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Pre-exposure ProphylaxisNCT03226873

Peer Outreach and Navigation Intervention to Increase PrEP Uptake Among Women at High Risk for HIV

A study testing Peer Navigation in people with Pre-exposure Prophylaxis and HIV-1-infection, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot study will assess the feasibility and acceptability of a peer outreach and navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis (PrEP) uptake among women at high risk for HIV. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pre-exposure Prophylaxis, HIV-1-infection
What is being tested?
Peer Navigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
16 Nov 2017to 19 Mar 2018
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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥18 years old
  • fluent in English
  • self-identifies as female or male-to-female transgender (or on the spectrum)

Who cannot join

  • 1) Incapable of providing informed consent (i.e., acutely intoxication, active psychosis, etc.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York Harm Reduction Educators

    New York, New York, 10035

Other trials in United States

About this study

Official title: Assessing the Feasibility and Acceptability of a Peer Outreach and Navigation Intervention to Increase Pre-exposure Prophylaxis Uptake Among Women at High Risk for HIV

This pilot study will assess the feasibility and acceptability of a peer outreach and navigation intervention designed to increase access and promote HIV pre-exposure prophylaxis (PrEP) uptake among women at high risk for HIV.

Read the detailed description

Women who engage in exchange sex (i.e., sex in exchange for money, drugs, or other services) remain are at substantial risk for HIV infection. (1-6) Due to a confluence of social and structural factors, exchange sex is relatively prevalent among women from socially and economically marginalized groups, such as women who are transgender, unstably housed/homeless and/or those who use and/or inject drugs. (1-3, 19-23) The overarching goal of this research is to decrease new HIV infections among women who engage in exchange sex. Daily oral HIV pre-exposure prophylaxis (PrEP) is an innovative method of HIV prevention that women, themselves, can control; as such, PrEP has the potential to reduce the risk of HIV acquisition among women who engage in exchange sex. Therefore, the investigators developed a theory-guided behavioral intervention (PrEP-UP) which utilizes street-based peer outreach and navigation to increase access to PrEP and promote PrEP uptake among women involved in exchange sex. Specifically, PrEP-UP involves a Peer delivering PrEP education and counseling during street-based outreach followed by offer of a PrEP care appointment along with peer navigation (e.g., appointment accompaniment and reminders, etc.) for the first several PrEP care visits. The objective of this study is to assess the feasibility and acceptability of PrEP-UP. To implement PrEP-UP, the investigators will collaborate with an established community-based organization (CBO) in East Harlem, NY, which uses street-based peer outreach and navigation to connect individuals to needed health and social services. Medical and pharmacy records will be reviewed to assess PrEP initiation. The investigators will conduct self-report surveys at baseline and at a week 4-12 follow-up visit that will collect data about sexual and drug use risk behaviors, perceived HIV risk, and PrEP-related knowledge, attitudes, and self-efficacy to assess for temporal changes in these variables. Additionally, individual interviews will be conducted post-intervention with a subset of the women as well as the CBO staff and leadership to access acceptability of the intervention.

Being tested
Peer Navigation
Keywords
HIV prevention, PrEP, peer navigation, women

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer NavigationBehavioural

    Peer education, counseling, and facilitation of PrEP care

Study groups in NCT03226873
Study groupRoleWhat they receive
Peer NavigationExperimentalPrEP-UP involves a Peer delivering PrEP education and counseling during street-based outreach followed by offer of a PrEP care appointment along with peer navigation (e.g., appointment accompaniment and reminders, etc.) for the first several PrEP visits.
Receives: Behavioral: Peer Navigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PrEP prescription filled

    Obtained from medical and/or pharmacy records

    Measured: 4-12 weeks

Secondary outcomes (9)

  1. HIV risk behaviors

    Revised Risk Behavior Assessment (Wechsberg)

    Measured: week 0, 4-12

  2. HIV risk perception

    Perceived HIV Risk Scale (Napper)

    Measured: week 0, 4-12

  3. Interest in PrEP

    PrEP Acceptability Scale (Marcus)

    Measured: week 0

  4. PrEP appointment acceptance

    PrEP appointment acceptance (yes/ no)

    Measured: week 0

  5. PrEP appointment scheduled

    Scheduled PrEP appointment (yes/ no)

    Measured: week 0-12

  6. PrEP appointment attendance

    PrEP appointment attendance (yes/ no)

    Measured: week 0-12

  7. PrEP-related knowledge

    PrEP Knowledge Scale (Rucinski) (Kalichman) (Kalichman) (Whiteside)

    Measured: week 0, 4-12

  8. PrEP-related attitudes

    Attitudes Towards PrEP Measurements (Golub) (Holt) (Mimiaga) (Tobias)

    Measured: week 0, 4-12

  9. PrEP-related self-efficacy

    PrEP Self-Efficacy Scale (adapted from HIV-ASES) (Johnson)

    Measured: week 0, 4-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2017
  2. Study start16 Nov 2017
  3. Primary completion19 Mar 2018
  4. Study completion19 Mar 2018

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03226873
Sponsor's protocol ID
2017-8139
Other IDs
1U01PS005111-01
Status last verified
Jul 2018
First submitted
19 Jul 2017
Last updated
16 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dunkle KL, Wingood GM, Camp CM, DiClemente RJ. Economically motivated relationships and transactional sex among unmarried African American and white women: results from a U.S. national telephone survey. Public Health Rep. 2010 Jul-Aug;125 Suppl 4(Suppl 4):90-100. doi: 10.1177/00333549101250S413.

