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Alcohol Use and Risky Sexual Behaviors Among HIV Infected Subjects in Kampala Uganda (ASK)

Primary Purpose

Alcohol Use, HIV

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Motivational intervention counselling plus SPP
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use focused on measuring Alcohol HIV intervention counselling, Alcohol Use in HIV infected Persons

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Very sick with Karnofsky clinical performance score < 50.
  • Pregnant women

Sites / Locations

  • Infectious Diseases Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Positive Prevention Counselling

Alcohol Motivational intervention counselling plus SPP

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in alcohol consumption Score as assessed by the AUDIT-C tool .

Secondary Outcome Measures

Change in Risky sexual behavior composite in the last 3 months assessed at baseline, 3 and 6 month visit.

Full Information

First Posted
February 25, 2013
Last Updated
February 28, 2013
Sponsor
Makerere University
Collaborators
Training Health research into Vocational excellence in East Africa (THRiVE), Wellcome Trust, Infectious Diseases Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01802736
Brief Title
Alcohol Use and Risky Sexual Behaviors Among HIV Infected Subjects in Kampala Uganda
Acronym
ASK
Official Title
Alcohol Consumption and Alcohol Reduction Intervention Among HIV Infected Persons in a Large Urban HIV Clinic in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University
Collaborators
Training Health research into Vocational excellence in East Africa (THRiVE), Wellcome Trust, Infectious Diseases Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, HIV
Keywords
Alcohol HIV intervention counselling, Alcohol Use in HIV infected Persons

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
510 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Positive Prevention Counselling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Alcohol Motivational intervention counselling plus SPP
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Motivational intervention counselling plus SPP
Other Intervention Name(s)
Alcohol Motivational Intervention counseling plus Standard Positive Prevention Counselling
Primary Outcome Measure Information:
Title
Change in alcohol consumption Score as assessed by the AUDIT-C tool .
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
CD4 Cell count in the last 6 months preceding the study visit
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Very sick with Karnofsky clinical performance score < 50. Pregnant women
Facility Information:
Facility Name
Infectious Diseases Institute
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
27215561
Citation
Wandera 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.
Results Reference
derived

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Alcohol Use and Risky Sexual Behaviors Among HIV Infected Subjects in Kampala Uganda

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