HIVNCT04054466
Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART
A study testing Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART and Habitual Counseling in people with HIV and Alcohol Drinking, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial summary
The success of treatment in patients with HIV depends not just on the therapeutic regimen used, but also on the adherence or level of compliance with the treatment achieved by the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Alcohol Drinking
- What is being tested?
- Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART and Habitual Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 sitePeru
- Study dates
- 15 Sep 2018to 31 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing to participate in the study.
- Have an assessment of the level of consumption and adherence to HAART.
Who cannot join
- Have been identified with a level of dependence on alcohol consumption, given that this group of patients requires specialized attention (50).
- Do not consume alcohol.
- Being hospitalized.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients Receiving HAART
The success of treatment in patients with HIV depends not just on the therapeutic regimen used, but also on the adherence or level of compliance with the treatment achieved by the patient. Patients who consume alcohol are at risk of not complying with antiretroviral treatment, because of the effects caused by alcohol consumption or the interaction that alcohol may have with medications. Differentiated counseling according to consumption levels could help improve the adherence of patients who receive HAART and who also consume alcohol.
The objective of the study is to determine the effectiveness of nursing counseling in improving behavior of alcohol consumption in patients with HIV.
Read more
An experimental study will be developed with three phases, and the sampling used in each of the phases will be random.
The first will identify the level of alcohol consumption and adherence to HAART of patients of the Health Strategy of the Hospital Nacional Cayetano Heredia and will develop two focus groups, one with patients and another with nurses to analyze the feasibility, utility, adaptability and Possible effectiveness of the counseling proposed in the improvement of adherence to HAART. In a second phase the intervention will proceed in two groups, one of them is the experimental group where the differentiated counseling will be applied and the second group the control where the habitual counseling will be applied. In the third phase, the counseling undergoing experimentation to evaluate its possible scalability will be subjected again to analysis through focus groups with patients and nurses.
For the evaluation of the variables, different validated instruments will be used: AUDIT for the evaluation of consumption, Simplified Medication Adherence Questionnaire (SMAQ) to assess adherence to HAART, some data will be taken from the patient's clinical history, guides for focus groups will be used.
Descriptive statistics will be used to estimate the level of alcohol consumption and adherence to HAART by patients. The comparability of the study groups in the experimental phase will be evaluated and the effectiveness of the counseling will be demonstrated by comparing means of adherence to HAART before after the intervention.
The project respects the bioethical principles of Charity, Justice and autonomy
Read the detailed description
Goals:
- Determine the necessary contents to include the usual counseling to improve the adherence to HAART of patients with HIV according to their different levels of alcohol consumption.
- To compare the prevalence of alcohol consumption in the last month and last six months between patients who receive and do not receive differentiated nursing counseling according to the level of alcohol consumption.
- Determine if the intervention is sustainable and scalable.
Material and methods:
Type of study and research design It is an experimental study with three phases, which are detailed below.
First phase The study will start with a formative research to define the content of the intervention strategy, the extension of it, the duration of each session and the approach to be used for each subgroup.
To do this, the level of alcohol consumption of HIV patients receiving HAART and their levels of adherence will first be identified.
Alcohol consumption will be evaluated through the measurement of the prevalence of consumption and the application of the AUDIT (see annex 2) that identifies, alcohol risk consumption, harmful alcohol consumption and dependence. Adherence to HAART will be identified mainly through the SMAQ instrument recommended by the Ministry of Health (see annex 3) for the patients of the strategy and the consistency of this measurement will be sought with the record of the delivery of medications, the treatment card.
Subsequently, the design of the differentiated counseling protocol for the levels of consumption presented by the patients will be concluded. For each component, contents with scientific evidence will be refined. The contrast with the scientific evidence, the available theory and the reality of consumption will consolidate the proposal of counseling.
