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.: PACTR201405000815100 Date of Approval: 22/04/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of an alcohol-focused intervention in improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes
Official scientific title Effectiveness of an alcohol-focused intervention in improving adherence to antiretroviral therapy (ART) and HIV treatment outcomes
Brief summary describing the background and objectives of the trial Background This research is based on emerging evidence of the adverse effects of alcohol use on adherence to ART, immune function, viral suppression, and mortality. Little prior research has examined whether alcohol reduction interventions may improve ART adherence and HIV treatment outcomes; this study seeks to address this gap. Aims The broad goal is to assess the efficacy of an intervention for hazardous/harmful drinking among PLWHA who are on ART. The primary research hypothesis is that the alcohol-focused intervention will bring about a significant reduction in average volume of alcohol consumed, which will lead to significant improvements in ART adherence and HIV treatment outcomes among PLWHA. Specific aims include: (1) adapting a blended Motivational Interviewing (MI) and Problem Solving Therapy (PST) intervention to address harmful/hazardous alcohol use in HIV populations in Tshwane, South Africa; (2) evaluating the efficacy of the alcohol-reduction intervention for (a) reducing alcohol consumption; (b) improving ART adherence, (c) increasing ART continuation, and (d) improving ART treatment response (HIV disease progression); and (3) assessing intervention participants¿ subjective assessments of the alcohol-reduction intervention. Methods Design: A repeated measures randomized controlled trial will evaluate the intervention among ART patients in four public sector hospital-based HIV clinics in Tshwane, South Africa. Given the required sample of 150 patients per site, 151 eligible patients will be recruited from each clinic, and randomly assigned to alcohol (75), nutrition (38), and control (38) conditions. Follow-up assessments will be conducted at 3, 6 and 12 months post-intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AlcoholHIV
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Alcohol-focused intervention
Anticipated trial start date 03/11/2014
Actual trial start date
Anticipated date of last follow up 29/07/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 604
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
EC003-2/2104 MRC Ethics Committee
EC003-2/2104 MRC Ethics Committee
EC003-2/2104 MRC Ethics Committee
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
Open-label(Masking Not Used) Outcome Assessors
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program allocation determined by the holder of the sequence who is situated off site Masking/blinding used
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MI-PST for alcohol 4 modules over two weeks 1 hour modules (4 hours total) a blended motivational interviewig and problem solving therapy intervention 300
Control Group MI-PST for mutrition 4 modules over 2 weeks 1 hour modules ( 4 hours total) a blended motivational interviewing and problem solving therapy itervention to address general wellness and good nutrition 152 Dose Comparison
Control Group Treatment as usual about 1 contact about 1 hour advice and referral to specialsied alcohol services 152 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) are HIV-positive; (2) have taken ART for at least three months; (3) are not currently receiving treatment for TB (or latent TB infection); (4) are 18 years or older; (5) are classified as ¿harmful/hazardous drinkers¿ (AUDIT score of 8-22); (6) are resident in the Tshwane Metropolitan Municipality; 1) have substantial cognitive impairment; (2) are currently enrolled in another trial; and (3) have extremely poor general health/functional status (Karnofsky clinical score > 50). 18 Year(s) 100 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 09/04/2014 Medical Research Council of South Africa's Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Francie Van Zijl Drive Tygerberg 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reductions in the volume of alcohol consumed 3 months post-intervention 6 months post-itervention 12 months post-intervention
Secondary Outcome Reductions in AUDIT scores 3 months post-intervention 6 months post-intervention 12 months post-intervention
Secondary Outcome reductions in Ethyl Glucuronide (EtG) and Posphatidylethanol (PEth) scores 3 months post-intervention 6 months-post-intervention 12 months post-intervention
Secondary Outcome increase in Antiretroviral adherence rates 3 months post-intervention 6 months post-intervention 12 months post-intervention
Secondary Outcome reductions in HIV RNA viral loads 3 months post-intervention 6 months post-intervention 12 months post-intervention
Secondary Outcome increases in CD4 T-cell counts. 3 months post-intervention 6 months post-intervention 12 months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tshwane District Hospital DR Savage Road Pretoria 0001 South Africa
Odi district hospital Klipgat Road Mabopane 0190 South Africa
Jubilee district hospital 92 Jubilee Road Hammanskraal 0400 South Africa
Pretoria West Hospital 380 Sytze Wierda Road Phillip Nel park 0183 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Council of South Africa Francie Van Zijl Drive Tygerberg 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council of South Africa Francie Van Zijl Drive Tygerberg 7505 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof Charles Parry Francie Van Zijl Drive Tygerberg 7505 South Africa
Prof Neo Morojele Soutpansberg Road Pretoria 0001 South Africa
Prof Bronwyn Myers Francie Van Zijl Drive Tygerberg 7505 South Africa
Dr Connie Kekwaletswe Soutpansberg Road Pretoria 0001 South Africa
Prof Gita Ramjee Jan Hofmeyer Road Westville 4091 South Africa
Dr Samuel Manda Soutpansberg Road Pretoria 0001 South Africa
Dr Paul Shuper 33 Russel Street Toronto M5S 2S1 Canada
Dr Jurgen Rehm 33 Russel Street Toronto M5S 2S1 Canada
Dr Judy Hahn 50 Beale Street San Francisco 94143 United States of America
Dr Katherine Sorsdahl Anzio Road Observatory 7925 South Africa
Dr Seth Kalichman 406 Babbidge Road Storrs 06269-1020 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Charles Parry cparry@mrc.ac.za 00 27 21 938 0419 Francie Van Zijl Drive
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Director
Role Name Email Phone Street address
Principal Investigator Neo Morojele neo.morojele@mrc.ac.za 00 27 12 339 8535 Soutpansberg Road
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Deputy director
Role Name Email Phone Street address
Public Enquiries Neo Morojele neo.morojele@mrc.ac.za 00 27 12 3398535 Soutpansberg Road
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Deputy Director
Role Name Email Phone Street address
Scientific Enquiries Charles Parry cparry@mrc.ac.za 00 27 21 9387 0419 Francie Van Zijl Drive
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information