Clinical trial NCT06969677: Personalized Normative Feedback to Increase HIV Testing
Official title: Personalized Normative Feedback to Increase HIV Testing Among Adults in Rural Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Testing
HIV Stigma
Keywords: HIV testing
HIV stigma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
name: National Institute of Mental Health (NIMH)
First posted: 2025-05-14
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants are randomly assigned to be read prompts with personalized normative feedback information with slight changes in content.
Primary purpose: TREATMENT

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.

Detailed description: HIV testing is a vital step in identifying and treating HIV. Research in rural Uganda reveals underestimation of community HIV testing rates and overestimation of HIV-related stigma among adults. At the same time, perceived norms (i.e., estimated rates regardless of their accuracy) are associated with personal HIV testing behavior and personal HIV-related attitudes.

This study employs a randomized controlled trial to evaluate how providing accurate information about local descriptive (i.e., behavioral) norms and local injunctive (i.e., attitudinal) norms affect HIV testing intentions. Participants are randomly assigned to one of four treatment arms: (1) they are reminded of what they thought community testing rates were in their village and then receive accurate information about high community testing rates, (2) they are reminded of what they thought local stigma rates were in their village and then receive accurate information about positive community perceptions of persons with HIV, (3) they are reminded of what they thought community testing rates and local stigma rates were in their village and then receive both types of accurate normative information, or (4) they are reminded of what they thought community testing rates were in their village and receive no further information (control group).

The study assesses how providing this type of personalized normative feedback within cohort-based data collection affects personal reports about getting tested for HIV in the next 12 months and how it affects perceptions about how many men and women in the same village will get tested for HIV in the next 12 months. It is hypothesized that providing accurate information about local community testing rates and/or attitudes toward persons with HIV will increase reported personal willingness to get tested (primary outcome) and improve the accuracy of estimated community testing rates in the future (secondary outcome).

Eligibility criteria: Inclusion Criteria:

* All adults who consider Nyakabare their primary place of residence and who are capable of providing consent

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Self-reported HIV testing intention in the next 12 months
timeFrame: Baseline (assessed at the time the survey is administered)
Secondary outcomes:
measure: Self-reported perception of HIV testing among men in one's village
timeFrame: Baseline (assessed at the time the survey is administered)
measure: Self-reported perception of HIV testing among women in one's village
timeFrame: Baseline (assessed at the time the survey is administered)
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University of Science and Technology
Study officials:
affiliation: Massachusetts General Hospital
name: Alexander C Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: