NCT06969677

Brief Summary

Randomized trial to measure the effect of personalized normative feedback about local HIV testing rates and local rates of HIV-related stigma on self-reported HIV testing intentions and perceptions about others' HIV testing intentions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

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

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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 testingHIV stigma

Outcome Measures

Primary Outcomes (1)

  • Self-reported HIV testing intention in the next 12 months

    Regarding yourself, how likely are you to go get tested for HIV in the next 12 months? (single item)

    Baseline (assessed at the time the survey is administered)

Secondary Outcomes (2)

  • Self-reported perception of HIV testing among men in one's village

    Baseline (assessed at the time the survey is administered)

  • Self-reported perception of HIV testing among women in one's village

    Baseline (assessed at the time the survey is administered)

Study Arms (4)

V1: Control Group

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific prompts. The first prompt states the participant's perceived estimate (elicited previously during the survey) of HIV testing rates among single and married people in their village. No other norms-based information is provided. Participants are then asked to report their likelihood of getting tested for HIV in the next 12 months, ranging from 1= I will definitely get tested to 5= I will definitely not get tested. Next they are asked to estimate the rate of HIV testing in the next 12 months among men and women in their village, ranging from 1 = All or almost all, at least 90% of group to 5= Very few, or no one, for example, less than 10% of group.

Other: Survey questionnaire

V2: PNF - Descriptive norms only

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The second treatment is a survey-based questionnaire with a prompt stating the participant's perceived estimate (elicited previously during the survey) of HIV testing rates among single and married people in their village. Participants are then provided with the true rates of HIV testing among men and women in their village, along with information that these rate are consistent across demographic groups. Participants are then asked to report their likelihood of getting tested for HIV in the next 12 months, ranging from 1= I will definitely get tested to 5= I will definitely not get tested. Next they are asked to estimate the rates of HIV testing in the next 12 months among men and women in their village, ranging from 1 = All or almost all, at least 90% of group to 5= Very few, or no one, for example, less than 10% of group.

Other: Survey questionnaire

V3: PNF - Injunctive norms only

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The third treatment is a survey-based questionnaire with a prompt stating the participant's perceived estimate (elicited previously during the survey) of HIV testing rates among single and married people in their village. Participants are then provided with information about the true rates of HIV stigma in their village. Participants are then asked to report their likelihood of getting tested for HIV in the next 12 months, ranging from 1= I will definitely get tested to 5= I will definitely not get tested. Next they are asked to estimate the rate of HIV testing in the next 12 months among men and women in their community, ranging from 1 = All or almost all, at least 90% of group to 5= Very few, or no one, for example, less than 10% of group.

Other: Survey questionnaire

V4: PNF - Descriptive and injunctive norms

EXPERIMENTAL

As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific treatments. The fourth treatment is a survey-based questionnaire with a prompt stating the participant's perceived estimate (elicited previously during the survey) of HIV testing rates among single and married people in their village. Participants are then provided with information about the true rates of both HIV testing and HIV stigma in their village. Participants are then asked to report their likelihood of getting tested for HIV in the next 12 months, ranging from 1= I will definitely get tested to 5= I will definitely not get tested. Next they are asked to estimate the rate of HIV testing in the next 12 months among men and women in their community, ranging from 1 = All or almost all, at least 90% of group to 5= Very few, or no one, for example, less than 10% of group.

Other: Survey questionnaire

Interventions

Each version of the questionnaire has similar questions about personal HIV testing intentions and perceived norms about other men and women's HIV testing intentions. The content of the prompt presented prior to the questions varies based on treatment arm. This version does not provide any normative feedback information.

V1: Control Group

Eligibility Criteria

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

You may qualify if:

  • All 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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
TREATMENT
Intervention Model
PARALLEL
Model Details: Study participants are randomly assigned to be read prompts with personalized normative feedback information with slight changes in content.
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