Social Media HIV Prevention Intervention for High Risk Rural Women

April 14, 2023 updated by: Michele Staton
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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 Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIDA Standard via Facebook
Participants will receive the NIDA Standard via Facebook
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.
No Intervention: Re-entry services as usual
Participants will receive standard re-entry services available in the community and through the criminal justice system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facebook Enrollment
Time Frame: 3 months
The number of participants who are released and accept the "friend" request from the Facebook study profile
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Use of Injected Drugs
Time Frame: 3 months
Use of injected drugs in the last 3-months at follow-up
3 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Michele Staton, PhD, University of Kentucky

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)

May 29, 2019

Primary Completion (Actual)

April 26, 2022

Study Completion (Actual)

April 26, 2022

Study Registration Dates

First Submitted

February 17, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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