    PubMed 20626196

  • Jenness SM, Kobrak P, Wendel T, Neaigus A, Murrill CS, Hagan H. Patterns of exchange sex and HIV infection in high-risk heterosexual men and women. J Urban Health. 2011 Apr;88(2):329-41. doi: 10.1007/s11524-010-9534-5.

    PubMed 21286827

  • Sinoean C. LR, Nerlander L.M., Paz-Bailey G. Prevalence and Correlates of Exchange Sex among Low-Income Heterosexual Women in 21 Cities. Conference on Retroviruses and Opportunistic Infections. Seattle, WA2015.

  • Denning P. HK, Paz-Bailey G.; for the NHBS Study Group. High Levels of HIV Infection Risk among Male Sex Partners of Low-Income Black Women in the United States. International AIDS Society on HIV Pathogenesis. Vancouver, Canada2015.

  • Operario D, Soma T, Underhill K. Sex work and HIV status among transgender women: systematic review and meta-analysis. J Acquir Immune Defic Syndr. 2008 May 1;48(1):97-103. doi: 10.1097/QAI.0b013e31816e3971.

    PubMed 18344875

  • Herbst JH, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N; HIV/AIDS Prevention Research Synthesis Team. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008 Jan;12(1):1-17. doi: 10.1007/s10461-007-9299-3. Epub 2007 Aug 13.

    PubMed 17694429

  • Rucinski KB, Mensah NP, Sepkowitz KA, Cutler BH, Sweeney MM, Myers JE. Knowledge and use of pre-exposure prophylaxis among an online sample of young men who have sex with men in New York City. AIDS Behav. 2013 Jul;17(6):2180-4. doi: 10.1007/s10461-013-0443-y.

    PubMed 23479003

  • Kalichman SC, Benotsch E, Suarez T, Catz S, Miller J, Rompa D. Health literacy and health-related knowledge among persons living with HIV/AIDS. Am J Prev Med. 2000 May;18(4):325-31. doi: 10.1016/s0749-3797(00)00121-5.

    PubMed 10788736

  • Kalichman SC, Rompa D. Functional health literacy is associated with health status and health-related knowledge in people living with HIV-AIDS. J Acquir Immune Defic Syndr. 2000 Dec 1;25(4):337-44. doi: 10.1097/00042560-200012010-00007.

    PubMed 11114834

  • Whiteside YO, Harris T, Scanlon C, Clarkson S, Duffus W. Self-perceived risk of HIV infection and attitudes about preexposure prophylaxis among sexually transmitted disease clinic attendees in South Carolina. AIDS Patient Care STDS. 2011 Jun;25(6):365-70. doi: 10.1089/apc.2010.0224. Epub 2011 Apr 6.

    PubMed 21470046

  • Golub SA, Kowalczyk W, Weinberger CL, Parsons JT. Preexposure prophylaxis and predicted condom use among high-risk men who have sex with men. J Acquir Immune Defic Syndr. 2010 Aug;54(5):548-55. doi: 10.1097/QAI.0b013e3181e19a54.

    PubMed 20512046

  • Holt M, Murphy D, Callander D, Ellard J, Rosengarten M, Kippax S, de Wit J. HIV-negative and HIV-positive gay men's attitudes to medicines, HIV treatments and antiretroviral-based prevention. AIDS Behav. 2013 Jul;17(6):2156-61. doi: 10.1007/s10461-012-0313-z.

    PubMed 23001412

  • Mimiaga MJ, Case P, Johnson CV, Safren SA, Mayer KH. Preexposure antiretroviral prophylaxis attitudes in high-risk Boston area men who report having sex with men: limited knowledge and experience but potential for increased utilization after education. J Acquir Immune Defic Syndr. 2009 Jan 1;50(1):77-83. doi: 10.1097/QAI.0b013e31818d5a27.

    PubMed 19295337

  • Tobias CR, Cunningham W, Cabral HD, Cunningham CO, Eldred L, Naar-King S, Bradford J, Sohler NL, Wong MD, Drainoni ML. Living with HIV but without medical care: barriers to engagement. AIDS Patient Care STDS. 2007 Jun;21(6):426-34. doi: 10.1089/apc.2006.0138.

    PubMed 17594252

  • Johnson MO, Neilands TB, Dilworth SE, Morin SF, Remien RH, Chesney MA. The role of self-efficacy in HIV treatment adherence: validation of the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). J Behav Med. 2007 Oct;30(5):359-70. doi: 10.1007/s10865-007-9118-3. Epub 2007 Jun 23.

    PubMed 17588200

Questions about this trial

What is this clinical trial studying?

A study testing Peer Navigation in people with Pre-exposure Prophylaxis and HIV-1-infection, run by Montefiore Medical Center 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 3 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 16 Jul 2018. 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 prescription filled (time frame: 4-12 weeks). 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 NCT03226873, which also lists 23 linked publications.

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 16 Jul 2018.

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