HIV InfectionsNCT00122902
Spirituality and Will to Live in Patients With HIV/AIDS
An observational study of HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
This study is assessing the extent of spirituality in patients with HIV/AIDS and will determine the relationship between spirituality, health status, and the will to live. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Feb 2004
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of HIV or AIDS
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of General Internal Medicine, University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
About this study
This study is assessing the extent of spirituality in patients with HIV/AIDS and will determine the relationship between spirituality, health status, and the will to live.
Read the detailed description
Approximately 1,000,000 Americans have HIV/AIDS. Although advances in treatment have made HIV/AIDS a relatively manageable chronic disease, the disease can cause significant morbidity and mortality. Surprisingly, research has found that some HIV/AIDS patients feel that their life is better than it was before they had HIV/AIDS. Many of these patients show a strong will to live and often express a preference for longevity over quality of life. Patients who prefer longevity often ascribe their feeling to spiritual growth, or finding a meaning to life. This study is examining the spiritual beliefs of HIV/AIDS patients and will determine the relationship between spirituality, health status, and the will to live.
The study consists of interviews with HIV/AIDS patients from Cincinnati and Washington, D.C. who have been interviewed twice over 12 to 18 months. During the interviews, participants completed self-report scales to assess their quality of life, life satisfaction, concerns about medication, trust in their health care providers, depressive symptoms, self-esteem, optimism, and various clinical and demographic variables. Participants were also asked about their spiritual well-being; spiritual beliefs; spiritual, religious, and social support; and overall functioning.
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Spirituality
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startFeb 2002
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Time perspective
- Prospective
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Joel Tsevat, MD, MPH, Principal investigator, Division of General Internal Medicine, University of Cincinnati Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122902
- Sponsor's protocol ID
- R01AT001147-01
- Status last verified
- Aug 2006
- First submitted
- 19 Jul 2005
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Luckhaupt SE, Yi MS, Mueller CV, Mrus JM, Peterman AH, Puchalski CM, Tsevat J. Beliefs of primary care residents regarding spirituality and religion in clinical encounters with patients: a study at a midwestern U.S. teaching institution. Acad Med. 2005 Jun;80(6):560-70. doi: 10.1097/00001888-200506000-00011.
PubMed 15917361Yi MS, Luckhaupt S, Mrus JM, Tsevat J. Do medical house officers value the health of veterans differently from the health of non-veterans? Health Qual Life Outcomes. 2004 Apr 7;2:19. doi: 10.1186/1477-7525-2-19.
PubMed 15070409Mrus JM, Yi MS, Freedberg KA, Wu AW, Zackin R, Gorski H, Tsevat J. Utilities derived from visual analog scale scores in patients with HIV/AIDS. Med Decis Making. 2003 Sep-Oct;23(5):414-21. doi: 10.1177/0272989X03256884.
PubMed 14570299Mrus JM, Sherman KE, Leonard AC, Sherman SN, Mandell KL, Tsevat J. Health values of patients coinfected with HIV/hepatitis C: are two viruses worse than one? Med Care. 2006 Feb;44(2):158-66. doi: 10.1097/01.mlr.0000197027.06808.e2.
PubMed 16434915Jacobson CJ Jr., Luckhaupt SE, DeLaney S, Tsevat J. Religio-biography, coping, and meaning-making among persons with HIV/AIDS. Journal for the Scientific Study of Religion. 2006;45:39-56.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spirituality and Will to Live in Patients With HIV/AIDS
- ClinicalTrials.gov ID
- NCT00122902
- Acronym / sponsor ID
- R01AT001147-01
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Spirituality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Feb 2002
- Study completion
- Feb 2004
- First posted
- 22 Jul 2005 (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.
This study is assessing the extent of spirituality in patients with HIV/AIDS and will determine the relationship between spirituality, health status, and the will to live.
Detailed description
Approximately 1,000,000 Americans have HIV/AIDS. Although advances in treatment have made HIV/AIDS a relatively manageable chronic disease, the disease can cause significant morbidity and mortality. Surprisingly, research has found that some HIV/AIDS patients feel that their life is better than it was before they had HIV/AIDS. Many of these patients show a strong will to live and often express a preference for longevity over quality of life. Patients who prefer longevity often ascribe their feeling to spiritual growth, or finding a meaning to life. This study is examining the spiritual beliefs of HIV/AIDS patients and will determine the relationship between spirituality, health status, and the will to live.
The study consists of interviews with HIV/AIDS patients from Cincinnati and Washington, D.C. who have been interviewed twice over 12 to 18 months. During the interviews, participants completed self-report scales to assess their quality of life, life satisfaction, concerns about medication, trust in their health care providers, depressive symptoms, self-esteem, optimism, and various clinical and demographic variables. Participants were also asked about their spiritual well-being; spiritual beliefs; spiritual, religious, and social support; and overall functioning.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of HIV or AIDS
Key exclusion criteria (1 listed)
- None
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 18 Aug 2006.
- Background: PubMed 15917361Luckhaupt SE, Yi MS, Mueller CV, Mrus JM, Peterman AH, Puchalski CM, Tsevat J. Beliefs of primary care residents regarding spirituality and religion in clinical encounters with patients: a study at a midwestern U.S. teaching institution. Acad Med. 2005 Jun;80(6):560-70. doi: 10.1097/00001888-200506000-00011.
- Background: PubMed 15070409Yi MS, Luckhaupt S, Mrus JM, Tsevat J. Do medical house officers value the health of veterans differently from the health of non-veterans? Health Qual Life Outcomes. 2004 Apr 7;2:19. doi: 10.1186/1477-7525-2-19.
- Results publication: PubMed 14570299Mrus JM, Yi MS, Freedberg KA, Wu AW, Zackin R, Gorski H, Tsevat J. Utilities derived from visual analog scale scores in patients with HIV/AIDS. Med Decis Making. 2003 Sep-Oct;23(5):414-21. doi: 10.1177/0272989X03256884.
- Results publication: PubMed 16434915Mrus JM, Sherman KE, Leonard AC, Sherman SN, Mandell KL, Tsevat J. Health values of patients coinfected with HIV/hepatitis C: are two viruses worse than one? Med Care. 2006 Feb;44(2):158-66. doi: 10.1097/01.mlr.0000197027.06808.e2.
- Results publicationJacobson CJ Jr., Luckhaupt SE, DeLaney S, Tsevat J. Religio-biography, coping, and meaning-making among persons with HIV/AIDS. Journal for the Scientific Study of Religion. 2006;45:39-56.
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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.
Joel Tsevat, MD, MPH principal investigator
Division of General Internal Medicine, University of Cincinnati Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site 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?
The sponsor lists 1 inclusion and 1 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 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 NCT00122902, which also lists 5 linked publications.
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 18 Aug 2006.