Ignite Creation Date:
2024-05-06 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01802736
Status:
UNKNOWN
Last Update Posted:
2013-03-01
First Post:
2013-02-25
Brief Title:
Alcohol Use and Risky Sexual Behaviors Among HIV Infected Subjects in Kampala Uganda
Sponsor:
Makerere University
Organization:
Makerere University
Study Overview
Official Title:
Alcohol Consumption and Alcohol Reduction Intervention Among HIV Infected Persons in a Large Urban HIV Clinic in Uganda
Status:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASK
Brief Summary:
Background Approximately 64 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 methodspersons living with HIVAIDS 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
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 methodspersons living with HIVAIDS 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 HIVAIDS
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
1 To identify and determine the prevalence of clinical factors associated with any alcohol consumption among PLWHA attending the IDI clinic in Kampala Uganda
2 To describe the association between moderate alcohol consumption and CD4 cell count at base-line among patients attending the IDI clinic
3 To determine the efficacy of standard positive prevention counseling plus Motivational intervention SPPMI 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
4 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 noBinary if reporting ANY ONE or ALL of the following behaviors non spousal sexual inter-course unprotected sex with any partner who is HIV negativeunknown HIV status or reporting multiple Non spousal sex partners within the study period under inquiry
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 HIVAIDS
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
1 To identify and determine the prevalence of clinical factors associated with any alcohol consumption among PLWHA attending the IDI clinic in Kampala Uganda
2 To describe the association between moderate alcohol consumption and CD4 cell count at base-line among patients attending the IDI clinic
3 To determine the efficacy of standard positive prevention counseling plus Motivational intervention SPPMI 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
4 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 noBinary if reporting ANY ONE or ALL of the following behaviors non spousal sexual inter-course unprotected sex with any partner who is HIV negativeunknown HIV status or reporting multiple Non spousal sex partners within the study period under inquiry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None