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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306731421427 Date of Registration: 05/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Behavioural Activation for Antiretroviral Therapy Adherence (BAATA)
Official scientific title A cluster randomized pilot study on improving adherence to antiretroviral therapy (ART) in young adults with problematic/hazardous alcohol/substance use in Zimbabwe
Brief summary describing the background and objectives of the trial Although young people constitute 36%) of all new HIV infections, poor adherence to antiretroviral therapy (ART) has been an impediment to achieving virological control and alcohol and substance use is contributory to this in many settings. Psychological or behavioural interventions to address problematic alcohol and substance use have been shown to consequently improve adherence to ART in several studies across the globe. Behavioural Activation has been shown to work elsewhere, but not been adapted to the Zimbabwean setting. The objectives of the study are to: adapt the Behavioural Activation Therapy intervention to the Zimbabwean context and to determine the effect of point of care behavioral interventions: Behavioral activation and blended Motivational Interviewing-Cognitive Behavioral Therapy on adherence to ART in young adults with problematic/hazardous alcohol/substance in Zimbabwe
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BAATA
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychological intervention to improve adherence to antiretroviral therapy ART
Anticipated trial start date 16/08/2021
Actual trial start date 07/10/2022
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the 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 BEHAVIOURAL ACTIVATION BASELINE AND BOOSTER SESSION AT THREE MONTHS POST ENROLMENT 6 MONTHS PER PARTICIPANT Behavioral activation is a structured, brief psychotherapeutic approach that aims to: increase engagement in adaptive activities (which often are those associated with the experience of pleasure or mastery; decrease engagement in activities that maintain depression or increase risk for depression and solve problems that limit access to reward or that maintain or increase aversive control. 33
Control Group BLENDED MOTIVATIONAL INTERVIEWING AND COGNITIVE BAHAVIOURAL THERAPY baseline and a booster 3 months after enrolment 6 months per participant Motivational Interviewing: motivated through counselling that emphasizes empathic listening, avoiding arguments, rolling with resistance, and self-efficacy Cognitive behavioural Therapy: : a psychotherapy basing its treatment on the understanding that certain behaviors are the result of faulty thinking, therefore if this is addressed, the behaviors such as substance use, can be modified. 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
HIV infected male and female participants; aged 18-24 years; documentation of HIV infection from local standard of care; HIV viral load >200 copies/ml; Problematic use of alcohol/substance or risk of alcohol/substance use shown by an Alcohol Use Disorders Identification Test (AUDIT) score of at least 6 for female participants and at least 7 for male participants or a Drug Use Disorders Identification Test (DUDIT) score of 2 or more for female participants and 6 or more for male participants; Current poor adherence to ART as noted by the HIV/ART care provider and measured by pill count; Able and willing to give informed consent Age less than 18 years of greater than 24 years; Unable or unwilling to give informed consent; Viral load <200 copies/ml; No history of alcohol or substance use Adult: 18 Year(s)-44 Year(s) 18 Year(s) 24 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 15/09/2021 Medical Research Council of Zimbabwe
Ethics Committee Address
Street address City Postal code Country
20 Cambridge Road, Avondale Harare 00000 Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Viral load suppression as defined by viral load<20 copies/ml measured at 24 weeks after initiation of the behavioral intervention. Tenofovir drug levels in hair samples demonstrating adherence to ART. 24 weeks after enrolment
Secondary Outcome Score demonstrating the reduction in substance use eg reduction in Alcohol Use Disorders Identification Test (AUDIT) /Drug use disorders identification test (DUDIT) score. 24 weeks after enrolment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Milton Park CRS 31 Lawson Avenue, Milton Park Harare 00000 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
US National Institutes of health Bethsda Maryland United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NIH BETHSDA MARYLAND United States of America Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Pamela Mukwekwerere marimbe.pamela4@gmail.com +263772951820 31 Lawson Avenue, Milton Park
City Postal code Country Position/Affiliation
Harare 00000 Zimbabwe Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Munyaradzi Madhombiro madhombirom@staff.msu.ac.zw +263773064519 20 Bath Road, Avondale
City Postal code Country Position/Affiliation
Harare Zimbabwe Midlands State University
Role Name Email Phone Street address
Public Enquiries Pamela Mukwekwerere marimbe.pamela4@gmail.com +263772951820 31 Lawson Avenue, Milton Park
City Postal code Country Position/Affiliation
Harare 00000 Zimbabwe University of Zimbabwe Clinical Trials Research Centre
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data after deidentification that was collected during the trial will be shared through publication of results. Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately following publication proposals should be directed to the principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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