HIV InfectionsNCT00447707
Positive Choice: Prevention for Positive Health
A study testing Positive Choice in people with HIV Infections and Sexual Risk Behavior, run by National Institute on Drug Abuse (NIDA) at 5 sites in United States.
Trial summary
This is a randomized, controlled trial of Positive Choice, an interactive multimedia computer program, to determine whether it can detect and reduce risky behaviors among HIV-positive adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexual Risk Behavior, Substance Use Risks
- What is being tested?
- Positive Choice
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 497 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2003to Sep 2006
- 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
- 18 years or older,
- HIV-positive 3 months or longer,
- English speaking; and
- Receiving medical care at a participating clinic.
Who cannot join
- Less than 18 years old,
- HIV-positive less than 3 months,
- Non-English speaking; and
- Not receiving medical care at a participating clinic.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Adult Immunology Clinic, Highland Hospital
Oakland, California, 94602
AIDS Project East Bay (APEB)
Oakland, California, 94607
East Bay AIDS Center (EBAC), Alta Bates Hospital
Oakland, California, 94609
Kaiser Permanente Medical Center
San Francisco, California, 94115
Adult Immunology Clinic, Fairmont Hospital
San Leandro, California, 94578
About this study
This is a randomized, controlled trial of Positive Choice, an interactive multimedia computer program, to determine whether it can detect and reduce risky behaviors among HIV-positive adults. The behaviors of interest are: unprotected anal or vaginal intercourse, illicit drug use, risky alcohol drinking, and failure to disclose HIV status to sex partners. The Positive Choice program is integrated into the routine operations of outpatient HIV clinics, where participating patients complete an in-depth risk assessment (computerized health questionnaire) before a regularly scheduled medical appointment. Participants assigned to the intervention arm receive brief, interactive risk-reduction counseling by an actor-portrayed Video Doctor and an educational worksheet. Their health care provider receives as summary cueing sheet, alerting them to the patient's risky behavior and readiness to change. Control participants complete the computerized risk assessment and receive the clinic's usual care. Three months after a baseline visit, intervention and control group patients are invited back to complete an additional risk assessment. The intervention group also receives a "booster" intervention. Six months after baseline, both groups complete a final risk assessment.
Read the detailed description
A preliminary analysis of baseline data was conducted in January 2006, which indicated that the Positive Choice intervention achieved significant reductions in drug use. These findings were reported in a poster presentation at the XVI International AIDS Conference in Toronto, Canada, in August 2006. A final analysis of outcomes data was conducted in fall 2006 (September - December). Aggregate results from all five study sites are summarized below.
We found a high prevalence of risky behaviors in our sample (497/918, or 54%) and achieved high retention for follow-up in both groups (>80%). We found significant elimination of any drug use in the intervention group at both follow-ups. Among all participants who reported drug use at baseline, 66% of intervention participants continued their drug use at 3-month follow-up compared to 85% of control participants (OR 0.356, p<0.01). At 6-month follow-up, 59% of intervention participants continued their drug use compared to 88% of the control group (<0.001). Among participants who reported methamphetamine use at baseline, 58% continued their methamphetamine use at 3-month follow-up compared to 83% of control participants (OR 0.285, p=0.02). At 6-month follow-up, 53% of intervention participants continued their methamphetamine use compared to 73% of the control group (OR 0.344, p=0.03). We also found significantly less unprotected sex with casual partners by intervention participants at 3-month follow up (69% vs. 87%, OR 0.313, p=0.04), and fewer intervention participants who exceeded the recommended number of drinks per week at 3-months (53% vs. 78%, OR 0.310, p=0.02) Our findings indicate that the Positive Choice program was effective at reducing important behavioral risks among HIV-positive adults in care. Positive Choice is an appropriate and effective adjunct to routine medical care for HIV-positive adults.
- Conditions
- HIV Infections, Sexual Risk Behavior, Substance Use Risks
- Being tested
- Positive Choice
- Keywords
- Substance use, Unprotected sex, Behavioral intervention, HIV care, Prevention with Positives, HIV seronegativity
- Medical subject headings
- HIV Infections, Substance-Related Disorders, Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive ChoiceBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Elimination of risky drinking, illicit alcohol use, unprotected sex, and non-disclosure of HIV status to sex partners.
Secondary outcomes (1)
Measures of change in risky alcohol use, illicit drug use, unprotected sex, and non-disclosure of HIV status to sex partners.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startDec 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 497 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Barbara Gerbert, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447707
- Sponsor's protocol ID
- R01DA015016
- Status last verified
- Mar 2007
- First submitted
- 13 Mar 2007
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerbert B, Danley DW, Herzig K, Clanon K, Ciccarone D, Gilbert P, Allerton M. Reframing "prevention with positives": incorporating counseling techniques that improve the health of HIV-positive patients. AIDS Patient Care STDS. 2006 Jan;20(1):19-29. doi: 10.1089/apc.2006.20.19.
PubMed 16426152Gilbert P, Ciccarone D, Gansky SA, Bangsberg DR, Clanon K, McPhee SJ, Calderon SH, Bogetz A, Gerbert B. Interactive "Video Doctor" counseling reduces drug and sexual risk behaviors among HIV-positive patients in diverse outpatient settings. PLoS One. 2008 Apr 23;3(4):e1988. doi: 10.1371/journal.pone.0001988.
