Risk FactorMI-PrEPNCT03592719
Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)
A study testing Experimental Intervention (MI-PrEP) and Enhanced Treatment as Usual (E-TAU) in people with Risk Factor, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to test a counseling program for Black women at high risk for HIV Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Factor
- What is being tested?
- Experimental Intervention (MI-PrEP) and Enhanced Treatment as Usual (E-TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 11 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not capable of completing/fully understanding the consent process and the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test a counseling program for Black women at high risk for HIV
- Conditions
- Risk Factor
- Being tested
- Experimental Intervention (MI-PrEP), Enhanced Treatment as Usual (E-TAU)
- Keywords
- HIV Prevention, PrEP, Black, African American, Women, Motivational Interviewing, At risk for HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Intervention (MI-PrEP)Behavioural
Also called Motivational Interviewing to Increase PrEP Uptake (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.
Enhanced Treatment as Usual (E-TAU)Behavioural
Participants assigned to the control condition will receive two sessions, both of which involve psychoeducation on PrEP.
| Study group | Role | What they receive |
|---|---|---|
| MI-PrEP | Experimental | Participants in this arm will receive the manualized two-session intervention entitled "Motivational Interviewing to Increase PrEP Uptake" Receives: Behavioral: Experimental Intervention (MI-PrEP) |
| Enhanced Treatment as Usual (E-TAU) | Active comparator | Participants in this arm will receive two sessions which entail psychoeducation on PrEP. Receives: Behavioral: Enhanced Treatment as Usual (E-TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Motivation for PrEP
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.
Measured: Baseline, Up to 6 weeks
Change in PrEP uptake
PrEP uptake will be verified by the participants' providers.
Measured: Baseline, Up to 6 weeks
Secondary outcomes (2)
Change in Knowledge of PrEP
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.
Measured: Baseline, Up to 6 weeks
Change in Barriers for PrEP
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.
Measured: Baseline, Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Oct 2018
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sannisha K Dale, University of Miami
- Investigators
- Sannisha K Dale, PhD, EdM, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592719
- Sponsor's protocol ID
- 20180516
- Acronym
- MI-PrEP
- Status last verified
- Dec 2020
- First submitted
- 9 Jul 2018
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)
- ClinicalTrials.gov ID
- NCT03592719
- Acronym / sponsor ID
- MI-PrEP / 20180516
- Conditions
- Risk Factor
- Keywords
- HIV Prevention, PrEP, Black, African American, Women, Motivational Interviewing, At risk for HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a counseling program for Black women at high risk for HIV
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI-PrEP | Experimental | Behavioral: Experimental Intervention (MI-PrEP)Participants in this arm will receive the manualized two-session intervention entitled "Motivational Interviewing to Increase PrEP Uptake" |
| Enhanced Treatment as Usual (E-TAU) | Active comparator | Behavioral: Enhanced Treatment as Usual (E-TAU)Participants in this arm will receive two sessions which entail psychoeducation on PrEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-negative
- Identify as Black and/or African American
- Age 18 or older
- Cis-gender Female
- English speaking
Key exclusion criteria (1 listed)
- Not capable of completing/fully understanding the consent process and the study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Intervention (MI-PrEP)Also: Motivational Interviewing to Increase PrEP Uptake (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. | Behavioural | MI-PrEP |
| Enhanced Treatment as Usual (E-TAU)Participants assigned to the control condition will receive two sessions, both of which involve psychoeducation on PrEP. | Behavioural | Enhanced Treatment as Usual (E-TAU) |
Primary outcome
Change in Motivation for PrEP
Time frame: 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
Time frame: Baseline, Up to 6 weeks
PrEP uptake will be verified by the participants' providers.
2 secondary outcomes
Change in Knowledge of PrEP
Time frame: Baseline, Up to 6 weeks
Change in Barriers for PrEP
Time frame: Baseline, Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sannisha K Dale, PhD, EdM principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Intervention (MI-PrEP) and Enhanced Treatment as Usual (E-TAU) in people with Risk Factor, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motivation for PrEP (time frame: Baseline, Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.