NCT06969690

Brief Summary

Question-order effect experiment to measure HIV-related stigma among people living with HIV (PWH).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable hiv

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

Study Start

First participant enrolled

November 2, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

May 5, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

HIV stigmadiscrimination

Outcome Measures

Primary Outcomes (3)

  • Self-esteem

    ...do you think less of yourself because of your HIV status? (single item)

    Baseline (assessed at the time the survey is administered)

  • Self-respect

    ...have you felt ashamed because of your HIV status? (single item)

    Baseline (assessed at the time the survey is administered)

  • Experiences of harassment due to HV status

    * have you lost respect or standing in the community because of your HIV status? * have people talked badly about you because of your HIV status? * have you been verbally insulted, harassed and/or threatened because of your HIV status? * have you been physically assaulted because of your HIV status? * has someone else disclosed your HIV status without your permission? * have you felt that people have not wanted to sit next to you, for example on public transport, at church or in the waiting room, because of your HIV status? (six items)

    Baseline (assessed at the time the survey is administered)

Study Arms (2)

V1

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The first treatment is a questionnaire with questions about internalized stigma followed by questions of experienced stigma. Each question is answered as Yes/No/It depends on knowing more details.

Other: Survey questionnaire V1

V2

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The second treatment is a questionnaire with questions about experienced stigma followed by questions about internalized stigma. Each question is answered as Yes/No/It depends on knowing more details.

Other: Survey questionnaire V2

Interventions

Each version of the questionnaire includes a different order of statements about which study participants are asked to provide a Yes, No, or It depends response.

V1

Each version of the questionnaire includes a different order of statements about which study participants are asked to provide a Yes, No, or It depends response.

V2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- All HIV-positive (self-reported) adults who consider Nyakabare their primary place of residence and who are capable of providing consent

You may not qualify if:

  • Minors younger than 18 years of age, with the exception of emancipated minors
  • Persons who do not consider Nyakabare Parish their primary place of residence, e.g. persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside of the parish
  • Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
  • Persons who are not HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Study Officials

  • Alexander C Tsai, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 14, 2025

Study Start

November 2, 2023

Primary Completion

January 6, 2025

Study Completion

January 6, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations