- How many people
- 492 participants
- Where
- 3 sitesMozambique
- Study dates
- Apr 2012to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- > 18 years old
- HIV-infected
- Fever > 37.5° C or history of fever
- Anemia with recorded hemoglobin level <10 mg/dL
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Mozambique3 sites
Inhassunge District Health Facility
Inhassunge
Namacurra District Health Facility
Namacurra
Coalane Health Facility
Quelimane
About this study
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)
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
- Medical subject headings
- Anemia, Fever, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 6 months
Secondary outcomes (6)
2. What diagnoses or syndromic classifications are assigned to patients managed per protocol (in accordance with the new algorithms)
Measured: 6 months
3. What are the confirmed or probable diagnoses of patients who improve when managed in accordance with the new algorithms?
Measured: 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?
Measured: 6 months
What is the relative prevalence of non-typhoidal salmonella (NTS) and other bacterial pathogens in febrile study subjects?
Measured: 6 months
For each bacterial pathogen isolated in blood cultures, summarize the number and % susceptible to each antibiotic evaluated.
Measured: 6 months
What proportion of study subjects with laboratory-confirmed P. falciparum parasitemia are also bacteremic?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Troy Moon, Vanderbilt University
- Investigators
- Paula E Brentlinger, MD, MPH, Principal investigator, Friends in Global HealthTroy Moon, MD, MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681914
- Sponsor's protocol ID
- 100803
- Other IDs
- U2GPS000631-05
- Status last verified
- Apr 2013
- First submitted
- 30 Aug 2012
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24386229
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01681914
- Acronym / sponsor ID
- 100803
- Conditions
- Anemia, Fever, HIV Positive
- Keywords
- adult HIV positive patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- > 18 years old
- HIV-infected
- Fever > 37.5° C or history of fever
- Anemia with recorded hemoglobin level <10 mg/dL
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
- Derived from this study: PubMed 24386229Moon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula E Brentlinger, MD, MPH principal investigator
Friends in Global Health
Troy Moon, MD, MPH principal investigator
Vanderbilt University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Fever, run by Vanderbilt University at 3 sites in Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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? (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.