HIV InfectionsNCT03651453
OPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings
A study testing Decision aid in people with HIV Infections and Substance Abuse, run by Yale University at 1 site in United States.
Trial summary
To develop and test the effect of a patient-centered HIV prevention decision aid on HIV pre-exposure prophylaxis (PrEP) uptake among women with substance use disorders (SUD) in treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections, Substance Abuse
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 11 Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self- identification as female (i.e., cis- or trans- women), age ≥18, HIV negative status (confirmed with APT date from rapid testing procedures), and entering or receiving treatment at our partnering site, the APT Foundation, Inc. (a drug treatment center).
Who cannot join
- Women on PrEP at baseline, unable or unwilling to provide informed consent, threatening to staff, pregnant, or experiencing symptoms of physiological withdrawal that interfere with ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Testing the Effect of a Patient-Centered HIV Prevention Decision Aid on PrEP Uptake for Women With Substance Use in Treatment Settings
To develop and test the effect of a patient-centered HIV prevention decision aid on HIV pre-exposure prophylaxis (PrEP) uptake among women with substance use disorders (SUD) in treatment.
Read the detailed description
To test the effect of the informed decision aid intervention on PrEP uptake among women with substance use disorders in treatment. Investigators hypothesize that compared to those receiving standard harm reduction information, women receiving the decision aid will have a significant increase in PrEP uptake at 6 and 12 months post-intervention.
- Conditions
- HIV Infections, Substance Abuse
- Being tested
- Decision aid, Standard care
- Medical subject headings
- HIV Infections, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
Also called PrEP decision aid
Participants in the experimental arm will receive the PrEP decision aid.
Standard careBehavioural
Also called treatment as usual
Standard harm reduction information
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants will receive standard information about harm reduction as available at the drug treatment centers. Receives: Behavioral: Standard care |
| Decision aid | Experimental | Participants in this arm will receive the adapted decision aid for PrEP. Receives: Behavioral: Decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Uptake
PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP.
Measured: 12 months
Secondary outcomes (4)
PrEP Adherence by Self Report
Adherence to PrEP is measured by pill count
Measured: 12 months
PrEP Adherence by Pharmacy Refill
Adherence to PrEP is measured by pharmacy refill data
Measured: 12 months
Changes in PrEP receptiveness
Receptiveness to PrEP (pre- and post- decision aid) is measured on a receptiveness scale (Likert 1-5)
Measured: 12 months
Changes in HIV risk behaviors
Changes in HIV risk is measured by a modified risk assessment form from NIDA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start15 Oct 2018
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A controlled un-blinded pilot study.
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaimie P Meyer, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651453
- Sponsor's protocol ID
- 2000021561
- Status last verified
- Jul 2021
- First submitted
- 1 Aug 2018
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing the Effect of a Patient-Centered HIV Prevention Decision Aid on PrEP Uptake for Women With Substance Use in Treatment Settings
- ClinicalTrials.gov ID
- NCT03651453
- Acronym / sponsor ID
- 2000021561
- Conditions
- HIV Infections, Substance Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 29 Aug 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.
To develop and test the effect of a patient-centered HIV prevention decision aid on HIV pre-exposure prophylaxis (PrEP) uptake among women with substance use disorders (SUD) in treatment.
Detailed description
To test the effect of the informed decision aid intervention on PrEP uptake among women with substance use disorders in treatment. Investigators hypothesize that compared to those receiving standard harm reduction information, women receiving the decision aid will have a significant increase in PrEP uptake at 6 and 12 months post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A controlled un-blinded pilot study.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Behavioral: Standard careParticipants will receive standard information about harm reduction as available at the drug treatment centers. |
| Decision aid | Experimental | Behavioral: Decision aidParticipants in this arm will receive the adapted decision aid for PrEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self- identification as female (i.e., cis- or trans- women), age ≥18, HIV negative status (confirmed with APT date from rapid testing procedures), and entering or receiving treatment at our partnering site, the APT Foundation, Inc. (a drug treatment center).
Key exclusion criteria (1 listed)
- Women on PrEP at baseline, unable or unwilling to provide informed consent, threatening to staff, pregnant, or experiencing symptoms of physiological withdrawal that interfere with ability to provide informed consent
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 |
|---|---|---|
| Decision aidAlso: PrEP decision aidParticipants in the experimental arm will receive the PrEP decision aid. | Behavioural | Decision aid |
| Standard careAlso: treatment as usualStandard harm reduction information | Behavioural | Standard Care |
Primary outcome
PrEP Uptake
Time frame: 12 months
PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP.
4 secondary outcomes
PrEP Adherence by Self Report
Time frame: 12 months
PrEP Adherence by Pharmacy Refill
Time frame: 12 months
Changes in PrEP receptiveness
Time frame: 12 months
Changes in HIV risk behaviors
Time frame: 12 months
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 28 Jul 2021.
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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.
Jaimie P Meyer, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with HIV Infections and Substance Abuse, run by Yale University 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 1 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 28 Jul 2021. 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?
PrEP Uptake (time frame: 12 months). 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 28 Jul 2021.