HIVNCT00611429
An Educational and Supportive Counseling Program for Increasing Antiretroviral Use and Adherence in People With HIV
A study testing Counseling sessions and Group workshop in people with HIV, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will develop and test the effectiveness of an educational and supportive counseling program called Preparing Patients to Start Antiretroviral Therapy in helping people with HIV make informed decisions about their health care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Counseling sessions and Group workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Apr 2014
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV infected
- Not taking antiretroviral medications
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Preparing Patients to Start Antiretroviral Therapy: A Randomized Controlled Trial
This study will develop and test the effectiveness of an educational and supportive counseling program called Preparing Patients to Start Antiretroviral Therapy in helping people with HIV make informed decisions about their health care.
Read the detailed description
HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. Antiretroviral therapy (ART) has proven to be an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival.
Despite the widespread availability and effectiveness of ART, a large number of people with advanced AIDS are not on the therapy, and a number of HIV-infected people die because they are unable to access ART. The Preparing Patients to Start Antiretroviral Therapy (PATH) program is designed to inform patients about HIV treatment and to provide motivation, information, and skills to enhance treatment decision-making. The PATH program may help increase ART use and adherence. This study will develop and test the effectiveness of PATH in helping people with HIV make informed decisions about their healthcare.
This study will be divided into two phases. Phase 1 will last a total of 60 to 90 minutes and will consist of an interview about participants' relationships with friends and family and a medical history. Participants will also provide a blood sample for CD4 count and viral load measurements, returning 1 week later for the lab results. Eligible participants will then be invited to partake in Phase II of the study, which will last 12 months.
Over the 12-month study, participants in Phase 2 will be randomly assigned to Group A or Group B. Group A will be asked to attend at least three individual sessions with a counselor and one group workshop meeting with HIV experts and other people with HIV who have previously been treated with ART. The individual sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment. The group workshop meeting will last 3 hours and will involve teaching participants about HIV treatment and what it is like to undergo treatment. Participants assigned to Group B will attend one individual counseling session and one group workshop, both of which will cover much of the same information as the Group A sessions. Treatment for Group B will not occur until the last month of the study. Any participants in either group who decide to start taking medications for HIV during the study will be visited monthly by a research assistant who will ask about medications and check medication adherence. Participants will also be expected to check in monthly with the research team.
All participants will complete four 90-minute interviews, occurring at baseline and Months 3, 6, and 12. Interviews will include questions about relationships with friends and family, healthcare and drug-using behaviors, mental state, personal background, and education. All participants will also provide blood samples to measure CD4 count and viral load at Months 6 and 12. Selected participants may be asked to complete an additional exit interview about their opinions surrounding participation in the study.
- Conditions
- HIV
- Being tested
- Counseling sessions, Group workshop
- Keywords
- Treatment, Adherence, Intervention, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling sessionsBehavioural
The individual counseling sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment.
Group workshopBehavioural
During the 3-hour group workshop, doctors, nurses, and case managers will talk to participants about HIV treatments and what it is like to undergo treatment. Participants will also hear from other people with HIV and their experiences with treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants will receive treatment consisting of at least three individual counseling sessions and one group workshop over 12 months Receives: Behavioral: Counseling sessions; Behavioral: Group workshop |
| Group B | Active comparator | Participants will receive treatment consisting of one individual counseling session and one group workshop during the last month of the study Receives: Behavioral: Counseling sessions; Behavioral: Group workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment uptake
Measured: Measured at Month 12
Secondary outcomes (1)
Treatment adherence
Measured: Measured at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Mallory O. Johnson, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611429
- Sponsor's protocol ID
- R01MH079700
- Other IDs
- R01MH079700, DAHBR 9A-ASGA
- Status last verified
- Dec 2014
- First submitted
- 6 Feb 2008
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Patients to Start Antiretroviral Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00611429
- Acronym / sponsor ID
- R01MH079700
- Conditions
- HIV
- Keywords
- Treatment, Adherence, Intervention, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2008
- Primary completion
- May 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Feb 2008 (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 will develop and test the effectiveness of an educational and supportive counseling program called Preparing Patients to Start Antiretroviral Therapy in helping people with HIV make informed decisions about their health care.
Detailed description
HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that breaks down the immune system and allows for entry of life-threatening secondary infections. HIV is transmitted through the exchange of bodily fluids, primarily through sexual intercourse. Antiretroviral therapy (ART) has proven to be an effective treatment for inhibiting the replication of HIV, allowing for improved quality of life and survival.
Despite the widespread availability and effectiveness of ART, a large number of people with advanced AIDS are not on the therapy, and a number of HIV-infected people die because they are unable to access ART. The Preparing Patients to Start Antiretroviral Therapy (PATH) program is designed to inform patients about HIV treatment and to provide motivation, information, and skills to enhance treatment decision-making. The PATH program may help increase ART use and adherence. This study will develop and test the effectiveness of PATH in helping people with HIV make informed decisions about their healthcare.
This study will be divided into two phases. Phase 1 will last a total of 60 to 90 minutes and will consist of an interview about participants' relationships with friends and family and a medical history. Participants will also provide a blood sample for CD4 count and viral load measurements, returning 1 week later for the lab results. Eligible participants will then be invited to partake in Phase II of the study, which will last 12 months.
Over the 12-month study, participants in Phase 2 will be randomly assigned to Group A or Group B. Group A will be asked to attend at least three individual sessions with a counselor and one group workshop meeting with HIV experts and other people with HIV who have previously been treated with ART. The individual sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment. The group workshop meeting will last 3 hours and will involve teaching participants about HIV treatment and what it is like to undergo treatment. Participants assigned to Group B will attend one individual counseling session and one group workshop, both of which will cover much of the same information as the Group A sessions. Treatment for Group B will not occur until the last month of the study. Any participants in either group who decide to start taking medications for HIV during the study will be visited monthly by a research assistant who will ask about medications and check medication adherence. Participants will also be expected to check in monthly with the research team.
All participants will complete four 90-minute interviews, occurring at baseline and Months 3, 6, and 12. Interviews will include questions about relationships with friends and family, healthcare and drug-using behaviors, mental state, personal background, and education. All participants will also provide blood samples to measure CD4 count and viral load at Months 6 and 12. Selected participants may be asked to complete an additional exit interview about their opinions surrounding participation in the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: Counseling sessions, Behavioral: Group workshopParticipants will receive treatment consisting of at least three individual counseling sessions and one group workshop over 12 months |
| Group B | Active comparator | Behavioral: Counseling sessions, Behavioral: Group workshopParticipants will receive treatment consisting of one individual counseling session and one group workshop during the last month of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV infected
- Not taking antiretroviral medications
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling sessionsThe individual counseling sessions will last 60 minutes and will involve discussion about health care options and information on the latest advances in HIV treatment. | Behavioural | Group A, Group B |
| Group workshopDuring the 3-hour group workshop, doctors, nurses, and case managers will talk to participants about HIV treatments and what it is like to undergo treatment. Participants will also hear from other people with HIV and their experiences with treatment. | Behavioural | Group A, Group B |
Primary outcome
Treatment uptake
Time frame: Measured at Month 12
1 secondary outcome
Treatment adherence
Time frame: Measured at Month 12
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 2 Dec 2014.
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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.
Mallory O. Johnson, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling sessions and Group workshop in people with HIV, run by University of California, San Francisco 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 2 inclusion and 0 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 2 Dec 2014. 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.
What does the primary outcome measure?
Treatment uptake (time frame: Measured at Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2014.