Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201509001211149 Date of Approval: 22/07/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ADAPTED ALCOHOL USE INTERVENTION FOR ZIMBABWE
Official scientific title An adapted intervention for alcohol use disorders in people living with AIDS and its impact on alcohol use, general functional ability, quality of life and adherence to highly active antiretroviral therapy (HAART) :A cluster randomized control trial at Opportunistic clinics in Zimbabwe
Brief summary describing the background and objectives of the trial Drinking is associated with increased risk of HIV infection. Alcohol use is associated with poor outcomes in HIV treatment. Most interventions in HIV treatment seeking individuals have focused on adherence to treatment. The studies also emphasized efficacy, but the utility in real life will see the client more mptivated. In this study therefore, we aim to investigate the effect with the outcome being the alcohol use , capacity to function and quality of life.This trial will invove development of an alcohol use disorders psychological intervention for people living with HIV. The aims of the trial is to evaluat the efectiveness of an adapted intervention for alcohol use disorders delvered by registered general nurses on alcohol use outcomes, function, qulity of life and adherence to antiretroviral therapy. Other objectives of this trial are to levels of adherence to antiretrioviral treatment by people living with aidsand assss the impact of an alcohol use disorder intervention on the adherence to antiretroviral drugs. The study will be at opportunistic infection. clinics that are in clusters and randomized per cluster. The intervention is compared with active intervention made up of mhgap brief intervention for alcohol abuse. Results from this trial will help the authoritiees implement behaviour change programs that will lead to benefits to clients. The limitations of this study will have to be inadequacy of adaptation with some of the core elements in the treatment not fitting the community and biases that are associated with use of self report screening tools.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) cluster RCT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 01/07/2016
Actual trial start date
Anticipated date of last follow up 30/06/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
S14/10/222
S14/10/222
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised stratification by centre will be carried out. allocationwas determined by a holder of sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group An adapted motivational interviewing cognitive behavioral therapy intervention four sessions per month at baseline, 3,6, and 12 months 45 minutes using principle of motivational interviewing, the client is moved into readiness to change in their use of alcohol. when ready to change, the client is taken through process that will sustain the change. this involves building coping skills and assrtiveness 180
Control Group WHO Mental health GAP four sessions per month at baseline, 3,6, and 12 months 45 minutes The clients will be assessed as to their alcohol use and if they are dependent on alcohol they will be refered for specialist care. If they are at risk, hazardous or harmul users of alcohol, then they go for the brief intervention. 180
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The clients must be on antiretroviral treatment for three month or more male clients must score 8 or more on the WHO Alcohol Use Disorders Identification Test and females must score at 7 or above on the same screener The score on the AUDIT must be above 21 nd these individuals will be refered to specialist care they must not be on another alcohol tretment program they must not be abusing other drugs they have a psychotic disordr that they are unable to folow and participate in therapy 18 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/05/2015 MEDICAL RESEARCH COUNCIL OF ZIMBABWE
Ethics Committee Address
Street address City Postal code Country
Joasiah Tongogara, Harare HARARE Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome alcohol use identification test (AUDIT) score baseline, 3,6 and 12 months
Primary Outcome ALCOHOL USE DISORDER IDENTIFICATION TEST SCORE The outcome measure will be administered at baseline, 3, 6 and twelve months.
Secondary Outcome viral load The viral load will be measured using dried blood spot at baseline, 3,6 and twelve months
Secondary Outcome CD4 The CD4 will be measured at baseline, 3, 6 and twelve months
Secondary Outcome WHODAS 2 score this will also be measured at baseline, 3, 6 and twelve months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Harare Central Hospital southerton HARARE hg 841, harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
Professor Soraya SEEDAT Francie van Zijl Drive, Parrow, Cape Town cape town 7500 Tygerberg South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PAAIR Stellenbosch University cape town 7500 Tygerberg South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Professor Soraya SEEDAT Francie van Zijl Drive, Parrow, Cape Town cape town 7500 Tygerberg South Africa
Professor Simbarashe Rusakaniko Mazowe Street , Harare HARARE A178, Avondale Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Munyaradzi Madhombiro mmadhombiro@gmail.com +263773064519 36 east road, avondale, harare
City Postal code Country Position/Affiliation
Harare hg 841 Zimbabwe principal investigator
Role Name Email Phone Street address
Public Enquiries wendline mukombachoto drmadhombirooffice@gmail.com +263779856466 36 east road, avondale, harare
City Postal code Country Position/Affiliation
Harare hg841 Zimbabwe research assistant
Role Name Email Phone Street address
Scientific Enquiries Munyaradzi Madhombiro mmadhombiro@gmail.com +263773064519 36 East Road, Avondale
City Postal code Country Position/Affiliation
Harare Zimbabwe Principal Investigator, Univ Zimbabwe
REPORTING
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