NCT03684252

Brief Summary

The investigators propose to lay the groundwork for a larger effectiveness clinical trial that will lead to the advancement of a novel evidence-based treatment for DUD and HIV among Spanish-speaking Latinos who suffer from self-stigma and have inadequate treatment adherence. This pilot project aims to: compare the outcomes of a culturally adapted CBT-based intervention to treatment as usual (TAU), in a randomized pilot trial of HIV+ individuals with a lifetime DUD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

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

September 14, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

September 14, 2018

Last Update Submit

October 1, 2019

Conditions

Drug Use DisordersHIV/AIDS

Keywords

Self-stigmaDrug Use DisordersHIV

Outcome Measures

Primary Outcomes (1)

  • Substance Abuse Self-stigma Scale (change is being assessed)

    Psychometrically sound and culturally adapted, this is a 40-item scale that contains four sub-scales that measures self-devaluation, fear of enacted stigma, stigma avoidance, and values disengagement due to self stigma. Internal consistency coefficients for the sub-scales ranged from .82 to .88. Study participants will need to endorse at least three items from the self-devaluation sub-scale to be considered as presenting self-stigma (this will be used as an inclusion criteria). Item endorsement will be analyzed as a count, per sub-scale. The greater number of items endorsed per sub-scale, will be indicative of a higher level of self-stigma as manifested by the sub-scale construct.

    Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after

Secondary Outcomes (3)

  • HIV Felt-stigma Scale (change is being assessed)

    Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after

  • Depressive symptoms (change is being assessed)

    Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after

  • Adherence to Combination Therapy Questionnaire (change is being assessed)

    Change from baseline/pre-treatment at any point from last intervention (for both groups) to up to 2 weeks after

Study Arms (2)

Control

OTHER

Treatment as usual

Other: Treatment as Usual

Intervention

EXPERIMENTAL

CBT-based intervention

Behavioral: CBT-based intervention

Interventions

CBT-based interventionBEHAVIORAL

Cognitive Behavioral Therapy (CBT) that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies.

Intervention
Treatment as UsualOTHER

Participants' will receive treatment as usual.

Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spanish speakers that comply with
  • A drug use disorder based on the Spanish version of the short form of the WHO Composite International Diagnostic Interview (CIDI) that has been used widely in Puerto Rico;
  • HIV clinical criteria;
  • Moderate to higher levels of HIV felt self-stigma (\>25);
  • Using the clinic as the main source of medical care during the study; and
  • Agreement to random assignment

You may not qualify if:

  • DUD/HIV+ individuals who are not prescribed ART;
  • An acute medical emergency (physical or psychiatric),
  • Unable to provide informed consent
  • Who are actively suicidal.
  • Cognitive impairment or dementia based on a score of 24 or less on the Mini Mental State Examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Puerto Rico Medical Sciences Campus

San Juan, 00936, Puerto Rico

Location

MeSH Terms

Conditions

Substance-Related DisordersAcquired Immunodeficiency Syndrome

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Coralee Perez-Pedrogo, PhD

    University of Puerto Rico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 25, 2018

Study Start

April 9, 2019

Primary Completion

June 25, 2019

Study Completion

August 31, 2019

Last Updated

October 2, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

PR(1)