PLUS PINK: HHRP+ Adaptation for Women With HIV Under Community Supervision
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|ClinicalTrials.gov Identifier: NCT03175094|
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : March 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Holistic Health Recovery Program for HIV+||Not Applicable|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|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|
|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|
- 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
- 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)
- 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)
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
|United States, Connecticut|
|Yale AIDS Program|
|New Haven, Connecticut, United States, 06106|
|Principal Investigator:||Jaimie Meyer, M.D., M.S.||Yale University|