HIVMWTNCT02180750
Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania
A study testing Memory Work Therapy in people with HIV, run by Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese at 1 site in Tanzania.
Trial summary
Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the intervention improves outcomes compared to standard care. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- HIV
- What is being tested?
- Memory Work Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTanzania
- Study dates
- Jun 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 14-18 years
- HIV positive
- Orphaned
- Naïve to the intervention
Who cannot join
- Adults
- Children under 14
- HIV negative
- Parent(s) living
- Previously attended the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of a Psychosocial Intervention for Orphans With HIV Infection: a Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania
Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the intervention improves outcomes compared to standard care. We aim to test the hypothesis that attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural difficulties, and self-efficacy compared to standard care.
- Conditions
- HIV
- Being tested
- Memory Work Therapy, Standard care
- Keywords
- Children, HIV, orphans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Work TherapyOther
Standard careOther
Pediatric clinic, ART
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Memory Work Therapy | Experimental | Residential week intervention consisting of memory box, memory book, tree of life, Active Citizen book, all activities facilitated. Receives: Other: Memory Work Therapy |
| Control: standard care | Active comparator | Usual care services. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change: Brief Symptom Inventory
The BSI measures psychological symptom patterns
Measured: T0( study entry), T1 (2 weeks), T2 (6 weeks)
Secondary outcomes (3)
Change: Rosenberg Self-Esteem Scale
A measure of self esteem
Measured: T0 (study entry), T1 (2 weeks), T2 (6 weeks)
Change: Goodman's strengths and difficulties questionnaire
Measures mental health in children and young people
Measured: T0 (study entry), T1 (2 weeks) T2 (6 weeks)
Change: Self-efficacy questionnaire for children
measure emotional and social self-efficacy.
Measured: T0 (study entry), T1 (2 weeks), T2 (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJun 2013
- Primary completionJul 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, King's College London
- Responsible party
- Principal investigator, Elvis Joseph Miti, Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180750
- Sponsor's protocol ID
- MWT01
- Acronym
- MWT
- Status last verified
- Jul 2014
- First submitted
- 24 Jun 2014
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Harding R, Wei G, Gwyther L, Miti E. Improving psychological outcomes for orphans living with HIV in Tanzania through a novel intervention to improve resilience: findings from a pilot RCT. AIDS Care. 2019 Mar;31(3):340-348. doi: 10.1080/09540121.2018.1533630. Epub 2018 Oct 17.
PubMed 30332895
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Psychosocial Intervention for Orphans With HIV Infection: a Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania
- ClinicalTrials.gov ID
- NCT02180750
- Acronym / sponsor ID
- MWT / MWT01
- Conditions
- HIV
- Keywords
- Children, HIV, orphans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Pastoral Activities and Service for AIDS Dar-Es-Salaam ArchdioceseUniversity, hospital or other
- Collaborators
- University of Cape Town, King's College London
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the intervention improves outcomes compared to standard care. We aim to test the hypothesis that attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural difficulties, and self-efficacy compared to standard care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Memory Work Therapy | Experimental | Other: Memory Work TherapyResidential week intervention consisting of memory box, memory book, tree of life, Active Citizen book, all activities facilitated. |
| Control: standard care | Active comparator | Other: Standard careUsual care services. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 14-18 years
- HIV positive
- Orphaned
- Naïve to the intervention
Key exclusion criteria (5 listed)
- Adults
- Children under 14
- HIV negative
- Parent(s) living
- Previously attended the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory Work Therapy | Other | Intervention: Memory Work Therapy |
| Standard carePediatric clinic, ART | Other | Control: standard care |
Primary outcome
Change: Brief Symptom Inventory
Time frame: T0( study entry), T1 (2 weeks), T2 (6 weeks)
The BSI measures psychological symptom patterns
3 secondary outcomes
Change: Rosenberg Self-Esteem Scale
Time frame: T0 (study entry), T1 (2 weeks), T2 (6 weeks)
Change: Goodman's strengths and difficulties questionnaire
Time frame: T0 (study entry), T1 (2 weeks) T2 (6 weeks)
Change: Self-efficacy questionnaire for children
Time frame: T0 (study entry), T1 (2 weeks), T2 (6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Derived from this study: PubMed 30332895Harding R, Wei G, Gwyther L, Miti E. Improving psychological outcomes for orphans living with HIV in Tanzania through a novel intervention to improve resilience: findings from a pilot RCT. AIDS Care. 2019 Mar;31(3):340-348. doi: 10.1080/09540121.2018.1533630. Epub 2018 Oct 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Work Therapy in people with HIV, run by Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change: Brief Symptom Inventory (time frame: T0( study entry), T1 (2 weeks), T2 (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2014.