HIV InfectionimPACTNCT01629316

Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX

A study testing Text reminders, counseling, and link coordination in people with HIV Infection, run by University of North Carolina, Chapel Hill at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Purpose: The purpose of this study is to determine if a comprehensive intervention supporting seek-test-and-treat results in a significant reduction in the potential for HIV-infected prisoners to transmit their virus after release from prison. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection
What is being tested?: Text reminders, counseling, and link coordination
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 381 participants
Where: 2 sitesUnited States
Study dates: Mar 2012to May 2015
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Documented HIV infection
Incarcerated in the NCDOC at a facility within a 3 hour drive from Chapel Hill OR incarcerated in the TDCJ at a facility within a 3 hour drive from Ft. Worth
Age 18 years or older
Receiving ART for at least 30 days
Last recorded viral load (must be within 90 days of entry) <400 copies/mL
English speaking

Show all 11Show fewer

Able and willing to provide informed consent
Willing to participate in post-release study activities
For NC - planning to remain in state after release and returning to a community within a 3 hour drive of Chapel Hill
For TX - returning to one of the following areas: Houston, Dallas, and Ft. Worth (including their suburbs)
Scheduled for release from prison

Who cannot join

Conviction for offenses that includes sexual assault or death or serious injury to a victim or is otherwise found, in the opinion of the investigators, to be at high risk for injury to staff (this criterion is designed to minimize risk to study personnel who will conduct study-related visits with participants in the communities to which they return and may be informed by input from correctional staff)
Pending charges that would likely lead to transfer of custody or other condition which would otherwise prevent or significantly delay release from custody.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Texas Christian University
Fort Worth, Texas, 76129

Other trials in United States

About this study

Official title: CID 1007 - Randomized Controlled Trial of an Augmented Test, Treat, Link & Retain Model for NC and TX Prisoners (imPACT Study)

Aim 2: Compare the effect of standard prison test-and-treat (sTNT) with the TNT-imPACT (imPACT) intervention on viral load 24 weeks following prison release.

Aim 3: Describe and model secondary outcomes, comparing them between sTNT and TNT-imPACT study arms. These outcomes include post-release HIV transmission risk behaviors, incident STIs, adherence to ART, medical care appointments, emergence of ART resistance mutations, and predicted HIV transmission events.

Read the detailed description

For Aims 2 and 3:

Participants:

We will enroll 400 HIV-infected men and women, age 18 years and older who are incarcerated in the NC Department of Correction (NCDOC) or the Texas Department of Criminal Justice (TDCJ) and scheduled for prison release in approximately 12 weeks, who are receiving ART and have an HIV RNA level that is below 400 copies/mL.

Procedures (methods): Participants will be consented, enrolled, and then randomized 1:1 to one of two conditions:

standard test-and-treat (sTNT), which is the current standard of care, wherein following HIV testing, the DOC provides to HIV-infected inmates ART during incarceration and referral to community-based care and services by prison staff as well as a supply of antiretroviral medication (30 days in NC, 10 in TX) upon release, or
TNT-imPACT (imPACT),which includes the sTNT plus our integrated, multi-component intervention targeting multiple levels to enhance adherence to HIV therapy and linkage to and engagement in clinical care, to maintain viral suppression after release.

All participants will be followed for up to 24 weeks post-release.

Conditions: HIV Infection
Being tested: Text reminders, counseling, and link coordination, Standard of care - control arm
Keywords: HIV, prisoners, test, treat, link coordination, retain, behavioral, intervention, text reminders, motivational interviewing, medication adherence
Medical subject headings: HIV Infections, Behavior, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Text reminders, counseling, and link coordinationBehavioural
This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination
Standard of care - control armBehavioural
The control arm is standard of care for each subject.

Study groups in NCT01629316
Study group	Role	What they receive
Text reminders, counseling, link coordinator	Experimental	Text reminders, counseling, link coordination Receives: Behavioral: Text reminders, counseling, and link coordination
Standard of care - control arm	Active comparator	Not described Receives: Behavioral: Standard of care - control arm

What is being measured

The primary outcome is the main question the study is designed to answer.

HIV RNA level (Viral Load)
Measured: Week 24 post-release from prison

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012May 2015

First posted27 Jun 2012 (estimated)
Study startMar 2012
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 381 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01629316
Sponsor's protocol ID: CID 1007 - UNC IRB 10-1183
Other IDs: R01DA030793-01
Acronym: imPACT
Status last verified: Jun 2015
First submitted: 4 Jun 2012
Last updated: 11 Jun 2015
Results posted: No
Data monitoring committee: Yes

Publications

Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet. 2009 Jan 3;373(9657):48-57. doi: 10.1016/S0140-6736(08)61697-9. Epub 2008 Nov 27.
PubMed 19038438
Lima VD, Johnston K, Hogg RS, Levy AR, Harrigan PR, Anema A, Montaner JS. Expanded access to highly active antiretroviral therapy: a potentially powerful strategy to curb the growth of the HIV epidemic. J Infect Dis. 2008 Jul 1;198(1):59-67. doi: 10.1086/588673.
PubMed 18498241
Dieffenbach CW, Fauci AS. Universal voluntary testing and treatment for prevention of HIV transmission. JAMA. 2009 Jun 10;301(22):2380-2. doi: 10.1001/jama.2009.828. No abstract available.
PubMed 19509386
Spaulding AC, Seals RM, Page MJ, Brzozowski AK, Rhodes W, Hammett TM. HIV/AIDS among inmates of and releasees from US correctional facilities, 2006: declining share of epidemic but persistent public health opportunity. PLoS One. 2009 Nov 11;4(11):e7558. doi: 10.1371/journal.pone.0007558.
PubMed 19907649
Leukefeld CG, Staton M, Hiller ML, Logan TK, Warner B, Shaw K, Purvis RT. A descriptive profile of health problems, health services utilization, and HIV serostatus among incarcerated male drug abusers. J Behav Health Serv Res. 2002 May;29(2):167-75. doi: 10.1007/BF02287703.
PubMed 12032974
Springer SA, Pesanti E, Hodges J, Macura T, Doros G, Altice FL. Effectiveness of antiretroviral therapy among HIV-infected prisoners: reincarceration and the lack of sustained benefit after release to the community. Clin Infect Dis. 2004 Jun 15;38(12):1754-60. doi: 10.1086/421392. Epub 2004 May 26.
PubMed 15227623
Baillargeon J, Giordano TP, Rich JD, Wu ZH, Wells K, Pollock BH, Paar DP. Accessing antiretroviral therapy following release from prison. JAMA. 2009 Feb 25;301(8):848-57. doi: 10.1001/jama.2009.202.
PubMed 19244192
Stephenson BL, Wohl DA, Golin CE, Tien HC, Stewart P, Kaplan AH. Effect of release from prison and re-incarceration on the viral loads of HIV-infected individuals. Public Health Rep. 2005 Jan-Feb;120(1):84-8. doi: 10.1177/003335490512000114.
PubMed 15736336
Haley D, Scheyett A, Golin C, et al. Perceptions of Release among Incarcerated HIV-Infected Persons and Implications for Practice: The UNC Bridges to Good Health and Treatment (BRIGHT) Project Qualitative Substudy. Abstract THPE0717. International AIDS Conference, 2006
Stephenson BL, Wohl DA, McKaig R, Golin CE, Shain L, Adamian M, Emrick C, Strauss RP, Fogel C, Kaplan AH. Sexual behaviours of HIV-seropositive men and women following release from prison. Int J STD AIDS. 2006 Feb;17(2):103-8. doi: 10.1258/095646206775455775.
PubMed 16464271
Grinstead O, Zack B, Faigeles B. Reducing postrelease risk behavior among HIV seropositive prison inmates: the health promotion program. AIDS Educ Prev. 2001 Apr;13(2):109-19. doi: 10.1521/aeap.13.2.109.19737.
PubMed 11398956
Best A, Stokols D, Green LW, Leischow S, Holmes B, Buchholz K. An integrative framework for community partnering to translate theory into effective health promotion strategy. Am J Health Promot. 2003 Nov-Dec;18(2):168-76. doi: 10.4278/0890-1171-18.2.168.
PubMed 14621414
Stokols D. Translating social ecological theory into guidelines for community health promotion. Am J Health Promot. 1996 Mar-Apr;10(4):282-98. doi: 10.4278/0890-1171-10.4.282.
PubMed 10159709
Golin CE, Knight K, Carda-Auten J, Gould M, Groves J, L White B, Bradley-Bull S, Amola K, Fray N, Rosen DL, Mugavaro MJ, Pence BW, Flynn PM, Wohl D. Individuals motivated to participate in adherence, care and treatment (imPACT): development of a multi-component intervention to help HIV-infected recently incarcerated individuals link and adhere to HIV care. BMC Public Health. 2016 Sep 6;16(1):935. doi: 10.1186/s12889-016-3511-1.
PubMed 27596559

