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

HIV Clinical Trial

— MWT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02180750
• Other study ID #: MWT01
• Status: Active, not recruiting
• Phase: N/A
• First received: June 24, 2014
• Last updated: July 1, 2014
• Start date: June 2013
• Est. completion date: August 2014

Study information

• Verified date: July 2014
• Source: Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical Research
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Memory Work Therapy

• Standard care
Pediatric clinic, ART

Locations

Country	Name	City	State
Tanzania	PASADA	Temeke

Sponsors (3)

Lead Sponsor	Collaborator
Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese	King's College London, University of Cape Town

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change: Brief Symptom Inventory	The BSI measures psychological symptom patterns	T0( study entry), T1 (2 weeks), T2 (6 weeks)	No
Secondary	Change: Rosenberg Self-Esteem Scale	A measure of self esteem	T0 (study entry), T1 (2 weeks), T2 (6 weeks)	No
Secondary	Change: Goodman's strengths and difficulties questionnaire	Measures mental health in children and young people	T0 (study entry), T1 (2 weeks) T2 (6 weeks)	No
Secondary	Change: Self-efficacy questionnaire for children	measure emotional and social self-efficacy.	T0 (study entry), T1 (2 weeks), T2 (6 weeks)	No