HIV Clinical Trial
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.
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
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 (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.
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 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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