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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03456453
Other study ID # 1R34DA045563-01A1
Secondary ID 1R34DA045563-01A
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2019
Est. completion date April 26, 2022

Study information

Verified date April 2023
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 26, 2022
Est. primary completion date April 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (2)

Lead Sponsor Collaborator
Michele Staton National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Facebook Enrollment The number of participants who are released and accept the "friend" request from the Facebook study profile 3 months
Secondary 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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