“Get Ready and Empowered About Treatment” (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV

  • Jennifer K. Carroll
  • Jonathan N. Tobin
  • Amneris Luque
  • Subrina Farah
  • Mechelle Sanders
  • Andrea Cassells
  • Steven M. Fine
  • Wendi Cross
  • Michele Boyd
  • Tameir Holder
  • Marie Thomas
  • Cleo Clarize Overa
  • Kevin FiscellaEmail author
Original Research



Little is known about strategies to improve patient activation, particularly among persons living with HIV (PLWH).


To assess the impact of a group intervention and individual coaching on patient activation for PLWH.


Pragmatic randomized controlled trial.


Eight practices in New York and two in New Jersey serving PLWH.


Three hundred sixty PLWH who received care at participating practices and had at least limited English proficiency and basic literacy.


Six 90-min group training sessions covering use of an ePersonal Health Record loaded onto a handheld mobile device and a single 20–30 min individual pre-visit coaching session.

Main Measures

The primary outcome was change in Patient Activation Measure (PAM). Secondary outcomes were changes in eHealth literacy (eHEALS), Decision Self-efficacy (DSES), Perceived Involvement in Care Scale (PICS), health (SF-12), receipt of HIV-related care, and change in HIV viral load (VL).

Key Results

The intervention group showed significantly greater improvement than the control group in the primary outcome, the PAM (difference 2.82: 95% confidence interval [CI] 0.32–5.32). Effects were largest among participants with lowest quartile PAM at baseline (p < 0.05). The intervention doubled the odds of improving one level on the PAM (odds ratio 1.96; 95% CI 1.16–3.31). The intervention group also had significantly greater improvement in eHEALS (difference 2.67: 95% CI 1.38–3.9) and PICS (1.27: 95% CI 0.41–2.13) than the control group. Intervention effects were similar by race/ethnicity and low education with the exception of eHealth literacy where effects were stronger for minority participants. No statistically significant effects were observed for decision self-efficacy, health status, adherence, receipt of HIV relevant care, or HIV viral load.


The patient activation intervention modestly improved several domains related to patient empowerment; effects on patient activation were largest among those with the lowest levels of baseline patient activation.

Trial Registration

This study is registered at Clinical Trials.Gov (NCT02165735).

Key Words

patient participation self-care HIV computer literacy health literacy 



Participating sites: Family Health Centers at NYU Langone, Brooklyn, NY; Horizon Health Center (Alliance Community Healthcare), Jersey City, NJ; Metropolitan Family Health Network, Jersey City, NJ; Morris Heights Health Center, Bronx, NY; Anthony Jordan Health Center, Rochester, NY; Strong Memorial Hospital/Infectious Diseases, Rochester, NY; Trillium Health, Rochester, NY; and Rochester Regional Health/Unity Hospital, Rochester, NY.

Authors’ Contributions

All authors listed have contributed sufficiently to the project to be included as authors, and all those who are qualified to be authors are listed in the author byline.


Patient-Centered Outcomes Research Institute [Grant# AD-1306-03104]

Compliance with Ethical Standards

Conflict of Interest

The authors declare that they do not have a conflict of interest.

Supplementary material

11606_2019_5102_MOESM1_ESM.docx (17 kb)
ESM 1 (DOCX 16 kb)


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Copyright information

© Society of General Internal Medicine 2019

Authors and Affiliations

  • Jennifer K. Carroll
    • 1
  • Jonathan N. Tobin
    • 2
  • Amneris Luque
    • 3
  • Subrina Farah
    • 4
  • Mechelle Sanders
    • 4
  • Andrea Cassells
    • 2
  • Steven M. Fine
    • 5
  • Wendi Cross
    • 6
  • Michele Boyd
    • 4
  • Tameir Holder
    • 2
  • Marie Thomas
    • 4
  • Cleo Clarize Overa
    • 2
  • Kevin Fiscella
    • 4
    • 5
    Email author
  1. 1.Department of Family MedicineUniversity of ColoradoAuroraUSA
  2. 2.Clinical Directors Network, Inc. (CDN)New YorkUSA
  3. 3.Department of MedicineUniversity of Texas Southwestern Medical CenterDallasUSA
  4. 4.Department of Family Medicine, Family Medicine Research Programs University of RochesterRochesterUSA
  5. 5.Department of Family MedicineUniversity of RochesterRochesterUSA
  6. 6.Department of PsychiatryUniversity of RochesterRochesterUSA

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