The elaborated protocol will be submitted to the opinion of focal groups with patients and nurses (see annexes 4 and 5) to validate the proposed counseling and evaluate its usefulness, acceptability, adaptability, feasibility (cost / time), sustainability and possible effectiveness of the proposal. Differentiated counseling for alcohol users according to their consumption levels. Focus groups will be recorded with the prior authorization of the participants.
Finally, the counseling proposal with the feedback received from the focus group will be submitted to the opinion of experts on the subject of HIV, alcohol consumption and nursing counseling. With these tools we will have a counseling protocol (including initial session and follow-up sessions) that will be applied in a pilot test to 10 volunteer patients in order to complete its validation and identify difficulties in its application: 05 patients (for the initial session ) and 05 patients (follow-up session).
Finally, a training program for nurses will be designed in order to have the required profile in the professionals for the application of the counseling.
Second stage Subsequently, the experimentation period will start with a randomized trial type design with concurrent control. The experimental group will receive the counseling and the control group will be constituted by a group of patients randomly selected from the population of patients who started HAART in the last three months in the Strategy who will receive the usual counseling.
Patients will have a baseline measurement of alcohol consumption, adherence to HAART; then monthly evaluations until six months of intervention.
Third phase This final phase will be the analysis of the opinion of patients and nurses on the sustainability (cost / time) scalability of the proposal of differentiated counseling for patients consuming alcohol according to their levels of consumption post experimental evaluation. This phase will be carried out using focus groups: of patients and nurses.
In this phase, the economic evaluation of the intervention will also be carried out. For this purpose, the costs at the market value of all the resources, services or supplies required to carry out the counseling will have been recorded. The cost for each counseling session provided to each patient will also be calculated to then obtain the simple average cost per session for each subgroup according to consumption levels.
- Conditions
- HIV, Alcohol Drinking
- Being tested
- Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART, Habitual Counseling
- Keywords
- HIV, Counseling, Antiretroviral Therapy, Alcohol Drinking, Nursing Care
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAARTBehavioural
Also called New Counseling
It is a health intervention, performed by the nurse with the purpose of providing support or support to the patient's health care. The main objective of counseling is to improve adherence to treatment in patients who receive HAART but also consume alcoholic beverages.
The components of the differentiated counseling according to the levels of consumption are consolidated according to the recommendations given by the World Health Organization (WHO) after the application of the AUDIT:
Social consumption (sometime in life, in the last year or in the last month) = mainly education about consumer risks, its application will be bi-monthly.
Habitual CounselingBehavioural
Also called Old Counseling
Regular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Intervention with counselling designed Receives: Behavioral: Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART |
| Control group | Other | Intervention with habitual counselling Receives: Behavioral: Habitual Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol consumption
Intake of any beverage with alcoholic content reported by the subject throughout his life, last year, last six months, last months and last seven days from an interview, additionally we evaluate Alcohol Disorders through Alcohol Disorders Identification Test (AUDIT).
Measured: At the beginning of the study and then every month until the end of six months of follow-up
Secondary outcomes (1)
HAART Adherence
Adherence to pharmacological therapy with antiretrovirals is the degree of compliance of the pharmacological treatment according to medical indication and evaluated by the application of the SMAQ. , the record of attendance to the pick up of the medicines and the treatment card.
Measured: One month after starting antiretroviral treatment and then every month until completing the six months of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start15 Sep 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimentation period will be carried out with a randomized trial type design with concurrent control. The experimental group will receive the counseling and the control group will be constituted by a group of patients randomly selected from the population of patients who started HAART in the last three months in the Strategy who will receive the usual counseling. Patients will have a baseline measurement of alcohol consumption, adherence to HAART; then monthly evaluations until six months of intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, CARIBBEAN, CENTRAL AND SOUTH AMERICA NETWORK FOR HIV EPIDEMIOLOGY
- Responsible party
- Principal investigator, Yesenia Musayon, Universidad Peruana Cayetano Heredia
- Investigators
- Flor Musayón, Dr, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054466
- Sponsor's protocol ID
- 066991
- Other IDs
- D43TW009763
- Status last verified
- Jul 2024
- First submitted
- 31 Mar 2019
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the registry of the ethics committee, the study data will only be used for the present investigation.
Publications
Thangavel S, Mulet CT, Atluri VSR, Agudelo M, Rosenberg R, Devieux JG, Nair MPN. Oxidative Stress in HIV Infection and Alcohol Use: Role of Redox Signals in Modulation of Lipid Rafts and ATP-Binding Cassette Transporters. Antioxid Redox Signal. 2018 Feb 1;28(4):324-337. doi: 10.1089/ars.2016.6830.
PubMed 29132227Dey A, Cederbaum AI. Alcohol and oxidative liver injury. Hepatology. 2006 Feb;43(2 Suppl 1):S63-74. doi: 10.1002/hep.20957.
PubMed 16447273Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PubMed 16079372Fishbein M. The role of theory in HIV prevention. AIDS Care. 2000 Jun;12(3):273-8. doi: 10.1080/09540120050042918.
PubMed 10928203Hankins CA, de Zalduondo BO. Combination prevention: a deeper understanding of effective HIV prevention. AIDS. 2010 Oct;24 Suppl 4:S70-80. doi: 10.1097/01.aids.0000390709.04255.fd.
PubMed 21042055Baum MK, Rafie C, Lai S, Sales S, Page JB, Campa A. Alcohol use accelerates HIV disease progression. AIDS Res Hum Retroviruses. 2010 May;26(5):511-8. doi: 10.1089/aid.2009.0211.
PubMed 20455765Room R, Babor T, Rehm J. Alcohol and public health. Lancet. 2005 Feb 5-11;365(9458):519-30. doi: 10.1016/S0140-6736(05)17870-2.
PubMed 15705462Cook RL, Zhou Z, Kelso-Chichetto NE, Janelle J, Morano JP, Somboonwit C, Carter W, Ibanez GE, Ennis N, Cook CL, Cohen RA, Brumback B, Bryant K. Alcohol consumption patterns and HIV viral suppression among persons receiving HIV care in Florida: an observational study. Addict Sci Clin Pract. 2017 Sep 27;12(1):22. doi: 10.1186/s13722-017-0090-0.
PubMed 28950912Pokhrel KN, Gaulee Pokhrel K, Neupane SR, Sharma VD. Harmful alcohol drinking among HIV-positive people in Nepal: an overlooked threat to anti-retroviral therapy adherence and health-related quality of life. Glob Health Action. 2018;11(1):1441783. doi: 10.1080/16549716.2018.1441783.
PubMed 29495948Shuper PA, Neuman M, Kanteres F, Baliunas D, Joharchi N, Rehm J. Causal considerations on alcohol and HIV/AIDS--a systematic review. Alcohol Alcohol. 2010 Mar-Apr;45(2):159-66. doi: 10.1093/alcalc/agp091. Epub 2010 Jan 8.
PubMed 20061510Chander 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 17099312Azar 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 20705402Samet JH, Horton NJ, Meli S, Freedberg KA, Palepu A. Alcohol consumption and antiretroviral adherence among HIV-infected persons with alcohol problems. Alcohol Clin Exp Res. 2004 Apr;28(4):572-7. doi: 10.1097/01.alc.0000122103.74491.78.
PubMed 15100608Cebeci F, Celik SS. Discharge training and counselling increase self-care ability and reduce postdischarge problems in CABG patients. J Clin Nurs. 2008 Feb;17(3):412-20. doi: 10.1111/j.1365-2702.2007.01952.x. Epub 2007 Nov 30.
PubMed 18047578Kamb ML, Fishbein M, Douglas JM Jr, Rhodes F, Rogers J, Bolan G, Zenilman J, Hoxworth T, Malotte CK, Iatesta M, Kent C, Lentz A, Graziano S, Byers RH, Peterman TA. Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases: a randomized controlled trial. Project RESPECT Study Group. JAMA. 1998 Oct 7;280(13):1161-7. doi: 10.1001/jama.280.13.1161.
PubMed 9777816
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients Receiving HAART
- ClinicalTrials.gov ID
- NCT04054466
- Acronym / sponsor ID
- 066991
- Conditions
- HIV, Alcohol Drinking
- Keywords
- HIV, Counseling, Antiretroviral Therapy, Alcohol Drinking, Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, CARIBBEAN, CENTRAL AND SOUTH AMERICA NETWORK FOR HIV EPIDEMIOLOGY
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Aug 2019 (actual)
- 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.
The success of treatment in patients with HIV depends not just on the therapeutic regimen used, but also on the adherence or level of compliance with the treatment achieved by the patient. Patients who consume alcohol are at risk of not complying with antiretroviral treatment, because of the effects caused by alcohol consumption or the interaction that alcohol may have with medications. Differentiated counseling according to consumption levels could help improve the adherence of patients who receive HAART and who also consume alcohol.
The objective of the study is to determine the effectiveness of nursing counseling in improving behavior of alcohol consumption in patients with HIV.
An experimental study will be developed with three phases, and the sampling used in each of the phases will be random.
The first will identify the level of alcohol consumption and adherence to HAART of patients of the Health Strategy of the Hospital Nacional Cayetano Heredia and will develop two focus groups, one with patients and another with nurses to analyze the feasibility, utility, adaptability and Possible effectiveness of the counseling proposed in the improvement of adherence to HAART. In a second phase the intervention will proceed in two groups, one of them is the experimental group where the differentiated counseling will be applied and the second group the control where the habitual counseling will be applied. In the third phase, the counseling undergoing experimentation to evaluate its possible scalability will be subjected again to analysis through focus groups with patients and nurses.
For the evaluation of the variables, different validated instruments will be used: AUDIT for the evaluation of consumption, Simplified Medication Adherence Questionnaire (SMAQ) to assess adherence to HAART, some data will be taken from the patient's clinical history, guides for focus groups will be used.
Descriptive statistics will be used to estimate the level of alcohol consumption and adherence to HAART by patients. The comparability of the study groups in the experimental phase will be evaluated and the effectiveness of the counseling will be demonstrated by comparing means of adherence to HAART before after the intervention.
The project respects the bioethical principles of Charity, Justice and autonomy
Detailed description
Goals:
- Determine the necessary contents to include the usual counseling to improve the adherence to HAART of patients with HIV according to their different levels of alcohol consumption.
- To compare the prevalence of alcohol consumption in the last month and last six months between patients who receive and do not receive differentiated nursing counseling according to the level of alcohol consumption.
- Determine if the intervention is sustainable and scalable.
Material and methods:
Type of study and research design It is an experimental study with three phases, which are detailed below.
First phase The study will start with a formative research to define the content of the intervention strategy, the extension of it, the duration of each session and the approach to be used for each subgroup.
To do this, the level of alcohol consumption of HIV patients receiving HAART and their levels of adherence will first be identified.
Alcohol consumption will be evaluated through the measurement of the prevalence of consumption and the application of the AUDIT (see annex 2) that identifies, alcohol risk consumption, harmful alcohol consumption and dependence. Adherence to HAART will be identified mainly through the SMAQ instrument recommended by the Ministry of Health (see annex 3) for the patients of the strategy and the consistency of this measurement will be sought with the record of the delivery of medications, the treatment card.
Subsequently, the design of the differentiated counseling protocol for the levels of consumption presented by the patients will be concluded. For each component, contents with scientific evidence will be refined. The contrast with the scientific evidence, the available theory and the reality of consumption will consolidate the proposal of counseling.
The elaborated protocol will be submitted to the opinion of focal groups with patients and nurses (see annexes 4 and 5) to validate the proposed counseling and evaluate its usefulness, acceptability, adaptability, feasibility (cost / time), sustainability and possible effectiveness of the proposal. Differentiated counseling for alcohol users according to their consumption levels. Focus groups will be recorded with the prior authorization of the participants.
Finally, the counseling proposal with the feedback received from the focus group will be submitted to the opinion of experts on the subject of HIV, alcohol consumption and nursing counseling. With these tools we will have a counseling protocol (including initial session and follow-up sessions) that will be applied in a pilot test to 10 volunteer patients in order to complete its validation and identify difficulties in its application: 05 patients (for the initial session ) and 05 patients (follow-up session).
Finally, a training program for nurses will be designed in order to have the required profile in the professionals for the application of the counseling.
Second stage Subsequently, the experimentation period will start with a randomized trial type design with concurrent control. The experimental group will receive the counseling and the control group will be constituted by a group of patients randomly selected from the population of patients who started HAART in the last three months in the Strategy who will receive the usual counseling.
Patients will have a baseline measurement of alcohol consumption, adherence to HAART; then monthly evaluations until six months of intervention.
Third phase This final phase will be the analysis of the opinion of patients and nurses on the sustainability (cost / time) scalability of the proposal of differentiated counseling for patients consuming alcohol according to their levels of consumption post experimental evaluation. This phase will be carried out using focus groups: of patients and nurses.
In this phase, the economic evaluation of the intervention will also be carried out. For this purpose, the costs at the market value of all the resources, services or supplies required to carry out the counseling will have been recorded. The cost for each counseling session provided to each patient will also be calculated to then obtain the simple average cost per session for each subgroup according to consumption levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The experimentation period will be carried out with a randomized trial type design with concurrent control. The experimental group will receive the counseling and the control group will be constituted by a group of patients randomly selected from the population of patients who started HAART in the last three months in the Strategy who will receive the usual counseling. Patients will have a baseline measurement of alcohol consumption, adherence to HAART; then monthly evaluations until six months of intervention.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAARTIntervention with counselling designed |
| Control group | Other | Behavioral: Habitual CounselingIntervention with habitual counselling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be willing to participate in the study.
- Have an assessment of the level of consumption and adherence to HAART.
Key exclusion criteria (3 listed)
- Have been identified with a level of dependence on alcohol consumption, given that this group of patients requires specialized attention (50).
- Do not consume alcohol.
- Being hospitalized.
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 |
|---|---|---|
| Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAARTAlso: New CounselingIt is a health intervention, performed by the nurse with the purpose of providing support or support to the patient's health care. The main objective of counseling is to improve adherence to treatment in patients who receive HAART but also consume alcoholic beverages. The components of the differentiated counseling according to the levels of consumption are consolidated according to the recommendations given by the World Health Organization (WHO) after the application of the AUDIT: Social consumption (sometime in life, in the last year or in the last month) = mainly education about consumer risks, its application will be bi-monthly. | Behavioural | Experimental group |
| Habitual CounselingAlso: Old CounselingRegular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment | Behavioural | Control group |
Primary outcome
Alcohol consumption
Time frame: At the beginning of the study and then every month until the end of six months of follow-up
Intake of any beverage with alcoholic content reported by the subject throughout his life, last year, last six months, last months and last seven days from an interview, additionally we evaluate Alcohol Disorders through Alcohol Disorders Identification Test (AUDIT).
1 secondary outcome
HAART Adherence
Time frame: One month after starting antiretroviral treatment and then every month until completing the six months of follow-up.
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 26 Jul 2024.
- Background: PubMed 29132227Thangavel S, Mulet CT, Atluri VSR, Agudelo M, Rosenberg R, Devieux JG, Nair MPN. Oxidative Stress in HIV Infection and Alcohol Use: Role of Redox Signals in Modulation of Lipid Rafts and ATP-Binding Cassette Transporters. Antioxid Redox Signal. 2018 Feb 1;28(4):324-337. doi: 10.1089/ars.2016.6830.
- Background: PubMed 16447273Dey A, Cederbaum AI. Alcohol and oxidative liver injury. Hepatology. 2006 Feb;43(2 Suppl 1):S63-74. doi: 10.1002/hep.20957.
- Background: PubMed 16079372Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Background: PubMed 10928203Fishbein M. The role of theory in HIV prevention. AIDS Care. 2000 Jun;12(3):273-8. doi: 10.1080/09540120050042918.
- Background: PubMed 21042055Hankins CA, de Zalduondo BO. Combination prevention: a deeper understanding of effective HIV prevention. AIDS. 2010 Oct;24 Suppl 4:S70-80. doi: 10.1097/01.aids.0000390709.04255.fd.
- Background: PubMed 20455765Baum MK, Rafie C, Lai S, Sales S, Page JB, Campa A. Alcohol use accelerates HIV disease progression. AIDS Res Hum Retroviruses. 2010 May;26(5):511-8. doi: 10.1089/aid.2009.0211.
- Background: PubMed 15705462Room R, Babor T, Rehm J. Alcohol and public health. Lancet. 2005 Feb 5-11;365(9458):519-30. doi: 10.1016/S0140-6736(05)17870-2.
- Results publication: PubMed 28950912Cook RL, Zhou Z, Kelso-Chichetto NE, Janelle J, Morano JP, Somboonwit C, Carter W, Ibanez GE, Ennis N, Cook CL, Cohen RA, Brumback B, Bryant K. Alcohol consumption patterns and HIV viral suppression among persons receiving HIV care in Florida: an observational study. Addict Sci Clin Pract. 2017 Sep 27;12(1):22. doi: 10.1186/s13722-017-0090-0.
- Results publication: PubMed 29495948Pokhrel KN, Gaulee Pokhrel K, Neupane SR, Sharma VD. Harmful alcohol drinking among HIV-positive people in Nepal: an overlooked threat to anti-retroviral therapy adherence and health-related quality of life. Glob Health Action. 2018;11(1):1441783. doi: 10.1080/16549716.2018.1441783.
- Results publication: PubMed 20061510Shuper PA, Neuman M, Kanteres F, Baliunas D, Joharchi N, Rehm J. Causal considerations on alcohol and HIV/AIDS--a systematic review. Alcohol Alcohol. 2010 Mar-Apr;45(2):159-66. doi: 10.1093/alcalc/agp091. Epub 2010 Jan 8.
- Results publication: 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.
- Results publication: 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.
- Información sobre la medicación y adherencia al tratamiento antirretroviral de gran actividad en pacientes con VIH/SIDA de un hospital de LimaLink provided by the sponsor.
- Incidence and associated factors to adverse reactions of the initial antiretroviral treatment in patients with HIVLink provided by the sponsor.
- Análisis de la Situación Epidemiológica del VIH/Sindrome de Inmuno Deficiencia Adquirida (SIDA) en el PerúLink provided by the sponsor.
- La Dependencia alcohólica como factor de riesgo de tuberculosis multidrogo-resistenteLink provided by the sponsor.
- Boletín VIH/Sindrome de Inmuno Deficiencia Adquirida (SIDA)Link provided by the sponsor.
- Norma Técnica de Salud de Atención Integral del Adulto con Infección por el Virus de la Inmunodeficiencia Humana (VIH)Link provided by the sponsor.
- Individual participant dataSharing planned: No. According to the registry of the ethics committee, the study data will only be used for the present investigation.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Flor Musayón, Dr principal investigator
Universidad Peruana Cayetano Heredia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART and Habitual Counseling in people with HIV and Alcohol Drinking, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
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 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 26 Jul 2024. 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 Peru. 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?
Alcohol consumption (time frame: At the beginning of the study and then every month until the end of six months of follow-up). 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 NCT04054466, which also lists 22 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 26 Jul 2024.