N/A
N=400
Brief Intervention for Rural Women at High Risk for HIV/HCV
Acquired Immune Deficiency Syndrome Virus · Hepatitis C · Drug Abuse
Bottom Line
View on ClinicalTrials.gov: NCT01840722 ↗Enrolled (actual)
400
Serious AEs
0.8%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants Having Unprotected Casual Sex — 27; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MI-based HIV Risk Reduction (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Michele Staton
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Having Unprotected Casual Sex |
27; 25 | — |
| SECONDARY Number of Participants Exchanging Sex |
9; 8 | — |
| SECONDARY Number of Participants Recently Receiving Physical or Behavioral Health Treatment |
83; 84 | — |
Summary
The overall aim of this study is to reduce risk behaviors and increase health and behavioral health service utilization among disadvantaged, drug-using rural women at high risk for HIV and HCV. This project has potential to make a significant contribution to science by providing knowledge about the health, risk behaviors, and service utilization of a vulnerable and understudied group of women during a time of emerging and significant public health risk in a rural Appalachian setting. Successful completion of the aims of this project will advance the delivery of a low-cost, potentially high impact intervention with implications for a number of other real world settings (such as criminal justice venues) where other disadvantaged high-risk drug users can be identified and targeted for intervention.
Eligibility Criteria
Inclusion Criteria
- ASSIST score of 4+
- engagement in at least one sex risk behavior in the past 3 months
- willingness to participate in brief intervention sessions
- no evidence of cognitive impairment
- no evidence of active psychosis (currently experiencing hallucinations)
- no self-reported current symptoms of physical withdrawal from a recent episode of drug use
- incarceration period of 1 week - 3 months in order to complete intervention sessions
Exclusion Criteria
- ASSIST score of <4
- no engagement in at least one sex risk behavior in the past 3 months
- not willing to participate in brief intervention sessions
- evidence of cognitive impairment
- evidence of active psychosis (currently experiencing hallucinations)
- self-reported current symptoms of physical withdrawal from a recent episode of drug use
- incarceration period of less than 1 week or greater than 3 months in order to complete intervention sessions
Data sourced from ClinicalTrials.gov (NCT01840722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.