Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania

NCT ID: NCT02180750

Last Updated: 2014-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention: Memory Work Therapy

Residential week intervention consisting of memory box, memory book, tree of life, Active Citizen book, all activities facilitated.

Group Type EXPERIMENTAL

Memory Work Therapy

Intervention Type OTHER

Control: standard care

Usual care services.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Pediatric clinic, ART

Interventions

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Memory Work Therapy

Intervention Type OTHER

Standard care

Pediatric clinic, ART

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Aged 14-18 years
* HIV positive
* Orphaned
* Naïve to the intervention

Exclusion Criteria

* Adults
* Children under 14
* HIV negative
* Parent(s) living
* Previously attended the intervention
Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cape Town

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese

OTHER

Sponsor Role lead

Responsible Party

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Elvis Joseph Miti

Social Worker

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PASADA

Temeke, , Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type DERIVED
PMID: 30332895 (View on PubMed)

Other Identifiers

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MWT01

Identifier Type: -

Identifier Source: org_study_id

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