Exploring a Digital HIV Onward Disclosure Intervention, in People Living With HIV of Sub-Saharan African Ethnicity.

NCT05804968 | Unknown DMC

• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

Research has shown that people living with HIV struggle to disclose their HIV status to others, (a process known as self-disclosure or onward disclosure) due to associated challenges, including fear of discrimination from others. However, there are a range of potentially positive outcomes associated with self-disclosure, such as increased medication adherence, improved wellbeing, and greater social support. Consequently, people living with HIV should be adequately supported, if they wish to disclose. This study intends to develop and assess a digital HIV disclosure intervention, based on an existing non-digital intervention, for Sub-Saharan African adults, living with HIV and residing in the U.K. Participants will be followed pre, during and post intervention, with various measures being collected throughout, including HIV disclosure behaviour, HIV disclosure intention, HIV disclosure motivation, general wellbeing and mood. Upon follow up, participants will also be asked to complete a questionnaire regarding their personal experiences of this digital intervention. It is hypothesised that this digital HIV self disclosure intervention may lead to increases in HIV disclosure intention, amongst other secondary variables. Statistical and visual analysis will allow outcomes of this intervention to be summarised and will hopefully lead to implications and suggestions for future digital HIV disclosure interventions, supporting those living with HIV to manage the self-disclosure process effectively.

Conditions

Hiv

Keywords

HIV; Single Case Experimental Design; Self Disclosure; Onward Disclosure; Digital Intervention

Outcome Measures

Primary Outcomes (3)

• Change from baseline HIV Disclosure Intention after 11 weeks

  Measured by a single item disclosure intention question.

  Up to 11 weeks

• Acceptability of Intervention

  Measured by a participant experiences questionnaire, concerning how they found the digital HIV disclosure intervention.

  After study completion

• Feasibility of the Intervention

  Measured by recruitment and retention rates and adherence rates to the modules of the digital HIV disclosure intervention.

  Up to 11 weeks

Secondary Outcomes (5)

• Change from baseline mood after 11 weeks

  Up to 11 weeks

• Change from baseline HIV Self Disclosure Behaviour after 11 weeks

  Up to 11 weeks

• Change from baseline HIV Self Disclosure Motivation after 11 weeks

  Up to 11 weeks

• Change from baseline Mental Wellbeing after 11 weeks

  Up to 11 weeks

• Change from baseline HIV Disclosure Cognition and Affect after 11 weeks

  Up to 11 weeks

Study Arms (1)

Digital HIV self disclosure intervention

EXPERIMENTAL

This study will develop a digital HIV onward disclosure intervention, drawing from the HEADSUP manual (Evangeli et al., 2020), which consists of four modules, including a HIV disclosure planning component. Participants will be asked to be involved in this study for 11 weeks, consisting of three weeks baseline, four weeks intervention and four weeks follow up. A single case experimental design will be used to explore HIV disclosure intention, HIV disclosure behaviour, HIV disclosure motivation, general wellbeing and mood via daily and weekly measures throughout baseline, intervention and follow up phases. All these measures will be completed online via a secure qualtrics network. Participants will further be asked to complete a participant experiences questionnaire to explore how they found this digital intervention. This project will recruit a diverse sample of Sub-Saharan Africa adults living with HIV and residing in the U.K.

Other: Digital HIV Self Disclosure Intervention

Interventions

Digital HIV Self Disclosure Intervention OTHER

This project will develop a digital HIV disclosure intervention, drawing from the HEADSUP manual (Evangeli et al., 2020), which consists of four modules, including a HIV disclosure planning component. A SCED will be used to explore HIV disclosure intention, amongst other variables throughout baseline, intervention and follow up phases. Participants will further be asked to complete a participant experiences questionnaire to explore how they found the digital intervention and assess acceptability. This project will recruit a diverse sample of Sub-Saharan Africa adults living with HIV and residing in the U.K.

Digital HIV self disclosure intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as HIV positive.
• Be an adult between the ages of 18 and 65 years old.
• Identify ethnically as sub-Saharan African.
• Have a good level of spoken and written English to ensure full engagement with the digital HIV disclosure intervention.
• Have access to a smart phone or laptop to complete the digital intervention and the associated measures.

You may not qualify if:

• Evidence of significant imminent risk of harm to self, or others, as identified from other professionals and clinical notes.
• Evidence of acute and very severe mental distress, as identified from other professionals.
• Significant ongoing safeguarding issues, as identified in participants' clinical notes or by the participant themselves.
• Have previously participated in the HEADS-UP HIV disclosure intervention trial.

Sponsors & Collaborators

• Royal Holloway University: lead
• Barts & The London NHS Trust: collaborator
• Chelsea and Westminster NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Megan Westhead, MSc

  Royal Holloway University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Westhead, MSc

CONTACT

07894435383; megan.westhead.2021@live.rhul.ac.uk

Michael Evangeli, Professor

CONTACT

+44 1784 276339; michael.evangeli@rhul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Model Details: Single Case Experimental Design

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: April 7, 2023
• Study Start: July 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share