Alcohol UseASKNCT01802736
Alcohol Use and Risky Sexual Behaviors Among HIV Infected Subjects in Kampala Uganda
A study testing Motivational intervention counselling plus SPP in people with Alcohol Use and HIV, run by Makerere University at 1 site in Uganda.
Trial summary
Background: Approximately 6.4% of Ugandans are living with HIV, that is acquired and transmitted mainly through sexual intercourse between an HIV infected and uninfected person. Uganda is ranked among 28 top per capita alcohol consumers in the world and second in Africa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use, HIV
- What is being tested?
- Motivational intervention counselling plus SPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteUganda
- Study dates
- Feb 2013to Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both males and females aged at least 18 years.
- Willing to continue receiving care /be followed up at the IDI for the next 6 months.
- Willing to provide written informed consent.
Who cannot join
- Very sick with Karnofsky clinical performance score < 50.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alcohol Consumption and Alcohol Reduction Intervention Among HIV Infected Persons in a Large Urban HIV Clinic in Uganda
Background: Approximately 6.4% of Ugandans are living with HIV, that is acquired and transmitted mainly through sexual intercourse between an HIV infected and uninfected person. Uganda is ranked among 28 top per capita alcohol consumers in the world and second in Africa. in the general population, Alcohol consumption is associated with increased sexual transmission risks for HIV. Data on alcohol consumption and its impact on sexual behaviors and HIV disease progression among HIV infected persons, the persons able to transmit HIV are lacking in this setting.
Objectives: To estimate the prevalence of alcohol consumption among HIV infected persons, assess associations between alcohol and CD4 cell count as well as evaluate the effect of alcohol motivational intervention counseling on alcohol consumption and the subsequent practice of risky sexual behaviors, among HIV infected persons.
Methodology: Using both cross-sectional and longitudinal methods,persons living with HIV/AIDS (PLWHA) attending the Infectious Diseases Institute Clinic (IDI clinic) will be recruited, baseline alcohol consumption evaluated, and eligible subjects reporting alcohol consumption will be randomized to receive either Standard positive prevention counseling alone or in addition to alcohol motivation intervention counseling. Sexual risk behaviors and alcohol consumption will be evaluated at 3 and 6 months and compared between randomization arms.
Read the detailed description
Uganda is among countries with the highest per capita consumption rates of alcohol as well as a high prevalence of HIV. Uganda is ranked the 28th in the world in alcohol consumption per capita and is 2nd top consumer of alcohol in Africa.
Little is known about alcohol use and its impact on sexual risk behaviors and HIV disease progression from this setting Understanding alcohol consumption burden and testing an intervention measure directed against alcohol consumption will result in reduced alcohol consumption and potentially reduced sexual risk behaviors hence boost the success of ART and subsequently reduce potential further HIV transmission from Persons Living With HIV/AIDS.
To increase the understanding of alcohol consumption among persons living with HIV in through a series of epidemiological studies by estimating the burden of alcohol consumption, its association with HIV disease progression and assess the effect of an alcohol motivational intervention plus standard positive prevention versus standard positive prevention counseling alone on alcohol and sexual risk behaviors among PLWHA at the IDI clinic.
Specific Objectives
- To identify and determine the prevalence of clinical factors associated with any alcohol consumption among PLWHA attending the IDI clinic in Kampala Uganda
- To describe the association between moderate alcohol consumption and CD4 cell count at base-line among patients attending the IDI clinic.
- To determine the efficacy of standard positive prevention counseling plus Motivational intervention (SPP+MI) for alcohol consumption versus standard positive prevention counseling (SPP) only in reducing alcohol consumption among HIV infected moderate alcohol drinkers attending the IDI clinic in Kampala Uganda.
- To determine whether reduction in alcohol consumption is associated with reductions in risky sexual behaviors among HIV infected moderate alcohol drinkers attending the AIDC in Kampala Uganda.
Risky Sexual Behavior for HIV transmission assessed as a summation of yes or no(Binary) if reporting ANY ONE or ALL of the following behaviors (non spousal sexual inter-course, unprotected sex with any partner who is HIV negative/unknown HIV status or reporting multiple Non spousal sex partners within the study period under inquiry.
