PLUS PINK: HHRP+ Adaptation for Women With HIV Under Community Supervision
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | October 2015 |
| End Date: | November 30, 2017 |
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.
(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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
