Pneumonia, Pneumocystis CariniiNCT00000784
A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
An observational study of Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
Trial summary
To examine, in patients enrolled in protocols CPCRA 006 and/or 007, the relationship between patient compliance and demographic, psychosocial, and lifestyle characteristics and Health Belief Model premises (i.e., patient's perception of susceptibility to and severity of disease and perception of benefits and barriers… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pneumonia, Pneumocystis Carinii, HIV Infections
- How many people
- 557 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 1994to Sep 1996
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006
Patients must meet the following criteria:
- New enrollment on CPCRA 006 or CPCRA 007.
- Life expectancy of at least 6 months.
- Willing and able, in clinician's opinion, to comply with treatment and clinical management.
- Able to read and write English or Spanish.
- Consent of parent of guardian for patients under 18 years.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
Richmond AIDS Consortium
Richmond, Virginia, 23298
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
About this study
To examine, in patients enrolled in protocols CPCRA 006 and/or 007, the relationship between patient compliance and demographic, psychosocial, and lifestyle characteristics and Health Belief Model premises (i.e., patient's perception of susceptibility to and severity of disease and perception of benefits and barriers to a particular treatment) in order to design more effective intervention protocols.
Patient noncompliance can influence the statistical findings of a clinical study, possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent. Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical research do not typify those traditionally included in clinical trials or compliance research, it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance.
Read the detailed description
Patient noncompliance can influence the statistical findings of a clinical study, possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent. Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical research do not typify those traditionally included in clinical trials or compliance research, it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance.
Patients who are enrolled on protocols CPCRA 006 and/or 007 are given a baseline questionnaire to complete during the enrollment visit for the qualifying treatment protocol. The survey concerns the patient's work, primary language, support systems, residence status, perception of disease and treatments, and substance use. At 4-month follow-up visits, patients are asked to complete a self-report questionnaire, which assesses the patient's perceptions of difficulties in protocol compliance requirements, clinic/office visits, and health beliefs. The duration of patients on this study will be defined by the qualifying protocol requirements.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Medical subject headings
- Pneumonia, Pneumocystis, HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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 |
|---|---|---|
| A | Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startOct 1994
- Primary completionSep 1996
- Study completionSep 1996
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 Pneumonia, Pneumocystis CariniiStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Besch CL, Study chairMorse EV, Study chairSimon PM, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000784
- Sponsor's protocol ID
- CPCRA 012
- Other IDs
- 11564
- Status last verified
- Sep 2013
- First submitted
- 2 Nov 1999
- Last updated
- 1 Oct 2013
- Results posted
- No
Publications
Simon PM, Morse EV, Besch L. Barriers to compliance among women co-enrolled in a PCP prophylaxis and compliance protocol. HIV Infect Women Conf. 1995 Feb 22-24:P109
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
- ClinicalTrials.gov ID
- NCT00000784
- Acronym / sponsor ID
- CPCRA 012
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 1994
- Primary completion
- Sep 1996 (actual)
- Study completion
- Sep 1996 (actual)
- First posted
- 31 Aug 2001 (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.
To examine, in patients enrolled in protocols CPCRA 006 and/or 007, the relationship between patient compliance and demographic, psychosocial, and lifestyle characteristics and Health Belief Model premises (i.e., patient's perception of susceptibility to and severity of disease and perception of benefits and barriers to a particular treatment) in order to design more effective intervention protocols.
Patient noncompliance can influence the statistical findings of a clinical study, possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent. Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical research do not typify those traditionally included in clinical trials or compliance research, it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance.
Detailed description
Patient noncompliance can influence the statistical findings of a clinical study, possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent. Since the special populations targeted by the CPCRA for inclusion in HIV-related clinical research do not typify those traditionally included in clinical trials or compliance research, it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance.
Patients who are enrolled on protocols CPCRA 006 and/or 007 are given a baseline questionnaire to complete during the enrollment visit for the qualifying treatment protocol. The survey concerns the patient's work, primary language, support systems, residence status, perception of disease and treatments, and substance use. At 4-month follow-up visits, patients are asked to complete a self-report questionnaire, which assesses the patient's perceptions of difficulties in protocol compliance requirements, clinic/office visits, and health beliefs. The duration of patients on this study will be defined by the qualifying protocol requirements.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006 |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consenting patients newly enrolled in either CPCRA 007 or CPCRA 006
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
Not reported in the source record.
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 1 Oct 2013.
- BackgroundSimon PM, Morse EV, Besch L. Barriers to compliance among women co-enrolled in a PCP prophylaxis and compliance protocol. HIV Infect Women Conf. 1995 Feb 22-24:P109
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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.
Besch CL study chair
Morse EV study chair
Simon PM study chair
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000784, 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 1 Oct 2013.