NCT02923141

Brief Summary

The Purpose of this study is to see if it is possible to deliver an intervention that targets trauma, substance use, and engagement in HIV care with HIV-positive women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

September 28, 2016

Last Update Submit

September 25, 2018

Conditions

Human Immunodeficiency VirusSubstance Related DisorderPost Traumatic Stress Disorder

Keywords

substance usetraumaHIVviral loadwomen

Outcome Measures

Primary Outcomes (1)

  • Reduction in HIV RNA Copies/mL

    6 months

Secondary Outcomes (6)

  • Increase in T-helper (CD4+) cell count

    6 months

  • Reduction in HIV transmission risk

    6 months

  • Decrease in stimulant use

    6 months

  • Decrease in stimulant use

    6 months

  • Decrease in post-traumatic stress disorder (PTSD) symptoms

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Neutral Writing + Contingency Management

ACTIVE COMPARATOR

Participants will attend four attention-matched control sessions, consisting of face-to-face administration of psychological measures and neutral writing exercises. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result.

Behavioral: Neutral WritingBehavioral: Contingency Management

Expressive Writing + Contingency Management

ACTIVE COMPARATOR

Participants will attend four expressive writing sessions focusing on traumatic or stressful events. Participants will also take part in 36 contingency management sessions in which they provide self-collected urine for toxicology screening and receive financial incentives for each negative drug result.

Behavioral: Expressive WritingBehavioral: Contingency Management

Interventions

Neutral WritingBEHAVIORAL
Neutral Writing + Contingency Management
Expressive WritingBEHAVIORAL
Expressive Writing + Contingency Management
Contingency ManagementBEHAVIORAL
Expressive Writing + Contingency ManagementNeutral Writing + Contingency Management

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIdentify as a woman (cisgender or transgender)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • woman or trans woman
  • substance use
  • elevated PTSD symptoms
  • HIV care difficulties

You may not qualify if:

  • not HIV positive
  • no substance use
  • men
  • no HIV care difficulties
  • no history of trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Building

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • Jemison D, Jackson S, Oni O, Cats-Baril D, Thomas-Smith S, Batchelder A, Rodriguez A, Dilworth SE, Metsch LR, Jones D, Feaster DJ, O'Cleirigh C, Ironson G, Carrico AW. Pilot Randomized Controlled Trial of a Syndemics Intervention with HIV-Positive, Cocaine-Using Women. AIDS Behav. 2019 Sep;23(9):2467-2476. doi: 10.1007/s10461-019-02625-2.

    PMID: 31407212DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSubstance-Related DisordersStress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Adam Carrico, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Public Health Sciences and Psychology

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 4, 2016

Study Start

January 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 27, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)