PubMed 18431475
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Choice: Prevention for Positive Health
- ClinicalTrials.gov ID
- NCT00447707
- Acronym / sponsor ID
- R01DA015016
- Conditions
- HIV Infections, Sexual Risk Behavior, Substance Use Risks
- Keywords
- Substance use, Unprotected sex, Behavioral intervention, HIV care, Prevention with Positives, HIV seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Dec 2003
- Study completion
- Sep 2006
- First posted
- 15 Mar 2007 (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 is a randomized, controlled trial of Positive Choice, an interactive multimedia computer program, to determine whether it can detect and reduce risky behaviors among HIV-positive adults. The behaviors of interest are: unprotected anal or vaginal intercourse, illicit drug use, risky alcohol drinking, and failure to disclose HIV status to sex partners. The Positive Choice program is integrated into the routine operations of outpatient HIV clinics, where participating patients complete an in-depth risk assessment (computerized health questionnaire) before a regularly scheduled medical appointment. Participants assigned to the intervention arm receive brief, interactive risk-reduction counseling by an actor-portrayed Video Doctor and an educational worksheet. Their health care provider receives as summary cueing sheet, alerting them to the patient's risky behavior and readiness to change. Control participants complete the computerized risk assessment and receive the clinic's usual care. Three months after a baseline visit, intervention and control group patients are invited back to complete an additional risk assessment. The intervention group also receives a "booster" intervention. Six months after baseline, both groups complete a final risk assessment.
Detailed description
A preliminary analysis of baseline data was conducted in January 2006, which indicated that the Positive Choice intervention achieved significant reductions in drug use. These findings were reported in a poster presentation at the XVI International AIDS Conference in Toronto, Canada, in August 2006. A final analysis of outcomes data was conducted in fall 2006 (September - December). Aggregate results from all five study sites are summarized below.
We found a high prevalence of risky behaviors in our sample (497/918, or 54%) and achieved high retention for follow-up in both groups (>80%). We found significant elimination of any drug use in the intervention group at both follow-ups. Among all participants who reported drug use at baseline, 66% of intervention participants continued their drug use at 3-month follow-up compared to 85% of control participants (OR 0.356, p<0.01). At 6-month follow-up, 59% of intervention participants continued their drug use compared to 88% of the control group (<0.001). Among participants who reported methamphetamine use at baseline, 58% continued their methamphetamine use at 3-month follow-up compared to 83% of control participants (OR 0.285, p=0.02). At 6-month follow-up, 53% of intervention participants continued their methamphetamine use compared to 73% of the control group (OR 0.344, p=0.03). We also found significantly less unprotected sex with casual partners by intervention participants at 3-month follow up (69% vs. 87%, OR 0.313, p=0.04), and fewer intervention participants who exceeded the recommended number of drinks per week at 3-months (53% vs. 78%, OR 0.310, p=0.02) Our findings indicate that the Positive Choice program was effective at reducing important behavioral risks among HIV-positive adults in care. Positive Choice is an appropriate and effective adjunct to routine medical care for HIV-positive adults.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older,
- HIV-positive 3 months or longer,
- English speaking; and
- Receiving medical care at a participating clinic.
Key exclusion criteria (4 listed)
- Less than 18 years old,
- HIV-positive less than 3 months,
- Non-English speaking; and
- Not receiving medical care at a participating clinic.
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 |
|---|---|---|
| Positive Choice | Behavioural | – |
Primary outcome
Elimination of risky drinking, illicit alcohol use, unprotected sex, and non-disclosure of HIV status to sex partners.
1 secondary outcome
Measures of change in risky alcohol use, illicit drug use, unprotected sex, and non-disclosure of HIV status to sex partners.
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 12 Jan 2017.
- Background: PubMed 16426152Gerbert B, Danley DW, Herzig K, Clanon K, Ciccarone D, Gilbert P, Allerton M. Reframing "prevention with positives": incorporating counseling techniques that improve the health of HIV-positive patients. AIDS Patient Care STDS. 2006 Jan;20(1):19-29. doi: 10.1089/apc.2006.20.19.
- Derived from this study: PubMed 18431475Gilbert P, Ciccarone D, Gansky SA, Bangsberg DR, Clanon K, McPhee SJ, Calderon SH, Bogetz A, Gerbert B. Interactive "Video Doctor" counseling reduces drug and sexual risk behaviors among HIV-positive patients in diverse outpatient settings. PLoS One. 2008 Apr 23;3(4):e1988. doi: 10.1371/journal.pone.0001988.
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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.
Barbara Gerbert, PhD principal investigator
University of California, San Francisco
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Choice in people with HIV Infections and Sexual Risk Behavior, run by National Institute on Drug Abuse (NIDA) at 5 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?
The sponsor lists 4 inclusion and 4 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does the primary outcome measure?
Elimination of risky drinking, illicit alcohol use, unprotected sex, and non-disclosure of HIV status to sex partners.. 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 NCT00447707, which also lists 2 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 12 Jan 2017.