Trial Outcomes & Findings for Brief Intervention for Rural Women at High Risk for HIV/HCV (NCT NCT01840722)

NCT ID: NCT01840722

Last Updated: 2019-10-08

Results Overview

Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 400 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-10-08

Participant Flow

Adult women were randomly selected from three rural jails in Appalachia, screened, and interviewed face-to-face in a private room in the jail. Study eligibility included: 1) moderate risk of substance abuse based on the NIDA-ASSIST score of 4+ for any drug; 2) residing in Appalachia before incarceration; and 3) willingness to participate.

Of the 688 screened, 248 (36%) did not meet eligibility criteria due to: not being released during time frame (n=203), not engaging in risky sexual practices (n=15), not being from Appalachian (n=21), and not meeting NM-ASSIST criteria (n=9). 440 (64%) met criteria, but 40 were released prior to completing the baseline. The final N=400.

Participant milestones

Measure	NIDA Standard HIV Education NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources	MI-based HIV Risk Reduction MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community. MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.
Overall Study STARTED	201	199
Overall Study COMPLETED	201	130
Overall Study NOT COMPLETED	0	69

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brief Intervention for Rural Women at High Risk for HIV/HCV

Baseline characteristics by cohort

Measure	NIDA Standard HIV Education n=201 Participants NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources	MI-based HIV Risk Reduction n=199 Participants MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community. MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.	Total n=400 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	201 Participants n=5 Participants	199 Participants n=7 Participants	400 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.5 years STANDARD_DEVIATION 8.4 • n=5 Participants	33.1 years STANDARD_DEVIATION 8.1 • n=7 Participants	32.8 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	201 Participants n=5 Participants	199 Participants n=7 Participants	400 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	200 Participants n=5 Participants	197 Participants n=7 Participants	397 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
Region of Enrollment United States	201 participants n=5 Participants	199 participants n=7 Participants	400 participants n=5 Participants
Risky Sexual Behavior	84 Participants n=5 Participants	90 Participants n=7 Participants	174 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants were lost to study attrition

Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months

Outcome measures

Measure	NIDA Standard HIV Education n=181 Participants NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources	MI-based HIV Risk Reduction n=184 Participants MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community. MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.
Number of Participants Having Unprotected Casual Sex	27 Participants	25 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants were lost to attrition.

Sex with a Partner in Exchange for Money, Drugs, Food, Shelter, Transportation, etc. in the past 6 months

Outcome measures

Measure	NIDA Standard HIV Education n=181 Participants NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources	MI-based HIV Risk Reduction n=184 Participants MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community. MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.
Number of Participants Exchanging Sex	9 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants were lost to study attrition.

Is currently being treated for a physical or mental health problem OR has been in a substance use treatment program in the last 6 months

Outcome measures

Measure	NIDA Standard HIV Education n=181 Participants NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources	MI-based HIV Risk Reduction n=184 Participants MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community. MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.
Number of Participants Recently Receiving Physical or Behavioral Health Treatment	83 Participants	84 Participants

Adverse Events

NIDA Standard HIV Education

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

MI-based HIV Risk Reduction

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	NIDA Standard HIV Education n=201 participants at risk NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources	MI-based HIV Risk Reduction n=199 participants at risk MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community. MI-based HIV Risk Reduction: As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.
Investigations Participant death	1.00% 2/201 • Number of events 2 • Adverse event data was collected for one year post-study enrollment. The definitions of adverse events in this study do not differ from clinicaltrials.gov definitions.	0.50% 1/199 • Number of events 1 • Adverse event data was collected for one year post-study enrollment. The definitions of adverse events in this study do not differ from clinicaltrials.gov definitions.

Other adverse events

Adverse event data not reported

Additional Information

Michele Staton, Associate Professor

University of Kentucky

Phone: 859-257-2483

Email: mstaton@uky.edu

Results disclosure agreements

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