NCT06869330

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

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 Mar 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 14, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
Last Updated

July 2, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 4, 2025

Last Update Submit

June 27, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • "Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Islamabad Pakistan

    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

    : 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.

Study Arms (1)

"Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Isla

EXPERIMENTAL
Behavioral: psychosocial

Interventions

psychosocialBEHAVIORAL

Measure changes in mental health indicators like depression, anxiety, and stress levels using validated scales (e.g. DASS 21).

"Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Isla

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsTransgender
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • :PLHIV who are registered at HIV Treatment Centre at PIMS Islamabad.
  • :PLHIV who are registered and visiting for regular follow up
  • :Participants willing to provide written informed consent.(Acceptance or willing of participants)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Institute of Medical Sciences Islamabad Pakistan

Islamabad, 44000, Pakistan

Location

Related Publications (1)

  • Arundell LL, Barnett P, Buckman JEJ, Saunders R, Pilling S. The effectiveness of adapted psychological interventions for people from ethnic minority groups: A systematic review and conceptual typology. Clin Psychol Rev. 2021 Aug;88:102063. doi: 10.1016/j.cpr.2021.102063. Epub 2021 Jul 7.

    PMID: 34265501BACKGROUND

Related Links

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Dr Shahzad Ali khan, phd

    Health Services Academy, Islamabad, Pakistan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 11, 2025

Study Start

March 14, 2025

Primary Completion

June 27, 2025

Study Completion

June 27, 2025

Last Updated

July 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

PARTICIPANT DATA IS CONFIDENTIAL

Locations