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

NCT01802736 | Unknown

• 1 other identifier: THRiVE- ASK
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use; HIV

Keywords

Alcohol HIV intervention counselling; Alcohol Use in HIV infected Persons

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

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

  3 and 6 months

Other Outcomes (1)

• CD4 Cell count in the last 6 months preceding the study visit

  6 months

Study Arms (2)

Standard Positive Prevention Counselling

ACTIVE COMPARATOR

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

Alcohol Motivational intervention counselling plus SPP

EXPERIMENTAL

Behavioral: Motivational intervention counselling plus SPP

Interventions

Motivational intervention counselling plus SPP BEHAVIORAL

Also known as: Alcohol Motivational Intervention counseling plus Standard Positive Prevention Counselling

Alcohol Motivational intervention counselling plus SPP; Standard Positive Prevention Counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Makerere University: lead
• Training Health research into Vocational excellence in East Africa (THRiVE): collaborator
• Wellcome Trust: collaborator
• Infectious Diseases Institute: collaborator

Study Sites (1)

Infectious Diseases Institute

Kampala, Uganda

Location

Related Publications (2)

• Greene MC, Kane J, Alto M, Giusto A, Lovero K, Stockton M, McClendon J, Nicholson T, Wainberg ML, Johnson RM, Tol WA. Psychosocial and pharmacologic interventions to reduce harmful alcohol use in low- and middle-income countries. Cochrane Database Syst Rev. 2023 May 9;5(5):CD013350. doi: 10.1002/14651858.CD013350.pub2.

  PMID: 37158538 DERIVED

• 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.

  PMID: 27215561 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

signal peptide peptidase; Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 1, 2013

Record last verified: 2013-02

Locations

UG (1)