NCT06014671

Brief Summary

Quality of life (QOL) is a significant importance for people living with HIV/AIDS by modifying the adverse psychosocial consequences that accompany the disease. In Ethiopia, interpersonal psychotherapy (IPT) has never been tried for people living with HIV/AIDS for quality of life. The objective of the study was to assess the effects of interpersonal psychotherapy on quality of life among PLWHA at Mettu Karl referral and Bedele hospital, southwest Ethiopia, 2022.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 14, 2023

Last Update Submit

August 23, 2023

Conditions

Breif Description: Patients' Quality of Life of

Outcome Measures

Primary Outcomes (1)

  • The effect of Interpersonal Psychotherapy on quality of life among people living with HIVAIDS

    Quality of Life measured by World Health Organization Health Related Quality of Life (WHOQOL- BREF).

    two months

Study Arms (2)

Intervention group

EXPERIMENTAL

intervention group were took interpersonal psychotherapy

Behavioral: Interpersonal Psychotherapy

Control group

EXPERIMENTAL

control group didn't took interpersonal psychotherapy

Behavioral: Interpersonal Psychotherapy

Interventions

Interpersonal PsychotherapyBEHAVIORAL

Intervention Group were took interpersonal psychotherapy

Control groupIntervention group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • PLWHA who were 18 years of age or above were included in the study

You may not qualify if:

  • PLWHA who are either currently or previously used IPT and acute physical or mental disturbances will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mattu University

Addis Ababa, Oromiya, 318 (mattu), Ethiopia

Location

MeSH Terms

Interventions

Interpersonal Psychotherapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychiatry

Study Record Dates

First Submitted

August 14, 2023

First Posted

August 28, 2023

Study Start

April 1, 2022

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

August 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

researchers need information could get it

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
at any time
Access Criteria
with formal letter and justification

Locations

ET(1)