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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

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.

Condition or disease Intervention/treatment Phase
HIV Infection Adherence Behavioral: Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : August 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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

  2. >=95% medication possession ratio (MPR) [ Time Frame: 6 months ]
    MPR is a measure of ART adherence that is correlated with viral suppression


Secondary Outcome Measures :
  1. The proportion of scheduled visits that were completed during the 6-month observation period [ Time Frame: 6 months ]
  2. Medication possession ratio (MPR), continuous scale [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938533


Locations
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Tanzania
Bugsi Dispensary
Kahama, Shinyanga, Tanzania
Tinde Health Center
Shinyanga, Tanzania
Sponsors and Collaborators
University of California, Berkeley
Ministry of Health, Tanzania
Mexican National Institute of Public Health
Investigators
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Principal Investigator: Sandra I McCoy, PhD University of California, Berkeley

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Berkeley
ClinicalTrials.gov Identifier: NCT02938533     History of Changes
Other Study ID Numbers: OPP1118511
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents