HIV PositivePLHIVNCT06869330
Implementation and Effectiveness of a Psychosocial Intervention Among Registered People Living With HIV(HIV Patients) at Pakistan Institute of Medical Sciences (PIMS) Islamabad Pakistan.
A study testing psychosocial in people with HIV Positive, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Positive
- What is being tested?
- psychosocial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Mar 2025to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Institute of Medical Sciences Islamabad Pakistan
Islamabad, 44000
About this study
Official title: 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:
- Participants: Registered PLHIV receiving care at PIMS.
- Data Tools: Standardized measures (e.g., DASS-21, WHO-5 Well-Being Index).
- Design: Randomized Control Trial (RCT) with intervention and control groups, including pre- and post-intervention assessments.
- Ethical Approval: Approved by Pakistan Institute of Medical Sciences Pakistan Islamabad's Ethical Review Board
Read the 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:
- Participants: Registered PLHIV receiving care at PIMS.
- Data Tools: Standardized measures (e.g., DASS-21, WHO-5 Well-Being Index).
- Design: Randomized Control Trial (RCT) with intervention and control groups, including pre- and post-intervention assessments.
- Ethical Approval: Approved by Pakistan Institute of Medical Sciences Pakistan Islamabad's Ethical Review Board
- Conditions
- HIV Positive
- Being tested
- psychosocial
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocialBehavioural
Measure changes in mental health indicators like depression, anxiety, and stress levels using validated scales (e.g. DASS 21).
| Study group | Role | What they receive |
|---|---|---|
| "Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Isla | Experimental | Not described Receives: Behavioral: psychosocial |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: 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.
Measured: From enrollment to the end of intervention at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start14 Mar 2025
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Israr khan, Pakistan Institute of Medical Sciences
- Investigators
- Dr Shahzad Ali khan, phd, Study director, Health Services Academy, Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869330
- Sponsor's protocol ID
- F-5-2/2024(ERRC)/PIMS
- Acronym
- PLHIV
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: PARTICIPANT DATA IS CONFIDENTIAL
Publications
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.
PubMed 34265501
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at Pakistan Institute of Medical Sciences (PIMS) Islamabad Pakistan.
- ClinicalTrials.gov ID
- NCT06869330
- Acronym / sponsor ID
- PLHIV / F-5-2/2024(ERRC)/PIMS
- Conditions
- HIV Positive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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:
- Participants: Registered PLHIV receiving care at PIMS.
- Data Tools: Standardized measures (e.g., DASS-21, WHO-5 Well-Being Index).
- Design: Randomized Control Trial (RCT) with intervention and control groups, including pre- and post-intervention assessments.
- 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:
- Participants: Registered PLHIV receiving care at PIMS.
- Data Tools: Standardized measures (e.g., DASS-21, WHO-5 Well-Being Index).
- Design: Randomized Control Trial (RCT) with intervention and control groups, including pre- and post-intervention assessments.
- Ethical Approval: Approved by Pakistan Institute of Medical Sciences Pakistan Islamabad's Ethical Review Board
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Isla | Experimental | Behavioral: psychosocial |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychosocialMeasure changes in mental health indicators like depression, anxiety, and stress levels using validated scales (e.g. DASS 21). | Behavioural | "Implementation and Effectiveness of a Psychosocial Intervention Among Registered PLHIV at PIMS Isla |
Primary outcome
"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.
"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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Background: PubMed 34265501Arundell 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. PARTICIPANT DATA IS CONFIDENTIAL
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Shahzad Ali khan, phd study director
Health Services Academy, Islamabad, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychosocial in people with HIV Positive, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.