NCT03651453

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2020

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

August 1, 2018

Last Update Submit

July 27, 2021

Conditions

HIV InfectionsSubstance Abuse

Outcome Measures

Primary Outcomes (1)

  • PrEP Uptake

    PrEP uptake is measured by attending an appointment with a provider for the purposes of starting PrEP.

    12 months

Secondary Outcomes (4)

  • PrEP Adherence by Self Report

    12 months

  • PrEP Adherence by Pharmacy Refill

    12 months

  • Changes in PrEP receptiveness

    12 months

  • Changes in HIV risk behaviors

    12 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Participants will receive standard information about harm reduction as available at the drug treatment centers.

Behavioral: Standard care

Decision aid

EXPERIMENTAL

Participants in this arm will receive the adapted decision aid for PrEP.

Behavioral: Decision aid

Interventions

Decision aidBEHAVIORAL

Participants in the experimental arm will receive the PrEP decision aid.

Also known as: PrEP decision aid
Decision aid
Standard careBEHAVIORAL

Standard harm reduction information

Also known as: treatment as usual
Standard Care

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailscis- or trans- female eligible
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale AIDS Program

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

HIV InfectionsSubstance-Related Disorders

Interventions

Decision Support TechniquesStandard of CareTherapeutics

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative TechniquesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jaimie P Meyer, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
A controlled un-blinded pilot study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A controlled un-blinded pilot study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 29, 2018

Study Start

October 15, 2018

Primary Completion

June 11, 2020

Study Completion

June 11, 2020

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

US(1)