Implementation and Effectiveness of a Psychosocial Intervention Among Registered People Living With HIV(HIV Patients) at Pakistan Institute of Medical Sciences (PIMS) Islamabad Pakistan. (PLHIV)

June 27, 2025 updated by: Dr Israr khan, Pakistan Institute of Medical Sciences

Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at Pakistan Institute of Medical Sciences (PIMS) Islamabad Pakistan.

"Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Islamabad Pakistan." The study aims to evaluate the impact of a structured psychosocial intervention on the mental health and well-being of people living with HIV (PLHIV) registered at PIMS.

Study Highlights:

  1. Participants: Registered PLHIV receiving care at PIMS.
  2. Data Tools: Standardized measures (e.g., DASS-21, WHO-5 Well-Being Index).
  3. Design: Randomized Control Trial (RCT) with intervention and control groups, including pre- and post-intervention assessments.
  4. Ethical Approval: Approved by Pakistan Institute of Medical Sciences Pakistan Islamabad's Ethical Review Board

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

"Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Islamabad Pakistan" The study aims to evaluate the impact of a structured psychosocial intervention on the mental health and well-being of people living with HIV (PLHIV) registered at PIMS.

Study Highlights:

  1. Participants: Registered PLHIV receiving care at PIMS.
  2. Data Tools: Standardized measures (e.g., DASS-21, WHO-5 Well-Being Index).
  3. Design: Randomized Control Trial (RCT) with intervention and control groups, including pre- and post-intervention assessments.
  4. Ethical Approval: Approved by Pakistan Institute of Medical Sciences Pakistan Islamabad's Ethical Review Board

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Pakistan Institute of Medical Sciences Islamabad Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:•

1:PLHIV who are registered at HIV Treatment Centre at PIMS Islamabad.

  • 2:PLHIV who are registered and visiting for regular follow up
  • 3:Participants willing to provide written informed consent.(Acceptance or willing of participants)

Exclusion Criteria:

  • 1:PLHIV who are registered, but with other co morbidities like TB, Hepatitis BC, Cardiac issues etc.
  • 2:PLHIV who are registered and admitted due to severe any co morbidities.
  • 3:PLHIV who are registered and are already involved in other studies
  • 4:PLHIV who are registered and have history of receiving any psychosocial support or counseling before this study.
  • 5:Participants not willing to provide written informed consent.(Refusal of participants).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Isla
Behavioral: psychosocial
Measure changes in mental health indicators like depression, anxiety, and stress levels using validated scales (e.g. DASS 21).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Islamabad Pakistan
Time Frame: From enrollment to the end of intervention at 6 months.
Measure changes in mental health indicators like depression, anxiety, and stress levels using validated scale (Depression, Anxiety and Stress scale 21). Minimum value is 0 and Maximum value is 3.Higher scores means a worse outcome.
From enrollment to the end of intervention at 6 months.
"Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Islamabad Pakistan
Time Frame: From enrollment to the end of intervention at 6 months.
: Assess overall wellbeing using validated scale(WHO-5 Well-Being Index.).Minimum value is 0 and maximum value is 5.Higher scores means a better outcome.
From enrollment to the end of intervention at 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Medical Sciences

Investigators

  • Study Director: Dr Shahzad Ali khan, phd, Health Services Academy, Islamabad, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2025

Primary Completion (Actual)

June 27, 2025

Study Completion (Actual)

June 27, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-5-2/2024(ERRC)/PIMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

PARTICIPANT DATA IS CONFIDENTIAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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