Skip to main content
OpenTrials
Completed

NCT Number: NCT03175094

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale AIDS Program

New Haven, Connecticut, 06106, United States

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2017
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.