- Conditions
- Alcohol Use, HIV
- Being tested
- Motivational intervention counselling plus SPP
- Keywords
- Alcohol HIV intervention counselling, Alcohol Use in HIV infected Persons
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational intervention counselling plus SPPBehavioural
Also called Alcohol Motivational Intervention counseling plus Standard Positive Prevention Counselling
| Study group | Role | What they receive |
|---|---|---|
| Standard Positive Prevention Counselling | Active comparator | Standard positive prevention counseling which includes alcohol reduction and sexual risk behavior counseling provided in the clinic by the clinic medical counselors on the day of enrollment and at month 3 visit.
Although there is awareness of the need to engage and include PLWHA in HIV prevention, there are little practical efforts devoted towards this engagement even in developed countries. One of the major reasons is the lack of a well-defined standard positive prevention package that needs to be delivered to PLWHA. The approach proposed by Kennedy et al modified to suit the local setting and involves a simpler understandable classification of the goals, interventions and expected outcomes of the treatment. Receives: Behavioral: Motivational intervention counselling plus SPP |
| Alcohol Motivational intervention counselling plus SPP | Experimental | Not described Receives: Behavioral: Motivational intervention counselling plus SPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol consumption Score as assessed by the AUDIT-C tool .
Measured: 6 months
Secondary outcomes (1)
Change in Risky sexual behavior composite in the last 3 months assessed at baseline, 3 and 6 month visit.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013 (estimated)
- Study completionMar 2014 (estimated)
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 Alcohol UseStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Training Health research into Vocational excellence in East Africa (THRiVE), Wellcome Trust, Infectious Diseases Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802736
- Sponsor's protocol ID
- THRiVE- ASK
- Acronym
- ASK
- Status last verified
- Feb 2013
- First submitted
- 25 Feb 2013
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Greene MC, Kane J, Alto M, Giusto A, Lovero K, Stockton M, McClendon J, Nicholson T, Wainberg ML, Johnson RM, Tol WA. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023 May 9;5(5):CD013350. doi: 10.1002/14651858.CD013350.pub2.
PubMed 37158538Wandera B, Tumwesigye NM, Nankabirwa JI, Mafigiri DK, Parkes-Ratanshi RM, Kapiga S, Hahn J, Sethi AK. Efficacy of a Single, Brief Alcohol Reduction Intervention among Men and Women Living with HIV/AIDS and Using Alcohol in Kampala, Uganda: A Randomized Trial. J Int Assoc Provid AIDS Care. 2017 May/Jun;16(3):276-285. doi: 10.1177/2325957416649669. Epub 2016 May 23.
PubMed 27215561
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Consumption and Alcohol Reduction Intervention Among HIV Infected Persons in a Large Urban HIV Clinic in Uganda
- ClinicalTrials.gov ID
- NCT01802736
- Acronym / sponsor ID
- ASK / THRiVE- ASK
- Conditions
- Alcohol Use, HIV
- Keywords
- Alcohol HIV intervention counselling, Alcohol Use in HIV infected Persons
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Training Health research into Vocational excellence in East Africa (THRiVE), Wellcome Trust, Infectious Diseases Institute
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 1 Mar 2013 (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.
Background: Approximately 6.4% of Ugandans are living with HIV, that is acquired and transmitted mainly through sexual intercourse between an HIV infected and uninfected person. Uganda is ranked among 28 top per capita alcohol consumers in the world and second in Africa. in the general population, Alcohol consumption is associated with increased sexual transmission risks for HIV. Data on alcohol consumption and its impact on sexual behaviors and HIV disease progression among HIV infected persons, the persons able to transmit HIV are lacking in this setting.
Objectives: To estimate the prevalence of alcohol consumption among HIV infected persons, assess associations between alcohol and CD4 cell count as well as evaluate the effect of alcohol motivational intervention counseling on alcohol consumption and the subsequent practice of risky sexual behaviors, among HIV infected persons.
Methodology: Using both cross-sectional and longitudinal methods,persons living with HIV/AIDS (PLWHA) attending the Infectious Diseases Institute Clinic (IDI clinic) will be recruited, baseline alcohol consumption evaluated, and eligible subjects reporting alcohol consumption will be randomized to receive either Standard positive prevention counseling alone or in addition to alcohol motivation intervention counseling. Sexual risk behaviors and alcohol consumption will be evaluated at 3 and 6 months and compared between randomization arms.
Detailed description
Uganda is among countries with the highest per capita consumption rates of alcohol as well as a high prevalence of HIV. Uganda is ranked the 28th in the world in alcohol consumption per capita and is 2nd top consumer of alcohol in Africa.
