Clinical trial NCT03175094: PLUS PINK: HHRP+ Adaptation for Women With HIV Under Community Supervision
Official title: PLUS PINK: HHRP+ Adaptation for Women With HIV Under Community Supervision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: women
HIV prevention
criminal justice
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-06-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in HIV knowledge from baseline
timeFrame: 3 months
Secondary outcomes:
measure: Change in Sex-related risk behaviors over time
timeFrame: baseline, 6 months, 12 months
measure: Change in Injection-related risk behaviors over time
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale AIDS Program
state: Connecticut
Study officials:
affiliation: Yale University
name: Jaimie Meyer, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: