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

NCT03175094 | Completed

• 2 other identifiers: 1407014291K23DA033858
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

women; HIV prevention; criminal justice

Outcome Measures

Primary Outcomes (1)

• Change in HIV knowledge from baseline

  HIV knowledge quiz with scores ranging from 0-100, a higher score indicating better knowledge

  3 months

Secondary Outcomes (2)

• Change in Sex-related risk behaviors over time

  baseline, 6 months, 12 months

• Change in Injection-related risk behaviors over time

  baseline, 6 months, 12 months

Study Arms (2)

Holistic Health Recovery Program for HIV+ Intervention

EXPERIMENTAL

Behavioral: Holistic Health Recovery Program for HIV+

Control

NO INTERVENTION

Interventions

Holistic Health Recovery Program for HIV+ BEHAVIORAL

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).

Holistic Health Recovery Program for HIV+ Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale AIDS Program

New Haven, Connecticut, 06106, United States

Location

MeSH Terms

Interventions

Seroconversion

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Jaimie Meyer, M.D., M.S.

  Yale University

  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: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 5, 2017
• Study Start: March 3, 2015
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)