N/A
N=35
PrEP Communication Intervention for Female Clients of a Needle Exchange
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT03541642 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in PrEP Uptake and Adherence — 0; 1; 2; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Intervention (Behavioral); Basic Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Temple University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PrEP Uptake and Adherence |
0; 1; 2; 3; 1; 0 | — |
| PRIMARY PrEP Adherence Within Past Week |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY PrEP Adherence Appraisal |
0; 3; 1; 0; 2; 0 | — |
| SECONDARY Coping Self-Efficacy |
122; 101; 130; 84 | — |
| SECONDARY Decisional Conflict |
5.00; 4.64; 5.00; 4.85 | — |
| SECONDARY PrEP Benefits |
9.00; 9.67; 9.00; 8.67; 2.00; 8.67 | — |
| SECONDARY PrEP Barriers |
0.00; 0.00; 0.00; 0.00; 0.00; 2.00 | — |
| SECONDARY PrEP Beliefs |
0.00; 0.67; 10.0; 0.00; 10.0; 0.00 | — |
Summary
This study will identify perceptions of PrEP in women who inject drugs (WWIDs) and develop and pilot test a targeted intervention that will be embedded in a large, urban syringe exchange program through an extensive formative evaluation process. Using perceptual mapping, an innovative marketing evaluation technique, WWIDs' PrEP perceptions will be incorporated into messaging in targeted counseling, materials, and text messaging to encourage PrEP adherence. This will then be tested in a pilot Randomized Controlled Trial (RCT) by comparing it to a general PrEP intervention to assess for uptake and adherence to PrEP, as well as improved self-efficacy and lower decisional conflict.
Eligibility Criteria
Inclusion Criteria
- self-identifying women -HIV-
- 18 or older
- self-report either sharing needles or having unprotected sex in last month
- speak and read English
- Is not currently PrEP
- have cell phone that receives text messages
- have Medicaid/Medicare or other insurance that covers PrEP
Exclusion Criteria
- self-identifying other than female
- HIV+
- under 18 years old
- Doesn't speak/read English
- No HIV risk in last three months
- Are on PrEP
- Do not have a cell phone that accepts text messages
- Do not have insurance that covers PrEP
- mental illness that interferes with cognitive understanding or ability to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT03541642). 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.