NCT03456453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 8, 2023

Completed
Last Updated

June 15, 2026

Status Verified

May 1, 2026

Enrollment Period

2.9 years

First QC Date

February 17, 2018

Results QC Date

March 20, 2023

Last Update Submit

May 26, 2026

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • Facebook Enrollment

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

    3 months

Secondary Outcomes (1)

  • Number of Participants With Use of Injected Drugs

    3 months

Study Arms (2)

NIDA Standard via Facebook

EXPERIMENTAL

Participants will receive the NIDA Standard via Facebook

Behavioral: NIDA Standard for HIV Prevention

Re-entry services as usual

NO INTERVENTION

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

Interventions

NIDA Standard for HIV PreventionBEHAVIORAL

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.

NIDA Standard via Facebook

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is based on self-representation of being female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not incarcerated and screened eligible based on above mentioned criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Michele Staton
Organization
University of Kentucky
mstaton@uky.edu
859-312-8245

Study Officials

  • Michele Staton, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2018

First Posted

March 7, 2018

Study Start

May 29, 2019

Primary Completion

April 26, 2022

Study Completion

April 26, 2022

Last Updated

June 15, 2026

Results First Posted

May 8, 2023

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)