NCT05107401

Brief Summary

This project will assess whether a digital crowdsourced intervention can reduce HIV stigma and promote HIV self-testing among adolescents and young adults (AYA). NIH has emphasized the need for research on interventions to reduce HIV-associated stigma and its impact on the prevention and treatment of HIV/AIDS, particularly in low and middle income countries (LMICs). The proposed study has the highest public health significance: it uses a community-based participatory approach to engage local AYA to develop a digital crowdsourced HIV stigma reduction and self-testing intervention to reduce HIV stigma and increase HIV testing. Study Aim 1: To develop a crowdsourced digital HIV stigma reduction and self-testing intervention targeting AYA in Kazakhstan. Using a community-based participatory approach that engages local adolescents and young adults (AYA) and youth organizations, we will launch a national crowdsourcing contest in which AYA will design multimedia content to reduce HIV stigma in order to promote HIV testing among peers. Study Aim 2: To pilot test this crowdsourced HIV stigma reduction and self-testing intervention in a preliminary efficacy trial. We will assess the intervention's feasibility and acceptability and obtain preliminary estimates of its effects on decreasing HIV stigma (primary outcome) and increasing HIV testing (secondary outcome) among AYA in Kazakhstan who received the intervention compared to individuals who did not. Participants (n=168) will be randomized 1:1 to: 1) receive the winning multimedia crowdsourced HIV stigma reduction content and a link for HIV self-testing, or 2) receive standard Kazakhstan Ministry of Health HIV informational materials and a link for HIV self-testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

October 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 17, 2024

Completed
Last Updated

December 17, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

October 25, 2021

Results QC Date

October 1, 2024

Last Update Submit

November 21, 2024

Conditions

Keywords

HIV stigma

Outcome Measures

Primary Outcomes (1)

  • Mean Score Change in Total HIV Stigma Scale

    The scale/questionnaire is comprised of 17 items on a 5-point Likert scale (score range from 17-85). Higher scores indicate higher levels of stigma. Outcome will be assessed in mean score change from baseline to 3 months follow-up.

    Baseline and 3 months

Secondary Outcomes (5)

  • Mean Change in Perceived HIV Test Stigma

    Baseline and 3 months

  • Mean Change in Perceived HIV Healthcare Stigma Subscale

    Baseline and 3 months

  • Mean Change in Fear & Judgement HIV Stigma Sub-scale

    Baseline and 3 months

  • Mean Change in Perceived Community HIV Stigma Subscale

    Baseline and 3 months

  • Uptake of HIV Self-test

    After baseline and by the 3 month follow-up period

Study Arms (2)

Crowdsourced Intervention

EXPERIMENTAL

The digital crowdsourced intervention will be presented to participants in the intervention arm.

Behavioral: Digital Crowdsourced Intervention to Reduce HIV Stigma among Adolescents and Young Adults

Standard of Care

NO INTERVENTION

Standard HIV informational materials currently used by the Kazakhstan Ministry of Health will be presented to participants in the control arm.

Interventions

Adolescents and young adults will participate in a crowdsourcing contest to create digital materials to reduce HIV stigma in order to increase HIV testing. Entries will be judged by a community judging panel and expert judging panel. Winning entries will be selected for the digital intervention and presented to participants in the intervention arm.

Crowdsourced Intervention

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 16-24
  • Report previous sex with another individual
  • Reside in Kazakhstan

You may not qualify if:

  • Not willing to provide consent or not able to understand study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Global Health Research Center of Central Asia

Almaty, 050040, Kazakhstan

Location

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Results Point of Contact

Title
Dr. Alissa Davis
Organization
Columbia University

Study Officials

  • Alissa Davis, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Participants will be randomized to receive the digital crowdsourced intervention or standard of care (existing HIV informational materials). We will examine effects of the intervention on reducing HIV stigma and increasing HIV testing.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Social Work, School of Social Work

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 4, 2021

Study Start

January 24, 2023

Primary Completion

August 22, 2023

Study Completion

August 22, 2023

Last Updated

December 17, 2024

Results First Posted

December 17, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Data will be shared with researchers who request access to the data and obtain appropriate IRB approval.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will become available to outside investigators after the study investigative team has cleaned and analyzed the data and written their proposed papers.
Access Criteria
Have a proposed plan for data analysis Completed human subjects training Obtained Institutional Review Board approval to access and analyze the data

Locations