HIVNCT01671501
Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients
A study testing Motivational Interviewing and Email Feedback in people with HIV and Acquired Immunodeficiency Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial summary
This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol screen; and examines innovative behavioral interventions, and their cost effectiveness, for hazardous drinking within a large HIV primary care clinic. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIV, Acquired Immunodeficiency Syndrome, Alcoholism
- What is being tested?
- Motivational Interviewing and Email Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Aug 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages 18 and over seeking HIV services at the KPNC San Francisco medical center
- Report of any unhealthy drinking in the previous year (≥ 3 drinks in a day or 7+ per week for women and ≥ 4 drinks in a day or 14+ per week for men) and,
- Report of web access at time of recruitment
Who cannot join
- Clinical recommendation from providers that patients are not appropriate due to:
- Acute psychiatric problems; OR
- Inability to understand consent procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California San Francisco Medical Center; 2238 Geary Blvd
San Francisco, California, 94115
About this study
This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol screen; and examines innovative behavioral interventions, and their cost effectiveness, for hazardous drinking within a large HIV primary care clinic. We will compare Motivational Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the interventions on unhealthy drinking, comorbid drug use, enrollment in substance use treatment programs, and HIV outcomes including antiretroviral therapy adherence, HIV RNA control, and unsafe sex. Given the well-known adverse effects of unhealthy drinking on HIV care and outcomes, the proposed study has the potential to make a significant impact in the care of HIV patients.
Read the detailed description
This application responds to RFA-AA12-009, Interventions to Improve HIV/AIDS and Alcohol-Related Outcomes (U01). The proposed study takes place in a HIV primary care clinic and uses the health plan's electronic medical record (EMR) for screening; it has the potential to provide a significant benefit to HIV-infected individuals by reducing unhealthy drinking and the associated complications. Prior studies have identified high rates of co-occurrence of HIV and unhealthy drinking (defined as drinking over threshold limits, i.e., 4+ daily or 14+ weekly drinks for men and 3+ daily or 7+ weekly drinks for women). Drinking at these levels can compromise antiretroviral (ART) treatment, and increase rates of drug use, depression, unsafe sex, and mortality. The proposed randomized trial examines the comparative effectiveness of two highly implementable behavioral interventions for reducing unhealthy drinking, each with an adaptive, stepped-care component: 1) Motivational Interviewing (MI), consisting of one in-person session with a study clinician and two phone sessions, with three additional phone sessions for those who report unhealthy drinking at 6 months; and 2) Interactive Email Feedback (EF) on alcohol use risks using a secure messaging system integrated into the Electronic Medical Record (EMR), with additional emailed feedback for those who report unhealthy drinking at 6 months. MI and EF are delivered by study staff. A third arm will be usual care only. Participants in all three arms are eligible to receive alcohol screening, brief intervention, and referral to treatment (SBIRT) from usual care clinic staff. We will also evaluate the cost-effectiveness of the two interventions which have the potential for wide adoption in other similar healthcare settings. The two proposed interventions, MI and EF, are promising approaches for reducing unhealthy drinking in the setting of behavioral health and/or primary care. EF also uses secure messaging, an emerging technology that has been tested in other health, behavior change and mental health treatment settings, for problems including alcohol use but not among HIV-infected individuals. In this trial, 600 patients (200 in each arm) will be recruited from Kaiser Permanente Northern California (KPNC) San Francisco. The study population and clinic are ideal to examine such interventions since NIAAA-based screening questions are recorded in the EMR, and comprehensive data are available on health care utilization, ART adherence, and HIV clinical outcomes, including the Veterans Aging Cohort Study (VACS) index, a recently validated prognostic index based on routine clinical laboratory measures. The research team is well-qualified with complementary expertise in clinical psychology, drug and alcohol abuse treatment, HIV epidemiology, and biostatistics. Thus, the team and study setting provide the ideal environment to test MI and EF, two innovative approaches for reducing unhealthy alcohol use in this population, and may provide powerful, and generalizable tools for assisting individuals with HIV infection.
- Conditions
- HIV, Acquired Immunodeficiency Syndrome, Alcoholism, Alcoholic Intoxication, Substance-Related Disorders
- Being tested
- Motivational Interviewing, Email Feedback, Usual Care
- Keywords
- HIV, Acquired Immunodeficiency Syndrome, Alcoholism, Alcoholic Intoxication, Substance-Related Disorders, Intervention Studies, Primary Health Care, therapy, prevention & control
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcoholism, Alcoholic Intoxication, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Email FeedbackBehavioural
Usual CareOther
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | The intervention consists of one 45-minute in-person session followed by two 20-minute telephone sessions.The first telephone MI session will occur approximately 10 days after the in-person session. The second call will occur 30 days after the first call. The same research clinician will conduct both the in-person session and phone sessions. The calls will include a review of material covered in the initial session, questions on alcohol use, open-ended questions regarding patients' current motivational level, and a review of the patient's initial goals regarding alcohol consumption and will last about 20 minutes. If after six months hazardous drinking is noted, three more motivational interviewing phone sessions will be delivered by the research clinician. Receives: Behavioral: Motivational Interviewing |
| Email Feedback | Experimental | Each participant will receive up to three detailed emails, (if participants respond to a first, initial email with information on alcohol use risks). The initial and subsequent emails will be brief in length, and will include specific information on hazardous drinking levels, standard drink size; as well as advice to reduce drinking to non-hazardous levels. Each email will conclude with contact numbers for patients to receive further information and assistance if needed, including information on how to easily access SU treatment; and will encourage participants to respond to the research clinician with questions. If after six months hazardous drinking is detected, up to 3 more detailed emails will be delivered to the participant. Receives: Behavioral: Email Feedback |
| Usual Care | Other | Participants in this arm will receive routine primary care services only. Usual care in this health care setting may include alcohol screening, brief intervention and referral to treatment (SBIRT) delivered by usual care clinic staff Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of motivational interviewing on unhealthy drinking and alcohol related problems
Measured: 3 Years
Secondary outcomes (1)
Impact of e-mail feedback on unhealthy drinking and alcohol related problems
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startMar 2013
- Primary completionAug 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (167)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Foundation Research Institute
- Responsible party
- Sponsor
- Investigators
- Derek Satre, PhD, Principal investigator, Associate Professor, University of California, San Francisco and Adjunct Investigator, Division of Research, Kaiser Permanente, Northern CaliforniaMichael J Silverberg, PhD, Principal investigator, Research Scientist II, Division of Research, Kaiser Permanente, Northern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671501
- Sponsor's protocol ID
- P0048609_Satre
- Status last verified
- Oct 2018
- First submitted
- 20 Aug 2012
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cook RL, Sereika SM, Hunt SC, Woodward WC, Erlen JA, Conigliaro J. Problem drinking and medication adherence among persons with HIV infection. J Gen Intern Med. 2001 Feb;16(2):83-8. doi: 10.1111/j.1525-1497.2001.00122.x.
PubMed 11251758Galvan FH, Bing EG, Fleishman JA, London AS, Caetano R, Burnam MA, Longshore D, Morton SC, Orlando M, Shapiro M. The prevalence of alcohol consumption and heavy drinking among people with HIV in the United States: results from the HIV Cost and Services Utilization Study. J Stud Alcohol. 2002 Mar;63(2):179-86. doi: 10.15288/jsa.2002.63.179.
PubMed 12033694Lefevre F, O'Leary B, Moran M, Mossar M, Yarnold PR, Martin GJ, Glassroth J. Alcohol consumption among HIV-infected patients. J Gen Intern Med. 1995 Aug;10(8):458-60. doi: 10.1007/BF02599920.
PubMed 7472704Samet JH, Phillips SJ, Horton NJ, Traphagen ET, Freedberg KA. Detecting alcohol problems in HIV-infected patients: use of the CAGE questionnaire. AIDS Res Hum Retroviruses. 2004 Feb;20(2):151-5. doi: 10.1089/088922204773004860.
PubMed 15018702Azar MM, Springer SA, Meyer JP, Altice FL. A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. Drug Alcohol Depend. 2010 Dec 1;112(3):178-93. doi: 10.1016/j.drugalcdep.2010.06.014. Epub 2010 Aug 11.
PubMed 20705402Chander G, Josephs J, Fleishman JA, Korthuis PT, Gaist P, Hellinger J, Gebo K; HIV Research Network. Alcohol use among HIV-infected persons in care: results of a multi-site survey. HIV Med. 2008 Apr;9(4):196-202. doi: 10.1111/j.1468-1293.2008.00545.x.
PubMed 18366443Parsons JT, Kutnick AH, Halkitis PN, Punzalan JC, Carbonari JP. Sexual risk behaviors and substance use among alcohol abusing HIV-positive men who have sex with men. J Psychoactive Drugs. 2005 Mar;37(1):27-36. doi: 10.1080/02791072.2005.10399746.
PubMed 15916249Chander G, Lau B, Moore RD. Hazardous alcohol use: a risk factor for non-adherence and lack of suppression in HIV infection. J Acquir Immune Defic Syndr. 2006 Dec 1;43(4):411-7. doi: 10.1097/01.qai.0000243121.44659.a4.
PubMed 17099312Jaquet A, Ekouevi DK, Bashi J, Aboubakrine M, Messou E, Maiga M, Traore HA, Zannou MD, Guehi C, Ba-Gomis FO, Minga A, Allou G, Eholie SP, Bissagnene E, Sasco AJ, Dabis F. Alcohol use and non-adherence to antiretroviral therapy in HIV-infected patients in West Africa. Addiction. 2010 Aug;105(8):1416-21. doi: 10.1111/j.1360-0443.2010.02978.x. Epub 2010 Jun 7.
PubMed 20528816Sullivan LE, Goulet JL, Justice AC, Fiellin DA. Alcohol consumption and depressive symptoms over time: a longitudinal study of patients with and without HIV infection. Drug Alcohol Depend. 2011 Sep 1;117(2-3):158-63. doi: 10.1016/j.drugalcdep.2011.01.014. Epub 2011 Feb 22.
PubMed 21345624Barta WD, Tennen H, Kiene SM. Alcohol-involved sexual risk behavior among heavy drinkers living with HIV/AIDS: negative affect, self-efficacy, and sexual craving. Psychol Addict Behav. 2010 Dec;24(4):563-70. doi: 10.1037/a0021414.
PubMed 21198219Gerbi GB, Habtemariam T, Tameru B, Nganwa D, Robnett V. A comparative study of substance use before and after establishing HIV infection status among people living with HIV/AIDS. J Subst Use. 2011 Dec;16(6):464-475. doi: 10.3109/14659891.2010.495820.
PubMed 22623879Shuper PA, Joharchi N, Irving H, Rehm J. Alcohol as a correlate of unprotected sexual behavior among people living with HIV/AIDS: review and meta-analysis. AIDS Behav. 2009 Dec;13(6):1021-36. doi: 10.1007/s10461-009-9589-z. Epub 2009 Jul 18.
PubMed 19618261DeLorenze GN, Satre DD, Quesenberry CP, Tsai AL, Weisner CM. Mortality after diagnosis of psychiatric disorders and co-occurring substance use disorders among HIV-infected patients. AIDS Patient Care STDS. 2010 Nov;24(11):705-12. doi: 10.1089/apc.2010.0139. Epub 2010 Oct 23.
PubMed 20969465DeLorenze GN, Weisner C, Tsai AL, Satre DD, Quesenberry CP Jr. Excess mortality among HIV-infected patients diagnosed with substance use dependence or abuse receiving care in a fully integrated medical care program. Alcohol Clin Exp Res. 2011 Feb;35(2):203-10. doi: 10.1111/j.1530-0277.2010.01335.x. Epub 2010 Nov 8.
PubMed 21058961
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care-Based Interventions to Reduce Alcohol Use Among HIV Patients
- ClinicalTrials.gov ID
- NCT01671501
- Acronym / sponsor ID
- P0048609_Satre
- Conditions
- HIV, Acquired Immunodeficiency Syndrome, Alcoholism, Alcoholic Intoxication, Substance-Related Disorders
- Keywords
- HIV, Acquired Immunodeficiency Syndrome, Alcoholism, Alcoholic Intoxication, Substance-Related Disorders, Intervention Studies, Primary Health Care, therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kaiser Foundation Research Institute
- Study start
- Mar 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 23 Aug 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.
This randomized clinical trial uses a health plan's electronic medical record (EMR) alcohol screen; and examines innovative behavioral interventions, and their cost effectiveness, for hazardous drinking within a large HIV primary care clinic. We will compare Motivational Interviewing (MI) and Email Feedback (EF) to usual care; and evaluate the effect of the interventions on unhealthy drinking, comorbid drug use, enrollment in substance use treatment programs, and HIV outcomes including antiretroviral therapy adherence, HIV RNA control, and unsafe sex. Given the well-known adverse effects of unhealthy drinking on HIV care and outcomes, the proposed study has the potential to make a significant impact in the care of HIV patients.
Detailed description
This application responds to RFA-AA12-009, Interventions to Improve HIV/AIDS and Alcohol-Related Outcomes (U01). The proposed study takes place in a HIV primary care clinic and uses the health plan's electronic medical record (EMR) for screening; it has the potential to provide a significant benefit to HIV-infected individuals by reducing unhealthy drinking and the associated complications. Prior studies have identified high rates of co-occurrence of HIV and unhealthy drinking (defined as drinking over threshold limits, i.e., 4+ daily or 14+ weekly drinks for men and 3+ daily or 7+ weekly drinks for women). Drinking at these levels can compromise antiretroviral (ART) treatment, and increase rates of drug use, depression, unsafe sex, and mortality. The proposed randomized trial examines the comparative effectiveness of two highly implementable behavioral interventions for reducing unhealthy drinking, each with an adaptive, stepped-care component: 1) Motivational Interviewing (MI), consisting of one in-person session with a study clinician and two phone sessions, with three additional phone sessions for those who report unhealthy drinking at 6 months; and 2) Interactive Email Feedback (EF) on alcohol use risks using a secure messaging system integrated into the Electronic Medical Record (EMR), with additional emailed feedback for those who report unhealthy drinking at 6 months. MI and EF are delivered by study staff. A third arm will be usual care only. Participants in all three arms are eligible to receive alcohol screening, brief intervention, and referral to treatment (SBIRT) from usual care clinic staff. We will also evaluate the cost-effectiveness of the two interventions which have the potential for wide adoption in other similar healthcare settings. The two proposed interventions, MI and EF, are promising approaches for reducing unhealthy drinking in the setting of behavioral health and/or primary care. EF also uses secure messaging, an emerging technology that has been tested in other health, behavior change and mental health treatment settings, for problems including alcohol use but not among HIV-infected individuals. In this trial, 600 patients (200 in each arm) will be recruited from Kaiser Permanente Northern California (KPNC) San Francisco. The study population and clinic are ideal to examine such interventions since NIAAA-based screening questions are recorded in the EMR, and comprehensive data are available on health care utilization, ART adherence, and HIV clinical outcomes, including the Veterans Aging Cohort Study (VACS) index, a recently validated prognostic index based on routine clinical laboratory measures. The research team is well-qualified with complementary expertise in clinical psychology, drug and alcohol abuse treatment, HIV epidemiology, and biostatistics. Thus, the team and study setting provide the ideal environment to test MI and EF, two innovative approaches for reducing unhealthy alcohol use in this population, and may provide powerful, and generalizable tools for assisting individuals with HIV infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingThe intervention consists of one 45-minute in-person session followed by two 20-minute telephone sessions.The first telephone MI session will occur approximately 10 days after the in-person session. The second call will occur 30 days after the first call. The same research clinician will conduct both the in-person session and phone sessions. The calls will include a review of material covered in the initial session, questions on alcohol use, open-ended questions regarding patients' current motivational level, and a review of the patient's initial goals regarding alcohol consumption and will last about 20 minutes. If after six months hazardous drinking is noted, three more motivational interviewing phone sessions will be delivered by the research clinician. |
| Email Feedback | Experimental | Behavioral: Email FeedbackEach participant will receive up to three detailed emails, (if participants respond to a first, initial email with information on alcohol use risks). The initial and subsequent emails will be brief in length, and will include specific information on hazardous drinking levels, standard drink size; as well as advice to reduce drinking to non-hazardous levels. Each email will conclude with contact numbers for patients to receive further information and assistance if needed, including information on how to easily access SU treatment; and will encourage participants to respond to the research clinician with questions. If after six months hazardous drinking is detected, up to 3 more detailed emails will be delivered to the participant. |
| Usual Care | Other | Other: Usual CareParticipants in this arm will receive routine primary care services only. Usual care in this health care setting may include alcohol screening, brief intervention and referral to treatment (SBIRT) delivered by usual care clinic staff |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ages 18 and over seeking HIV services at the KPNC San Francisco medical center
- Report of any unhealthy drinking in the previous year (≥ 3 drinks in a day or 7+ per week for women and ≥ 4 drinks in a day or 14+ per week for men) and,
- Report of web access at time of recruitment
Key exclusion criteria (3 listed)
- Acute psychiatric problems; OR
- Inability to understand consent procedures
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 |
|---|---|---|
| Motivational Interviewing | Behavioural | Motivational Interviewing |
| Email Feedback | Behavioural | Email Feedback |
| Usual Care | Other | Usual Care |
Primary outcome
Impact of motivational interviewing on unhealthy drinking and alcohol related problems
Time frame: 3 Years
1 secondary outcome
Impact of e-mail feedback on unhealthy drinking and alcohol related problems
Time frame: 3 Years
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 10 Oct 2018.
- Background: PubMed 11251758Cook RL, Sereika SM, Hunt SC, Woodward WC, Erlen JA, Conigliaro J. Problem drinking and medication adherence among persons with HIV infection. J Gen Intern Med. 2001 Feb;16(2):83-8. doi: 10.1111/j.1525-1497.2001.00122.x.
- Background: PubMed 12033694Galvan FH, Bing EG, Fleishman JA, London AS, Caetano R, Burnam MA, Longshore D, Morton SC, Orlando M, Shapiro M. The prevalence of alcohol consumption and heavy drinking among people with HIV in the United States: results from the HIV Cost and Services Utilization Study. J Stud Alcohol. 2002 Mar;63(2):179-86. doi: 10.15288/jsa.2002.63.179.
- Background: PubMed 7472704Lefevre F, O'Leary B, Moran M, Mossar M, Yarnold PR, Martin GJ, Glassroth J. Alcohol consumption among HIV-infected patients. J Gen Intern Med. 1995 Aug;10(8):458-60. doi: 10.1007/BF02599920.
- Background: PubMed 15018702Samet JH, Phillips SJ, Horton NJ, Traphagen ET, Freedberg KA. Detecting alcohol problems in HIV-infected patients: use of the CAGE questionnaire. AIDS Res Hum Retroviruses. 2004 Feb;20(2):151-5. doi: 10.1089/088922204773004860.
- Background: PubMed 20705402Azar MM, Springer SA, Meyer JP, Altice FL. A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. Drug Alcohol Depend. 2010 Dec 1;112(3):178-93. doi: 10.1016/j.drugalcdep.2010.06.014. Epub 2010 Aug 11.
- Background: PubMed 18366443Chander G, Josephs J, Fleishman JA, Korthuis PT, Gaist P, Hellinger J, Gebo K; HIV Research Network. Alcohol use among HIV-infected persons in care: results of a multi-site survey. HIV Med. 2008 Apr;9(4):196-202. doi: 10.1111/j.1468-1293.2008.00545.x.
- Background: PubMed 15916249Parsons JT, Kutnick AH, Halkitis PN, Punzalan JC, Carbonari JP. Sexual risk behaviors and substance use among alcohol abusing HIV-positive men who have sex with men. J Psychoactive Drugs. 2005 Mar;37(1):27-36. doi: 10.1080/02791072.2005.10399746.
- Background: PubMed 17099312Chander G, Lau B, Moore RD. Hazardous alcohol use: a risk factor for non-adherence and lack of suppression in HIV infection. J Acquir Immune Defic Syndr. 2006 Dec 1;43(4):411-7. doi: 10.1097/01.qai.0000243121.44659.a4.
- Background: PubMed 20528816Jaquet A, Ekouevi DK, Bashi J, Aboubakrine M, Messou E, Maiga M, Traore HA, Zannou MD, Guehi C, Ba-Gomis FO, Minga A, Allou G, Eholie SP, Bissagnene E, Sasco AJ, Dabis F. Alcohol use and non-adherence to antiretroviral therapy in HIV-infected patients in West Africa. Addiction. 2010 Aug;105(8):1416-21. doi: 10.1111/j.1360-0443.2010.02978.x. Epub 2010 Jun 7.
- Background: PubMed 21345624Sullivan LE, Goulet JL, Justice AC, Fiellin DA. Alcohol consumption and depressive symptoms over time: a longitudinal study of patients with and without HIV infection. Drug Alcohol Depend. 2011 Sep 1;117(2-3):158-63. doi: 10.1016/j.drugalcdep.2011.01.014. Epub 2011 Feb 22.
- Background: PubMed 21198219Barta WD, Tennen H, Kiene SM. Alcohol-involved sexual risk behavior among heavy drinkers living with HIV/AIDS: negative affect, self-efficacy, and sexual craving. Psychol Addict Behav. 2010 Dec;24(4):563-70. doi: 10.1037/a0021414.
- Background: PubMed 22623879Gerbi GB, Habtemariam T, Tameru B, Nganwa D, Robnett V. A comparative study of substance use before and after establishing HIV infection status among people living with HIV/AIDS. J Subst Use. 2011 Dec;16(6):464-475. doi: 10.3109/14659891.2010.495820.
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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.
Derek Satre, PhD principal investigator
Associate Professor, University of California, San Francisco and Adjunct Investigator, Division of Research, Kaiser Permanente, Northern California
Michael J Silverberg, PhD principal investigator
Research Scientist II, Division of Research, Kaiser Permanente, Northern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Email Feedback in people with HIV and Acquired Immunodeficiency Syndrome, 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 3 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 10 Oct 2018. 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?
Impact of motivational interviewing on unhealthy drinking and alcohol related problems (time frame: 3 Years). 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 NCT01671501, which also lists 167 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 10 Oct 2018.