Crowdsourcing to Reduce HIV Stigma Among Adolescents and Young Adults in Kazakhstan

November 21, 2024 updated by: Alissa Davis, Columbia University

Reducing HIV Stigma to Increase HIV Testing Among Adolescents and Young Adults in Kazakhstan Using a Crowdsourcing Approach

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This project will assess whether a digital crowdsourced intervention can reduce HIV stigma and promote HIV self-testing among adolescents and young adults (AYA). Globally AYA are at increased risk for HIV acquisition. In Eastern Europe and Central Asia (EECA), new HIV infections among 15-24 year old AYA are expected to increase 28% by 2030. In Kazakhstan, one in four HIV infections occur among AYA. Despite the growing HIV burden among AYA in Kazakhstan, this population has some of the lowest HIV testing rates in the country, largely due to stigma. Yet few efforts in Kazakhstan address HIV stigma and the role it plays as a barrier to HIV testing. Digital technologies and crowdsourcing campaigns (i.e., engaging groups of AYA online to address public health challenges and share solutions) are scalable, cost-effective tools that can increase HIV testing services and reduce HIV stigma in low and middle income countries (LMICs) and other resource- constrained settings. Crowdsourcing may be particularly successful among AYA, given their high levels of social media use and technological literacy. Complementing the crowdsourcing approach, mailing HIV rapid test kits can enable AYA to avoid the stigma associated with attending the AIDS Center and overcome transportation barriers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan, 050040
        • Columbia University Global Health Research Center of Central Asia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Crowdsourced Intervention
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
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.
No Intervention: Standard of Care
Standard HIV informational materials currently used by the Kazakhstan Ministry of Health will be presented to participants in the control arm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Score Change in Total HIV Stigma Scale
Time Frame: Baseline and 3 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in Perceived HIV Test Stigma
Time Frame: Baseline and 3 months
This is a subscale of the Total HIV Stigma scale. It contains 2 items, each on a 1-5 point Likert scale, with a range of 5-10. Higher values indicate higher levels of HIV stigma.
Baseline and 3 months
Mean Change in Perceived HIV Healthcare Stigma Subscale
Time Frame: Baseline and 3 months
This is a subscale of the Total HIV Stigma Scale. It contains two items, each on a 1-5 point Likert scale, with a range of 5-10. Higher values indicate higher levels of HIV healthcare stigma.
Baseline and 3 months
Mean Change in Fear & Judgement HIV Stigma Sub-scale
Time Frame: Baseline and 3 months
This is a subscale of the Total HIV Stigma Scale. It consists of 5 items, each on a 1-5 point Likert scale, with a range of 5-25. Higher values indicate higher levels of fear & judgement HIV stigma.
Baseline and 3 months
Mean Change in Perceived Community HIV Stigma Subscale
Time Frame: Baseline and 3 months
This is a subscale of the Total HIV Stigma Scale. It consists of 8 items, each on a 1-5 point Likert-scale, with a range of 6-40. Higher values indicate higher levels of perceived community HIV stigma.
Baseline and 3 months
Uptake of HIV Self-test
Time Frame: After baseline and by the 3 month follow-up period
The number of participants who ordered an HIV self-test kit after baseline and by the 3-month follow-up. It is a dichotomous outcome (yes/no).
After baseline and by the 3 month follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Fogarty International Center of the National Institute of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alissa Davis, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAT7871
  • R21TW012017 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing Access Criteria

Have a proposed plan for data analysis Completed human subjects training Obtained Institutional Review Board approval to access and analyze the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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