Psycho-social intervention for people with HIV

Not Applicable

• Conditions: HIV; Infections and Infestations

• Registration Number: ISRCTN47187932
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-12
• Last Update Posted: 26 August 2024
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 966

Inclusion Criteria

1. HIV positive and attending a specialist HIV clinic
2. Aged 18 years or over
3. Able to give valid informed consent for study participation
4. Willing and able to participate in the study and be available for the duration of follow-up

For randomisation only:
5. Scoring >=16 on the HIV Positive Outcomes-11 PROM (PO-11) tool

Exclusion Criteria

For RCT only:
1. Active major mental illness (i.e. psychosis or bipolar disorder or active suicidality)
2. Within the first 12 weeks of receiving a new psychotherapy intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A binary health and wellbeing measure based on the change in PO-11 score where an individual will be counted as a ‘success’ if there is a reduction of 40% or more in their score from their baseline value. This will be assessed at 6 months post-randomisation.<br>PO-11 is comprised of 11 questions, each with a 5-point Likert response scale scoring from 0 (best response) to 4 (worst response). The total score will be 0-44 where a higher score indicates a higher burden of symptoms and concerns.