Trial Outcomes & Findings for Social Media HIV Prevention Intervention for High Risk Rural Women (NCT NCT03456453)

NCT ID: NCT03456453

Last Updated: 2023-05-08

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-05-08

Participant Flow

Participant milestones

Measure	NIDA Standard Via Facebook Participants will receive the NIDA Standard via Facebook 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.	Re-entry Services as Usual Participants will receive standard re-entry services available in the community and through the criminal justice system
Overall Study STARTED	30	30
Overall Study COMPLETED	27	23
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Measure	NIDA Standard Via Facebook Participants will receive the NIDA Standard via Facebook 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.	Re-entry Services as Usual Participants will receive standard re-entry services available in the community and through the criminal justice system
Overall Study Withdrawal by Subject	2	0
Overall Study Not released to community	1	5
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Individuals who completed follow-up interviews were included

Baseline characteristics by cohort

Measure	NIDA Standard Via Facebook n=30 Participants Participants will receive the NIDA Standard via Facebook 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.	Re-entry Services as Usual n=30 Participants Participants will receive standard re-entry services available in the community and through the criminal justice system	Total n=60 Participants Total of all reporting groups
Age, Continuous	34.6 years STANDARD_DEVIATION 8.6 • n=5 Participants • Individuals who completed follow-up interviews were included	38.3 years STANDARD_DEVIATION 7.3 • n=7 Participants • Individuals who completed follow-up interviews were included	36.4 years STANDARD_DEVIATION 8.1 • n=5 Participants • Individuals who completed follow-up interviews were included
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Number of Years of Education Completed	11.6 years STANDARD_DEVIATION 2.0 • n=5 Participants • Individuals who completed follow-up interviews were included	12.7 years STANDARD_DEVIATION 1.9 • n=7 Participants • Individuals who completed follow-up interviews were included	12.1 years STANDARD_DEVIATION 2.0 • n=5 Participants • Individuals who completed follow-up interviews were included

PRIMARY outcome

Timeframe: 3 months

Population: Number of participants released from jail, thus eligible to accept the "friend" request from the Facebook profile. All participants who were released were eligible to accept the "friend" request then individuals randomized to the NIDA Standard via Facebook were sent an additional invite to the closed intervention group

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

Outcome measures

Measure	NIDA Standard Via Facebook n=29 Participants Participants will receive the NIDA Standard via Facebook 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.	Re-entry Services as Usual n=25 Participants Participants will receive standard re-entry services available in the community and through the criminal justice system
Facebook Enrollment	15 Participants	15 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Individuals who were released and completed the 3 month follow up

Use of injected drugs in the last 3-months at follow-up

Outcome measures

Measure	NIDA Standard Via Facebook n=27 Participants Participants will receive the NIDA Standard via Facebook 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.	Re-entry Services as Usual n=23 Participants Participants will receive standard re-entry services available in the community and through the criminal justice system
Number of Participants With Use of Injected Drugs	8 Participants	6 Participants

Adverse Events

NIDA Standard Via Facebook

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Re-entry Services as Usual

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	NIDA Standard Via Facebook n=27 participants at risk Participants will receive the NIDA Standard via Facebook 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.	Re-entry Services as Usual n=23 participants at risk Participants will receive standard re-entry services available in the community and through the criminal justice system
General disorders Non-fatal overdose	7.4% 2/27 • 3 months after Baseline completion Adverse event information was only collected at the 3 month follow up	0.00% 0/23 • 3 months after Baseline completion Adverse event information was only collected at the 3 month follow up

Other adverse events

Measure	NIDA Standard Via Facebook n=27 participants at risk Participants will receive the NIDA Standard via Facebook 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.	Re-entry Services as Usual n=23 participants at risk Participants will receive standard re-entry services available in the community and through the criminal justice system
Social circumstances Reincarcerated	29.6% 8/27 • 3 months after Baseline completion Adverse event information was only collected at the 3 month follow up	30.4% 7/23 • 3 months after Baseline completion Adverse event information was only collected at the 3 month follow up
General disorders Any health problems	37.0% 10/27 • 3 months after Baseline completion Adverse event information was only collected at the 3 month follow up	47.8% 11/23 • 3 months after Baseline completion Adverse event information was only collected at the 3 month follow up
Psychiatric disorders Any mental health problems	33.3% 9/27 • 3 months after Baseline completion Adverse event information was only collected at the 3 month follow up	39.1% 9/23 • 3 months after Baseline completion Adverse event information was only collected at the 3 month follow up

Additional Information

Michele Staton

University of Kentucky

Phone: 859-312-8245

Email: mstaton@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place