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Clinical Trials/NCT06869330
NCT06869330CompletedNot Applicable

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

Pakistan Institute of Medical Sciences2 sites in 1 country128 target enrollmentStarted: March 14, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
128
Locations
2
Primary Endpoint
"Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Islamabad Pakistan

Study Overview

Brief Summary

"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

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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).

Outcomes

Primary Outcomes

"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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Dr Israr khan

Principal Investigator

Pakistan Institute of Medical Sciences

Study Sites (2)

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