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.: PACTR201511001150307 Date of Approval: 27/05/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title TENDAI STUDY: Treatment to reduce depression and improve adherence to anti-retroviral therapy in Harare, Zimbabwe
Official scientific title Treatment to reduce depression and improve adherence to anti-retroviral therapy in Harare, Zimbabwe
Brief summary describing the background and objectives of the trial The TENDAI Study has two phases. Phase One (formative phase), to finalize an integrated intervention to treat depression and improve adherence to antiretroviral therapy in people living with HIV in Zimbabwe attending an antiretroviral therapy prescribing facility. To do this we will carry out qualitative testing to develop more understanding of our intervention, of the best method of delivering it, and of its possible effects. 2. Phase Two (pilot trial): To carry out an exploratory trial to test the effect of the integrated depression-adherence intervention on antiretroviral adherence, CD4 lymphocyte count, and depression. The main aims of the exploratory trial are: a) to test the feasibility of recruiting and randomising people living with HIV (PLWH) with co-morbid depression into an RCT of the depression-adherence intervention; b) to monitor the delivery of the intervention using audio recording of 10% of sessions for each practitioner; c) to test ways of following up and minimizing drop out at 3 and 6 months; d) to determine a comparison arm for a future main trial; and e) to gather data to allow estimates to be made of the effect of the intervention to inform the sample required for a main trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TENDAI
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 02/06/2014
Actual trial start date 25/06/2014
Anticipated date of last follow up 30/06/2015
Actual Last follow-up date 27/07/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 42
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
MRCZ/1736 Medical Research Council of Zimbabwe
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 randomisation using number cards Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group LifeSteps and Problem Solving Therapy 5 sessions 6 weeks 22 Active-Treatment of Control Group
Control Group Standard care - adherence counselling 1 or 2 monthly sessions 1 or 2 months Participants receive standard adherence counselling as routinely provided by the clinic. This involves an individual session with an adherence counsellor who emphasises the importance of taking ART medication and gives advice on related issues such as nutrition and safe sex. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Aged 18 or above 2. On ART for at least 4 months as confirmed by pharmacy records 3. Score ¿ 10 OR meet criteria for a diagnosis of depression on the 9 item Patient Health Questionnaire (PHQ-9) OR Score ¿ 9 on the Shona Symptom Questionnaire (SSQ-14) 4. Screen positive for recent non-adherence, as detected by any of the following methods: i) Self Report Adherence Questionnaire ii) Missed one HIV clinic appointment in the previous 6 months iii) Falling CD4 count (CD4 below 350 that has fallen by at least 50 in the past 6 months) iv) Detectable viral loads 1. Score ¿6 on the International HIV Dementia Scale (IHDS) 2. Score of 3 or higher for women and a score of 4 or higher for men on the short AUDIT-C screen for alcohol dependance 3. On medication for tuberculosis 4.Have suicidal intent as determined by the P4 Suicidality Screener 5. Interviewer assesses person too unwell and/ agitated to take part 18 Year(s) 70 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 05/03/2014 Medical Research Council
Ethics Committee Address
Street address City Postal code Country
P.O Box CY573 Causeway Harare Zimbabwe
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 29/08/2014 King's College London Research Ethics Committee (Psychiatry, Nursing & Midwifery Subcommittee)
Ethics Committee Address
Street address City Postal code Country
5.12 Franklin Wilkins Building, Waterloo Bridge Wing, Waterloo Road London SE1 9NH United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depression Score Session 3 and Session 6 of intervention; 3 month follow up
Primary Outcome Wisepill Adherence Percentage 2 weeks after recruitment (baseline measure); 3 months follow up
Secondary Outcome Viral Load Baseline (Viral load at recruitment); 3 month follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Parirenyatwa OI Clinic Mazoe Street Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute of Mental Health 6001 Executive Boulevard Rockville MD 20852 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor UZ-CHS NECTAR Ward C10, C-Floor, Parirenyatwa Hospital Complex Harare (none) Zimbabwe University
Primary Sponsor King's College London Strand London WC2R 2LS United Kingdom University
Secondary Sponsor UZ-CHS NECTAR University
COLLABORATORS
Name Street address City Postal code Country
Dr Steve Safren Behavioral Medicine Service One Bowdoin Square 7th Floor Boston MA 02114-2927 United States of America
Dr Dixon Chibanda UZ-CHS, Department of Psychiatry, Mazowe Street, Old Building, C Floor, Avondale Harare P.O. Box A 178 Zimbabwe
Dr Melanie Abas David Goldberg Building, IoPPN, De Crespigny Park London SE5 8AF United Kingdom
Dr Alfred Chingono UZ-CHS, Department of Psychiatry, Mazowe Street, Old Building, C Floor, Avondale Harare P.O. Box A 178 Zimbabwe
Prof Conall O'Cleirigh Behavioral Medicine Service One Bowdoin Square 7th Floor Boston MA 02114-2927 United States of America
Prof Ricardo Araya London School of Hygiene & Tropical Medicine, Keppel Street London WC1E 7HT United Kingdom
Prof Michael Dewey David Goldberg Building, IoPPN, De Crespigny Park London SE5 8AF United Kingdom
Prof John Joska UCT Faculty of Health Sciences, Barnard Fuller Building, Anzio Road, Observatory Cape Town South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Melanie Abas melanie.abas@kcl.ac.uk +442078480316 David Goldberg Building, IoPPN, De Crespigny Park
City Postal code Country Position/Affiliation
London SE5 8AF United Kingdom Reader in Global Mental Health (King's College London)
Role Name Email Phone Street address
Public Enquiries Melanie Abas melanie.abas@kcl.ac.uk +442078480316 David Goldberg Building, IoPPN, De Crespigny Park
City Postal code Country Position/Affiliation
London SE5 8AF United Kingdom Reader in Global Mental Health (King's College London)
Role Name Email Phone Street address
Scientific Enquiries Melanie Abas melanie.abas@kcl.ac.uk +442078480316 David Goldberg Building, IoPPN, De Crespigny Park
City Postal code Country Position/Affiliation
London SE5 8AF United Kingdom Reader in Global Mental Health (King's College London)
REPORTING
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