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Social Media HIV Prevention Intervention for High Risk Rural Women

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ClinicalTrials.gov Identifier: NCT03456453
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michele Staton, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: NIDA Standard for HIV Prevention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Social Media HIV Prevention Intervention for High Risk Rural Women
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: NIDA Standard via Facebook Behavioral: 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.

No Intervention: Re-entry services as usual



Primary Outcome Measures :
  1. Study enrollment [ Time Frame: 3 months ]
    the number of participants who "friend" the closed study site


Secondary Outcome Measures :
  1. HIV risk behaviors [ Time Frame: 3 months ]
    number of times using shared needles



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility is based on self-representation of being female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456453


Contacts
Contact: Michele Staton, PhD 859-257-2483 mstaton@uky.edu

Sponsors and Collaborators
University of Kentucky
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Michele Staton, PhD University of Kentucky

Responsible Party: Michele Staton, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03456453     History of Changes
Other Study ID Numbers: 1R34DA045563-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No