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.: PACTR202212796722256 Date of Approval: 12/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Thusa Thuso
Official scientific title Building the capacity of lay health counsellors to improve ART uptake among high CD4 patients under the “treat all” policy in South Africa.
Brief summary describing the background and objectives of the trial The success of test-and-treat depends on early testing and treatment as well as maintaining lifelong treatment. Attrition after a positive HIV test, a form of silent refusal of HIV care, is estimated at nearly 70%. An estimated 20% of patients who were eligible under the CD4<200 eligibility threshold refused ART. More recently, in the ANRS 12249 study in rural South Africa, 67% of patients in the “treat all” randomization arm who were not previously in HIV care, did not initiate ART after diagnosis.In South Africa, lay HIV counsellors are the first to introduce ART to newly diagnosed patients. However, most are undertrained with little professional supervision and emotional support and a well-designed training and support program with a focus on MI counselling skills development and maintenance is needed to increase lay counsellors’ capacity to improve ART acceptance and patient retention. Furthermore, grounding MI in the social context and culturally adapting MI therapy is necessary to enhance patient response. Such a training and support program should be tailored to address counselling and ART uptake and retention challenges specific to the South African context. We applied the Intervention Mapping process to develop a contextually adapted MI training and support program tailored to improve lay HIV counsellors’ capacity to deliver MI based ART demand creation focused counselling at primary care settings in the South African context. Aim one: To Pre-test the MI counselling training and support intervention for lay health counsellors with district and facility managers in the Gauteng province of South Africa. This will be done to make final amendments before production of training manual and supporting implementation tools. Aim two: Aim 2: Conduct a two-phase cluster-randomized controlled trial to assess: a. The impact of the training and support program on the MI capacity of lay HIV counsellors. b. The impact of MI trained lay HIV counsellors on early ART acceptance and 12 months retention post ART initiation by HIV positive patient diagnosed under the test and treat guidelines in Gauteng province, South Africa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2018
Actual trial start date
Anticipated date of last follow up 30/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 616
Actual target sample size (number of participants) 609
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
DRC ref 2018 12 006 Johannesburg Health District Research Committee
M170579 Human Research Ethics Committee of the University of the Witwatersrand
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 a randomization table created by a computer software program 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 Motivational Interviewing Training and support Programme for Lay Counsellors The lay counsellor training and support program: 10 days baseline training followed with three (two-days) quarterly refresher training and debriefing sessions focused on building lay counsellors capacity to use brief MI to increase patients demand for ART and retention in HIV care. Baseline: 10 days Quarter two: Two days Quarter three: Two days Quarter four: Two days All consenting counsellors will complete: • A baseline survey (pre-training) using a structured questionnaire. • An exit structured interview to assess the impact of the support program on MI competency and overall psychosocial wellbeing after participating in the support program. We created an intervention planning group consisting of HIV researchers, HIV prevention and treatment program implementers, seasoned psychologists and HIV counsellors. We applied the Intervention Mapping process to develop a contextually adapted MI training and support program to strengthen general counselling skill, build MI skills and improve the psychosocial wellbeing of lay HIV counsellors in South Africa. Specifically, this context-specific intervention has been tailored to improve lay HIV counsellors’ capacity to deliver MI based ART demand creation focused counselling at primary care settings in the South African context. We identified critical counselling skills gaps and adapted the Boston University Brief Negotiated Interview (BNI) MI training model. Adaptations include adjusting the readability level of English training materials; translating materials to spoken Zulu and Sotho to ensure understanding; anchoring the training around interactive sessions to build MI self-efficacy; using visual modelling by local trainers, locally produced videos with contextually relevant scenarios; role plays and on-site (clinic) practice time with feedback sessions using Motivational Interviewing Treatment Integrity (MITI) rated practice sessions. The baseline training will last 10 days in total, including 3 days on-site practice time. Additionally, quarterly follow-up support sessions (two days/quarter) will include debriefing sessions with a trained therapist, feedback on MITI rated recorded sessions to reinforce learned concepts and skills. 25
Experimental Group Motivational Interviewing counselling by trained and supported counsellors 15 to 30 minutes post-HIV test counselling Quarter two: 15 minutes follow-up telephonic counselling Quarter three: 15 minutes follow-up telephonic counselling Quarter four: 15 minutes follow-up telephonic counselling 15 to 30 minutes post-HIV test counselling Quarter two: 15 minutes follow-up telephonic counselling Quarter three: 15 minutes follow-up telephonic counselling Quarter four: 15 minutes follow-up telephonic counselling participants from the MI intervention sites will receive three MI counselling sessions focused on assisting patients to work through barriers to ART initiation and adherence, identify potential treatment adherence enablers and create a plan of action to maximise their use : • A post-test face-to-face MI counselling using the developed MI implementation tools, • Telephonic follow-up MI sessions at three, six and nine months after the date of HIV diagnosis, irrespective of whether the patient has initiated ART or not. 293
Control Group Standard lay counsellor support Control interventions will not receive any training but regularly interact with study team in the study implementation phase Interaction with study team will occur during patient enrolment and follow-up data collection All consenting counsellors will complete: • A baseline survey (pre-training) using a structured questionnaire. • An exit structured interview to assess the impact of the support program on MI competency and overall psychosocial wellbeing after participating in the support program. Control interventions will not receive any training but regularly interact with study team in the study implementation phase 30 Placebo
