Risk Factor
Conditions
Keywords
HIV Prevention, PrEP, Black, African American, Women, Motivational Interviewing, At risk for HIV
Brief summary
The purpose of this study is to test a counseling program for Black women at high risk for HIV
Interventions
BEHAVIORALExperimental Intervention (MI-PrEP)
The experimental intervention will consist of two sessions. The first session will involve psycho-education on PrEP and Motivational Interviewing to explore ambivalence about PrEP uptake. The second session will involve Motivational Interviewing and case management to explore barriers to accessing PrEP.
BEHAVIORALEnhanced Treatment as Usual (E-TAU)
Participants assigned to the control condition will receive two sessions, both of which involve psychoeducation on PrEP.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* HIV-negative * Identify as Black and/or African American * Age 18 or older * Cis-gender Female * English speaking * Is capable of completing and fully understanding the informed consent process and the study procedures and * Meets the Center for Disease Control's indications for PrEP use (17): (a) any sex with opposite sex partners in the past 6 months and (b) not in a monogamous partnership with a recently tested HIV-negative partner or (c) any injection of drugs not prescribed by a clinician in the past 6 months AND (d) at least one of the following: (i) infrequently uses condoms in sex with one/more partners of unknown HIV status (ii) in a sexual relationship with an HIV-positive partner or (iii) any sharing of injection/drug preparation equipment in past 6 months.
Exclusion criteria
* Not capable of completing/fully understanding the consent process and the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motivation for PrEP | Baseline, Up to 6 weeks | Motivation to use PrEP will be measured with the Contemplation Ladder and the Readiness Ruler, which assess intention to use PrEP and the perceived importance of using PrEP. The Contemplation Ladder and the Readiness Ruler each have a total score range from 0 to 10. Higher scores on the Contemplation Ladder indicate higher levels of contemplation or consideration about PrEP use. Higher scores on the Readiness Ruler indicate higher perceived importance of starting PrEP. |
| Change in PrEP uptake | Baseline, Up to 6 weeks | PrEP uptake will be verified by the participants' providers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knowledge of PrEP | Baseline, Up to 6 weeks | Knowledge of PrEP will be measured using a PrEP fact sheet, with basic information about PrEP. The PrEP Fact Sheet has a total score range of 0 to 12, with higher scores indicating higher levels of PrEP knowledge. |
| Change in Barriers for PrEP | Baseline, Up to 6 weeks | Perceived barriers to PrEP uptake/usage will be measured by an adapted version of the Barriers to Care Scale, in which participants are asked about factors that make it difficult to receive PrEP related services. The Barriers to Care scale has a total score range of 7 to 28, with higher scores indicating increased difficulty regarding barriers to PrEP uptake. |
Countries
United States
Outcome results
None listed