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| ID | Type | Description | Link |
|---|---|---|---|
| R21TW012017 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Fogarty International Center of the National Institute of Health | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crowdsourced Intervention | Experimental | The digital crowdsourced intervention will be presented to participants in the intervention arm. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Crowdsourced Intervention to Reduce HIV Stigma among Adolescents and Young Adults | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Perceived HIV Test Stigma | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alissa Davis, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Global Health Research Center of Central Asia | Almaty | 050040 | Kazakhstan |
Data will be shared with researchers who request access to the data and obtain appropriate IRB approval.
Data will become available to outside investigators after the study investigative team has cleaned and analyzed the data and written their proposed papers.
Have a proposed plan for data analysis Completed human subjects training Obtained Institutional Review Board approval to access and analyze the data
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Adolescents and young adults were recruited online via websites and social media advertisements and in-person at youth events in Almaty, Kazakhstan from January to August 2023. Those who were interested in study participation completed an online screening survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crowdsourced Intervention | The digital crowdsourced intervention developed by adolescents and young adults will be presented to participants in the intervention arm. |
| FG001 | Standard of Care | Standard HIV informational materials currently used by the Kazakhstan Ministry of Health will be presented to participants in the control arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Crowdsourced Intervention | The digital crowdsourced intervention will be presented to participants in the intervention arm. 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 and expert judging panel. Winning entries will be selected for the digital intervention and presented to participants in the intervention arm. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and 3 months |
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Adverse event data were collected over 3 months, from baseline assessment to the last follow-up assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crowdsourced Intervention | The digital crowdsourced intervention will be presented to participants in the intervention arm. 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 and expert judging panel. Winning entries will be selected for the digital intervention and presented to participants in the intervention arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alissa Davis | Columbia University | 212-851-2224 | ad3324@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 30, 2022 | Oct 29, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2024 | Oct 29, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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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.
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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 | 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 | 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 | 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 |
| BG001 | Standard of Care | Standard HIV informational materials currently used by the Kazakhstan Ministry of Health will be presented to participants in the control arm. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Sexual Orientation | Count of Participants | Participants |
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| OG001 | Standard of Care | Standard HIV informational materials currently used by the Kazakhstan Ministry of Health will be presented to participants in the control arm. |
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| Secondary | Mean Change in Perceived HIV Test Stigma | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and 3 months |
|
|
|
|
| Secondary | Mean Change in Perceived HIV Healthcare Stigma Subscale | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and 3 months |
|
|
|
|
| Secondary | Mean Change in Fear & Judgement HIV Stigma Sub-scale | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and 3 months |
|
|
|
|
| Secondary | Mean Change in Perceived Community HIV Stigma Subscale | 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. | Posted | Mean | Standard Error | units on a scale | Baseline and 3 months |
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|
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| Secondary | Uptake of HIV Self-test | 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). | Posted | Count of Participants | Participants | After baseline and by the 3 month follow-up period |
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| Post-Hoc | Subgroup Analyses By Sex of Mean Change in Total HIV Stigma Scale | The Total HIV Stigma scale consists of 17 items, each on a 1-5 point Likert scale, with a range of 17-85. Higher values indicate higher levels of HIV stigma. | Posted | Mean | Standard Error | units on a scale | Baseline and 3 months |
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|
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| 0 |
| 111 |
| 0 |
| 111 |
| 0 |
| 111 |
| EG001 | Standard of Care | Standard HIV informational materials currently used by the Kazakhstan Ministry of Health will be presented to participants in the control arm. | 0 | 105 | 0 | 105 | 0 | 105 |
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| Superiority |
| Superiority |
| Superiority |
| Superiority |
| 3 months follow-up |
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| Superiority |
| Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models. | Mixed Models Analysis | 0.56 | To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach. | Mean Difference (Final Values) | 1.58 | 2-Sided | 95 | -2.26 | 5.42 | The statistical values presented are the Estimated Value of Mean Difference in males between study arms from baseline to the three-month follow-up. | Superiority |