Control Group Patient control group Participants from the control clinic site will receive the standard post-test counselling. Participants from the control clinic site will receive the standard post-test counselling. Participants from the control clinic site will receive the standard post-test counselling. 261 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for patient participants: • ≥18 years old • Diagnosed as HIV positive • Able to provide consent • ART naive • Not pregnant at HIV test Exclusion criteria for patient participants : • <18 years old • HIV negative • Pregnant at HIV test • Previously on ART • Unable/ unwilling to provide informed consent • Plan to engage in HIV care and treatment services elsewhere 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 26/05/2017 Human Research Ethics Committee of the University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Phillip Tobias Building, 3rd Floor, Office 302, Corner York Road and Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
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 23/03/2018 Johannesburg District Research Committee
Ethics Committee Address
Street address City Postal code Country
Hillbrow CHC administrative building, Cnr Smith and Klein Streets Johannesburg 2017 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome MI Competency Audio-recording will be assessed for fidelity to the MI process using the Motivational Interviewing Treatment Integrity (MITI) coding system. MITI has two components: (1) global scores are assigned on a five-point Linkert scale to characterize an entire interaction: cultivating change talks (CCT), softening sustain talk (SST), empathy (EM) and partnership (PA) (2) behaviour counts that require that assessors tally instances of particular counsellor behaviours such as complex reflections (CR), simple reflections (SR), affirmations and emphasizing client autonomy Each counsellor will be rated by two independent assessors. The ratings for each session/participant will be averaged to determine the final values. Overall, MI adherence scores for each user were determined using the MITI formula. We will compare the mean scores for each MI adherent measure for each timeline pair, using paired t-tests to assess changes to MI proficiency. An overall assessment will be conducted using q1 and q4 data to assess mean differences across time points. MITI formula Technical Global (Technical) - (Cultivating Change Talk + Softening Sustain Talk)/2 Relational Global (Relational) - (Partnership + Empathy)/2 Baseline, quarter 1, quarter 2, quarter 3, quarter 4
Primary Outcome ART initiation by key endpoints: 3, 6, 9 and 12 months post HIV diagnosis. An analysis of covariance (ANCOVA) will be conducted to determine the intervention effect on the timing of ART initiation while controlling for baseline covariates. Months 3, 6, 9 and 12 months post HIV diagnosis
Secondary Outcome Patients becoming lost to follow-up (LTFU) during the observation period will be defined as being late for a scheduled visit by 90 days or longer. We will compare the intervention effect on LTFU using Cox proportional regression. 12- months post HIV diagnosis
Secondary Outcome Psychological wellbeing Psychological wellbeing will be measured using a 9-item questionnaire indicating the overall degree of agreement with questions relating to different psychological components. Higher scores specify higher levels of psychological wellbeing. Overall mean scores will be categorized into low (score ≤2), medium (score ≤4) or high (score >4) psychological wellbeing. Baseline, 3, 9 and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
OR Tambo 383 Main Road, Diepsloot West, Diepsloot, 2189 Johannesburg South Africa
Crosby clinic 82 Foyle Ave, Crosby, Johannesburg, 2092 Johannesburg South Africa
Parkhurst Clinic Cnr 5th Avenue and 14th Street, Parkhurst, Randburg, 2193 Johannesburg South Africa
Bophelong Clinic Erf 3699 and 3700 Freedom Dr, Ivory Park X6, Johannesburg, 1689 Johannesburg South Africa
Midrand West Clinic 57 Seventh Rd, Halfway Gardens, Midrand, 1686 Johannesburg South Africa
Claremont Clinic 91 Princess Rd, Claremont, Randburg, 2092 Johannesburg South Africa
Mpumelelo Clinic 13985 Nkosi St, Ivory Park, Midrand, 1693 Johannesburg South Africa
Bosmont Clinic Albertina Sisulu Rd, Bosmont, Johannesburg, 2093 Johannesburg South Africa
Ebony Kaalfontein clinic 3855 Prichard Street, Ebony Park Johannesburg South Africa
Rabie Ridge Clinic Korhaan Cres, Rabie Ridge, Johannesburg, 1687 Johannesburg South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
United States Agency for International Development 100 Totius St, Groenkloof Pretoria 0027 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wits Health Consortium 31 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa Non Profit Research Organisation
COLLABORATORS
Name Street address City Postal code Country
Prof Robert Ruiter Section Applied Social Psychology, Work and Social Psychology, Faculty of Psychology and Neuroscience, Maastricht University Maastricht Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dorina Onoya donoya@heroza.org +27785065190 39 Empire Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg South Africa Health Economics and Epidemiology Research Office
Role Name Email Phone Street address
Scientific Enquiries Idah Mokhele imokhele@heroza.org +27100600028 39 Empire Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg South Africa Senior Researcher
Role Name Email Phone Street address
Public Enquiries Thembeka Sineke tsineke@heroza.org +27100017930 39 Empire Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg South Africa Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Resource Sharing Plan All quantitative data created for this project will be publicly posted in de-identified format, as an addendum to papers written. Qualitative data are more difficult to de-identify, but transcripts will be made available by the PIs by request and if IRB-approved. Methods to develop the intervention and to evaluate it will be documented and published for transparency and to enable replication of the approach. The Thusa-Thuso facilitator’s manual and training tools itself will be made available to stakeholders in the South African Department of Health for feedback and review. We will make the intervention publicly available, once its impact is established, and we will specifically liaise with the South African government and non-governmental organizations to assess opportunities for wider dissemination. Clinical Study Report,Informed Consent Form,Study Protocol We anticipate participant data collection will be completed in June 2022, Therefore data will be accessible from January 2024 for 24 months. The datasets generated during and/or analyzed during the current study will be availed on reasonable request.
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