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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Training Health research into Vocational excellence in East Africa (THRiVE)
Wellcome Trust
Infectious Diseases Institute
Information provided by (Responsible Party):
Makerere University
ClinicalTrials.gov Identifier:
NCT01802736
First received: February 25, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Alcohol Use
HIV
Behavioral: Motivational intervention counselling plus SPP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alcohol Consumption and Alcohol Reduction Intervention Among HIV Infected Persons in a Large Urban HIV Clinic in Uganda

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Change in alcohol consumption Score as assessed by the AUDIT-C tool . [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • CD4 Cell count in the last 6 months preceding the study visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 510
Study Start Date: February 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Positive Prevention Counselling

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.

Behavioral: Motivational intervention counselling plus SPP
Other Name: Alcohol Motivational Intervention counseling plus Standard Positive Prevention Counselling
Experimental: Alcohol Motivational intervention counselling plus SPP Behavioral: Motivational intervention counselling plus SPP
Other Name: Alcohol Motivational Intervention counseling plus Standard Positive Prevention Counselling

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

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802736

Locations
Uganda
Infectious Diseases Institute
Kampala, Uganda
Sponsors and Collaborators
Makerere University
Training Health research into Vocational excellence in East Africa (THRiVE)
Wellcome Trust
Infectious Diseases Institute
  More Information

No publications provided

Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT01802736     History of Changes
Other Study ID Numbers: THRiVE- ASK
Study First Received: February 25, 2013
Last Updated: February 28, 2013
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Alcohol HIV intervention counselling
Alcohol Use in HIV infected Persons

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014