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CID 1007 - Randomized Controlled Trial of an Augmented Test, Treat, Link & Retain Model for NC and TX Prisoners (imPACT Study)
ClinicalTrials.gov ID: NCT01629316
Acronym / sponsor ID: imPACT / CID 1007 - UNC IRB 10-1183
Conditions: HIV Infection
Keywords: HIV, prisoners, test, treat, link coordination, retain, behavioral, intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 381 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Study start: Mar 2012
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 27 Jun 2012 (estimated)
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.

Aim 2: Compare the effect of standard prison test-and-treat (sTNT) with the TNT-imPACT (imPACT) intervention on viral load 24 weeks following prison release.

Detailed description

For Aims 2 and 3:

Participants:

Procedures (methods): Participants will be consented, enrolled, and then randomized 1:1 to one of two conditions:

standard test-and-treat (sTNT), which is the current standard of care, wherein following HIV testing, the DOC provides to HIV-infected inmates ART during incarceration and referral to community-based care and services by prison staff as well as a supply of antiretroviral medication (30 days in NC, 10 in TX) upon release, or
TNT-imPACT (imPACT),which includes the sTNT plus our integrated, multi-component intervention targeting multiple levels to enhance adherence to HIV therapy and linkage to and engagement in clinical care, to maintain viral suppression after release.

All participants will be followed for up to 24 weeks post-release.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Text reminders, counseling, link coordinator	Experimental	Behavioral: Text reminders, counseling, and link coordinationText reminders, counseling, link coordination
Standard of care - control arm	Active comparator	Behavioral: Standard of care - control arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Documented HIV infection
Incarcerated in the NCDOC at a facility within a 3 hour drive from Chapel Hill OR incarcerated in the TDCJ at a facility within a 3 hour drive from Ft. Worth
Age 18 years or older
Receiving ART for at least 30 days
Last recorded viral load (must be within 90 days of entry) <400 copies/mL

Key exclusion criteria (2 listed)

Conviction for offenses that includes sexual assault or death or serious injury to a victim or is otherwise found, in the opinion of the investigators, to be at high risk for injury to staff (this criterion is designed to minimize risk to study personnel who will conduct study-related visits with participants in the communities to which they return and may be informed by input from correctional staff)
Pending charges that would likely lead to transfer of custody or other condition which would otherwise prevent or significantly delay release from custody.

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
Text reminders, counseling, and link coordinationThis is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination	Behavioural	Text reminders, counseling, link coordinator
Standard of care - control armThe control arm is standard of care for each subject.	Behavioural	Standard of care - control arm

