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Social Media HIV Prevention Intervention for High Risk Rural Women

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIDA Standard for HIV Prevention
Sponsored by
Michele Staton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • NM-ASSIST indicators of high-risk drug use during the 6 months before jail (including injection);
  • engagement in at least one sexual risk behavior in the past 3 months;
  • no evidence of cognitive impairment (GAIN, Dennis, 1998),
  • no evidence of active psychosis (currently experiencing hallucinations),
  • no self-reported current symptoms of physical withdrawal from a recent episode of drug use;
  • self-reported HIV negative status;
  • projected jail release date within 3 months;
  • active Facebook user prior to entering jail (defined as having a Facebook account that was checked at least once a week); and
  • reside in a rural, Appalachian county prior to incarceration.

Exclusion Criteria:

  • Not incarcerated and screened eligible based on above mentioned criteria

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NIDA Standard via Facebook

Re-entry services as usual

Arm Description

Participants will receive the NIDA Standard via Facebook

Participants will receive standard re-entry services available in the community and through the criminal justice system

Outcomes

Primary Outcome Measures

Facebook Enrollment
The number of participants who are released and accept the "friend" request from the Facebook study profile

Secondary Outcome Measures

Number of Participants With Use of Injected Drugs
Use of injected drugs in the last 3-months at follow-up

Full Information

First Posted
February 17, 2018
Last Updated
April 14, 2023
Sponsor
Michele Staton
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03456453
Brief Title
Social Media HIV Prevention Intervention for High Risk Rural Women
Official Title
Social Media HIV Prevention Intervention for High Risk Rural Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michele Staton
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIDA Standard via Facebook
Arm Type
Experimental
Arm Description
Participants will receive the NIDA Standard via Facebook
Arm Title
Re-entry services as usual
Arm Type
No Intervention
Arm Description
Participants will receive standard re-entry services available in the community and through the criminal justice system
Intervention Type
Behavioral
Intervention Name(s)
NIDA Standard for HIV Prevention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Facebook Enrollment
Description
The number of participants who are released and accept the "friend" request from the Facebook study profile
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Participants With Use of Injected Drugs
Description
Use of injected drugs in the last 3-months at follow-up
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Eligibility is based on self-representation of being female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: NM-ASSIST indicators of high-risk drug use during the 6 months before jail (including injection); engagement in at least one sexual risk behavior in the past 3 months; no evidence of cognitive impairment (GAIN, Dennis, 1998), no evidence of active psychosis (currently experiencing hallucinations), no self-reported current symptoms of physical withdrawal from a recent episode of drug use; self-reported HIV negative status; projected jail release date within 3 months; active Facebook user prior to entering jail (defined as having a Facebook account that was checked at least once a week); and reside in a rural, Appalachian county prior to incarceration. Exclusion Criteria: Not incarcerated and screened eligible based on above mentioned criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Staton, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Social Media HIV Prevention Intervention for High Risk Rural Women

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