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

Primary Purpose

HIV Infection, Adherence

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Intervention
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bugsi Dispensary
  • Tinde Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Behavioral Intervention Using Social Norms and Priming

Arm Description

Standard HIV primary care services available at HIV care and treatment clinics in Tanzania.

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.

Outcomes

Primary Outcome Measures

Retention in care, defined as an attended visit between 150-210 days after the baseline visit
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)
MPR is a measure of ART adherence that is correlated with viral suppression

Secondary Outcome Measures

The proportion of scheduled visits that were completed during the 6-month observation period
Medication possession ratio (MPR), continuous scale

Full Information

First Posted
October 11, 2016
Last Updated
October 26, 2017
Sponsor
University of California, Berkeley
Collaborators
Ministry of Health, Tanzania, Mexican National Institute of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT02938533
Brief Title
Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care
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 Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley
Collaborators
Ministry of Health, Tanzania, Mexican National Institute of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard HIV primary care services available at HIV care and treatment clinics in Tanzania.
Arm Title
Behavioral Intervention Using Social Norms and Priming
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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 Measure Information:
Title
Retention in care, defined as an attended visit between 150-210 days after the baseline visit
Description
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
Time Frame
6 months
Title
>=95% medication possession ratio (MPR)
Description
MPR is a measure of ART adherence that is correlated with viral suppression
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The proportion of scheduled visits that were completed during the 6-month observation period
Time Frame
6 months
Title
Medication possession ratio (MPR), continuous scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Living with HIV infection Receiving HIV primary care at one of the two study clinics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra I McCoy, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bugsi Dispensary
City
Kahama
State/Province
Shinyanga
Country
Tanzania
Facility Name
Tinde Health Center
City
Shinyanga
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
28486553
Citation
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.
Results Reference
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Social Norms and Priming to Improve Adherence to Antiretroviral Therapy and Retention in Care

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