Primary outcome

HIV RNA level (Viral Load)
Time frame: Week 24 post-release from prison

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 11 Jun 2015.
Background: PubMed 19038438Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet. 2009 Jan 3;373(9657):48-57. doi: 10.1016/S0140-6736(08)61697-9. Epub 2008 Nov 27.
Background: PubMed 18498241Lima VD, Johnston K, Hogg RS, Levy AR, Harrigan PR, Anema A, Montaner JS. Expanded access to highly active antiretroviral therapy: a potentially powerful strategy to curb the growth of the HIV epidemic. J Infect Dis. 2008 Jul 1;198(1):59-67. doi: 10.1086/588673.
Background: PubMed 19509386Dieffenbach CW, Fauci AS. Universal voluntary testing and treatment for prevention of HIV transmission. JAMA. 2009 Jun 10;301(22):2380-2. doi: 10.1001/jama.2009.828. No abstract available.
Background: PubMed 19907649Spaulding AC, Seals RM, Page MJ, Brzozowski AK, Rhodes W, Hammett TM. HIV/AIDS among inmates of and releasees from US correctional facilities, 2006: declining share of epidemic but persistent public health opportunity. PLoS One. 2009 Nov 11;4(11):e7558. doi: 10.1371/journal.pone.0007558.
Background: PubMed 12032974Leukefeld CG, Staton M, Hiller ML, Logan TK, Warner B, Shaw K, Purvis RT. A descriptive profile of health problems, health services utilization, and HIV serostatus among incarcerated male drug abusers. J Behav Health Serv Res. 2002 May;29(2):167-75. doi: 10.1007/BF02287703.
Background: PubMed 15227623Springer SA, Pesanti E, Hodges J, Macura T, Doros G, Altice FL. Effectiveness of antiretroviral therapy among HIV-infected prisoners: reincarceration and the lack of sustained benefit after release to the community. Clin Infect Dis. 2004 Jun 15;38(12):1754-60. doi: 10.1086/421392. Epub 2004 May 26.
Background: PubMed 19244192Baillargeon J, Giordano TP, Rich JD, Wu ZH, Wells K, Pollock BH, Paar DP. Accessing antiretroviral therapy following release from prison. JAMA. 2009 Feb 25;301(8):848-57. doi: 10.1001/jama.2009.202.
Background: PubMed 15736336Stephenson BL, Wohl DA, Golin CE, Tien HC, Stewart P, Kaplan AH. Effect of release from prison and re-incarceration on the viral loads of HIV-infected individuals. Public Health Rep. 2005 Jan-Feb;120(1):84-8. doi: 10.1177/003335490512000114.
BackgroundHaley D, Scheyett A, Golin C, et al. Perceptions of Release among Incarcerated HIV-Infected Persons and Implications for Practice: The UNC Bridges to Good Health and Treatment (BRIGHT) Project Qualitative Substudy. Abstract THPE0717. International AIDS Conference, 2006
Background: PubMed 16464271Stephenson BL, Wohl DA, McKaig R, Golin CE, Shain L, Adamian M, Emrick C, Strauss RP, Fogel C, Kaplan AH. Sexual behaviours of HIV-seropositive men and women following release from prison. Int J STD AIDS. 2006 Feb;17(2):103-8. doi: 10.1258/095646206775455775.
Background: PubMed 11398956Grinstead O, Zack B, Faigeles B. Reducing postrelease risk behavior among HIV seropositive prison inmates: the health promotion program. AIDS Educ Prev. 2001 Apr;13(2):109-19. doi: 10.1521/aeap.13.2.109.19737.
Background: PubMed 14621414Best A, Stokols D, Green LW, Leischow S, Holmes B, Buchholz K. An integrative framework for community partnering to translate theory into effective health promotion strategy. Am J Health Promot. 2003 Nov-Dec;18(2):168-76. doi: 10.4278/0890-1171-18.2.168.
Maruschak LM, Beavers R. Bureau of justice statistics: HIV in prisons, 2007-08. U.S. Department of Justice: Bureau of Justice Statistics; 2009 12/09. Report No.: NCJ 228307. http://bjs.ojp.usdoj.gov/content/pub/pdf/hivp08.pdfLink provided by the sponsor.
15\. Sabol WJ, West H and Cooper M. Bureau of justice statistics: Prisoners in 2008. U.S. Department of Justice: Bureau of Justice Statistics; 2009 12/09. Report No.: NCJ 228417. http://bjs.ojp.usdoj.gov/index.cfm?ty=pbdetail\&iid=1763Link provided by the sponsor.

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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.

David A Wohl, MD principal investigator

University of North Carolina, Chapel Hill

Carol Golin, MD principal investigator

University of North Carolina, Chapel Hill

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Text reminders, counseling, and link coordination in people with HIV Infection, run by University of North Carolina, Chapel Hill at 2 sites 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 11 inclusion and 2 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 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

HIV RNA level (Viral Load) (time frame: Week 24 post-release from prison). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01629316, which also lists 14 linked publications.

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 11 Jun 2015.