Little is known about alcohol use and its impact on sexual risk behaviors and HIV disease progression from this setting Understanding alcohol consumption burden and testing an intervention measure directed against alcohol consumption will result in reduced alcohol consumption and potentially reduced sexual risk behaviors hence boost the success of ART and subsequently reduce potential further HIV transmission from Persons Living With HIV/AIDS.
To increase the understanding of alcohol consumption among persons living with HIV in through a series of epidemiological studies by estimating the burden of alcohol consumption, its association with HIV disease progression and assess the effect of an alcohol motivational intervention plus standard positive prevention versus standard positive prevention counseling alone on alcohol and sexual risk behaviors among PLWHA at the IDI clinic.
Specific Objectives
- To identify and determine the prevalence of clinical factors associated with any alcohol consumption among PLWHA attending the IDI clinic in Kampala Uganda
- To describe the association between moderate alcohol consumption and CD4 cell count at base-line among patients attending the IDI clinic.
- To determine the efficacy of standard positive prevention counseling plus Motivational intervention (SPP+MI) for alcohol consumption versus standard positive prevention counseling (SPP) only in reducing alcohol consumption among HIV infected moderate alcohol drinkers attending the IDI clinic in Kampala Uganda.
- To determine whether reduction in alcohol consumption is associated with reductions in risky sexual behaviors among HIV infected moderate alcohol drinkers attending the AIDC in Kampala Uganda.
Risky Sexual Behavior for HIV transmission assessed as a summation of yes or no(Binary) if reporting ANY ONE or ALL of the following behaviors (non spousal sexual inter-course, unprotected sex with any partner who is HIV negative/unknown HIV status or reporting multiple Non spousal sex partners within the study period under inquiry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Positive Prevention Counselling | Active comparator | Behavioral: Motivational intervention counselling plus SPPStandard positive prevention counseling which includes alcohol reduction and sexual risk behavior counseling provided in the clinic by the clinic medical counselors on the day of enrollment and at month 3 visit. Although there is awareness of the need to engage and include PLWHA in HIV prevention, there are little practical efforts devoted towards this engagement even in developed countries. One of the major reasons is the lack of a well-defined standard positive prevention package that needs to be delivered to PLWHA. The approach proposed by Kennedy et al modified to suit the local setting and involves a simpler understandable classification of the goals, interventions and expected outcomes of the treatment. |
| Alcohol Motivational intervention counselling plus SPP | Experimental | Behavioral: Motivational intervention counselling plus SPP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both males and females aged at least 18 years.
- Willing to continue receiving care /be followed up at the IDI for the next 6 months.
- Willing to provide written informed consent.
Key exclusion criteria (2 listed)
- Very sick with Karnofsky clinical performance score < 50.
- Pregnant women
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 intervention counselling plus SPPAlso: Alcohol Motivational Intervention counseling plus Standard Positive Prevention Counselling | Behavioural | Alcohol Motivational intervention counselling plus SPP, Standard Positive Prevention Counselling |
Primary outcome
Change in alcohol consumption Score as assessed by the AUDIT-C tool .
Time frame: 6 months
1 secondary outcome
Change in Risky sexual behavior composite in the last 3 months assessed at baseline, 3 and 6 month visit.
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
- Derived from this study: PubMed 37158538Greene MC, Kane J, Alto M, Giusto A, Lovero K, Stockton M, McClendon J, Nicholson T, Wainberg ML, Johnson RM, Tol WA. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023 May 9;5(5):CD013350. doi: 10.1002/14651858.CD013350.pub2.
- Derived from this study: PubMed 27215561Wandera B, Tumwesigye NM, Nankabirwa JI, Mafigiri DK, Parkes-Ratanshi RM, Kapiga S, Hahn J, Sethi AK. Efficacy of a Single, Brief Alcohol Reduction Intervention among Men and Women Living with HIV/AIDS and Using Alcohol in Kampala, Uganda: A Randomized Trial. J Int Assoc Provid AIDS Care. 2017 May/Jun;16(3):276-285. doi: 10.1177/2325957416649669. Epub 2016 May 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 intervention counselling plus SPP in people with Alcohol Use and HIV, run by Makerere University at 1 site in Uganda.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Mar 2013. 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 Uganda. 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?
Results are not available in the source record.
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?
Change in alcohol consumption Score as assessed by the AUDIT-C tool . (time frame: 6 months). 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 NCT01802736, 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 1 Mar 2013.