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临床试验/NCT01802736
NCT01802736Unknown不适用

Alcohol Consumption and Alcohol Reduction Intervention Among HIV Infected Persons in a Large Urban HIV Clinic in Uganda

Makerere University1 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
510
试验地点
1
主要终点
Change in alcohol consumption Score as assessed by the AUDIT-C tool .

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 6 months

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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