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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34DA045563-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The overall aim of this R34 application is to adapt and feasibility test an evidence-based HIV prevention education for high-risk, underserved rural women in Appalachia. This study has potential to make a significant contribution to science by advancing knowledge on the use of social media to increase access to prevention interventions to reduce high-risk substance use and related health disparities among rural women during a time of emerging and significant public health risk in Appalachia. Successfully accomplishing study aims will respond to a critical and unmet need to increase access to prevention interventions using social media, as well as advance knowledge about the high-risk drug use behaviors among vulnerable populations.
The overall aim of this R34 application is to adapt and feasibility test an evidence-based intervention for HIV prevention for a high-risk group of rural women in Appalachia. This study has potential to make a significant contribution to science by advancing knowledge on the use of social media to increase access to prevention interventions to reduce high-risk substance use and related health disparities among rural women during a time of emerging and significant public health risk in Appalachia. Successfully accomplishing study aims will respond to a critical and unmet need to increase the reach and scope of prevention interventions using social media, as well as advance knowledge about the high-risk drug use behaviors of this underserved group. Considering the need for prevention interventions among this high-risk group and the popularity of Facebook, the purpose of this R34 proposal is to adapt an evidence-based HIV prevention intervention for social media delivery and to feasibility test through a randomized control trial with 60 high-risk rural women drug users. The following aims guide the proposed study: (1) Adapt the NIDA Standard for HIV prevention for delivery via Facebook; and (2) Examine the feasibility of the adapted intervention with high-risk rural women through a randomized control pilot. The proposed use of Facebook in this study is promising because it is a stable, widely used, cost-efficient platform that could be leveraged to increase access to critically needed HIV prevention education. This study presents an exciting opportunity to examine the use of Facebook as a technique to expand the reach of evidence-based preventions interventions for high-risk drug users who are not likely to engage in formal treatment. Findings from this study will inform development of the larger R01 which would allow examination of the effectiveness and sustainability of this HIV prevention intervention in understudied, high risk populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIDA Standard via Facebook | Experimental | Participants will receive the NIDA Standard via Facebook |
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| Re-entry services as usual | No Intervention | Participants will receive standard re-entry services available in the community and through the criminal justice system |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIDA Standard for HIV Prevention | Behavioral | The NIDA Standard is a manualized, HIV prevention education intervention focused on reducing risky sexual and drug use practices. It will be adapted for Facebook in this pilot trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Facebook Enrollment | The number of participants who are released and accept the "friend" request from the Facebook study profile | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Use of Injected Drugs | Use of injected drugs in the last 3-months at follow-up | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility is based on self-representation of being female
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| Name | Affiliation | Role |
|---|---|---|
| Michele Staton, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NIDA Standard Via Facebook | Participants will receive the NIDA Standard via Facebook NIDA Standard for HIV Prevention: The NIDA Standard is a manualized, HIV prevention education intervention focused on reducing risky sexual and drug use practices. It will be adapted for Facebook in this pilot trial. |
| FG001 | Re-entry Services as Usual | Participants will receive standard re-entry services available in the community and through the criminal justice system |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NIDA Standard Via Facebook | Participants will receive the NIDA Standard via Facebook NIDA Standard for HIV Prevention: The NIDA Standard is a manualized, HIV prevention education intervention focused on reducing risky sexual and drug use practices. It will be adapted for Facebook in this pilot trial. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Individuals who completed follow-up interviews were included |
| 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 | Facebook Enrollment | The number of participants who are released and accept the "friend" request from the Facebook study profile | Number of participants released from jail, thus eligible to accept the "friend" request from the Facebook profile. All participants who were released were eligible to accept the "friend" request then individuals randomized to the NIDA Standard via Facebook were sent an additional invite to the closed intervention group | Posted | Count of Participants | Participants | 3 months |
|
3 months after Baseline completion
Adverse event information was only collected at the 3 month follow up
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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 | NIDA Standard Via Facebook | Participants will receive the NIDA Standard via Facebook NIDA Standard for HIV Prevention: The NIDA Standard is a manualized, HIV prevention education intervention focused on reducing risky sexual and drug use practices. It will be adapted for Facebook in this pilot trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-fatal overdose | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reincarcerated | Social circumstances | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Staton | University of Kentucky | 859-312-8245 | mstaton@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 3, 2023 | Apr 14, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Lost to Follow-up |
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| Re-entry Services as Usual |
Participants will receive standard re-entry services available in the community and through the criminal justice system |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Number of Years of Education Completed | Individuals who completed follow-up interviews were included | Mean | Standard Deviation | years |
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| OG001 | Re-entry Services as Usual | Participants will receive standard re-entry services available in the community and through the criminal justice system |
|
|
| Secondary | Number of Participants With Use of Injected Drugs | Use of injected drugs in the last 3-months at follow-up | Individuals who were released and completed the 3 month follow up | Posted | Count of Participants | Participants | 3 months |
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|
|
| 0 |
| 27 |
| 2 |
| 27 |
| 20 |
| 27 |
| EG001 | Re-entry Services as Usual | Participants will receive standard re-entry services available in the community and through the criminal justice system | 0 | 23 | 0 | 23 | 19 | 23 |
| Any health problems | General disorders | Non-systematic Assessment |
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| Any mental health problems | Psychiatric disorders | Non-systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |