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Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care

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ClinicalTrials.gov Identifier: NCT02938533
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Ministry of Health, Tanzania
Mexican National Institute of Public Health
Information provided by (Responsible Party):
University of California, Berkeley

Tracking Information
First Submitted Date  ICMJE October 11, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date October 30, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Retention in care, defined as an attended visit between 150-210 days after the baseline visit [ Time Frame: 6 months ]
    This measure of retention in care accounts for variability in visit scheduling by individual providers and therefore uses a window period of 150-210 days to determine whether the patient was in care at 6 months
  • >=95% medication possession ratio (MPR) [ Time Frame: 6 months ]
    MPR is a measure of ART adherence that is correlated with viral suppression
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02938533 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • The proportion of scheduled visits that were completed during the 6-month observation period [ Time Frame: 6 months ]
  • Medication possession ratio (MPR), continuous scale [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care
Official Title  ICMJE Pilot Study of a Multi-Pronged Intervention Using Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care Among Adults Living With HIV in Tanzania
Brief Summary Interventions incorporating constructs from behavioral economics and psychology have the potential to enhance HIV 'treatment as prevention' (TasP) strategies. To test this hypothesis, the investigators evaluated a combination intervention to improve antiretroviral therapy (ART) adherence based on the concepts of social norms and priming.
Detailed Description The investigators conducted a quasi-experimental pilot study of a combination behavioral intervention based on the concepts of social norms and priming. The intervention included visual feedback about clinic-level retention in care, a self-relevant prime, and useful take-home items with the priming image. The intervention was developed using tools from marketing research and patient-centered design. The hypothesis was that the intervention would improve retention in care and adherence to ART among patients living with HIV infection (PLHIV). The intervention was implemented at two HIV primary clinics in Shinyanga, Tanzania in 2-week intervals for six months. The investigators reviewed medical records of a random sample of exposed and unexposed adult PLHIV to compare retention and the proportion of patients with medication possession ratio (MPR) ≥95% after six months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • HIV Infection
  • Adherence
Intervention  ICMJE Behavioral: Intervention
The intervention includes a clinic-based component and a take-home component. All components include the priming image of a Baobab tree. The clinic-based component is an interactive poster that rewarded appointment attendance. Patients who attend three consecutive on-time visits are congratulated and given a colored sticker to place on a poster that is publicly displayed at the clinic. In one clinic, the take-home component is a 2015 calendar in Kiswahili that contained the priming Baobab image. In the other clinic, the take-home component is a small plastic pillbox featuring the Baobab logo.
Study Arms  ICMJE
  • No Intervention: Standard of Care
    Standard HIV primary care services available at HIV care and treatment clinics in Tanzania.
  • Experimental: Behavioral Intervention Using Social Norms and Priming
    Patients in this arm may have been exposed to the behavioral intervention, which included the following components: 1) visual feedback about clinic-level retention in care through an interactive poster; 2) a self-relevant priming image that appeared on all components; and 3) a take-home item (i.e., pillbox or calendar) with the priming image.
    Intervention: Behavioral: Intervention
Publications * McCoy SI, Fahey C, Rao A, Kapologwe N, Njau PF, Bautista-Arredondo S. Pilot study of a multi-pronged intervention using social norms and priming to improve adherence to antiretroviral therapy and retention in care among adults living with HIV in Tanzania. PLoS One. 2017 May 9;12(5):e0177394. doi: 10.1371/journal.pone.0177394. eCollection 2017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2016)
438
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. At least 18 years of age
  2. Living with HIV infection
  3. Receiving HIV primary care at one of the two study clinics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02938533
Other Study ID Numbers  ICMJE OPP1118511
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Berkeley
Study Sponsor  ICMJE University of California, Berkeley
Collaborators  ICMJE
  • Ministry of Health, Tanzania
  • Mexican National Institute of Public Health
Investigators  ICMJE
Principal Investigator: Sandra I McCoy, PhD University of California, Berkeley
PRS Account University of California, Berkeley
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP