HIVNCT03175094
PLUS PINK: HHRP+ Adaptation for Women With HIV Under Community Supervision
A study testing Holistic Health Recovery Program for HIV+ in people with HIV, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV
- What is being tested?
- Holistic Health Recovery Program for HIV+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2015to 10 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable or unwilling to provide informed consent,
- have <3 months of remaining scheduled supervision term,
- or are threatening to staff
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- 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.
- Conditions
- HIV
- Being tested
- Holistic Health Recovery Program for HIV+
- Keywords
- women, HIV prevention, criminal justice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holistic Health Recovery Program for HIV+Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Holistic Health Recovery Program for HIV+ Intervention | Experimental | Not described Receives: Behavioral: Holistic Health Recovery Program for HIV+ |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV knowledge from baseline
HIV knowledge quiz with scores ranging from 0-100, a higher score indicating better knowledge
Measured: 3 months
Secondary outcomes (2)
Change in Sex-related risk behaviors over time
NIDA Risk Behavior Assessment (0-18 with higher scores indicating higher risk)
Measured: baseline, 6 months, 12 months
Change in Injection-related risk behaviors over time
NIDA Risk Behavior Assessment (0-18 with higher scores indicating higher risk)
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start3 Mar 2015
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jaimie Meyer, M.D., M.S., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175094
- Sponsor's protocol ID
- 1407014291
- Other IDs
- K23DA033858
- Status last verified
- Aug 2021
- First submitted
- 24 May 2017
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLUS PINK: HHRP+ Adaptation for Women With HIV Under Community Supervision
- ClinicalTrials.gov ID
- NCT03175094
- Acronym / sponsor ID
- 1407014291
- Conditions
- HIV
- Keywords
- women, HIV prevention, criminal justice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Mar 2015 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holistic Health Recovery Program for HIV+ Intervention | Experimental | Behavioral: Holistic Health Recovery Program for HIV+ |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- unable or unwilling to provide informed consent,
- have <3 months of remaining scheduled supervision term,
- or are threatening to staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Holistic Health Recovery Program for HIV+ Intervention |
Primary outcome
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
2 secondary outcomes
Change in Sex-related risk behaviors over time
Time frame: baseline, 6 months, 12 months
Change in Injection-related risk behaviors over time
Time frame: baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaimie Meyer, M.D., M.S. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holistic Health Recovery Program for HIV+ in people with HIV, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIV knowledge from baseline (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.