PreventionNCT03281343
Linking Women to PrEP Care
A study testing Motivational Interviewing & Patient Navigator in people with Prevention, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women at high-risk for HIV but is underused in this population. Periods of incarceration represent an opportunity to identify women at risk and link them to PrEP care as they leave jail or prison. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prevention
- What is being tested?
- Motivational Interviewing & Patient Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 31 Aug 2023
- 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
- Female at birth; at least 18 years of age; not currently pregnant; risk behavior prior to incarceration that meets CDC indications for PrEP; likely to be incarcerated for less than 6 months; able to understand and speak English and to provide written and verbal informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Linkage to Community-Based HIV Pre-Exposure Prophylaxsis Care Among at Risk Women Upon Release From Incarceration
Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women at high-risk for HIV but is underused in this population. Periods of incarceration represent an opportunity to identify women at risk and link them to PrEP care as they leave jail or prison. This study aims to improve linkage to community-based PrEP care to reduce HIV acquisition in a high-need, underserved community.
Read the detailed description
Incarcerated women engage in high rates of sex- and drug-related behavior that place them at risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV acquisition. There is a general lack of knowledge regarding PrEP among women at elevated risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The period of incarceration represents an opportunity to identify at-risk women, initiate PrEP during incarceration, and establish linkage to community-based PrEP care upon release from incarceration. Further, post-release is a time period that is particularly risky, and there are numerous barriers that may impede linkage to community-based care in the absence of intervention.
To date, very little research has been done to improve linkage to PrEP care among US women. The proposed study will examine the acceptability, feasibility, and preliminary efficacy of a psychoeducation and motivational interviewing intervention to promote PrEP initiation during incarceration, followed by a patient navigator intervention to facilitate linkage to community-based PrEP care upon release from incarceration. The long-term goal of this line of research is to disseminate an efficacious PrEP Care linkage intervention for at-risk women post-release from incarceration. The present proposal seeks to develop intervention materials and conduct a small randomized controlled trial (RCT) of the intervention.
- Conditions
- Prevention
- Being tested
- Motivational Interviewing & Patient Navigator, Standard of Care (SOC)
- Keywords
- PrEP, Women, Linkage to Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing & Patient NavigatorBehavioural
The specific content, structure, and implementation approach for MI-NAV will be guided by IDIs conducted during Phase 1 and Phase 2. Our initial plan is to deliver MI-NAV in two waves. The first wave will be aimed at promoting uptake of PrEP at the prison, through the use of motivational interviewing. The second wave will be aimed at linking at-risk women to community-based PrEP care upon release from incarceration, by utilizing a patient navigator approach.
Standard of Care (SOC)Behavioural
SOC will consist of a pamphlet regarding PrEP during incarceration, an offer of PrEP while incarcerated, and referral to community-based PrEP care upon release.
| Study group | Role | What they receive |
|---|---|---|
| MI-NAV | Experimental | A study therapist will deliver a motivational interviewing session with participants while they are incarcerated and serve as a role of patient navigator post-release. Receives: Behavioral: Motivational Interviewing & Patient Navigator |
| Standard of Care (SOC) | Active comparator | Approximates care currently provided at the prison. Receives: Behavioral: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of linkage to community-based PrEP care
Linkage to community-based care is operationalized as receipt of a prescription for PrEP from a community-based provider within 3 months of release from prison, confirmed through medical record data extraction.
Measured: 3 Months post-release
Secondary outcomes (6)
PrEP Adherence
PrEP adherence will be determined by drug concentrations in urine samples collected from participants who have been prescribed PrEP at 3 and 6 months. Presence of PrEP will be assessed with immunoassay developed by UrSure Inc.
Measured: 3 Months and 6 Months post-release
PrEP Care Retention
PrEP retention in care will be defined as attending 3-month clinical appointments (+/- 1 month) which is in accordance with current CDC guidelines. This will be verified with medical records.
Measured: 3 Month clinical appointments (+/- 1 month)
Alcohol and Drug Use
The Timeline Followback (TLFB) will be used to assess alcohol and drug use behavior at baseline, as well as during the follow-up interviews.
Measured: 6-months
HIV Risk Behavior
The TLFB will be used to assess drug and sex risk behavior at baseline and during the follow-up interviews. In addition, the HIV Risk Assessment Battery will serve as a measure of overall sex and drug risk behavior.
Measured: 6-months
Depressive Symptoms
The Center for Epidemiologic Studies Depression Scale (CES-D) will be administered at baseline and follow-up interviews to assess depressive symptoms
Measured: 6-months
Treatment Received and Medications/Pregnancies
The Treatment Services Review (TSR) and Use of Medications Questionnaire will be used to measure the number and types of treatment services utilized, medications prescribed, and pregnancies experienced during the follow-up period.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start29 Nov 2017
- Primary completion31 Oct 2022
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreventionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan E Ramsey, Ph.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281343
- Sponsor's protocol ID
- R34DA045621
- Status last verified
- Apr 2023
- First submitted
- 11 Sep 2017
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ramsey SE, Ames EG, Brinkley-Rubinstein L, Teitelman AM, Clarke J, Kaplan C. Linking women experiencing incarceration to community-based HIV pre-exposure prophylaxis care: protocol of a pilot trial. Addict Sci Clin Pract. 2019 Mar 4;14(1):8. doi: 10.1186/s13722-019-0137-5.
PubMed 30832717
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linkage to Community-Based HIV Pre-Exposure Prophylaxsis Care Among at Risk Women Upon Release From Incarceration
- ClinicalTrials.gov ID
- NCT03281343
- Acronym / sponsor ID
- R34DA045621
- Conditions
- Prevention
- Keywords
- PrEP, Women, Linkage to Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 13 Sep 2017 (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.
Pre-exposure prophylaxis (PrEP) can be very effective at preventing HIV infection among women at high-risk for HIV but is underused in this population. Periods of incarceration represent an opportunity to identify women at risk and link them to PrEP care as they leave jail or prison. This study aims to improve linkage to community-based PrEP care to reduce HIV acquisition in a high-need, underserved community.
Detailed description
Incarcerated women engage in high rates of sex- and drug-related behavior that place them at risk for HIV. Pre-exposure prophylaxis (PrEP) is an efficacious means of reducing HIV acquisition. There is a general lack of knowledge regarding PrEP among women at elevated risk, and only a small percentage of at-risk women are currently engaged in PrEP care. The period of incarceration represents an opportunity to identify at-risk women, initiate PrEP during incarceration, and establish linkage to community-based PrEP care upon release from incarceration. Further, post-release is a time period that is particularly risky, and there are numerous barriers that may impede linkage to community-based care in the absence of intervention.
To date, very little research has been done to improve linkage to PrEP care among US women. The proposed study will examine the acceptability, feasibility, and preliminary efficacy of a psychoeducation and motivational interviewing intervention to promote PrEP initiation during incarceration, followed by a patient navigator intervention to facilitate linkage to community-based PrEP care upon release from incarceration. The long-term goal of this line of research is to disseminate an efficacious PrEP Care linkage intervention for at-risk women post-release from incarceration. The present proposal seeks to develop intervention materials and conduct a small randomized controlled trial (RCT) of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI-NAV | Experimental | Behavioral: Motivational Interviewing & Patient NavigatorA study therapist will deliver a motivational interviewing session with participants while they are incarcerated and serve as a role of patient navigator post-release. |
| Standard of Care (SOC) | Active comparator | Behavioral: Standard of Care (SOC)Approximates care currently provided at the prison. |
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)
- Female at birth; at least 18 years of age; not currently pregnant; risk behavior prior to incarceration that meets CDC indications for PrEP; likely to be incarcerated for less than 6 months; able to understand and speak English and to provide written and verbal informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Motivational Interviewing & Patient NavigatorThe specific content, structure, and implementation approach for MI-NAV will be guided by IDIs conducted during Phase 1 and Phase 2. Our initial plan is to deliver MI-NAV in two waves. The first wave will be aimed at promoting uptake of PrEP at the prison, through the use of motivational interviewing. The second wave will be aimed at linking at-risk women to community-based PrEP care upon release from incarceration, by utilizing a patient navigator approach. | Behavioural | MI-NAV |
| Standard of Care (SOC)SOC will consist of a pamphlet regarding PrEP during incarceration, an offer of PrEP while incarcerated, and referral to community-based PrEP care upon release. | Behavioural | Standard of Care (SOC) |
Primary outcome
Rates of linkage to community-based PrEP care
Time frame: 3 Months post-release
Linkage to community-based care is operationalized as receipt of a prescription for PrEP from a community-based provider within 3 months of release from prison, confirmed through medical record data extraction.
6 secondary outcomes
PrEP Adherence
Time frame: 3 Months and 6 Months post-release
PrEP Care Retention
Time frame: 3 Month clinical appointments (+/- 1 month)
Alcohol and Drug Use
Time frame: 6-months
HIV Risk Behavior
Time frame: 6-months
Depressive Symptoms
Time frame: 6-months
Treatment Received and Medications/Pregnancies
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 30832717Ramsey SE, Ames EG, Brinkley-Rubinstein L, Teitelman AM, Clarke J, Kaplan C. Linking women experiencing incarceration to community-based HIV pre-exposure prophylaxis care: protocol of a pilot trial. Addict Sci Clin Pract. 2019 Mar 4;14(1):8. doi: 10.1186/s13722-019-0137-5.
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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.
Susan E Ramsey, Ph.D. principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing & Patient Navigator in people with Prevention, run by Rhode Island Hospital 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 0 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: status not confirmed, as of the sponsor's last update on 5 Apr 2023. 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?
Results are not available in the source record.
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?
Rates of linkage to community-based PrEP care (time frame: 3 Months post-release). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281343, which also lists 1 linked publication.
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 5 Apr 2023.