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PLUS PINK: HHRP+ Adaptation for Women With HIV Under Community Supervision

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03175094
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : March 26, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
After enrollment, participants will be randomized to either receive the intervention (treatment) from trained health educators or undergo observation as usual (control group). Randomization will be stratified by HIV serostatus. A control group is appropriate because participants will still receive services offered through probation and will be offered the intervention after completion of the trial. Subjects will be paid, not for participating in the intervention, but for providing research assessments. The newly adapted intervention will be delivered over no more than a 3-month period (it will be shorter if the adaptation process is supportive). Baseline assessments will assess the pre-intervention period. The 3-month assessment will be the end-of-intervention effects and the post-intervention assessments will be at 6, 9 and 12 months. HIV prevention knowledge will be assessed based on quizzes used previously for HHRP+; though final quiz content will depend on final selected materials for the intervention. Subjects will be followed for 12 months with assessments by trained research assistants.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Holistic Health Recovery Program for HIV+ Not Applicable

Detailed Description:

The aim of this study is to adapt and pilot test the Holistic Health Recovery Program for women with and at risk for HIV (HHRP+), a CDC evidence-based secondary HIV prevention intervention, that will serve as a framework to optimize HIV treatment outcomes and reduce HIV-associated risk for women under correctional community supervision.

Hypotheses

  1. It will be feasible to recruit and retain HIV+ and at-risk women under community correctional supervision in the pilot study.
  2. Using the ADAPT-ITT methods, we will be able to adequately adapt HHRP+ for HIV-infected and at-risk women under community supervision.
  3. The adapted intervention will be feasible to implement and acceptable to participants.
  4. The adapted intervention will produce higher measureable preliminary effects on HIV-focused treatment outcomes in the intervention group compared with the control group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: PLUS PINK: HHRP+ Adaptation for Women With HIV Under Community Supervision
Actual Study Start Date : October 2015
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Holistic Health Recovery Program for HIV+ Intervention Behavioral: Holistic Health Recovery Program for HIV+
Holistic Health Recovery Program for HIV+ (HHRP+) is a CDC-recommended, evidence based behavioral (psychoeducational) group intervention focused on harm reduction principles. The investigators systematically adapted HHRP+ using findings from qualitative interviews with the target population of adult women living with and at-risk for HIV who are justice-involved (on probation, parole, or recently released from prison or jail).

No Intervention: Control



Primary Outcome Measures :
  1. Change in HIV knowledge from baseline [ Time Frame: 3 months ]
    HIV knowledge quiz with scores ranging from 0-100, a higher score indicating better knowledge


Secondary Outcome Measures :
  1. Change in Sex-related risk behaviors over time [ Time Frame: baseline, 6 months, 12 months ]
    NIDA Risk Behavior Assessment (0-18 with higher scores indicating higher risk)

  2. Change in Injection-related risk behaviors over time [ Time Frame: baseline, 6 months, 12 months ]
    NIDA Risk Behavior Assessment (0-18 with higher scores indicating higher risk)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥18 years old
  • female
  • have laboratory confirmed HIV OR are at-risk for HIV (ever injected drugs, ever engaged in commercial sex work, were incarcerated in prison or jail within the past 2 years, had condomless sex with an HIV+ partner or partner whose HIV status is unknown in the past 90 days, or had a diagnosed sexually transmitted infection in the past 90 days),
  • and are under or anticipating transfer to probation.are either a) sentenced to probation or on intensive pretrial supervision by a probation officer; b) sentenced to parole; or c) incarcerated in jail or prison in the prior 60 days.

Potential participants will be excluded

Exclusion Criteria:

  • unable or unwilling to provide informed consent,
  • have <3 months of remaining scheduled supervision term,
  • or are threatening to staff

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175094


Locations
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United States, Connecticut
Yale AIDS Program
New Haven, Connecticut, United States, 06106
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Jaimie Meyer, M.D., M.S. Yale University
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03175094    
Other Study ID Numbers: 1407014291
K23DA033858 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
women
HIV prevention
criminal justice