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.: PACTR202208763577207 Date of Approval: 05/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title NITUE INTERVENTION STUDY
Official scientific title Pilot randomized controlled trial of a brief psychological intervention to address depressive symptoms and enhance adherence to ART medication in adolescents Living with HIV in Tanzania
Brief summary describing the background and objectives of the trial The study will utilize a pilot randomized trial design with a six-month follow-up to randomize 4 HIV care and treatment clinics and 60 adolescents with depression and ART adherence problems to either six sessions of new locally developed psychological intervention for depression and adherence delivered by trained nurse counselors, or to treatment as usual.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/09/2021
Actual trial start date 16/10/2021
Anticipated date of last follow up 01/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cognitive behaviral therapy Motivational interviewing and problem solving six sessions 30 to 40 minutes Nitue intervention, a locally developed intervention has a series of cognitive, behavioral, problem- solving and motivational steps.The first session of NI offers psychoeducation on depression and building of psychotherapeutic (helping relationship) between adolescent and the counselor. Session 2–4 f emphasize on reduction of depressive symptoms using mood monitoring, behavioral activation, cognitive restructuring, and problem solving. Behavioral techniques like deep breathing exercises and progressive muscle relaxation will also be practiced and given as homework for each session. Session 5 and 6 will be the application of Motivation Interviewing strategies to enhance and promote healthy behaviors and adhere to treatment regime. 30
Control Group Treatment as usual 6 Sessions 30 to 45 minutes Counsellors providing Treatment as usual will be asked to give information they normally provide during HIV and adherence counselling to an adolescent with adherence problems and suspected mental health psychological or behavioral challenges. Adherence Counselling sessions include information about living with HIV/AIDS, correct use of ART and why ART is important. Counselling is also provided when an adolescent, a caregiver, or healthcare provider report or suspect changes in behaviour or misconduct at home, clinic or school. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adolescents between 11 and 24 years, Living with HIV and knowing their status, Screen positive for depression on PHQ-A, Report non-adherence to ART within the past 4 weeks, Provide written informed consent and or parental informed consent and assent to participate Those who will be assessed to be physically or mentally unstable to participate Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 13 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 12/10/2021 Muhimbili University of Health and Allied Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Upanga Daressalaam 65001 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in depressive symptoms before the intervention, at the end of intervention, and six month after the intervention
Primary Outcome Adherence to ART medication Before the intervention, at the end of the intervention and six months after the intervention
Secondary Outcome Feasibility of the Intervention End of the intervention
Secondary Outcome Acceptability of the intervention End of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Magomeni HIV care and treatment centre Magomeni Usalama Dar es Salaam 285 United Republic of Tanzania
Tandale HIV care and Treatment Center Tandale Manzese Dar es Salaam 200 United Republic of Tanzania
Tegeta Mission HIV care and treatment Centre Tegeta kwa Ndevu Dar es Salaam 7600 United Republic of Tanzania
Bunju HIV care and treatment Centre Bunju A Dar es Salaam 2507 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Centre for Innovative Drug Development and Therapeutics Trial for Africa Zambia street Addis Ababa 9036 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre for Innovative Drug Development and Therapeutics Trial for Africa Zabia street Addis Ababa 9036 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tasiana Njau tasiana2009@live.com +255717547606 Upanga
City Postal code Country Position/Affiliation
Dar es Salaam 65001 United Republic of Tanzania Muhimbili University of Health and Allied Sciences
Role Name Email Phone Street address
Public Enquiries Tasiana Njau tasiana2009@live.com +255717547606 Upanga
City Postal code Country Position/Affiliation
Dar es Salaam 65001 United Republic of Tanzania Muhimbili University of Health and Allied Sciences
Role Name Email Phone Street address
Scientific Enquiries Abebaw Fekadu abebaw.fekadu@aau.edu.et +251118787311 Zambia Street
City Postal code Country Position/Affiliation
Addis Ababa 251 Ethiopia Addis Ababa University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes A summary of the results will be shared. IPD will be shared upon request Clinical Study Report,Informed Consent Form 12 months Request to IPD is open and the principal investigator of the study will decide to whom to share the data.
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